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Proclivity ID
18811001
Unpublish
Citation Name
OBG Manag
Specialty Focus
Obstetrics
Gynecology
Surgery
Negative Keywords
gaming
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
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Fibroids: Growing management options for a prevalent problem

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OBG Manag. 33(12). | doi 10.12788/obgm.0169

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COMMENT & CONTROVERSY

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HOW TO CHOOSE THE RIGHT VAGINAL MOISTURIZER OR LUBRICANT FOR YOUR PATIENT

JOHN PENNYCUFF, MD, MSPH, AND CHERYL IGLESIA, MD (JUNE 2021)

    Which vaginal products to recommend

    We applaud Drs. Pennycuff and Iglesia for providing education on lubricants and vaginal moisturizers in their recent article, and agree that ObGyns, urogynecologists, and primary care providers should be aware of the types of products available. However, the authors underplayed the health risks associated with the use of poor-quality lubricants and moisturizers.

    Women often turn to lubricants or vaginal moisturizers because they experience vaginal dryness during intercourse, related to menopause, and from certain medications. Vaginal fluid is primarily composed of exudate from capillaries in the vaginal wall. During sexual arousal, blood flow to the vaginal wall increases, and in turn, this should increase exudate. But chronic inflammation can suppress these increases in vaginal blood flow, preventing adequate vaginal fluid production. One such cause of chronic inflammation is using hyperosmolar lubricants, as this has been shown to negatively affect the vaginal epithelium.1,2 In this way, use of hyperosmolar lubricants can actually worsen symptoms, creating a vicious circle of dryness, lubricant use, and worsening dryness.

    In addition, hyperosmolar lubricants have been shown to reduce the epithelial barrier properties of the vaginal epithelium, increasing susceptibility to microbes associated with bacterial vaginosis and to true pathogens, including herpes simplex virus type 2.3 In fact, hyperosmolar lubricants are a serious enough problem that the World Health Organization has weighed in, recommending osmolality of personal lubricants be under 380 mOsm/kg to prevent damage to the vaginal epithelium.4

    Appropriately acidic pH is just as critical as osmolality. Using products with a pH higher than 4.5 will reduce amounts of protective lactobacilli and other commensal vaginal bacteria, encouraging growth of opportunistic bacteria and yeast already present. This can lead to bacterial vaginosis, aerobic vaginitis, and candidiasis. Bacterial vaginosis can lead to other serious sequelae such as increased risk in acquisition of HIV infection and preterm birth in pregnancy. Unfortunately, much of the data cited in Drs. Pennycuff and Iglesia’s article were sourced from another study (by Edwards and Panay published in Climacteric in 2016), which measured product pH values with an inappropriately calibrated device; the study’s supplemental information stated that calibration was between 5 and 9, and so any measurement below 5 was invalid and subject to error. For example, the Good Clean Love lubricant is listed as having a pH of 4.7, but its pH is never higher than 4.4.

    The products on the market that meet the dual criteria of appropriate pH and isotonicity to vaginal epithelial cells may be less well known to consumers. But this should not be a reason to encourage use of hyperosmolar products whose main selling point is that they are the “leading brand.” Educating women on their choices in personal lubricants should include a full discussion of product ingredients and properties, based upon the available literature to help them select a product that supports the health of their intimate tissues.

    Members of the Scientific Advisory Board for the Sexual Health and Wellness Institute: Jill Krapf, MD, MEd, IF; Cathy Chung Hwa Yi, MD; Christine Enzmann, MD, PhD, NMCP; Susan Kellogg-Spadt, PhD, CRNP, IF, CSC, FCST; Betsy Greenleaf, DO, MBA; Elizabeth DuPriest, PhD

    References

    1. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7:e48328. doi: 10.1371/journal .pone.0048328.
    2. Ayehunie S, Wang YY, Landry T, et al. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a threedimensional vaginal epithelium model. Toxicol Rep. 2017;5:134-140. doi: 10.1016 /j.toxrep.2017.12.011.
    3. Moench TR, Mumper RJ, Hoen TE, et al. Microbicide excipients can greatly increase susceptibility to genital herpes transmission in the mouse. BMC Infect Dis.  2010;10:331. doi: 10.1186/1471 -2334-10-331.
    4. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA /FHI360 Advisory note. World Health Organization, 2012. http://apps.who.int/iris/bitstream /handle/10665/76580/WHO_RHR_12.33_eng .pdf?sequence=1. Accessed December 27, 2021.
    Drs. Pennycuff And Iglesia Respond

    We thank the members of the scientific advisory board for the Sexual Health and Wellness Institute for their thoughtful and insightful comments to our article. We agree with their comments on the importance of both pH and osmolality for vaginal moisturizers and lubricants. We also agree that selection of an incorrectly formulated product may lead to worsening of vulvovaginal symptoms as well as dysbiosis and all of its sequelae as the letter writers mentioned.

    In writing the review article, we attempted to address the role that pH and osmolality play in vaginal moisturizers and lubricants and make clinicians more aware of the importance of these factors in product formulation. Our goal was to help to improve patient counseling. We tried to amass as much of the available literature as we could to act as a resource for practitioners, such as the table included in the article as well as the supplemental table included online. We hoped that by writing this article we would heighten awareness among female health practitioners about vaginal health products and encourage them to consider those products that may be better suited for their patients based on pH and osmolality.

    While there remains a paucity of research on vaginal moisturizers and lubricants, there is even less consumer knowledge regarding ingredients and formulations of these products. We wholeheartedly agree with the scientific advisory board that we as health providers need to help educate women on the full spectrum of products available beyond the “leading brands.” Furthermore, we advocate that there be continued research on these products as well as more manufacturer transparency regarding not only the ingredients contained within these products but also the pH and osmolality. Simple steps such as these would ensure that providers could help counsel patients to make informed decisions regarding products for their pelvic health.

      Continue to: DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES...

       

       

      DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES

      CASSANDRA CARBERRY, MD, MS; ANNETTA MADSEN, MD; OLIVIA CARDENAS-TROWERS, MD; OLUWATENIOLA BROWN, MD; MOIURI SIDDIQUE, MD; AND BLAIR WASHINGTON, MD, MHA (AUGUST 2021)

      Dissenting opinion

      “Race is real but it’s not biologic.” “Race is not based on genetic or biologic inheritance.” Am I the only one with a dissenting voice of opinion when it comes to these types of statements?

      Scott Peters, MD

      Oak Ridge, Tennessee

      The Authors Respond

      Thank you for your opinion, Dr. Peters. Although it is not completely clear what your question is, it seems that it concerns the validity of the idea that race is a social construct. We will address this question with the assumption that this letter was an effort to invite discussion and increase understanding.

      The National Human Genome Research Institute describes race in this way: “Race is a fluid concept used to group people according to various factors, including ancestral background and social identity. Race is also used to group people that share a set of visible characteristics, such as skin color and facial features. Though these visible traits are influenced by genes, the vast majority of genetic variation exists within racial groups and not between them.”1

      The understanding that race is a social construct has been upheld by numerous medical organizations. In August 2020, a Joint Statement was published by the American College of Obstetricians and Gynecologists, the American Board of Obstetricians and Gynecologists, and 22 other organizations representing our specialty.  This document states: “Recognizing that race is a social construct, not biologically based, is important to understanding that racism, not race, impacts health care, health, and health outcomes.”2

      This idea is also endorsed by the AMA, who in November 2020 adopted the following policies3:

      • “Recognize that race is a social construct and is distinct from ethnicity, genetic ancestry, or biology
      • Support ending the practice of using race as a proxy for biology or genetics in medical education, research, and clinical practice.”

      There are numerous sources that further illuminate why race is a social construct. Here are a few:

      • https://www.racepowerofanillusion .org/resources/
      • https ://www.pewresearch.org /fact-tank/2020/02/25/the-changing -categories-the-u-s-has-used-to -measure-race/
      • Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press. 2011.
      • Yudell M, Roberts D, DeSalle R, et al. Science and society. Taking race out of human genetics. Science. 2016;351(6273):564-5. doi: 10.1126/science.aac4951.

      References 

      1. National Human Genome Research Institute. Race. https://www.genome.gov/genetic-glossary /Race. Accessed December 27, 2021.
      2. The American College of Obstetricians and Gynecologists. Joint Statement: Collective Action Addressing Racism. https://www.acog.org /news/news-articles/2020/08/joint-statementobstetrics-and-gynecology-collective-actionaddressing-racism.
      3. O’Reilly KB. AMA: Racism is a threat to public health. November 16, 2020. https://www.ama -assn.org/delivering-care/health-equity/ama -racism-threat-public-health. Accessed December 27, 2021.
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      HOW TO CHOOSE THE RIGHT VAGINAL MOISTURIZER OR LUBRICANT FOR YOUR PATIENT

      JOHN PENNYCUFF, MD, MSPH, AND CHERYL IGLESIA, MD (JUNE 2021)

        Which vaginal products to recommend

        We applaud Drs. Pennycuff and Iglesia for providing education on lubricants and vaginal moisturizers in their recent article, and agree that ObGyns, urogynecologists, and primary care providers should be aware of the types of products available. However, the authors underplayed the health risks associated with the use of poor-quality lubricants and moisturizers.

        Women often turn to lubricants or vaginal moisturizers because they experience vaginal dryness during intercourse, related to menopause, and from certain medications. Vaginal fluid is primarily composed of exudate from capillaries in the vaginal wall. During sexual arousal, blood flow to the vaginal wall increases, and in turn, this should increase exudate. But chronic inflammation can suppress these increases in vaginal blood flow, preventing adequate vaginal fluid production. One such cause of chronic inflammation is using hyperosmolar lubricants, as this has been shown to negatively affect the vaginal epithelium.1,2 In this way, use of hyperosmolar lubricants can actually worsen symptoms, creating a vicious circle of dryness, lubricant use, and worsening dryness.

        In addition, hyperosmolar lubricants have been shown to reduce the epithelial barrier properties of the vaginal epithelium, increasing susceptibility to microbes associated with bacterial vaginosis and to true pathogens, including herpes simplex virus type 2.3 In fact, hyperosmolar lubricants are a serious enough problem that the World Health Organization has weighed in, recommending osmolality of personal lubricants be under 380 mOsm/kg to prevent damage to the vaginal epithelium.4

        Appropriately acidic pH is just as critical as osmolality. Using products with a pH higher than 4.5 will reduce amounts of protective lactobacilli and other commensal vaginal bacteria, encouraging growth of opportunistic bacteria and yeast already present. This can lead to bacterial vaginosis, aerobic vaginitis, and candidiasis. Bacterial vaginosis can lead to other serious sequelae such as increased risk in acquisition of HIV infection and preterm birth in pregnancy. Unfortunately, much of the data cited in Drs. Pennycuff and Iglesia’s article were sourced from another study (by Edwards and Panay published in Climacteric in 2016), which measured product pH values with an inappropriately calibrated device; the study’s supplemental information stated that calibration was between 5 and 9, and so any measurement below 5 was invalid and subject to error. For example, the Good Clean Love lubricant is listed as having a pH of 4.7, but its pH is never higher than 4.4.

        The products on the market that meet the dual criteria of appropriate pH and isotonicity to vaginal epithelial cells may be less well known to consumers. But this should not be a reason to encourage use of hyperosmolar products whose main selling point is that they are the “leading brand.” Educating women on their choices in personal lubricants should include a full discussion of product ingredients and properties, based upon the available literature to help them select a product that supports the health of their intimate tissues.

        Members of the Scientific Advisory Board for the Sexual Health and Wellness Institute: Jill Krapf, MD, MEd, IF; Cathy Chung Hwa Yi, MD; Christine Enzmann, MD, PhD, NMCP; Susan Kellogg-Spadt, PhD, CRNP, IF, CSC, FCST; Betsy Greenleaf, DO, MBA; Elizabeth DuPriest, PhD

        References

        1. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7:e48328. doi: 10.1371/journal .pone.0048328.
        2. Ayehunie S, Wang YY, Landry T, et al. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a threedimensional vaginal epithelium model. Toxicol Rep. 2017;5:134-140. doi: 10.1016 /j.toxrep.2017.12.011.
        3. Moench TR, Mumper RJ, Hoen TE, et al. Microbicide excipients can greatly increase susceptibility to genital herpes transmission in the mouse. BMC Infect Dis.  2010;10:331. doi: 10.1186/1471 -2334-10-331.
        4. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA /FHI360 Advisory note. World Health Organization, 2012. http://apps.who.int/iris/bitstream /handle/10665/76580/WHO_RHR_12.33_eng .pdf?sequence=1. Accessed December 27, 2021.
        Drs. Pennycuff And Iglesia Respond

        We thank the members of the scientific advisory board for the Sexual Health and Wellness Institute for their thoughtful and insightful comments to our article. We agree with their comments on the importance of both pH and osmolality for vaginal moisturizers and lubricants. We also agree that selection of an incorrectly formulated product may lead to worsening of vulvovaginal symptoms as well as dysbiosis and all of its sequelae as the letter writers mentioned.

        In writing the review article, we attempted to address the role that pH and osmolality play in vaginal moisturizers and lubricants and make clinicians more aware of the importance of these factors in product formulation. Our goal was to help to improve patient counseling. We tried to amass as much of the available literature as we could to act as a resource for practitioners, such as the table included in the article as well as the supplemental table included online. We hoped that by writing this article we would heighten awareness among female health practitioners about vaginal health products and encourage them to consider those products that may be better suited for their patients based on pH and osmolality.

        While there remains a paucity of research on vaginal moisturizers and lubricants, there is even less consumer knowledge regarding ingredients and formulations of these products. We wholeheartedly agree with the scientific advisory board that we as health providers need to help educate women on the full spectrum of products available beyond the “leading brands.” Furthermore, we advocate that there be continued research on these products as well as more manufacturer transparency regarding not only the ingredients contained within these products but also the pH and osmolality. Simple steps such as these would ensure that providers could help counsel patients to make informed decisions regarding products for their pelvic health.

          Continue to: DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES...

           

           

          DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES

          CASSANDRA CARBERRY, MD, MS; ANNETTA MADSEN, MD; OLIVIA CARDENAS-TROWERS, MD; OLUWATENIOLA BROWN, MD; MOIURI SIDDIQUE, MD; AND BLAIR WASHINGTON, MD, MHA (AUGUST 2021)

          Dissenting opinion

          “Race is real but it’s not biologic.” “Race is not based on genetic or biologic inheritance.” Am I the only one with a dissenting voice of opinion when it comes to these types of statements?

          Scott Peters, MD

          Oak Ridge, Tennessee

          The Authors Respond

          Thank you for your opinion, Dr. Peters. Although it is not completely clear what your question is, it seems that it concerns the validity of the idea that race is a social construct. We will address this question with the assumption that this letter was an effort to invite discussion and increase understanding.

          The National Human Genome Research Institute describes race in this way: “Race is a fluid concept used to group people according to various factors, including ancestral background and social identity. Race is also used to group people that share a set of visible characteristics, such as skin color and facial features. Though these visible traits are influenced by genes, the vast majority of genetic variation exists within racial groups and not between them.”1

          The understanding that race is a social construct has been upheld by numerous medical organizations. In August 2020, a Joint Statement was published by the American College of Obstetricians and Gynecologists, the American Board of Obstetricians and Gynecologists, and 22 other organizations representing our specialty.  This document states: “Recognizing that race is a social construct, not biologically based, is important to understanding that racism, not race, impacts health care, health, and health outcomes.”2

          This idea is also endorsed by the AMA, who in November 2020 adopted the following policies3:

          • “Recognize that race is a social construct and is distinct from ethnicity, genetic ancestry, or biology
          • Support ending the practice of using race as a proxy for biology or genetics in medical education, research, and clinical practice.”

          There are numerous sources that further illuminate why race is a social construct. Here are a few:

          • https://www.racepowerofanillusion .org/resources/
          • https ://www.pewresearch.org /fact-tank/2020/02/25/the-changing -categories-the-u-s-has-used-to -measure-race/
          • Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press. 2011.
          • Yudell M, Roberts D, DeSalle R, et al. Science and society. Taking race out of human genetics. Science. 2016;351(6273):564-5. doi: 10.1126/science.aac4951.

          References 

          1. National Human Genome Research Institute. Race. https://www.genome.gov/genetic-glossary /Race. Accessed December 27, 2021.
          2. The American College of Obstetricians and Gynecologists. Joint Statement: Collective Action Addressing Racism. https://www.acog.org /news/news-articles/2020/08/joint-statementobstetrics-and-gynecology-collective-actionaddressing-racism.
          3. O’Reilly KB. AMA: Racism is a threat to public health. November 16, 2020. https://www.ama -assn.org/delivering-care/health-equity/ama -racism-threat-public-health. Accessed December 27, 2021.

           

          HOW TO CHOOSE THE RIGHT VAGINAL MOISTURIZER OR LUBRICANT FOR YOUR PATIENT

          JOHN PENNYCUFF, MD, MSPH, AND CHERYL IGLESIA, MD (JUNE 2021)

            Which vaginal products to recommend

            We applaud Drs. Pennycuff and Iglesia for providing education on lubricants and vaginal moisturizers in their recent article, and agree that ObGyns, urogynecologists, and primary care providers should be aware of the types of products available. However, the authors underplayed the health risks associated with the use of poor-quality lubricants and moisturizers.

            Women often turn to lubricants or vaginal moisturizers because they experience vaginal dryness during intercourse, related to menopause, and from certain medications. Vaginal fluid is primarily composed of exudate from capillaries in the vaginal wall. During sexual arousal, blood flow to the vaginal wall increases, and in turn, this should increase exudate. But chronic inflammation can suppress these increases in vaginal blood flow, preventing adequate vaginal fluid production. One such cause of chronic inflammation is using hyperosmolar lubricants, as this has been shown to negatively affect the vaginal epithelium.1,2 In this way, use of hyperosmolar lubricants can actually worsen symptoms, creating a vicious circle of dryness, lubricant use, and worsening dryness.

            In addition, hyperosmolar lubricants have been shown to reduce the epithelial barrier properties of the vaginal epithelium, increasing susceptibility to microbes associated with bacterial vaginosis and to true pathogens, including herpes simplex virus type 2.3 In fact, hyperosmolar lubricants are a serious enough problem that the World Health Organization has weighed in, recommending osmolality of personal lubricants be under 380 mOsm/kg to prevent damage to the vaginal epithelium.4

            Appropriately acidic pH is just as critical as osmolality. Using products with a pH higher than 4.5 will reduce amounts of protective lactobacilli and other commensal vaginal bacteria, encouraging growth of opportunistic bacteria and yeast already present. This can lead to bacterial vaginosis, aerobic vaginitis, and candidiasis. Bacterial vaginosis can lead to other serious sequelae such as increased risk in acquisition of HIV infection and preterm birth in pregnancy. Unfortunately, much of the data cited in Drs. Pennycuff and Iglesia’s article were sourced from another study (by Edwards and Panay published in Climacteric in 2016), which measured product pH values with an inappropriately calibrated device; the study’s supplemental information stated that calibration was between 5 and 9, and so any measurement below 5 was invalid and subject to error. For example, the Good Clean Love lubricant is listed as having a pH of 4.7, but its pH is never higher than 4.4.

            The products on the market that meet the dual criteria of appropriate pH and isotonicity to vaginal epithelial cells may be less well known to consumers. But this should not be a reason to encourage use of hyperosmolar products whose main selling point is that they are the “leading brand.” Educating women on their choices in personal lubricants should include a full discussion of product ingredients and properties, based upon the available literature to help them select a product that supports the health of their intimate tissues.

            Members of the Scientific Advisory Board for the Sexual Health and Wellness Institute: Jill Krapf, MD, MEd, IF; Cathy Chung Hwa Yi, MD; Christine Enzmann, MD, PhD, NMCP; Susan Kellogg-Spadt, PhD, CRNP, IF, CSC, FCST; Betsy Greenleaf, DO, MBA; Elizabeth DuPriest, PhD

            References

            1. Dezzutti CS, Brown ER, Moncla B, et al. Is wetter better? An evaluation of over-the-counter personal lubricants for safety and anti-HIV-1 activity. PLoS One. 2012;7:e48328. doi: 10.1371/journal .pone.0048328.
            2. Ayehunie S, Wang YY, Landry T, et al. Hyperosmolal vaginal lubricants markedly reduce epithelial barrier properties in a threedimensional vaginal epithelium model. Toxicol Rep. 2017;5:134-140. doi: 10.1016 /j.toxrep.2017.12.011.
            3. Moench TR, Mumper RJ, Hoen TE, et al. Microbicide excipients can greatly increase susceptibility to genital herpes transmission in the mouse. BMC Infect Dis.  2010;10:331. doi: 10.1186/1471 -2334-10-331.
            4. Use and procurement of additional lubricants for male and female condoms: WHO/UNFPA /FHI360 Advisory note. World Health Organization, 2012. http://apps.who.int/iris/bitstream /handle/10665/76580/WHO_RHR_12.33_eng .pdf?sequence=1. Accessed December 27, 2021.
            Drs. Pennycuff And Iglesia Respond

            We thank the members of the scientific advisory board for the Sexual Health and Wellness Institute for their thoughtful and insightful comments to our article. We agree with their comments on the importance of both pH and osmolality for vaginal moisturizers and lubricants. We also agree that selection of an incorrectly formulated product may lead to worsening of vulvovaginal symptoms as well as dysbiosis and all of its sequelae as the letter writers mentioned.

            In writing the review article, we attempted to address the role that pH and osmolality play in vaginal moisturizers and lubricants and make clinicians more aware of the importance of these factors in product formulation. Our goal was to help to improve patient counseling. We tried to amass as much of the available literature as we could to act as a resource for practitioners, such as the table included in the article as well as the supplemental table included online. We hoped that by writing this article we would heighten awareness among female health practitioners about vaginal health products and encourage them to consider those products that may be better suited for their patients based on pH and osmolality.

            While there remains a paucity of research on vaginal moisturizers and lubricants, there is even less consumer knowledge regarding ingredients and formulations of these products. We wholeheartedly agree with the scientific advisory board that we as health providers need to help educate women on the full spectrum of products available beyond the “leading brands.” Furthermore, we advocate that there be continued research on these products as well as more manufacturer transparency regarding not only the ingredients contained within these products but also the pH and osmolality. Simple steps such as these would ensure that providers could help counsel patients to make informed decisions regarding products for their pelvic health.

              Continue to: DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES...

               

               

              DISMANTLING RACISM IN YOUR PERSONAL AND PROFESSIONAL SPHERES

              CASSANDRA CARBERRY, MD, MS; ANNETTA MADSEN, MD; OLIVIA CARDENAS-TROWERS, MD; OLUWATENIOLA BROWN, MD; MOIURI SIDDIQUE, MD; AND BLAIR WASHINGTON, MD, MHA (AUGUST 2021)

              Dissenting opinion

              “Race is real but it’s not biologic.” “Race is not based on genetic or biologic inheritance.” Am I the only one with a dissenting voice of opinion when it comes to these types of statements?

              Scott Peters, MD

              Oak Ridge, Tennessee

              The Authors Respond

              Thank you for your opinion, Dr. Peters. Although it is not completely clear what your question is, it seems that it concerns the validity of the idea that race is a social construct. We will address this question with the assumption that this letter was an effort to invite discussion and increase understanding.

              The National Human Genome Research Institute describes race in this way: “Race is a fluid concept used to group people according to various factors, including ancestral background and social identity. Race is also used to group people that share a set of visible characteristics, such as skin color and facial features. Though these visible traits are influenced by genes, the vast majority of genetic variation exists within racial groups and not between them.”1

              The understanding that race is a social construct has been upheld by numerous medical organizations. In August 2020, a Joint Statement was published by the American College of Obstetricians and Gynecologists, the American Board of Obstetricians and Gynecologists, and 22 other organizations representing our specialty.  This document states: “Recognizing that race is a social construct, not biologically based, is important to understanding that racism, not race, impacts health care, health, and health outcomes.”2

              This idea is also endorsed by the AMA, who in November 2020 adopted the following policies3:

              • “Recognize that race is a social construct and is distinct from ethnicity, genetic ancestry, or biology
              • Support ending the practice of using race as a proxy for biology or genetics in medical education, research, and clinical practice.”

              There are numerous sources that further illuminate why race is a social construct. Here are a few:

              • https://www.racepowerofanillusion .org/resources/
              • https ://www.pewresearch.org /fact-tank/2020/02/25/the-changing -categories-the-u-s-has-used-to -measure-race/
              • Roberts D. Fatal Invention: How Science, Politics and Big Business Re-create Race in the Twenty-First Century. The New Press. 2011.
              • Yudell M, Roberts D, DeSalle R, et al. Science and society. Taking race out of human genetics. Science. 2016;351(6273):564-5. doi: 10.1126/science.aac4951.

              References 

              1. National Human Genome Research Institute. Race. https://www.genome.gov/genetic-glossary /Race. Accessed December 27, 2021.
              2. The American College of Obstetricians and Gynecologists. Joint Statement: Collective Action Addressing Racism. https://www.acog.org /news/news-articles/2020/08/joint-statementobstetrics-and-gynecology-collective-actionaddressing-racism.
              3. O’Reilly KB. AMA: Racism is a threat to public health. November 16, 2020. https://www.ama -assn.org/delivering-care/health-equity/ama -racism-threat-public-health. Accessed December 27, 2021.
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              2022 Update on obstetrics

              Article Type
              Changed
              Wed, 01/26/2022 - 13:04

              Obstetrical practice saw updates in 2021 to 3 major areas of pregnancy management: preterm birth prevention, antepartum fetal surveillance, and the use of antenatal corticosteroids.

              Updated guidance on predicting and preventing spontaneous PTB

              American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138:e65-e90.

              Preterm birth (PTB) continues to pose a challenge in clinical obstetrics, with the most recently reported rate of 10.2% in the United States.1 This accounts for almost 75% of perinatal mortality and more than half of neonatal morbidity, in which effects last well past the neonatal period. PTB is classified as spontaneous (following preterm labor, preterm prelabor rupture of membranes, or cervical insufficiency) or iatrogenic (indicated due to maternal and/or fetal complications).

              Assessing risk for PTB

              The single strongest predictor of subsequent PTB is a history of spontaneous PTB. Recurrence risk is further increased by the number of prior PTBs and the gestational age at prior PTB. Identification of and intervention for a short cervix has been shown to prolong gestation. Transvaginal ultrasonography of the cervix is the most accurate method for evaluating cervical length (CL). Specific examination criteria exist to ensure that CL measurements are reproducible and reliable.2 A short CL is generally defined as a measurement of less than 25 mm between 16 and 24 weeks’ gestation.

              Screening strategies

              The American College of Obstetricians and Gynecologists (ACOG), with an endorsement from the Society for Maternal-Fetal Medicine (SMFM), recommends cervical evaluation during the anatomy ultrasound exam between 18 0/7 and 22 6/7 weeks’ gestation in all pregnant patients regardless of prior PTB.3 If transabdominal imaging is concerning for a shortened cervix, transvaginal ultrasonography should be performed to assess the CL.

              Serial transvaginal CL measurements are recommended between 16 0/7 and 24 0/7 weeks’ gestation for patients with a current singleton pregnancy and history of a spontaneous PTB, but not for patients with a history of iatrogenic or indicated PTB.

              Interventions: Mind your p’s and c’s

              Interventions to reduce the risk of spontaneous PTB depend on whether the current pregnancy is a singleton, twins, or higher-order multiples; CL measurement; and history of spontaneous PTB. Preconception optimization of underlying medical conditions also is important to reduce the risk of recurrent indicated PTB.

              Continue to: Progesterone...

               

               

              Progesterone

              Vaginal administration. Several trials have shown that vaginal progesterone can be used to reduce the risk of spontaneous PTB in asymptomatic patients with a singleton pregnancy, incidental finding of a short cervix (<25 mm), and no history of spontaneous PTB. This is a change from the prior recommendation of CL of less than 20 mm. In the setting of a twin pregnancy, regardless of CL, data do not definitively support the use of vaginal progesterone.

              Intramuscular administration.4,5 The popularity of intramuscular progesterone has waxed and waned. At present, ACOG recommends that all patients with a singleton pregnancy and history of spontaneous PTB be offered progesterone beginning at 16 0/7 weeks’ gestation following a shared decision-making process that includes the limited data of efficacy noted in existing studies.

              In a twin pregnancy with no history of spontaneous PTB, the use of intramuscular progesterone has been shown to potentially increase the risk of PTB and admission to the neonatal intensive care unit. As such, intramuscular progesterone in the setting of a twin gestation without a history of spontaneous PTB is not recommended. When a prior spontaneous PTB has occurred, there may be some benefit to intramuscular progesterone in twin gestations.

              Cerclage

              Ultrasound indicated. In a singleton pregnancy with an incidental finding of short cervix (<25 mm) and no history of PTB, the use of cerclage is of uncertain benefit. Effectiveness may be seen if the cervix is less than 10 mm. Ultrasound-indicated cerclage should be considered in a singleton pregnancy with a CL less than 25 mm and a history of spontaneous PTB.

              Possibly one of the most controversial topics is ultrasound-indicated cerclage placement in twin gestation. As with many situations in obstetrics, data regarding ultrasound-indicated cerclage in twin gestation is based on small retrospective studies fraught with bias. Results from these studies range from no benefit, to potential benefit, to even possible increased risk of PTB. Since data are limited, as we await more evidence, it is recommended that the clinician and patient use shared decision making to decide on cerclage placement in a twin gestation.

              Exam indicated. In a singleton pregnancy with a dilated cervix on digital or speculum exam between 16 0/7 to 23 6/7 weeks’ gestation, a physical exam–indicated cerclage should be offered. Exam-indicated cerclage also may reduce the incidence of PTB in twin gestations with cervical dilation between 16 0/7 and 23 6/7 weeks’ gestation. Indomethacin tocolysis and perioperative antibiotics should be considered when an exam-indicated cerclage is placed.

              As the limits of viability are continually pushed earlier, more in-depth conversation is needed with patients who are considering an exam-indicated cerclage. The nuances of periviability and the likelihood that an exam-indicated cerclage will commit a pregnancy to a periviable or extremely preterm birth should be discussed in detail using a shared decision making model.

              Regardless of whether the cerclage is ultrasound or exam indicated, once it is placed there is no utility in additional CL ultrasound monitoring.

              Pessary

              Vaginal pessaries for prevention of PTB have not gained popularity in the United States as they have in other countries. Trials are being conducted to determine the utility of vaginal pessary, but current data have not proven its effectiveness in preventing PTB in the setting of singleton pregnancy, short cervix, and no history of spontaneous PTB. So for now, pessary is not recommended. The same can be said for use in the twin gestation.

               

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • All patients should have cervical evaluation during pregnancy. Serial imaging is reserved for those with a history of spontaneous PTB.
              • Progesterone supplementation should be offered to patients with a singleton pregnancy and a history of spontaneous PTB or to patients with a singleton pregnancy and no history of spontaneous PTB who have cervical shortening at less than 24 weeks.
              • Cerclage may be offered between 16 and 24 weeks for a cervical length less than 25 mm in a patient with a singleton gestation who has a history of spontaneous PTB (<10 mm if no history of spontaneous PTB) or for a dilated cervix on exam regardless of history.
              • Women who have a twin gestation with cervical dilation may be offered physical exam–indicated cerclage.

              Which patients may benefit from antepartum fetal surveillance and when to initiate it

              American College of Obstetricians and Gynecologists’ Committee on Obstetrics Practice, Society for Maternal-Fetal Medicine. Indications for outpatient antenatal surveillance: ACOG committee opinion, number 828. Obstet Gynecol. 2021;137:e177-e197.

              American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics. Antepartum fetal surveillance: ACOG practice bulletin, number 229. Obstet Gynecol. 2021;137:e116-e127.

              The ultimate purpose of antenatal fetal surveillance is to prevent stillbirth. However, stillbirth has multiple etiologies, not all of which are preventable with testing. In June 2021, ACOG released a new Committee Opinion containing guidelines for fetal surveillance, including suggested gestational age at initiation and frequency of testing, for the most common high-risk conditions. ACOG also released an update to the Practice Bulletin on antepartum fetal surveillance; additions include randomized controlled trial level data on the utility of fetal kick counts (FKCs) and recommendations that align with the new Committee Opinion.

              Data for the efficacy of antepartum fetal surveillance are lacking, mainly due to the difficulty of performing prospective studies in stillbirth. The existing evidence is subject to intervention bias, as deliveries increase in tested patients, and recommendations rely heavily on expert consensus and nonrandomized studies. Antenatal testing is also time, cost, and labor intensive, with the risk of intervention for a false-positive result. Despite these limitations, obstetrical practices routinely perform antenatal fetal surveillance.

              The new guidelines: The why, when, and how often

              Why. Antepartum fetal surveillance is suggested for conditions that have a risk of stillbirth greater than 0.8 per 1,000 (that is, the false-negative rate of a biophysical profile or a modified biophysical profile) and the relative risk or odds ratio is greater than 2.0 for stillbirth compared with unaffected pregnancies.

              When. For most conditions, ACOG recommends initiation of testing at 32 weeks or later, with notable earlier exceptions for some of the highest-risk patients. For certain conditions, such as fetal growth restriction and hypertensive disorders of pregnancy, the recommendation is to start “at diagnosis,” with the corollary “or at a gestational age when delivery would be considered because of abnormal results.” Shared decision making with the patient about pregnancy goals therefore is required, particularly in cases of fetal anomalies, genetic conditions, or at very early gestational ages.

              How often. The recommended frequency of testing is at least weekly. Testing frequency should be increased to twice-weekly outpatient or daily inpatient for the most complicated pregnancies (for example, fetal growth restriction with abnormal umbilical artery Doppler studies, preeclampsia with severe features).

              Once or twice weekly is an option for many conditions, which gives the clinician the opportunity to assess clinical stability as well as the patient’s input in terms of logistics and anxiety.

              Patients with multiple conditions may fall into the “individualized” category, as do patients with suboptimal control of conditions (for example, diabetes, hypertension) that may affect the fetus as the pregnancy progresses.

              New diagnoses included for surveillance

              Several diagnoses not previously included now qualify for antepartum fetal surveillance under the new guidelines, most notably:

              • history of obstetrical complications in the immediate preceding pregnancy

              —history of prior fetal growth restriction requiring preterm delivery

              —history of prior preeclampsia requiring delivery

              • alcohol use of 5 or more drinks per day
              • in vitro fertilization
              • abnormal serum markers

              —pregnancy-associated plasma protein A (PAPP-A) in the fifth or lower percentile or 0.4 multiples of the median (MoM)

              —second trimester inhibin A of 2 or greater MoM

              • prepregnancy body mass index (BMI)

              —this is divided into 2 categories for timing of initiation of testing:

              1.  37 weeks for BMI of 35 to 39.9 kg/m2
              2.  34 weeks for BMI of or greater than 40 kg/m2.

              Fetal kick counts

              The major change to the updated Practice Bulletin on antenatal surveillance is the inclusion of data on FKCs, a simple modality of fetal surveillance that does not require a clinical visit. For FKCs, a meta-analysis of more than 450,000 patients did not demonstrate a difference in perinatal death between the FKC intervention group (0.54%) and the control group (0.59%). Of note, there were small but statistically significant increases in the rates of induction of labor, cesarean delivery, and preterm delivery in the FKC intervention group. Therefore, this update does not recommend a formal program of FKCs for all patients.

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • The antenatal fetal surveillance guidelines are just that—guidelines, not mandates. Their use will need to be adapted for specific patient populations and practice management patterns.
              • Many conditions qualify for “individualized” surveillance, which offers the opportunity for detailed discussions on the patient’s care. This includes shared decision making with patients to meet their goals for the pregnancy.
              • Although patient-perceived decreased fetal movement always warrants clinical evaluation, a regular program of fetal kick count monitoring is not recommended for all patients due to lack of data supporting its benefit in reducing perinatal death.
              • As with any change, new guidelines potentially are a source of frustration, so a concerted effort by obstetrical clinicians to agree on adoption of the guidelines is needed. Additional clinical resources and both clinician and patient education may be required depending on current practice style, as the new strategy may increase the number of appointments and ultrasound exams required.

              Continue to: Use of antenatal corticosteroids now may be considered at 22 weeks’ gestation...

               

               

              Use of antenatal corticosteroids now may be considered at 22 weeks’ gestation

              American College of Obstetricians and Gynecologists. Use of antenatal corticosteroids at 22 weeks of gestation: ACOG practice advisory. September 2021. https://www .acog.org/clinical/clinical-guidance/practice-advisory /articles/2021/09/use-of-antenatal-corticosteroids-at -22-weeks-of-gestation. Accessed December 11, 2021.

              In September 2021, ACOG and SMFM released a Practice Advisory updating the current recommendations for the administration of antenatal corticosteroids in the periviable period (22 to 25 6/7 weeks’ gestation). Whereas the prior lower limit of gestational age for consideration of steroids was 23 weeks, the new recommendation now extends this consideration down to 22 weeks.

              The cited data include a meta-analysis of more than 2,200 patients in which the survival rate of infants born between 22 and 22 6/7 weeks who were exposed to antenatal steroids was 39% compared with 19.5% in the unexposed group. Another study of more than 1,000 patients demonstrated a statistically significant increase in overall survival in patients treated with antenatal steroids plus life support compared with life support only (38.5% vs 17.7%). Survival without major morbidity in this study, although increased from 1% to 4.4%, was still low.

              Recommendation carries caveats

              Given this information, the Practice Advisory offers a 2C level recommendation (weak recommendation, low quality of evidence) for antenatal steroids at 22 to 22 6/7 weeks’ gestation if neonatal resuscitation is planned, acknowledging the limitations and potential bias of the available data.

              The Practice Advisory emphasizes the importance of counseling and patient involvement in the decision making. This requires a multidisciplinary collaboration among the neonatology and obstetrical teams, flexibility in the plan after birth depending on the infant’s condition, and redirection of care if appropriate. Estimated fetal weight, the presence of multiple gestations, fetal biologic sex, and any anomalies are also important in helping families make an informed decision for their particular pregnancy. As described in the Obstetric Care Consensus on periviable birth,6 it is important to remember that considerations and recommendations are not the same as requirements, and redirection of care to comfort and family memory making is not the same as withholding care.

              The rest of the recommendations for the administration of antenatal steroids remain the same: Antenatal steroids are not recommended at less than 22 weeks due to lack of evidence of benefit, and they continue to be recommended at 24 weeks and beyond. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • Antenatal corticosteroids may be considered at 22 to 22 6/7 weeks’ gestation if, after thorough patient counseling, neonatal resuscitation is desired and planned by the family.
              • The overall likelihood of survival and survival without major morbidities continues to be very low in the periviable period, especially at 22 weeks. Gestational age is only one of the many factors that must be considered in the shared decision making for this very difficult decision.
              • Palliative care is a valid and appropriate option for patients facing a periviable delivery after appropriate counseling or after evaluation of the infant has occurred after birth.
              References
              1. Martin JA, Hamilton BE, Osterman MJK. Births in the United States, 2019. NCHS Data Brief, no 387. Hyattsville, MD: National Center for Health Statistics. October 2020. www.cdc.gov/nchs /data/databriefs/db387-H.pdf. Accessed December 20, 2021.
              2. To MS, Skentou C, Chan C, et al. Cervical assessment at the routine 23-week scan: standardizing techniques. Ultrasound Obstet Gynecol. 2001;17:217-219.
              3. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138:e65-e90.
              4. Society for Maternal-Fetal Medicine (SMFM) Publications Committee. SMFM statement: use of 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth. Am J Obstet Gynecol. 2020;223:B16-B18.
              5. Blackwell SC, Gyamfi-Bannerman C, Biggio JR Jr, et al. 17-OHPC to prevent recurrent preterm birth in singleton gestations (PROLONG study): a multicenter, international, randomized double-blind trial. Am J Perinatol. 2020;37:127-136.
              6. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric care consensus no. 6: Periviable birth. Obstet Gynecol. 2017;130:e187-e199.
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              Jaimie L. Maines, MD

              Dr. Maines is Attending Physician in Maternal-Fetal Medicine and Assistant Professor, Department of Obstetrics and Gynecology, Pennsylvania State College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania.

              Jaimey M. Pauli, MD

              Dr. Pauli is Associate Professor of Obstetrics and Gynecology and Chief, Division of Maternal-Fetal Medicine, Pennsylvania State College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania. She serves on the OBG Management Board of Editors.

              Dr. Pauli reports receiving grant or research support from Pfizer. Dr. Maines reports no financial relationships relevant to this article.

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              Dr. Maines is Attending Physician in Maternal-Fetal Medicine and Assistant Professor, Department of Obstetrics and Gynecology, Pennsylvania State College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania.

              Jaimey M. Pauli, MD

              Dr. Pauli is Associate Professor of Obstetrics and Gynecology and Chief, Division of Maternal-Fetal Medicine, Pennsylvania State College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania. She serves on the OBG Management Board of Editors.

              Dr. Pauli reports receiving grant or research support from Pfizer. Dr. Maines reports no financial relationships relevant to this article.

              Author and Disclosure Information

              Jaimie L. Maines, MD

              Dr. Maines is Attending Physician in Maternal-Fetal Medicine and Assistant Professor, Department of Obstetrics and Gynecology, Pennsylvania State College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania.

              Jaimey M. Pauli, MD

              Dr. Pauli is Associate Professor of Obstetrics and Gynecology and Chief, Division of Maternal-Fetal Medicine, Pennsylvania State College of Medicine, Milton S. Hershey Medical Center, Hershey, Pennsylvania. She serves on the OBG Management Board of Editors.

              Dr. Pauli reports receiving grant or research support from Pfizer. Dr. Maines reports no financial relationships relevant to this article.

              Article PDF
              Article PDF

              Obstetrical practice saw updates in 2021 to 3 major areas of pregnancy management: preterm birth prevention, antepartum fetal surveillance, and the use of antenatal corticosteroids.

              Updated guidance on predicting and preventing spontaneous PTB

              American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138:e65-e90.

              Preterm birth (PTB) continues to pose a challenge in clinical obstetrics, with the most recently reported rate of 10.2% in the United States.1 This accounts for almost 75% of perinatal mortality and more than half of neonatal morbidity, in which effects last well past the neonatal period. PTB is classified as spontaneous (following preterm labor, preterm prelabor rupture of membranes, or cervical insufficiency) or iatrogenic (indicated due to maternal and/or fetal complications).

              Assessing risk for PTB

              The single strongest predictor of subsequent PTB is a history of spontaneous PTB. Recurrence risk is further increased by the number of prior PTBs and the gestational age at prior PTB. Identification of and intervention for a short cervix has been shown to prolong gestation. Transvaginal ultrasonography of the cervix is the most accurate method for evaluating cervical length (CL). Specific examination criteria exist to ensure that CL measurements are reproducible and reliable.2 A short CL is generally defined as a measurement of less than 25 mm between 16 and 24 weeks’ gestation.

              Screening strategies

              The American College of Obstetricians and Gynecologists (ACOG), with an endorsement from the Society for Maternal-Fetal Medicine (SMFM), recommends cervical evaluation during the anatomy ultrasound exam between 18 0/7 and 22 6/7 weeks’ gestation in all pregnant patients regardless of prior PTB.3 If transabdominal imaging is concerning for a shortened cervix, transvaginal ultrasonography should be performed to assess the CL.

              Serial transvaginal CL measurements are recommended between 16 0/7 and 24 0/7 weeks’ gestation for patients with a current singleton pregnancy and history of a spontaneous PTB, but not for patients with a history of iatrogenic or indicated PTB.

              Interventions: Mind your p’s and c’s

              Interventions to reduce the risk of spontaneous PTB depend on whether the current pregnancy is a singleton, twins, or higher-order multiples; CL measurement; and history of spontaneous PTB. Preconception optimization of underlying medical conditions also is important to reduce the risk of recurrent indicated PTB.

              Continue to: Progesterone...

               

               

              Progesterone

              Vaginal administration. Several trials have shown that vaginal progesterone can be used to reduce the risk of spontaneous PTB in asymptomatic patients with a singleton pregnancy, incidental finding of a short cervix (<25 mm), and no history of spontaneous PTB. This is a change from the prior recommendation of CL of less than 20 mm. In the setting of a twin pregnancy, regardless of CL, data do not definitively support the use of vaginal progesterone.

              Intramuscular administration.4,5 The popularity of intramuscular progesterone has waxed and waned. At present, ACOG recommends that all patients with a singleton pregnancy and history of spontaneous PTB be offered progesterone beginning at 16 0/7 weeks’ gestation following a shared decision-making process that includes the limited data of efficacy noted in existing studies.

              In a twin pregnancy with no history of spontaneous PTB, the use of intramuscular progesterone has been shown to potentially increase the risk of PTB and admission to the neonatal intensive care unit. As such, intramuscular progesterone in the setting of a twin gestation without a history of spontaneous PTB is not recommended. When a prior spontaneous PTB has occurred, there may be some benefit to intramuscular progesterone in twin gestations.

              Cerclage

              Ultrasound indicated. In a singleton pregnancy with an incidental finding of short cervix (<25 mm) and no history of PTB, the use of cerclage is of uncertain benefit. Effectiveness may be seen if the cervix is less than 10 mm. Ultrasound-indicated cerclage should be considered in a singleton pregnancy with a CL less than 25 mm and a history of spontaneous PTB.

              Possibly one of the most controversial topics is ultrasound-indicated cerclage placement in twin gestation. As with many situations in obstetrics, data regarding ultrasound-indicated cerclage in twin gestation is based on small retrospective studies fraught with bias. Results from these studies range from no benefit, to potential benefit, to even possible increased risk of PTB. Since data are limited, as we await more evidence, it is recommended that the clinician and patient use shared decision making to decide on cerclage placement in a twin gestation.

              Exam indicated. In a singleton pregnancy with a dilated cervix on digital or speculum exam between 16 0/7 to 23 6/7 weeks’ gestation, a physical exam–indicated cerclage should be offered. Exam-indicated cerclage also may reduce the incidence of PTB in twin gestations with cervical dilation between 16 0/7 and 23 6/7 weeks’ gestation. Indomethacin tocolysis and perioperative antibiotics should be considered when an exam-indicated cerclage is placed.

              As the limits of viability are continually pushed earlier, more in-depth conversation is needed with patients who are considering an exam-indicated cerclage. The nuances of periviability and the likelihood that an exam-indicated cerclage will commit a pregnancy to a periviable or extremely preterm birth should be discussed in detail using a shared decision making model.

              Regardless of whether the cerclage is ultrasound or exam indicated, once it is placed there is no utility in additional CL ultrasound monitoring.

              Pessary

              Vaginal pessaries for prevention of PTB have not gained popularity in the United States as they have in other countries. Trials are being conducted to determine the utility of vaginal pessary, but current data have not proven its effectiveness in preventing PTB in the setting of singleton pregnancy, short cervix, and no history of spontaneous PTB. So for now, pessary is not recommended. The same can be said for use in the twin gestation.

               

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • All patients should have cervical evaluation during pregnancy. Serial imaging is reserved for those with a history of spontaneous PTB.
              • Progesterone supplementation should be offered to patients with a singleton pregnancy and a history of spontaneous PTB or to patients with a singleton pregnancy and no history of spontaneous PTB who have cervical shortening at less than 24 weeks.
              • Cerclage may be offered between 16 and 24 weeks for a cervical length less than 25 mm in a patient with a singleton gestation who has a history of spontaneous PTB (<10 mm if no history of spontaneous PTB) or for a dilated cervix on exam regardless of history.
              • Women who have a twin gestation with cervical dilation may be offered physical exam–indicated cerclage.

              Which patients may benefit from antepartum fetal surveillance and when to initiate it

              American College of Obstetricians and Gynecologists’ Committee on Obstetrics Practice, Society for Maternal-Fetal Medicine. Indications for outpatient antenatal surveillance: ACOG committee opinion, number 828. Obstet Gynecol. 2021;137:e177-e197.

              American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics. Antepartum fetal surveillance: ACOG practice bulletin, number 229. Obstet Gynecol. 2021;137:e116-e127.

              The ultimate purpose of antenatal fetal surveillance is to prevent stillbirth. However, stillbirth has multiple etiologies, not all of which are preventable with testing. In June 2021, ACOG released a new Committee Opinion containing guidelines for fetal surveillance, including suggested gestational age at initiation and frequency of testing, for the most common high-risk conditions. ACOG also released an update to the Practice Bulletin on antepartum fetal surveillance; additions include randomized controlled trial level data on the utility of fetal kick counts (FKCs) and recommendations that align with the new Committee Opinion.

              Data for the efficacy of antepartum fetal surveillance are lacking, mainly due to the difficulty of performing prospective studies in stillbirth. The existing evidence is subject to intervention bias, as deliveries increase in tested patients, and recommendations rely heavily on expert consensus and nonrandomized studies. Antenatal testing is also time, cost, and labor intensive, with the risk of intervention for a false-positive result. Despite these limitations, obstetrical practices routinely perform antenatal fetal surveillance.

              The new guidelines: The why, when, and how often

              Why. Antepartum fetal surveillance is suggested for conditions that have a risk of stillbirth greater than 0.8 per 1,000 (that is, the false-negative rate of a biophysical profile or a modified biophysical profile) and the relative risk or odds ratio is greater than 2.0 for stillbirth compared with unaffected pregnancies.

              When. For most conditions, ACOG recommends initiation of testing at 32 weeks or later, with notable earlier exceptions for some of the highest-risk patients. For certain conditions, such as fetal growth restriction and hypertensive disorders of pregnancy, the recommendation is to start “at diagnosis,” with the corollary “or at a gestational age when delivery would be considered because of abnormal results.” Shared decision making with the patient about pregnancy goals therefore is required, particularly in cases of fetal anomalies, genetic conditions, or at very early gestational ages.

              How often. The recommended frequency of testing is at least weekly. Testing frequency should be increased to twice-weekly outpatient or daily inpatient for the most complicated pregnancies (for example, fetal growth restriction with abnormal umbilical artery Doppler studies, preeclampsia with severe features).

              Once or twice weekly is an option for many conditions, which gives the clinician the opportunity to assess clinical stability as well as the patient’s input in terms of logistics and anxiety.

              Patients with multiple conditions may fall into the “individualized” category, as do patients with suboptimal control of conditions (for example, diabetes, hypertension) that may affect the fetus as the pregnancy progresses.

              New diagnoses included for surveillance

              Several diagnoses not previously included now qualify for antepartum fetal surveillance under the new guidelines, most notably:

              • history of obstetrical complications in the immediate preceding pregnancy

              —history of prior fetal growth restriction requiring preterm delivery

              —history of prior preeclampsia requiring delivery

              • alcohol use of 5 or more drinks per day
              • in vitro fertilization
              • abnormal serum markers

              —pregnancy-associated plasma protein A (PAPP-A) in the fifth or lower percentile or 0.4 multiples of the median (MoM)

              —second trimester inhibin A of 2 or greater MoM

              • prepregnancy body mass index (BMI)

              —this is divided into 2 categories for timing of initiation of testing:

              1.  37 weeks for BMI of 35 to 39.9 kg/m2
              2.  34 weeks for BMI of or greater than 40 kg/m2.

              Fetal kick counts

              The major change to the updated Practice Bulletin on antenatal surveillance is the inclusion of data on FKCs, a simple modality of fetal surveillance that does not require a clinical visit. For FKCs, a meta-analysis of more than 450,000 patients did not demonstrate a difference in perinatal death between the FKC intervention group (0.54%) and the control group (0.59%). Of note, there were small but statistically significant increases in the rates of induction of labor, cesarean delivery, and preterm delivery in the FKC intervention group. Therefore, this update does not recommend a formal program of FKCs for all patients.

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • The antenatal fetal surveillance guidelines are just that—guidelines, not mandates. Their use will need to be adapted for specific patient populations and practice management patterns.
              • Many conditions qualify for “individualized” surveillance, which offers the opportunity for detailed discussions on the patient’s care. This includes shared decision making with patients to meet their goals for the pregnancy.
              • Although patient-perceived decreased fetal movement always warrants clinical evaluation, a regular program of fetal kick count monitoring is not recommended for all patients due to lack of data supporting its benefit in reducing perinatal death.
              • As with any change, new guidelines potentially are a source of frustration, so a concerted effort by obstetrical clinicians to agree on adoption of the guidelines is needed. Additional clinical resources and both clinician and patient education may be required depending on current practice style, as the new strategy may increase the number of appointments and ultrasound exams required.

              Continue to: Use of antenatal corticosteroids now may be considered at 22 weeks’ gestation...

               

               

              Use of antenatal corticosteroids now may be considered at 22 weeks’ gestation

              American College of Obstetricians and Gynecologists. Use of antenatal corticosteroids at 22 weeks of gestation: ACOG practice advisory. September 2021. https://www .acog.org/clinical/clinical-guidance/practice-advisory /articles/2021/09/use-of-antenatal-corticosteroids-at -22-weeks-of-gestation. Accessed December 11, 2021.

              In September 2021, ACOG and SMFM released a Practice Advisory updating the current recommendations for the administration of antenatal corticosteroids in the periviable period (22 to 25 6/7 weeks’ gestation). Whereas the prior lower limit of gestational age for consideration of steroids was 23 weeks, the new recommendation now extends this consideration down to 22 weeks.

              The cited data include a meta-analysis of more than 2,200 patients in which the survival rate of infants born between 22 and 22 6/7 weeks who were exposed to antenatal steroids was 39% compared with 19.5% in the unexposed group. Another study of more than 1,000 patients demonstrated a statistically significant increase in overall survival in patients treated with antenatal steroids plus life support compared with life support only (38.5% vs 17.7%). Survival without major morbidity in this study, although increased from 1% to 4.4%, was still low.

              Recommendation carries caveats

              Given this information, the Practice Advisory offers a 2C level recommendation (weak recommendation, low quality of evidence) for antenatal steroids at 22 to 22 6/7 weeks’ gestation if neonatal resuscitation is planned, acknowledging the limitations and potential bias of the available data.

              The Practice Advisory emphasizes the importance of counseling and patient involvement in the decision making. This requires a multidisciplinary collaboration among the neonatology and obstetrical teams, flexibility in the plan after birth depending on the infant’s condition, and redirection of care if appropriate. Estimated fetal weight, the presence of multiple gestations, fetal biologic sex, and any anomalies are also important in helping families make an informed decision for their particular pregnancy. As described in the Obstetric Care Consensus on periviable birth,6 it is important to remember that considerations and recommendations are not the same as requirements, and redirection of care to comfort and family memory making is not the same as withholding care.

              The rest of the recommendations for the administration of antenatal steroids remain the same: Antenatal steroids are not recommended at less than 22 weeks due to lack of evidence of benefit, and they continue to be recommended at 24 weeks and beyond. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • Antenatal corticosteroids may be considered at 22 to 22 6/7 weeks’ gestation if, after thorough patient counseling, neonatal resuscitation is desired and planned by the family.
              • The overall likelihood of survival and survival without major morbidities continues to be very low in the periviable period, especially at 22 weeks. Gestational age is only one of the many factors that must be considered in the shared decision making for this very difficult decision.
              • Palliative care is a valid and appropriate option for patients facing a periviable delivery after appropriate counseling or after evaluation of the infant has occurred after birth.

              Obstetrical practice saw updates in 2021 to 3 major areas of pregnancy management: preterm birth prevention, antepartum fetal surveillance, and the use of antenatal corticosteroids.

              Updated guidance on predicting and preventing spontaneous PTB

              American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138:e65-e90.

              Preterm birth (PTB) continues to pose a challenge in clinical obstetrics, with the most recently reported rate of 10.2% in the United States.1 This accounts for almost 75% of perinatal mortality and more than half of neonatal morbidity, in which effects last well past the neonatal period. PTB is classified as spontaneous (following preterm labor, preterm prelabor rupture of membranes, or cervical insufficiency) or iatrogenic (indicated due to maternal and/or fetal complications).

              Assessing risk for PTB

              The single strongest predictor of subsequent PTB is a history of spontaneous PTB. Recurrence risk is further increased by the number of prior PTBs and the gestational age at prior PTB. Identification of and intervention for a short cervix has been shown to prolong gestation. Transvaginal ultrasonography of the cervix is the most accurate method for evaluating cervical length (CL). Specific examination criteria exist to ensure that CL measurements are reproducible and reliable.2 A short CL is generally defined as a measurement of less than 25 mm between 16 and 24 weeks’ gestation.

              Screening strategies

              The American College of Obstetricians and Gynecologists (ACOG), with an endorsement from the Society for Maternal-Fetal Medicine (SMFM), recommends cervical evaluation during the anatomy ultrasound exam between 18 0/7 and 22 6/7 weeks’ gestation in all pregnant patients regardless of prior PTB.3 If transabdominal imaging is concerning for a shortened cervix, transvaginal ultrasonography should be performed to assess the CL.

              Serial transvaginal CL measurements are recommended between 16 0/7 and 24 0/7 weeks’ gestation for patients with a current singleton pregnancy and history of a spontaneous PTB, but not for patients with a history of iatrogenic or indicated PTB.

              Interventions: Mind your p’s and c’s

              Interventions to reduce the risk of spontaneous PTB depend on whether the current pregnancy is a singleton, twins, or higher-order multiples; CL measurement; and history of spontaneous PTB. Preconception optimization of underlying medical conditions also is important to reduce the risk of recurrent indicated PTB.

              Continue to: Progesterone...

               

               

              Progesterone

              Vaginal administration. Several trials have shown that vaginal progesterone can be used to reduce the risk of spontaneous PTB in asymptomatic patients with a singleton pregnancy, incidental finding of a short cervix (<25 mm), and no history of spontaneous PTB. This is a change from the prior recommendation of CL of less than 20 mm. In the setting of a twin pregnancy, regardless of CL, data do not definitively support the use of vaginal progesterone.

              Intramuscular administration.4,5 The popularity of intramuscular progesterone has waxed and waned. At present, ACOG recommends that all patients with a singleton pregnancy and history of spontaneous PTB be offered progesterone beginning at 16 0/7 weeks’ gestation following a shared decision-making process that includes the limited data of efficacy noted in existing studies.

              In a twin pregnancy with no history of spontaneous PTB, the use of intramuscular progesterone has been shown to potentially increase the risk of PTB and admission to the neonatal intensive care unit. As such, intramuscular progesterone in the setting of a twin gestation without a history of spontaneous PTB is not recommended. When a prior spontaneous PTB has occurred, there may be some benefit to intramuscular progesterone in twin gestations.

              Cerclage

              Ultrasound indicated. In a singleton pregnancy with an incidental finding of short cervix (<25 mm) and no history of PTB, the use of cerclage is of uncertain benefit. Effectiveness may be seen if the cervix is less than 10 mm. Ultrasound-indicated cerclage should be considered in a singleton pregnancy with a CL less than 25 mm and a history of spontaneous PTB.

              Possibly one of the most controversial topics is ultrasound-indicated cerclage placement in twin gestation. As with many situations in obstetrics, data regarding ultrasound-indicated cerclage in twin gestation is based on small retrospective studies fraught with bias. Results from these studies range from no benefit, to potential benefit, to even possible increased risk of PTB. Since data are limited, as we await more evidence, it is recommended that the clinician and patient use shared decision making to decide on cerclage placement in a twin gestation.

              Exam indicated. In a singleton pregnancy with a dilated cervix on digital or speculum exam between 16 0/7 to 23 6/7 weeks’ gestation, a physical exam–indicated cerclage should be offered. Exam-indicated cerclage also may reduce the incidence of PTB in twin gestations with cervical dilation between 16 0/7 and 23 6/7 weeks’ gestation. Indomethacin tocolysis and perioperative antibiotics should be considered when an exam-indicated cerclage is placed.

              As the limits of viability are continually pushed earlier, more in-depth conversation is needed with patients who are considering an exam-indicated cerclage. The nuances of periviability and the likelihood that an exam-indicated cerclage will commit a pregnancy to a periviable or extremely preterm birth should be discussed in detail using a shared decision making model.

              Regardless of whether the cerclage is ultrasound or exam indicated, once it is placed there is no utility in additional CL ultrasound monitoring.

              Pessary

              Vaginal pessaries for prevention of PTB have not gained popularity in the United States as they have in other countries. Trials are being conducted to determine the utility of vaginal pessary, but current data have not proven its effectiveness in preventing PTB in the setting of singleton pregnancy, short cervix, and no history of spontaneous PTB. So for now, pessary is not recommended. The same can be said for use in the twin gestation.

               

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • All patients should have cervical evaluation during pregnancy. Serial imaging is reserved for those with a history of spontaneous PTB.
              • Progesterone supplementation should be offered to patients with a singleton pregnancy and a history of spontaneous PTB or to patients with a singleton pregnancy and no history of spontaneous PTB who have cervical shortening at less than 24 weeks.
              • Cerclage may be offered between 16 and 24 weeks for a cervical length less than 25 mm in a patient with a singleton gestation who has a history of spontaneous PTB (<10 mm if no history of spontaneous PTB) or for a dilated cervix on exam regardless of history.
              • Women who have a twin gestation with cervical dilation may be offered physical exam–indicated cerclage.

              Which patients may benefit from antepartum fetal surveillance and when to initiate it

              American College of Obstetricians and Gynecologists’ Committee on Obstetrics Practice, Society for Maternal-Fetal Medicine. Indications for outpatient antenatal surveillance: ACOG committee opinion, number 828. Obstet Gynecol. 2021;137:e177-e197.

              American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins—Obstetrics. Antepartum fetal surveillance: ACOG practice bulletin, number 229. Obstet Gynecol. 2021;137:e116-e127.

              The ultimate purpose of antenatal fetal surveillance is to prevent stillbirth. However, stillbirth has multiple etiologies, not all of which are preventable with testing. In June 2021, ACOG released a new Committee Opinion containing guidelines for fetal surveillance, including suggested gestational age at initiation and frequency of testing, for the most common high-risk conditions. ACOG also released an update to the Practice Bulletin on antepartum fetal surveillance; additions include randomized controlled trial level data on the utility of fetal kick counts (FKCs) and recommendations that align with the new Committee Opinion.

              Data for the efficacy of antepartum fetal surveillance are lacking, mainly due to the difficulty of performing prospective studies in stillbirth. The existing evidence is subject to intervention bias, as deliveries increase in tested patients, and recommendations rely heavily on expert consensus and nonrandomized studies. Antenatal testing is also time, cost, and labor intensive, with the risk of intervention for a false-positive result. Despite these limitations, obstetrical practices routinely perform antenatal fetal surveillance.

              The new guidelines: The why, when, and how often

              Why. Antepartum fetal surveillance is suggested for conditions that have a risk of stillbirth greater than 0.8 per 1,000 (that is, the false-negative rate of a biophysical profile or a modified biophysical profile) and the relative risk or odds ratio is greater than 2.0 for stillbirth compared with unaffected pregnancies.

              When. For most conditions, ACOG recommends initiation of testing at 32 weeks or later, with notable earlier exceptions for some of the highest-risk patients. For certain conditions, such as fetal growth restriction and hypertensive disorders of pregnancy, the recommendation is to start “at diagnosis,” with the corollary “or at a gestational age when delivery would be considered because of abnormal results.” Shared decision making with the patient about pregnancy goals therefore is required, particularly in cases of fetal anomalies, genetic conditions, or at very early gestational ages.

              How often. The recommended frequency of testing is at least weekly. Testing frequency should be increased to twice-weekly outpatient or daily inpatient for the most complicated pregnancies (for example, fetal growth restriction with abnormal umbilical artery Doppler studies, preeclampsia with severe features).

              Once or twice weekly is an option for many conditions, which gives the clinician the opportunity to assess clinical stability as well as the patient’s input in terms of logistics and anxiety.

              Patients with multiple conditions may fall into the “individualized” category, as do patients with suboptimal control of conditions (for example, diabetes, hypertension) that may affect the fetus as the pregnancy progresses.

              New diagnoses included for surveillance

              Several diagnoses not previously included now qualify for antepartum fetal surveillance under the new guidelines, most notably:

              • history of obstetrical complications in the immediate preceding pregnancy

              —history of prior fetal growth restriction requiring preterm delivery

              —history of prior preeclampsia requiring delivery

              • alcohol use of 5 or more drinks per day
              • in vitro fertilization
              • abnormal serum markers

              —pregnancy-associated plasma protein A (PAPP-A) in the fifth or lower percentile or 0.4 multiples of the median (MoM)

              —second trimester inhibin A of 2 or greater MoM

              • prepregnancy body mass index (BMI)

              —this is divided into 2 categories for timing of initiation of testing:

              1.  37 weeks for BMI of 35 to 39.9 kg/m2
              2.  34 weeks for BMI of or greater than 40 kg/m2.

              Fetal kick counts

              The major change to the updated Practice Bulletin on antenatal surveillance is the inclusion of data on FKCs, a simple modality of fetal surveillance that does not require a clinical visit. For FKCs, a meta-analysis of more than 450,000 patients did not demonstrate a difference in perinatal death between the FKC intervention group (0.54%) and the control group (0.59%). Of note, there were small but statistically significant increases in the rates of induction of labor, cesarean delivery, and preterm delivery in the FKC intervention group. Therefore, this update does not recommend a formal program of FKCs for all patients.

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • The antenatal fetal surveillance guidelines are just that—guidelines, not mandates. Their use will need to be adapted for specific patient populations and practice management patterns.
              • Many conditions qualify for “individualized” surveillance, which offers the opportunity for detailed discussions on the patient’s care. This includes shared decision making with patients to meet their goals for the pregnancy.
              • Although patient-perceived decreased fetal movement always warrants clinical evaluation, a regular program of fetal kick count monitoring is not recommended for all patients due to lack of data supporting its benefit in reducing perinatal death.
              • As with any change, new guidelines potentially are a source of frustration, so a concerted effort by obstetrical clinicians to agree on adoption of the guidelines is needed. Additional clinical resources and both clinician and patient education may be required depending on current practice style, as the new strategy may increase the number of appointments and ultrasound exams required.

              Continue to: Use of antenatal corticosteroids now may be considered at 22 weeks’ gestation...

               

               

              Use of antenatal corticosteroids now may be considered at 22 weeks’ gestation

              American College of Obstetricians and Gynecologists. Use of antenatal corticosteroids at 22 weeks of gestation: ACOG practice advisory. September 2021. https://www .acog.org/clinical/clinical-guidance/practice-advisory /articles/2021/09/use-of-antenatal-corticosteroids-at -22-weeks-of-gestation. Accessed December 11, 2021.

              In September 2021, ACOG and SMFM released a Practice Advisory updating the current recommendations for the administration of antenatal corticosteroids in the periviable period (22 to 25 6/7 weeks’ gestation). Whereas the prior lower limit of gestational age for consideration of steroids was 23 weeks, the new recommendation now extends this consideration down to 22 weeks.

              The cited data include a meta-analysis of more than 2,200 patients in which the survival rate of infants born between 22 and 22 6/7 weeks who were exposed to antenatal steroids was 39% compared with 19.5% in the unexposed group. Another study of more than 1,000 patients demonstrated a statistically significant increase in overall survival in patients treated with antenatal steroids plus life support compared with life support only (38.5% vs 17.7%). Survival without major morbidity in this study, although increased from 1% to 4.4%, was still low.

              Recommendation carries caveats

              Given this information, the Practice Advisory offers a 2C level recommendation (weak recommendation, low quality of evidence) for antenatal steroids at 22 to 22 6/7 weeks’ gestation if neonatal resuscitation is planned, acknowledging the limitations and potential bias of the available data.

              The Practice Advisory emphasizes the importance of counseling and patient involvement in the decision making. This requires a multidisciplinary collaboration among the neonatology and obstetrical teams, flexibility in the plan after birth depending on the infant’s condition, and redirection of care if appropriate. Estimated fetal weight, the presence of multiple gestations, fetal biologic sex, and any anomalies are also important in helping families make an informed decision for their particular pregnancy. As described in the Obstetric Care Consensus on periviable birth,6 it is important to remember that considerations and recommendations are not the same as requirements, and redirection of care to comfort and family memory making is not the same as withholding care.

              The rest of the recommendations for the administration of antenatal steroids remain the same: Antenatal steroids are not recommended at less than 22 weeks due to lack of evidence of benefit, and they continue to be recommended at 24 weeks and beyond. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE
              • Antenatal corticosteroids may be considered at 22 to 22 6/7 weeks’ gestation if, after thorough patient counseling, neonatal resuscitation is desired and planned by the family.
              • The overall likelihood of survival and survival without major morbidities continues to be very low in the periviable period, especially at 22 weeks. Gestational age is only one of the many factors that must be considered in the shared decision making for this very difficult decision.
              • Palliative care is a valid and appropriate option for patients facing a periviable delivery after appropriate counseling or after evaluation of the infant has occurred after birth.
              References
              1. Martin JA, Hamilton BE, Osterman MJK. Births in the United States, 2019. NCHS Data Brief, no 387. Hyattsville, MD: National Center for Health Statistics. October 2020. www.cdc.gov/nchs /data/databriefs/db387-H.pdf. Accessed December 20, 2021.
              2. To MS, Skentou C, Chan C, et al. Cervical assessment at the routine 23-week scan: standardizing techniques. Ultrasound Obstet Gynecol. 2001;17:217-219.
              3. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138:e65-e90.
              4. Society for Maternal-Fetal Medicine (SMFM) Publications Committee. SMFM statement: use of 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth. Am J Obstet Gynecol. 2020;223:B16-B18.
              5. Blackwell SC, Gyamfi-Bannerman C, Biggio JR Jr, et al. 17-OHPC to prevent recurrent preterm birth in singleton gestations (PROLONG study): a multicenter, international, randomized double-blind trial. Am J Perinatol. 2020;37:127-136.
              6. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric care consensus no. 6: Periviable birth. Obstet Gynecol. 2017;130:e187-e199.
              References
              1. Martin JA, Hamilton BE, Osterman MJK. Births in the United States, 2019. NCHS Data Brief, no 387. Hyattsville, MD: National Center for Health Statistics. October 2020. www.cdc.gov/nchs /data/databriefs/db387-H.pdf. Accessed December 20, 2021.
              2. To MS, Skentou C, Chan C, et al. Cervical assessment at the routine 23-week scan: standardizing techniques. Ultrasound Obstet Gynecol. 2001;17:217-219.
              3. American College of Obstetricians and Gynecologists’ Committee on Practice Bulletins–Obstetrics. Prediction and prevention of spontaneous preterm birth: ACOG practice bulletin, number 234. Obstet Gynecol. 2021;138:e65-e90.
              4. Society for Maternal-Fetal Medicine (SMFM) Publications Committee. SMFM statement: use of 17-alpha hydroxyprogesterone caproate for prevention of recurrent preterm birth. Am J Obstet Gynecol. 2020;223:B16-B18.
              5. Blackwell SC, Gyamfi-Bannerman C, Biggio JR Jr, et al. 17-OHPC to prevent recurrent preterm birth in singleton gestations (PROLONG study): a multicenter, international, randomized double-blind trial. Am J Perinatol. 2020;37:127-136.
              6. American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric care consensus no. 6: Periviable birth. Obstet Gynecol. 2017;130:e187-e199.
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              OBG Management - 34(1)
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              Do recent data on use of menopausal HT and subsequent risk of dementia indicate an association?

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              Vinogradova Y, Dening T, Hippisley-Cox J, et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. BMJ. 2021;374:n2182. doi: 10.1136/bmj.n2182.

              Much interest has surrounded whether the use of menopausal HT impacts future risk of cognitive decline. Recently, Vinogradova and colleagues conducted an observational study using data from 2 large primary care databases, QResearch and the Clinical Practice Research Datalink (CPRD), in the United Kingdom.1 The investigators conducted case-control studies that included women aged 55 and older diagnosed with dementia and up to 5 controls without dementia. Only cases and controls with at least 10 years of medical records prior to the index date (that is, the time of dementia diagnosis in cases) were included. Since early symptoms of dementia prior to diagnosis may cause sleep problems and dysphoria (which also may be symptoms of menopause), HT prescriptions during the 3 years prior to the index date were excluded.

              Details of the study

              Among 16,291 cases and 68,726 controls, the women’s mean age was approximately 83 years. Cases were identified by using codes for dementia from patients’ clinical records or records of prescriptions for drugs used to treat dementia.

              More than half the women were being treated for hypertension, and 14% of women in both groups had used HT. Women were considered users of estrogen-only therapy if they had no prescriptions containing a progestogen after their first prescription for systemic estrogen as the start of exposure to HT. Those with any subsequent prescription containing a progestogen were classified as combined HT users.

              Results. In an analysis adjusted for all available potential confounders—including lifestyle factors, ethnicity, family history of dementia, early menopause, oophorectomy/ hysterectomy, comorbidities, and use of other relevant drugs—the use of HT was not associated with risk of dementia.

              A reduced risk of dementia was noted among women who had been taking estrogen-only HT for 10 years or more (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.76–0.94). An elevated risk of Alzheimer disease was noted among women who had used estrogen-progestin HT for 5 to 9 years (OR, 1.19; CI, 1.06–1.33).1

              Study strengths and limitations

              The authors pointed out that this study’s main strengths were that it had a very large sample size representative of the general population and that its design permitted capture of all known cases as well as precision recording for prescribed drugs. On the other hand, the study is limited by the possible lack of data for some older women before the index date; that is, menopause in this latter group started before their registration or before these data were gathered electronically by their practice. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE

              The authors of this British large observational study took pains to minimize potential bias. The finding that long-term use of estrogen-only HT may be neuroprotective is consistent with results of recent studies in the United States and Finland,2-4 as well as with the Women’s Health Initiative randomized trial, which found that with 18 years of follow-up, treatment with conjugated estrogen alone was associated with a 26% reduced risk of death from Alzheimer disease.5 Overall, however, the main message we should glean from this important study by Vinogradova and colleagues is that women with bothersome vasomotor symptoms considering use of menopausal HT can be reassured that such therapy has little if any impact on future risk of cognitive decline.

              ANDREW M. KAUNITZ, MD, NCMP

              References
              1. Vinogradova Y, Dening T, Hippisley-Cox J, et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. BMJ. 2021;374:n2182. doi: 10.1136/bmj.n2182.
              2. Matyi JM, Rattinger GB, Schwartz S, et al. Lifetime estrogen exposure and cognition in late life: the Cache County study. Menopause. 2019;26:1366-1374. doi: 10.1097 /GME.0000000000001405.
              3. Liu JH. Does estrogen provide “neuroprotection” for postmenopausal women? Menopause. 2019;26:1361-1362. doi: 10.1097/GME.0000000000001459.
              4. Imtiaz B, Tuppurainen M, Rikkonen T, et al. Postmenopausal hormone therapy and Alzheimer disease: a prospective cohort study. Neurology. 2017;88:1062-1068. doi: 10.1212 /WNL.0000000000003696.
              5. Manson JE, Aragaki AK, Rossouw JE, et al; WHI Investigators. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials. JAMA. 2017;318:927-938. doi: 10.1001 /jama.2017.11217.
              Article PDF
              Author and Disclosure Information

              Andrew M. Kaunitz, MD, NCMP, is Tenured Professor and Associate Chair, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; and Medical Director and Director of Menopause and Gynecologic Ultrasound Services, University of Florida Health Women’s Specialist Services–Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

              Dr. Kaunitz reports serving as a consultant to Mithra and Pfizer and that the University of Florida receives grant or research support from Mithra.

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              Andrew M. Kaunitz, MD, NCMP, is Tenured Professor and Associate Chair, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; and Medical Director and Director of Menopause and Gynecologic Ultrasound Services, University of Florida Health Women’s Specialist Services–Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

              Dr. Kaunitz reports serving as a consultant to Mithra and Pfizer and that the University of Florida receives grant or research support from Mithra.

              Author and Disclosure Information

              Andrew M. Kaunitz, MD, NCMP, is Tenured Professor and Associate Chair, Department of Obstetrics and Gynecology, University of Florida College of Medicine–Jacksonville; and Medical Director and Director of Menopause and Gynecologic Ultrasound Services, University of Florida Health Women’s Specialist Services–Emerson, Jacksonville. He serves on the OBG Management Board of Editors.

              Dr. Kaunitz reports serving as a consultant to Mithra and Pfizer and that the University of Florida receives grant or research support from Mithra.

              Article PDF
              Article PDF

              Vinogradova Y, Dening T, Hippisley-Cox J, et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. BMJ. 2021;374:n2182. doi: 10.1136/bmj.n2182.

              Much interest has surrounded whether the use of menopausal HT impacts future risk of cognitive decline. Recently, Vinogradova and colleagues conducted an observational study using data from 2 large primary care databases, QResearch and the Clinical Practice Research Datalink (CPRD), in the United Kingdom.1 The investigators conducted case-control studies that included women aged 55 and older diagnosed with dementia and up to 5 controls without dementia. Only cases and controls with at least 10 years of medical records prior to the index date (that is, the time of dementia diagnosis in cases) were included. Since early symptoms of dementia prior to diagnosis may cause sleep problems and dysphoria (which also may be symptoms of menopause), HT prescriptions during the 3 years prior to the index date were excluded.

              Details of the study

              Among 16,291 cases and 68,726 controls, the women’s mean age was approximately 83 years. Cases were identified by using codes for dementia from patients’ clinical records or records of prescriptions for drugs used to treat dementia.

              More than half the women were being treated for hypertension, and 14% of women in both groups had used HT. Women were considered users of estrogen-only therapy if they had no prescriptions containing a progestogen after their first prescription for systemic estrogen as the start of exposure to HT. Those with any subsequent prescription containing a progestogen were classified as combined HT users.

              Results. In an analysis adjusted for all available potential confounders—including lifestyle factors, ethnicity, family history of dementia, early menopause, oophorectomy/ hysterectomy, comorbidities, and use of other relevant drugs—the use of HT was not associated with risk of dementia.

              A reduced risk of dementia was noted among women who had been taking estrogen-only HT for 10 years or more (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.76–0.94). An elevated risk of Alzheimer disease was noted among women who had used estrogen-progestin HT for 5 to 9 years (OR, 1.19; CI, 1.06–1.33).1

              Study strengths and limitations

              The authors pointed out that this study’s main strengths were that it had a very large sample size representative of the general population and that its design permitted capture of all known cases as well as precision recording for prescribed drugs. On the other hand, the study is limited by the possible lack of data for some older women before the index date; that is, menopause in this latter group started before their registration or before these data were gathered electronically by their practice. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE

              The authors of this British large observational study took pains to minimize potential bias. The finding that long-term use of estrogen-only HT may be neuroprotective is consistent with results of recent studies in the United States and Finland,2-4 as well as with the Women’s Health Initiative randomized trial, which found that with 18 years of follow-up, treatment with conjugated estrogen alone was associated with a 26% reduced risk of death from Alzheimer disease.5 Overall, however, the main message we should glean from this important study by Vinogradova and colleagues is that women with bothersome vasomotor symptoms considering use of menopausal HT can be reassured that such therapy has little if any impact on future risk of cognitive decline.

              ANDREW M. KAUNITZ, MD, NCMP

              Vinogradova Y, Dening T, Hippisley-Cox J, et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. BMJ. 2021;374:n2182. doi: 10.1136/bmj.n2182.

              Much interest has surrounded whether the use of menopausal HT impacts future risk of cognitive decline. Recently, Vinogradova and colleagues conducted an observational study using data from 2 large primary care databases, QResearch and the Clinical Practice Research Datalink (CPRD), in the United Kingdom.1 The investigators conducted case-control studies that included women aged 55 and older diagnosed with dementia and up to 5 controls without dementia. Only cases and controls with at least 10 years of medical records prior to the index date (that is, the time of dementia diagnosis in cases) were included. Since early symptoms of dementia prior to diagnosis may cause sleep problems and dysphoria (which also may be symptoms of menopause), HT prescriptions during the 3 years prior to the index date were excluded.

              Details of the study

              Among 16,291 cases and 68,726 controls, the women’s mean age was approximately 83 years. Cases were identified by using codes for dementia from patients’ clinical records or records of prescriptions for drugs used to treat dementia.

              More than half the women were being treated for hypertension, and 14% of women in both groups had used HT. Women were considered users of estrogen-only therapy if they had no prescriptions containing a progestogen after their first prescription for systemic estrogen as the start of exposure to HT. Those with any subsequent prescription containing a progestogen were classified as combined HT users.

              Results. In an analysis adjusted for all available potential confounders—including lifestyle factors, ethnicity, family history of dementia, early menopause, oophorectomy/ hysterectomy, comorbidities, and use of other relevant drugs—the use of HT was not associated with risk of dementia.

              A reduced risk of dementia was noted among women who had been taking estrogen-only HT for 10 years or more (odds ratio [OR], 0.85; 95% confidence interval [CI], 0.76–0.94). An elevated risk of Alzheimer disease was noted among women who had used estrogen-progestin HT for 5 to 9 years (OR, 1.19; CI, 1.06–1.33).1

              Study strengths and limitations

              The authors pointed out that this study’s main strengths were that it had a very large sample size representative of the general population and that its design permitted capture of all known cases as well as precision recording for prescribed drugs. On the other hand, the study is limited by the possible lack of data for some older women before the index date; that is, menopause in this latter group started before their registration or before these data were gathered electronically by their practice. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE

              The authors of this British large observational study took pains to minimize potential bias. The finding that long-term use of estrogen-only HT may be neuroprotective is consistent with results of recent studies in the United States and Finland,2-4 as well as with the Women’s Health Initiative randomized trial, which found that with 18 years of follow-up, treatment with conjugated estrogen alone was associated with a 26% reduced risk of death from Alzheimer disease.5 Overall, however, the main message we should glean from this important study by Vinogradova and colleagues is that women with bothersome vasomotor symptoms considering use of menopausal HT can be reassured that such therapy has little if any impact on future risk of cognitive decline.

              ANDREW M. KAUNITZ, MD, NCMP

              References
              1. Vinogradova Y, Dening T, Hippisley-Cox J, et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. BMJ. 2021;374:n2182. doi: 10.1136/bmj.n2182.
              2. Matyi JM, Rattinger GB, Schwartz S, et al. Lifetime estrogen exposure and cognition in late life: the Cache County study. Menopause. 2019;26:1366-1374. doi: 10.1097 /GME.0000000000001405.
              3. Liu JH. Does estrogen provide “neuroprotection” for postmenopausal women? Menopause. 2019;26:1361-1362. doi: 10.1097/GME.0000000000001459.
              4. Imtiaz B, Tuppurainen M, Rikkonen T, et al. Postmenopausal hormone therapy and Alzheimer disease: a prospective cohort study. Neurology. 2017;88:1062-1068. doi: 10.1212 /WNL.0000000000003696.
              5. Manson JE, Aragaki AK, Rossouw JE, et al; WHI Investigators. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials. JAMA. 2017;318:927-938. doi: 10.1001 /jama.2017.11217.
              References
              1. Vinogradova Y, Dening T, Hippisley-Cox J, et al. Use of menopausal hormone therapy and risk of dementia: nested case-control studies using QResearch and CPRD databases. BMJ. 2021;374:n2182. doi: 10.1136/bmj.n2182.
              2. Matyi JM, Rattinger GB, Schwartz S, et al. Lifetime estrogen exposure and cognition in late life: the Cache County study. Menopause. 2019;26:1366-1374. doi: 10.1097 /GME.0000000000001405.
              3. Liu JH. Does estrogen provide “neuroprotection” for postmenopausal women? Menopause. 2019;26:1361-1362. doi: 10.1097/GME.0000000000001459.
              4. Imtiaz B, Tuppurainen M, Rikkonen T, et al. Postmenopausal hormone therapy and Alzheimer disease: a prospective cohort study. Neurology. 2017;88:1062-1068. doi: 10.1212 /WNL.0000000000003696.
              5. Manson JE, Aragaki AK, Rossouw JE, et al; WHI Investigators. Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials. JAMA. 2017;318:927-938. doi: 10.1001 /jama.2017.11217.
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              OBG Management - 34(1)
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              Infectious disease pop quiz: Clinical challenge #10 for the ObGyn

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              Changed
              Fri, 01/14/2022 - 13:04

               

               

              What are the characteristic mucocutaneous lesions of primary, secondary, and tertiary syphilis?

              Continue to answer...

               

               

              The characteristic mucosal lesion of primary syphilis is the painless chancre. The usual mucocutaneous manifestations of secondary syphilis are maculopapular lesions (red or violet in color) on the palms and soles, mucous patches on the oral membranes, and condyloma lata on the genitalia. The classic mucocutaneous lesion of tertiary syphilis is the gumma.

              Other serious manifestations of advanced syphilis include central nervous system abnormalities, such as tabes dorsalis, the Argyll Robertson pupil, and dementia, and cardiac abnormalities, such as aortitis, which can lead to a dissecting aneurysm of the aortic root. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)

              References
              1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
              2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
              Author and Disclosure Information

              Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.


              Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.

              The authors report no financial relationships relevant to this article.

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              Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.


              Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.

              The authors report no financial relationships relevant to this article.

              Author and Disclosure Information

              Dr. Edwards is a Resident in the Department of Medicine, University of Florida College of Medicine, Gainesville.


              Dr. Duff is Professor of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville.

              The authors report no financial relationships relevant to this article.

               

               

              What are the characteristic mucocutaneous lesions of primary, secondary, and tertiary syphilis?

              Continue to answer...

               

               

              The characteristic mucosal lesion of primary syphilis is the painless chancre. The usual mucocutaneous manifestations of secondary syphilis are maculopapular lesions (red or violet in color) on the palms and soles, mucous patches on the oral membranes, and condyloma lata on the genitalia. The classic mucocutaneous lesion of tertiary syphilis is the gumma.

              Other serious manifestations of advanced syphilis include central nervous system abnormalities, such as tabes dorsalis, the Argyll Robertson pupil, and dementia, and cardiac abnormalities, such as aortitis, which can lead to a dissecting aneurysm of the aortic root. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)

               

               

              What are the characteristic mucocutaneous lesions of primary, secondary, and tertiary syphilis?

              Continue to answer...

               

               

              The characteristic mucosal lesion of primary syphilis is the painless chancre. The usual mucocutaneous manifestations of secondary syphilis are maculopapular lesions (red or violet in color) on the palms and soles, mucous patches on the oral membranes, and condyloma lata on the genitalia. The classic mucocutaneous lesion of tertiary syphilis is the gumma.

              Other serious manifestations of advanced syphilis include central nervous system abnormalities, such as tabes dorsalis, the Argyll Robertson pupil, and dementia, and cardiac abnormalities, such as aortitis, which can lead to a dissecting aneurysm of the aortic root. (Workowski KA, Bolan GA. Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;64[RR3]:1-137.)

              References
              1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
              2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
              References
              1. Duff P. Maternal and perinatal infections: bacterial. In: Landon MB, Galan HL, Jauniaux ERM, et al. Gabbe’s Obstetrics: Normal and Problem Pregnancies. 8th ed. Elsevier; 2021:1124-1146.
              2. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TJ, et al. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862-919.
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              UTIs in pregnancy: Managing urethritis, asymptomatic bacteriuria, cystitis, and pyelonephritis

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              Wed, 01/26/2022 - 13:21

              CASE Pregnant woman with dysuria and suprapubic pain

              A 25-year-old primigravid woman at 18 weeks of gestation requests evaluation because of the acute onset of frequent urination, dysuria, urination hesitancy, and suprapubic pain on the morning following intercourse. She has not experienced similar symptoms in the past. On physical examination, her temperature is 38 °C, pulse is 96 beats per minute, respirations are 18 per minute, and blood pressure is 100/76 mm Hg. She has no urethral discharge but is tender to palpation in the suprapubic area.

              • What is the most likely diagnosis?
              • What tests would be of greatest value in confirming the diagnosis?
              • What is the most appropriate treatment for this patient?

              Meet our perpetrator

              Urinary tract infections (UTIs) are among the most common infections that occur during pregnancy. They may take one of 4 forms: acute urethritis, asymptomatic bacteriuria, acute cystitis, and acute pyelonephritis.1 The first 3 conditions usually are straightforward to diagnose and treat, and they usually do not cause major problems for the mother or fetus. The latter, however, can cause serious complications that pose risk to the mother and fetus.

              This article will review the microbiology, clinical manifestations, diagnosis, and treatment of these 4 disorders in pregnancy. Particular emphasis will be placed on measures to avoid adverse effects on the mother and fetus from antimicrobial agents.

              Acute urethritis

              Acute urethritis can be caused by low concentrations of coliform organisms in the lower urinary tract, but it usually is secondary to infection by Neisseria gonorrhea or Chlamydia trachomatis. In most prenatal populations, the prevalence of one or the other of these 2 infections is approximately 5%.1

              The most common clinical manifestations of acute urethritis are a purulent urethral discharge, increased frequency of urination, dysuria, and urination hesitancy. The diagnosis most easily is confirmed by obtaining a specimen of urethral discharge or urine and evaluating the sample by a nucleic acid amplification test for both gonorrhea and chlamydia.

              Antibiotic therapy is preferred. The current recommended treatment for gonococcal urethritis is a single intramuscular injection of ceftriaxone 500 mg. If the patient prefers oral therapy, she can receive cefixime 800 mg in a single dose. For patients with an allergy to beta-lactam antibiotics, the alternative regimen is gentamicin 240 mg in a single intramuscular injection, combined with oral azithromycin in a single 2,000-mg dose. For treatment of chlamydia in pregnancy, the recommended therapy is azithromycin 1,000 mg in a single oral dose.2 A test of cure should be performed within 4 weeks of treatment.

              Asymptomatic bacteriuria

              Asymptomatic bacteriuria (ASB) is the most common UTI in women. Approximately 5% to 8% of all sexually active women have ASB. The condition is not unique to pregnancy; it is associated primarily with the assumption of coital activity. In point of fact, the ASB typically precedes pregnancy by several years.1

              The principal pathogens responsible for ASB are shown in the FIGURE. Over 80% of first-time infections are secondary to Escherichia coli. As more recurrent episodes occur, the other Gram-negative bacilli (ie, Klebsiella pneumoniae, Proteus species) become more prevalent. The 3 major Gram-positive cocci that cause UTIs are enterococci, Staphylococcus saprophyticus, and group B streptococci.1,3,4

              In nonpregnant women, ASB usually remains completely asymptomatic, and ascending infections only rarely occur. In pregnancy, however, urinary stasis is present due to the effects of progesterone on ureteral peristalsis and because of pressure on the ureters (particularly the right) by the expanding gravid uterus. As a result, ascending infection may occur in approximately 20% of patients if the lower tract infection is not identified and treated adequately.1

              Clean-catch specimens and treatment

              The standard criterion for the diagnosis of ASB is a urine culture that shows greater than 100,000 colonies/mL of a recognized uropathogen.1 The urine usually is obtained as a midstream, clean-catch specimen, and the test should be performed at the time of the first prenatal appointment. Once identified, ASB should be treated promptly with one of the antibiotics listed in the TABLE. Nitrofurantoin monohydrate macrocrystals (nitrofurantoin) and trimethoprim-sulfamethoxazole should be avoided in the first trimester unless no other drug is active against the identified microorganism.

              Both have been linked to teratogenic fetal effects.5-8 The defects associated with the former drug include eye abnormalities, heart defects, and facial clefts. The abnormalities associated with the latter include neural tube defects, heart defects, choanal atresia, and diaphragmatic hernia. In the first trimester, amoxicillin and cephalexin are reasonable choices for treatment. As a general rule, a 3-day course of antibiotics will be effective for eradicating the initial episode of ASB. For recurrent infections, a 7- to 10-day course is indicated.1,3,4

              Acute cystitis

              The microbiology of acute cystitis essentially is identical to that of asymptomatic bacteriuria. The usual clinical manifestations include increased frequency of urination, dysuria, and urination hesitancy in association with suprapubic discomfort and a lowgrade fever.

              The diagnosis can be quickly confirmed by testing the urine pH and assessing for leukocyte esterase and nitrites. If both the leukocyte esterase and nitrite test are positive, the probability of a positive urine culture is high; however, the nitrite test can be falsely negative if the urine has been incubating in the bladder for only a short period of time or if a Gram-positive organism is responsible for the infection. The urine pH is particularly helpful if it is elevated in the range of 8. This finding strongly is associated with a Proteus infection.1,9-11

              Continue to: In-out catheterization is ideal...

               

               

              In-out catheterization is ideal

              I recommend that the urine sample be obtained by an in-out catheterization in symptomatic patients. This technique eliminates any concern about contamination of the specimen by vaginal organisms and provides a “pure” sample for culture. When urine is obtained by this method, the criterion for a positive culture result is greater than 100 colonies/mL.3 If the urine is obtained by the midstream clean-catch method, the cutoff for a positive culture remains greater than 100,000 colonies/mL.1,3

              Unless the clinician is working in a low resource environment, the culture should always be obtained even though the patient will be empirically treated prior to the culture result being available. The culture can be helpful in guiding changes in antibiotic therapy if the initial response to treatment is poor.

              In the first trimester, empiric treatment should be with amoxicillin or cephalexin. Beyond the first trimester, nitrofurantoin should be the drug of choice. This antibiotic is inexpensive and well-tolerated. It has limited effect on the bowel or vaginal flora and is unlikely to cause a secondary yeast infection or diarrhea. If a Proteus infection is suspected, however, trimethoprim-sulfamethoxazole double strength (800 mg/ 160 mg) should be used because this organism is not susceptible to nitrofurantoin. The duration of therapy should be a minimum of 3 days with the first infection and 7 to 10 days with recurrent infections.1,3,4

              Acute pyelonephritis

              Pyelonephritis may develop de novo or may result from inadequate treatment of lower urinary tract infection. The right kidney is affected in approximately 75% of cases because the right ureter is more subject to compression by the gravid uterus. The principal pathogen is E coli, although Klebsiella pneumoniae and Proteus species also are of importance. Other aerobic Gram-negative bacilli, such as Pseudomonas and Serratia species, are much less common unless the patient is immunosuppressed or has an indwelling catheter.1

              The characteristic clinical manifestations of acute pyelonephritis are high fever (>39 °C), shaking chills, nausea and vomiting, and flank pain and tenderness. Increased frequency of urination and dysuria also may be present. In addition, pyelonephritis may be accompanied by preterm labor, sepsis, and acute respiratory distress syndrome (ARDS). The diagnosis is established by clinical findings, urinalysis, and urine culture. The urine specimen should be obtained by an in-out catheterization, analyzed initially by dipstick for nitrites and leukocyte esterase, and submitted for culture and sensitivity. Blood cultures should be obtained, and chest radiography should be performed if ARDS is suspected.

              Empiric treatment should be started as soon as these initial diagnostic tests are completed. Many women in the first 20 weeks of pregnancy will not be seriously ill and may be treated as outpatients. I recommend an initial dose of intramuscular ceftriaxone 2 g followed by oral amoxicillin-clavulanate (875 mg twice daily) for a total of 10 days. If the patient is allergic to beta-lactam antibiotics, oral trimethoprim-sulfamethoxazole double strength (800 mg/160 mg) twice daily would be an excellent alternative.1,12

              Treating seriously ill patients

              Patients who are more seriously ill, particularly in the second half of pregnancy when preterm labor is more likely, should be hospitalized for supportive care (intravenous [IV] fluids, antipyretics, anti-emetics) and treatment with parenteral antibiotics.1,12 At our medical center, IV ceftriaxone (2 g every 24 hours), is the agent of choice. It has a convenient dosing schedule and covers almost all of the potential uropathogens. If an unusually drug-resistant organism is suspected, gentamicin or aztreonam can be combined with ceftriaxone to ensure complete coverage (see dosage recommendations below).

              If the patient is allergic to beta-lactam antibiotics, alternative IV agents include:

              • trimethoprim-sulfamethoxazole (8–10 mg/kg/d in 2 divided doses)
              • gentamicin (5 mg/kg of ideal body weight every 24 hours)
              • aztreonam (2 g every 8 hours)

              Parenteral antibiotics should be administered until the patient has been afebrile and asymptomatic for 24 hours. At this point, oral antibiotics, based on sensitivity testing, can be started, and the patient can be discharged to complete a 10-day course of therapy.

              Continue to: Treatment failure...

               

               

              Treatment failure

              Obstetric patients with pyelonephritis usually respond promptly to antibiotics. More than 75% will be afebrile within 48 hours, and more than 90% will be afebrile within 72 hours. When patients fail to respond promptly, 2 major causes should be considered. The first is antibiotic resistance, and this problem can be corrected on the basis of the sensitivity studies. The second is ureteral obstruction, secondary either to the effect of the gravid uterus or a urinary stone. If obstruction is suspected, renal ultrasonography should be performed. Depending upon the cause of the obstruction, a procedure such as a percutaneous nephrostomy or cystoscopic removal of the stone may be necessary.

              Recurrence is possible. Following an initial episode of pyelonephritis, approximately 20% of patients will experience a recurrent lower or upper tract infection.1 Because of this recurrence rate, I recommend that these patients receive suppressive doses of antibiotics for the remainder of pregnancy. An ideal agent for suppression is nitrofurantoin (100 mg at bedtime). An alternative agent is trimethoprim-sulfamethoxazole double strength (800 mg/160 mg) once daily. Amoxicillin and cephalexin are less desirable for prophylaxis because of their adverse effects on vaginal and bowel flora and their propensity for precipitating yeast infection and/or diarrhea.

              CASE Resolved

              The most likely diagnosis in this patient is acute cystitis. An in-out catheterization should be performed to obtain an uncontaminated urine specimen. A portion of the specimen should be forwarded to the laboratory for urine culture and sensitivity. Another portion should be used for assessment by dipstick. If the nitrite and leukocyte tests are positive, the diagnosis of acute cystitis is confirmed. Since this infection is the patient’s first episode, a reasonable antibiotic regimen would be oral nitrofurantoin (100 mg twice daily) for 3 days. The course should be extended to 7 days if symptoms persist at the end of 3 days. ●

              References
              1. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TR, et al, eds. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862- 919.
              2. St Cyr S, Barbee L, Workowski KA, et al. Update to CDC’s Treatment Guidelines for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1911-1916.
              3. Hooton TM. Uncomplicated urinary tract infection. N Engl J Med. 2012;366:1028-1037.
              4. Finn SD. Acute uncomplicated urinary tract infection in women. N Engl J Med. 2003;349:259-266.
              5. Crider KS, Cleves MA, Reefhuis J, et al. Antibacterial medication use during pregnancy and risk of birth defects. Arch Pediatr Adolesc Med. 2009;163:978-985.
              6. Ailes EC, Gilboa SM, Gill SK, et al. Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011. Birth Defects Res A Clin Mol Teratol. 2016;106:940-949.
              7. ACOG Committee Opinion No. 717 summary: sulfonamides, nitrofurantoin, and risk of birth defects. Obstet Gynecol. 2017;130:666-667.
              8. Duff P. Which antibiotics should be used with caution in pregnant women with UTI? OBG Manag. 2018;30:14-17.
              9. Hooton TM, Roberts PL, Cox ME, et al. Voided midstream urine culture and acute cystitis in premenopausal women. N Engl J Med. 2013;369:1883-1891.
              10. Mignini L, Carroli G, Abalos E, et al. Accuracy of diagnostic tests to detect asymptomatic bacteriuria during pregnancy. Obstet Gynecol. 2009;113:346-352.
              11. Schneeberger C, van den Heuvel ER, Erwich JJHM, et al. Contamination rates of three urine-sampling methods to assess bacteriuria in pregnant women. Obstet Gynecol. 2013;121:299-305.
              12. Duff P. Antibiotic selection in obstetrics: making cost-effective choices. Clin Obstet Gynecol. 2002;45:59-72.
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              CASE Pregnant woman with dysuria and suprapubic pain

              A 25-year-old primigravid woman at 18 weeks of gestation requests evaluation because of the acute onset of frequent urination, dysuria, urination hesitancy, and suprapubic pain on the morning following intercourse. She has not experienced similar symptoms in the past. On physical examination, her temperature is 38 °C, pulse is 96 beats per minute, respirations are 18 per minute, and blood pressure is 100/76 mm Hg. She has no urethral discharge but is tender to palpation in the suprapubic area.

              • What is the most likely diagnosis?
              • What tests would be of greatest value in confirming the diagnosis?
              • What is the most appropriate treatment for this patient?

              Meet our perpetrator

              Urinary tract infections (UTIs) are among the most common infections that occur during pregnancy. They may take one of 4 forms: acute urethritis, asymptomatic bacteriuria, acute cystitis, and acute pyelonephritis.1 The first 3 conditions usually are straightforward to diagnose and treat, and they usually do not cause major problems for the mother or fetus. The latter, however, can cause serious complications that pose risk to the mother and fetus.

              This article will review the microbiology, clinical manifestations, diagnosis, and treatment of these 4 disorders in pregnancy. Particular emphasis will be placed on measures to avoid adverse effects on the mother and fetus from antimicrobial agents.

              Acute urethritis

              Acute urethritis can be caused by low concentrations of coliform organisms in the lower urinary tract, but it usually is secondary to infection by Neisseria gonorrhea or Chlamydia trachomatis. In most prenatal populations, the prevalence of one or the other of these 2 infections is approximately 5%.1

              The most common clinical manifestations of acute urethritis are a purulent urethral discharge, increased frequency of urination, dysuria, and urination hesitancy. The diagnosis most easily is confirmed by obtaining a specimen of urethral discharge or urine and evaluating the sample by a nucleic acid amplification test for both gonorrhea and chlamydia.

              Antibiotic therapy is preferred. The current recommended treatment for gonococcal urethritis is a single intramuscular injection of ceftriaxone 500 mg. If the patient prefers oral therapy, she can receive cefixime 800 mg in a single dose. For patients with an allergy to beta-lactam antibiotics, the alternative regimen is gentamicin 240 mg in a single intramuscular injection, combined with oral azithromycin in a single 2,000-mg dose. For treatment of chlamydia in pregnancy, the recommended therapy is azithromycin 1,000 mg in a single oral dose.2 A test of cure should be performed within 4 weeks of treatment.

              Asymptomatic bacteriuria

              Asymptomatic bacteriuria (ASB) is the most common UTI in women. Approximately 5% to 8% of all sexually active women have ASB. The condition is not unique to pregnancy; it is associated primarily with the assumption of coital activity. In point of fact, the ASB typically precedes pregnancy by several years.1

              The principal pathogens responsible for ASB are shown in the FIGURE. Over 80% of first-time infections are secondary to Escherichia coli. As more recurrent episodes occur, the other Gram-negative bacilli (ie, Klebsiella pneumoniae, Proteus species) become more prevalent. The 3 major Gram-positive cocci that cause UTIs are enterococci, Staphylococcus saprophyticus, and group B streptococci.1,3,4

              In nonpregnant women, ASB usually remains completely asymptomatic, and ascending infections only rarely occur. In pregnancy, however, urinary stasis is present due to the effects of progesterone on ureteral peristalsis and because of pressure on the ureters (particularly the right) by the expanding gravid uterus. As a result, ascending infection may occur in approximately 20% of patients if the lower tract infection is not identified and treated adequately.1

              Clean-catch specimens and treatment

              The standard criterion for the diagnosis of ASB is a urine culture that shows greater than 100,000 colonies/mL of a recognized uropathogen.1 The urine usually is obtained as a midstream, clean-catch specimen, and the test should be performed at the time of the first prenatal appointment. Once identified, ASB should be treated promptly with one of the antibiotics listed in the TABLE. Nitrofurantoin monohydrate macrocrystals (nitrofurantoin) and trimethoprim-sulfamethoxazole should be avoided in the first trimester unless no other drug is active against the identified microorganism.

              Both have been linked to teratogenic fetal effects.5-8 The defects associated with the former drug include eye abnormalities, heart defects, and facial clefts. The abnormalities associated with the latter include neural tube defects, heart defects, choanal atresia, and diaphragmatic hernia. In the first trimester, amoxicillin and cephalexin are reasonable choices for treatment. As a general rule, a 3-day course of antibiotics will be effective for eradicating the initial episode of ASB. For recurrent infections, a 7- to 10-day course is indicated.1,3,4

              Acute cystitis

              The microbiology of acute cystitis essentially is identical to that of asymptomatic bacteriuria. The usual clinical manifestations include increased frequency of urination, dysuria, and urination hesitancy in association with suprapubic discomfort and a lowgrade fever.

              The diagnosis can be quickly confirmed by testing the urine pH and assessing for leukocyte esterase and nitrites. If both the leukocyte esterase and nitrite test are positive, the probability of a positive urine culture is high; however, the nitrite test can be falsely negative if the urine has been incubating in the bladder for only a short period of time or if a Gram-positive organism is responsible for the infection. The urine pH is particularly helpful if it is elevated in the range of 8. This finding strongly is associated with a Proteus infection.1,9-11

              Continue to: In-out catheterization is ideal...

               

               

              In-out catheterization is ideal

              I recommend that the urine sample be obtained by an in-out catheterization in symptomatic patients. This technique eliminates any concern about contamination of the specimen by vaginal organisms and provides a “pure” sample for culture. When urine is obtained by this method, the criterion for a positive culture result is greater than 100 colonies/mL.3 If the urine is obtained by the midstream clean-catch method, the cutoff for a positive culture remains greater than 100,000 colonies/mL.1,3

              Unless the clinician is working in a low resource environment, the culture should always be obtained even though the patient will be empirically treated prior to the culture result being available. The culture can be helpful in guiding changes in antibiotic therapy if the initial response to treatment is poor.

              In the first trimester, empiric treatment should be with amoxicillin or cephalexin. Beyond the first trimester, nitrofurantoin should be the drug of choice. This antibiotic is inexpensive and well-tolerated. It has limited effect on the bowel or vaginal flora and is unlikely to cause a secondary yeast infection or diarrhea. If a Proteus infection is suspected, however, trimethoprim-sulfamethoxazole double strength (800 mg/ 160 mg) should be used because this organism is not susceptible to nitrofurantoin. The duration of therapy should be a minimum of 3 days with the first infection and 7 to 10 days with recurrent infections.1,3,4

              Acute pyelonephritis

              Pyelonephritis may develop de novo or may result from inadequate treatment of lower urinary tract infection. The right kidney is affected in approximately 75% of cases because the right ureter is more subject to compression by the gravid uterus. The principal pathogen is E coli, although Klebsiella pneumoniae and Proteus species also are of importance. Other aerobic Gram-negative bacilli, such as Pseudomonas and Serratia species, are much less common unless the patient is immunosuppressed or has an indwelling catheter.1

              The characteristic clinical manifestations of acute pyelonephritis are high fever (>39 °C), shaking chills, nausea and vomiting, and flank pain and tenderness. Increased frequency of urination and dysuria also may be present. In addition, pyelonephritis may be accompanied by preterm labor, sepsis, and acute respiratory distress syndrome (ARDS). The diagnosis is established by clinical findings, urinalysis, and urine culture. The urine specimen should be obtained by an in-out catheterization, analyzed initially by dipstick for nitrites and leukocyte esterase, and submitted for culture and sensitivity. Blood cultures should be obtained, and chest radiography should be performed if ARDS is suspected.

              Empiric treatment should be started as soon as these initial diagnostic tests are completed. Many women in the first 20 weeks of pregnancy will not be seriously ill and may be treated as outpatients. I recommend an initial dose of intramuscular ceftriaxone 2 g followed by oral amoxicillin-clavulanate (875 mg twice daily) for a total of 10 days. If the patient is allergic to beta-lactam antibiotics, oral trimethoprim-sulfamethoxazole double strength (800 mg/160 mg) twice daily would be an excellent alternative.1,12

              Treating seriously ill patients

              Patients who are more seriously ill, particularly in the second half of pregnancy when preterm labor is more likely, should be hospitalized for supportive care (intravenous [IV] fluids, antipyretics, anti-emetics) and treatment with parenteral antibiotics.1,12 At our medical center, IV ceftriaxone (2 g every 24 hours), is the agent of choice. It has a convenient dosing schedule and covers almost all of the potential uropathogens. If an unusually drug-resistant organism is suspected, gentamicin or aztreonam can be combined with ceftriaxone to ensure complete coverage (see dosage recommendations below).

              If the patient is allergic to beta-lactam antibiotics, alternative IV agents include:

              • trimethoprim-sulfamethoxazole (8–10 mg/kg/d in 2 divided doses)
              • gentamicin (5 mg/kg of ideal body weight every 24 hours)
              • aztreonam (2 g every 8 hours)

              Parenteral antibiotics should be administered until the patient has been afebrile and asymptomatic for 24 hours. At this point, oral antibiotics, based on sensitivity testing, can be started, and the patient can be discharged to complete a 10-day course of therapy.

              Continue to: Treatment failure...

               

               

              Treatment failure

              Obstetric patients with pyelonephritis usually respond promptly to antibiotics. More than 75% will be afebrile within 48 hours, and more than 90% will be afebrile within 72 hours. When patients fail to respond promptly, 2 major causes should be considered. The first is antibiotic resistance, and this problem can be corrected on the basis of the sensitivity studies. The second is ureteral obstruction, secondary either to the effect of the gravid uterus or a urinary stone. If obstruction is suspected, renal ultrasonography should be performed. Depending upon the cause of the obstruction, a procedure such as a percutaneous nephrostomy or cystoscopic removal of the stone may be necessary.

              Recurrence is possible. Following an initial episode of pyelonephritis, approximately 20% of patients will experience a recurrent lower or upper tract infection.1 Because of this recurrence rate, I recommend that these patients receive suppressive doses of antibiotics for the remainder of pregnancy. An ideal agent for suppression is nitrofurantoin (100 mg at bedtime). An alternative agent is trimethoprim-sulfamethoxazole double strength (800 mg/160 mg) once daily. Amoxicillin and cephalexin are less desirable for prophylaxis because of their adverse effects on vaginal and bowel flora and their propensity for precipitating yeast infection and/or diarrhea.

              CASE Resolved

              The most likely diagnosis in this patient is acute cystitis. An in-out catheterization should be performed to obtain an uncontaminated urine specimen. A portion of the specimen should be forwarded to the laboratory for urine culture and sensitivity. Another portion should be used for assessment by dipstick. If the nitrite and leukocyte tests are positive, the diagnosis of acute cystitis is confirmed. Since this infection is the patient’s first episode, a reasonable antibiotic regimen would be oral nitrofurantoin (100 mg twice daily) for 3 days. The course should be extended to 7 days if symptoms persist at the end of 3 days. ●

              CASE Pregnant woman with dysuria and suprapubic pain

              A 25-year-old primigravid woman at 18 weeks of gestation requests evaluation because of the acute onset of frequent urination, dysuria, urination hesitancy, and suprapubic pain on the morning following intercourse. She has not experienced similar symptoms in the past. On physical examination, her temperature is 38 °C, pulse is 96 beats per minute, respirations are 18 per minute, and blood pressure is 100/76 mm Hg. She has no urethral discharge but is tender to palpation in the suprapubic area.

              • What is the most likely diagnosis?
              • What tests would be of greatest value in confirming the diagnosis?
              • What is the most appropriate treatment for this patient?

              Meet our perpetrator

              Urinary tract infections (UTIs) are among the most common infections that occur during pregnancy. They may take one of 4 forms: acute urethritis, asymptomatic bacteriuria, acute cystitis, and acute pyelonephritis.1 The first 3 conditions usually are straightforward to diagnose and treat, and they usually do not cause major problems for the mother or fetus. The latter, however, can cause serious complications that pose risk to the mother and fetus.

              This article will review the microbiology, clinical manifestations, diagnosis, and treatment of these 4 disorders in pregnancy. Particular emphasis will be placed on measures to avoid adverse effects on the mother and fetus from antimicrobial agents.

              Acute urethritis

              Acute urethritis can be caused by low concentrations of coliform organisms in the lower urinary tract, but it usually is secondary to infection by Neisseria gonorrhea or Chlamydia trachomatis. In most prenatal populations, the prevalence of one or the other of these 2 infections is approximately 5%.1

              The most common clinical manifestations of acute urethritis are a purulent urethral discharge, increased frequency of urination, dysuria, and urination hesitancy. The diagnosis most easily is confirmed by obtaining a specimen of urethral discharge or urine and evaluating the sample by a nucleic acid amplification test for both gonorrhea and chlamydia.

              Antibiotic therapy is preferred. The current recommended treatment for gonococcal urethritis is a single intramuscular injection of ceftriaxone 500 mg. If the patient prefers oral therapy, she can receive cefixime 800 mg in a single dose. For patients with an allergy to beta-lactam antibiotics, the alternative regimen is gentamicin 240 mg in a single intramuscular injection, combined with oral azithromycin in a single 2,000-mg dose. For treatment of chlamydia in pregnancy, the recommended therapy is azithromycin 1,000 mg in a single oral dose.2 A test of cure should be performed within 4 weeks of treatment.

              Asymptomatic bacteriuria

              Asymptomatic bacteriuria (ASB) is the most common UTI in women. Approximately 5% to 8% of all sexually active women have ASB. The condition is not unique to pregnancy; it is associated primarily with the assumption of coital activity. In point of fact, the ASB typically precedes pregnancy by several years.1

              The principal pathogens responsible for ASB are shown in the FIGURE. Over 80% of first-time infections are secondary to Escherichia coli. As more recurrent episodes occur, the other Gram-negative bacilli (ie, Klebsiella pneumoniae, Proteus species) become more prevalent. The 3 major Gram-positive cocci that cause UTIs are enterococci, Staphylococcus saprophyticus, and group B streptococci.1,3,4

              In nonpregnant women, ASB usually remains completely asymptomatic, and ascending infections only rarely occur. In pregnancy, however, urinary stasis is present due to the effects of progesterone on ureteral peristalsis and because of pressure on the ureters (particularly the right) by the expanding gravid uterus. As a result, ascending infection may occur in approximately 20% of patients if the lower tract infection is not identified and treated adequately.1

              Clean-catch specimens and treatment

              The standard criterion for the diagnosis of ASB is a urine culture that shows greater than 100,000 colonies/mL of a recognized uropathogen.1 The urine usually is obtained as a midstream, clean-catch specimen, and the test should be performed at the time of the first prenatal appointment. Once identified, ASB should be treated promptly with one of the antibiotics listed in the TABLE. Nitrofurantoin monohydrate macrocrystals (nitrofurantoin) and trimethoprim-sulfamethoxazole should be avoided in the first trimester unless no other drug is active against the identified microorganism.

              Both have been linked to teratogenic fetal effects.5-8 The defects associated with the former drug include eye abnormalities, heart defects, and facial clefts. The abnormalities associated with the latter include neural tube defects, heart defects, choanal atresia, and diaphragmatic hernia. In the first trimester, amoxicillin and cephalexin are reasonable choices for treatment. As a general rule, a 3-day course of antibiotics will be effective for eradicating the initial episode of ASB. For recurrent infections, a 7- to 10-day course is indicated.1,3,4

              Acute cystitis

              The microbiology of acute cystitis essentially is identical to that of asymptomatic bacteriuria. The usual clinical manifestations include increased frequency of urination, dysuria, and urination hesitancy in association with suprapubic discomfort and a lowgrade fever.

              The diagnosis can be quickly confirmed by testing the urine pH and assessing for leukocyte esterase and nitrites. If both the leukocyte esterase and nitrite test are positive, the probability of a positive urine culture is high; however, the nitrite test can be falsely negative if the urine has been incubating in the bladder for only a short period of time or if a Gram-positive organism is responsible for the infection. The urine pH is particularly helpful if it is elevated in the range of 8. This finding strongly is associated with a Proteus infection.1,9-11

              Continue to: In-out catheterization is ideal...

               

               

              In-out catheterization is ideal

              I recommend that the urine sample be obtained by an in-out catheterization in symptomatic patients. This technique eliminates any concern about contamination of the specimen by vaginal organisms and provides a “pure” sample for culture. When urine is obtained by this method, the criterion for a positive culture result is greater than 100 colonies/mL.3 If the urine is obtained by the midstream clean-catch method, the cutoff for a positive culture remains greater than 100,000 colonies/mL.1,3

              Unless the clinician is working in a low resource environment, the culture should always be obtained even though the patient will be empirically treated prior to the culture result being available. The culture can be helpful in guiding changes in antibiotic therapy if the initial response to treatment is poor.

              In the first trimester, empiric treatment should be with amoxicillin or cephalexin. Beyond the first trimester, nitrofurantoin should be the drug of choice. This antibiotic is inexpensive and well-tolerated. It has limited effect on the bowel or vaginal flora and is unlikely to cause a secondary yeast infection or diarrhea. If a Proteus infection is suspected, however, trimethoprim-sulfamethoxazole double strength (800 mg/ 160 mg) should be used because this organism is not susceptible to nitrofurantoin. The duration of therapy should be a minimum of 3 days with the first infection and 7 to 10 days with recurrent infections.1,3,4

              Acute pyelonephritis

              Pyelonephritis may develop de novo or may result from inadequate treatment of lower urinary tract infection. The right kidney is affected in approximately 75% of cases because the right ureter is more subject to compression by the gravid uterus. The principal pathogen is E coli, although Klebsiella pneumoniae and Proteus species also are of importance. Other aerobic Gram-negative bacilli, such as Pseudomonas and Serratia species, are much less common unless the patient is immunosuppressed or has an indwelling catheter.1

              The characteristic clinical manifestations of acute pyelonephritis are high fever (>39 °C), shaking chills, nausea and vomiting, and flank pain and tenderness. Increased frequency of urination and dysuria also may be present. In addition, pyelonephritis may be accompanied by preterm labor, sepsis, and acute respiratory distress syndrome (ARDS). The diagnosis is established by clinical findings, urinalysis, and urine culture. The urine specimen should be obtained by an in-out catheterization, analyzed initially by dipstick for nitrites and leukocyte esterase, and submitted for culture and sensitivity. Blood cultures should be obtained, and chest radiography should be performed if ARDS is suspected.

              Empiric treatment should be started as soon as these initial diagnostic tests are completed. Many women in the first 20 weeks of pregnancy will not be seriously ill and may be treated as outpatients. I recommend an initial dose of intramuscular ceftriaxone 2 g followed by oral amoxicillin-clavulanate (875 mg twice daily) for a total of 10 days. If the patient is allergic to beta-lactam antibiotics, oral trimethoprim-sulfamethoxazole double strength (800 mg/160 mg) twice daily would be an excellent alternative.1,12

              Treating seriously ill patients

              Patients who are more seriously ill, particularly in the second half of pregnancy when preterm labor is more likely, should be hospitalized for supportive care (intravenous [IV] fluids, antipyretics, anti-emetics) and treatment with parenteral antibiotics.1,12 At our medical center, IV ceftriaxone (2 g every 24 hours), is the agent of choice. It has a convenient dosing schedule and covers almost all of the potential uropathogens. If an unusually drug-resistant organism is suspected, gentamicin or aztreonam can be combined with ceftriaxone to ensure complete coverage (see dosage recommendations below).

              If the patient is allergic to beta-lactam antibiotics, alternative IV agents include:

              • trimethoprim-sulfamethoxazole (8–10 mg/kg/d in 2 divided doses)
              • gentamicin (5 mg/kg of ideal body weight every 24 hours)
              • aztreonam (2 g every 8 hours)

              Parenteral antibiotics should be administered until the patient has been afebrile and asymptomatic for 24 hours. At this point, oral antibiotics, based on sensitivity testing, can be started, and the patient can be discharged to complete a 10-day course of therapy.

              Continue to: Treatment failure...

               

               

              Treatment failure

              Obstetric patients with pyelonephritis usually respond promptly to antibiotics. More than 75% will be afebrile within 48 hours, and more than 90% will be afebrile within 72 hours. When patients fail to respond promptly, 2 major causes should be considered. The first is antibiotic resistance, and this problem can be corrected on the basis of the sensitivity studies. The second is ureteral obstruction, secondary either to the effect of the gravid uterus or a urinary stone. If obstruction is suspected, renal ultrasonography should be performed. Depending upon the cause of the obstruction, a procedure such as a percutaneous nephrostomy or cystoscopic removal of the stone may be necessary.

              Recurrence is possible. Following an initial episode of pyelonephritis, approximately 20% of patients will experience a recurrent lower or upper tract infection.1 Because of this recurrence rate, I recommend that these patients receive suppressive doses of antibiotics for the remainder of pregnancy. An ideal agent for suppression is nitrofurantoin (100 mg at bedtime). An alternative agent is trimethoprim-sulfamethoxazole double strength (800 mg/160 mg) once daily. Amoxicillin and cephalexin are less desirable for prophylaxis because of their adverse effects on vaginal and bowel flora and their propensity for precipitating yeast infection and/or diarrhea.

              CASE Resolved

              The most likely diagnosis in this patient is acute cystitis. An in-out catheterization should be performed to obtain an uncontaminated urine specimen. A portion of the specimen should be forwarded to the laboratory for urine culture and sensitivity. Another portion should be used for assessment by dipstick. If the nitrite and leukocyte tests are positive, the diagnosis of acute cystitis is confirmed. Since this infection is the patient’s first episode, a reasonable antibiotic regimen would be oral nitrofurantoin (100 mg twice daily) for 3 days. The course should be extended to 7 days if symptoms persist at the end of 3 days. ●

              References
              1. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TR, et al, eds. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862- 919.
              2. St Cyr S, Barbee L, Workowski KA, et al. Update to CDC’s Treatment Guidelines for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1911-1916.
              3. Hooton TM. Uncomplicated urinary tract infection. N Engl J Med. 2012;366:1028-1037.
              4. Finn SD. Acute uncomplicated urinary tract infection in women. N Engl J Med. 2003;349:259-266.
              5. Crider KS, Cleves MA, Reefhuis J, et al. Antibacterial medication use during pregnancy and risk of birth defects. Arch Pediatr Adolesc Med. 2009;163:978-985.
              6. Ailes EC, Gilboa SM, Gill SK, et al. Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011. Birth Defects Res A Clin Mol Teratol. 2016;106:940-949.
              7. ACOG Committee Opinion No. 717 summary: sulfonamides, nitrofurantoin, and risk of birth defects. Obstet Gynecol. 2017;130:666-667.
              8. Duff P. Which antibiotics should be used with caution in pregnant women with UTI? OBG Manag. 2018;30:14-17.
              9. Hooton TM, Roberts PL, Cox ME, et al. Voided midstream urine culture and acute cystitis in premenopausal women. N Engl J Med. 2013;369:1883-1891.
              10. Mignini L, Carroli G, Abalos E, et al. Accuracy of diagnostic tests to detect asymptomatic bacteriuria during pregnancy. Obstet Gynecol. 2009;113:346-352.
              11. Schneeberger C, van den Heuvel ER, Erwich JJHM, et al. Contamination rates of three urine-sampling methods to assess bacteriuria in pregnant women. Obstet Gynecol. 2013;121:299-305.
              12. Duff P. Antibiotic selection in obstetrics: making cost-effective choices. Clin Obstet Gynecol. 2002;45:59-72.
              References
              1. Duff P. Maternal and fetal infections. In: Resnik R, Lockwood CJ, Moore TR, et al, eds. Creasy & Resnik’s Maternal-Fetal Medicine: Principles and Practice. 8th ed. Elsevier; 2019:862- 919.
              2. St Cyr S, Barbee L, Workowski KA, et al. Update to CDC’s Treatment Guidelines for Gonococcal Infection, 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1911-1916.
              3. Hooton TM. Uncomplicated urinary tract infection. N Engl J Med. 2012;366:1028-1037.
              4. Finn SD. Acute uncomplicated urinary tract infection in women. N Engl J Med. 2003;349:259-266.
              5. Crider KS, Cleves MA, Reefhuis J, et al. Antibacterial medication use during pregnancy and risk of birth defects. Arch Pediatr Adolesc Med. 2009;163:978-985.
              6. Ailes EC, Gilboa SM, Gill SK, et al. Association between antibiotic use among pregnant women with urinary tract infections in the first trimester and birth defects, National Birth Defects Prevention Study 1997 to 2011. Birth Defects Res A Clin Mol Teratol. 2016;106:940-949.
              7. ACOG Committee Opinion No. 717 summary: sulfonamides, nitrofurantoin, and risk of birth defects. Obstet Gynecol. 2017;130:666-667.
              8. Duff P. Which antibiotics should be used with caution in pregnant women with UTI? OBG Manag. 2018;30:14-17.
              9. Hooton TM, Roberts PL, Cox ME, et al. Voided midstream urine culture and acute cystitis in premenopausal women. N Engl J Med. 2013;369:1883-1891.
              10. Mignini L, Carroli G, Abalos E, et al. Accuracy of diagnostic tests to detect asymptomatic bacteriuria during pregnancy. Obstet Gynecol. 2009;113:346-352.
              11. Schneeberger C, van den Heuvel ER, Erwich JJHM, et al. Contamination rates of three urine-sampling methods to assess bacteriuria in pregnant women. Obstet Gynecol. 2013;121:299-305.
              12. Duff P. Antibiotic selection in obstetrics: making cost-effective choices. Clin Obstet Gynecol. 2002;45:59-72.
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              The Supreme Court and reproductive rights

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              Wed, 01/26/2022 - 13:22

              DIGITAL ILLUSTRATION BY JOHN J. DENAPOLI/DREW ANGERER/ALEX WONG/STONE RF / GETTY IMAGES

              There is now great interest in the Supreme Court’s handling of cases that involve a woman’s ability to have an abortion. Recent decisions, and those planned in the next few months will be the source of intense scrutiny. But the Court’s involvement in reproductive rights did not begin with abortion. In fact, the Supreme Court has a long history of controversial decisions dealing with reproductive rights.

              Involuntary sterilization

              A notable, even infamous, case was Buck v Bell (1927)—later discredited—in which the Court reviewed a state law that provided for the involuntary sterilization of the “feeble minded.”1 The 8-1 decision was that the state could choose to have such a law to protect the so-called genetic health of the state. The law was based on a theory of eugenics. The opinion by the highly respected Justice Oliver Wendell Holmes included the unfortunate conclusion, “Three generations of imbeciles are enough.”2 As mentioned, the law has since been thoroughly discredited. In 1942, the Court did come to a different result, holding in Skinner v Oklahoma that it was unconstitutional for a state to involuntarily sterilize “habitual criminals.”3

              Contraception

              Forty years after Buck, in Griswold v Connecticut, the Court reviewed a state law that prohibited the distribution of any drug or device used for contraception (even for married couples).4 In a 7-2 decision, the Supreme Court struck down the state law as violating a marital right of privacy. Beyond its specific holding, Griswold was important in several ways. First, a physician was raising the rights of patients (not specifically his own rights). This is notable because, ordinarily in court, litigants may argue their own rights, not the rights of others. This has been important in later reproductive rights cases because often it has been physicians raising and arguing the rights of patients.

              A second interesting part of Griswold was the source of this constitutional right of privacy. The Constitution contains no express privacy provision. In Griswold, the Court found that the 1st, 3rd, 4th, and 9th Amendments create the right to privacy in marital relations. Writing for the majority, Justice Douglas found that “emanations” from these amendments have “penumbras” that create a right of marital privacy.

              Although Griswold was based on marital privacy, a few years later, in 1972, the Court essentially converted that right to one of reproductive privacy (“the decision whether to bear or beget a child.”) In Eisenstadt v Baird, the Court held that it was a violation of equal protection (the 14th Amendment) for a state to allow contraception to the married but deny it to an unmarried person.5

              Continue to: Abortion...

               

               

              Abortion

              In 1971, the Court had heard arguments in 2 cases that raised issues regarding whether state laws prohibiting abortion were constitutional. The first oral argument in Roe v Wade is widely considered one of the worst oral arguments in modern history, and for several reasons the Court set the case for rehearing the following Term (October 1972). In January 1973, the Court decided Roe v Wade.6 The 7-2 decision was written by Justice Blackmun, who had at one point been the attorney for the Mayo Clinic and might be considered one of the first “health lawyers.” The Court held that the Constitution (perhaps in the 14th or 9th Amendment) includes a right of privacy that includes the right of a woman to choose to have, or not to have, an abortion. In implementing the right, the Court held that a state may impose only modest medical safeguards for the mother (eg, requiring that abortions be performed by a licensed physician). In the second trimester, to the point of viability, a state could impose only limitations on abortion that were reasonably directed to ensure the health of the mother. After a fetus was viable (could live outside the mother’s body), the state was free to regulate or prohibit abortions and protect the fetus. At the time, viability was approximately the beginning of the third trimester.6

              The clear majority of the Court in Roe (7-2) may have suggested that there was not strong opposition to the decision. That, of course, was not the case. Legal and political conflict surrounding the case has been, and remains, intense. Since 1973, the Court has been called upon to decide many abortion cases, and each case seems to beget more controversy and still more cases.

              Some of the legal objections to Roe and other abortion decisions are that the constitutional basis for the decision remains unclear—a specific right of privacy is not contained in the text of the Constitution. Several locations of a possible right of privacy have been mentioned by various justices, but “substantive due process” became the common constitutional basis for the right. Critics note that “substantive” due process (as opposed to procedural due process) is not mentioned in the Constitution, and it is short on clear guiding principles. Beyond those jurisprudential issues, of course, there were strong religious and philosophical objections to abortion. What followed Roe has been a long series of efforts to limit or discourage access to abortion, and the Supreme Court has had to decide a great many abortion cases (and a few contraception cases) over the last 50 years. Most years (except from 2008‒2013) the Court has heard, on average, at least one abortion case.

              By way of examples, here are some of the issues related to abortion that the Court has decided:

              • Payment and facilities. States and the federal government are not required to pay for abortions for women who cannot afford them or to provide facilities for abortion.7-10
              • Informed consent. Some states’ special informed consent requirements for abortion were upheld, but complex consents that required the father’s participation were not.
              • Ability to advertise. Prohibitions on advertisement of abortion services were struck down.
              • Location. Requirements for hospital-only abortions (or similar regulations) were struck down.
              • Anti-abortion protests. Several cases addressed guidelines involving demonstrations near abortion clinics.

              Of particular importance was the case of Planned Parenthood of Southeastern Pennsylvania v Casey“Casey.”11 In 1992 that case reaffirmed the “essential” holding of Roe v Wade. A plurality in that case de-emphasized the trimester framework and applied an “undue burden” test on limitations on abortion. In the more recent cases argued before the Court, Casey is frequently referred to as specifically reaffirming, and therefore solidifying, Roe.

              Consent for minors

              There have been several cases since 1973 that involved contraceptives or abortions and “minors” (generally, adolescents aged <18 years, although there are some state-defined exceptions). These cases typically involve 2 issues: the right of minors to consent to treatment and the obligation of the physician to provide information to parents about treatment to their minor daughter. In 1977 the Court struck down a New York law that prohibited the distribution of contraceptives to minors.12 However, abortion issues involving minors have been more complicated. While the Court has struck down “2-parent” consent statutes,13 it has generally upheld 1-parent consent statutes, but only if those statutes contain a “judicial bypass” provision and an emergency medical provision.11,14,15 (This bypass allows a minor to “bypass” parental consent to abortion in some circumstances, and instead seek judicial authorization for an abortion.) Generally, the Court has upheld parental notification for abortions, with exceptions where it would be harmful to the minor who is seeking the abortion.16-19

              Continue to: Who can perform an abortion...

               

               

              Who can perform an abortion

              Over the years there have also been several cases raising questions about the professionals who can perform abortions, their hospital privileges, and what facilities can perform abortions. Two of those cases in recent years have, for example, seen the Court strike down state statutes that required the physicians who perform abortions to have admitting privileges at least in 1 nearby hospital.20,21 The basis for these decisions is that the admitting qualification is an “undue burden” because it serves almost no health purpose, while significantly limiting the number of professionals who can perform abortions.

              Cases this Term

              The current Term of the Court (officially the “October 2021 Term”) may be one of the most significant for reproductive rights in recent history. The Court accepted 6 abortion-related cases to hear. It dismissed 3 of those cases, which had become “moot” because the Biden administration changed the rules that had been legally challenged.22-24 It has heard arguments in the 3 (technically 4) remaining cases, in which decisions will be announced over the next several months.

              The first of these cases (involving the Texas Heartbeat Act) raises very important, but vexing, procedural issues about a Texas abortion law. The second (Whole Woman’s Health v Jackson) is a direct challenge to Roe v Wade. The third case (Cameron v EMW Women’s Surgical Center) involves the narrow question of whether a state attorney general can intervene in a case to uphold a state abortion law when another state official refuses to defend the law.25 It is worthwhile taking a look at the first 2 of these cases.

              Texas Heartbeat Act

              In the first case (technically, it is 2 cases, as we will see), the Texas legislature adopted a law that prohibits abortions after there is a discernable heartbeat (around 6 weeks of pregnancy). The law precludes state officials from enforcing the law. Instead, it allows almost any private citizen to seek monetary damages ($10,000 plus fees) from anyone who performs an abortion or “aids and abets” an abortion. (This is in some ways similar to “private attorney general” actions found in the False Claims Act, and in some civil rights and labor laws.) This statute is clearly inconsistent with Roe in that it prohibits abortions before the end of the second trimester. If it were a usual law—a Texas law being enforced by state officials—federal courts would issue injunctions to state officials against enforcing the law. The difficulty with the Texas law (and its very purpose) is that there are procedural limitations in federal law that make it very difficult to find a path for federal courts to review the Texas statute quickly. For example, would federal courts enjoin every private citizen of the state? There is a longstanding Constitutional doctrine that precludes federal courts from enjoining state courts.26 Therefore, it is difficult to challenge the law before someone performing or aiding an abortion has been ordered to pay the private citizen who is enforcing it. In the interim, which could be months or even years, health care providers face uncertainty about continuing to provide abortion services. Some providers would stop providing abortion services, reducing the availability of those services.

              Two cases challenge this Texas procedure. In the first, Whole Woman’s Health v Jackson, 27 abortion providers seek to find some way through the procedural thicket to allow an immediate challenge to the statute. It is important because this technique of exclusive private enforcement could be used in any number of ways by the state to chill important constitutional rights (beyond abortion—to speech, to bear arms). In the second case involving the Texas law, U.S. v Texas, the federal government seeks to intervene in the case, which is another unusual procedure.28 The Court found these questions so important and difficult that it allowed 3 hours of argument (and 4 sets of lawyers). It seems likely that the Court will find a mechanism for allowing some early federal court review of individual enforcement of state laws, while minimizing harm to the state-national federalism that is at the heart of the Constitution.

              For the recent procedural decisions in the Texas cases, see the “Current Court Decisions” box below.

              Current Court decisions

              On December 10, 2021, the Court handed down two decisions in reproductive freedom (abortion) cases, both involving the Texas abortion law (which prohibits most abortions after a fetal heartbeat can be detected and allows only private individuals to enforce the law). The more significant of the two cases, Whole Woman’s Health v Jackson,1 was the request of abortion providers (and others) to allow them to challenge the constitutionality of the Texas law by suing various state officials or a private individual, before the enforcement of the new Texas law.

              The decision of the Court was somewhat complex because of the split among justices. Overall:

              • The Court held 8-1 that before the law is enforced, providers have the ability to sue executives of medical licensing boards. This was based on the possibility that there could be licensure discipline for professionals who violate the new abortion law. Only Justice Thomas dissented from this part of the decision, which was written by Justice Gorsuch.
              • The Court unanimously held that state-court judges could not be sued to stop enforcement of the law, and dismissed them from the suit.
              • In a 5-4 split the Court held that state court clerks (and the state attorney general) could not be brought into federal court as a way of challenging the law. This was based on the 11th Amendment, sovereign immunity, and an important precedent from 1908.2 Chief Justice Roberts wrote from the justices who were essentially in dissent (Justices Bryer, Kagan, and Sotomayor). Justice Sotomayor also wrote a dissent (joined by Justices Breyer and Kagan) urging that there should be some way for providers to test the constitutionality of the law before enforcement. Allowing an action against state court clerks would be a good way to do that. She also expressly noted the problem of the Texas law approach being used by other states to attack any number of constitutional rights.
              • The Court unanimously dismissed (for lack of standing) the one private citizen who had been sued. He had signed a sworn statement that he did not intend to seek the damages against abortion providers under the Texas law.
              • The Court declined again to stay the Texas law while it is being challenged. That is, it left standing the 5th Circuit order allowing the law to go into effect.
              • In a second, related case, the Court dismissed, without deciding, the Biden administration’s request to become a party in the Texas abortion case.3

              References

              1. Whole Woman’s Health v Jackson, No. 21–463 (Dec. 10, 2021). https://www.supremecourt.gov /opinions/21pdf/21-463_new_8o6b.pdf.
              2. Ex parte Young, 209 U.S. 123 (1908).
              3. U.S. v Texas, 21-588 (Dec. 10, 2021). https://www.supremecourt.gov/opinions/21pdf/21-588 _c07d.pdf

              Continue to: Re-evaluating the viability standard...

               

               

              Re-evaluating the viability standard

              The substantive abortion issue in Dobbs v Jackson Women’s Health Organization is the constitutionality of the Mississippi Gestational Age Act, which allows abortions after 15 weeks of pregnancy only for medical emergencies or severe fetal abnormality.29 This case is likely the most watched and controversial case of the Term. Many medical organizations have filed amicus curiae briefs, including the American College of Obstetricians and Gynecologists joined by the American Medical Association,30 the International Federation of Gynecology and Obstetrics,31 and the American Association of Pro-Life Obstetricians and Gynecologists.32 The reason for all this attention is that the Court has accepted to resolve “whether all pre-viability prohibitions on elective abortions are unconstitutional.” Thus, it represents a direct challenge to the trimester/viability structure of Roe.

              It appears that there are 3 justices ready to outright overrule Roe, 3 that would uphold it as is, and 3 who are not in favor of Roe, but feel bound by precedent or are not in favor of a traumatic move. For that reason, there may be a narrow decision in this case. For example, the Court might find a procedural way to avoid directly deciding the abortion issue in this case, or it might uphold the right to abortion but change the viability standard. It is also true that predicting what the Court will do in controversial cases is a fool’s errand.

              The complexity of reproductive rights and the ObGyn practice

              These cases and policies affect the day-to-day practice of obstetrics. It is the most legally complex area of medical practice for several reasons. The law varies considerably from state to state. The clinician who practices both in California and across the border in Arizona will face substantially different laws, especially regarding the treatment of adolescents. And the reproductive rights laws in many states are a complicated mix of state statutes and state court decisions, with an overlay of federal statutes and court decisions, and a series of both state and federal regulations. This article demonstrates an additional complexity for practitioners—the continuous change in the law surrounding reproductive rights—and practice involving adolescent patients is especially difficult.

              There are some good state-by-state reviews of laws related to abortion and contraception. We find the Guttmacher Institute particularly helpful. (See “State-by-state reviews of laws related to abortion and contraception”.) Although these are good resources, they are not the basis for legal practice with the current law in a state. The complexity and ever-changing nature of reproductive rights is one of the reasons we believe that it is important that anyone in active ObGyn practice maintain an ongoing professional relationship with a lawyer with expertise in this area of practice. This relationship should establish and update policies and procedures consistent with local law, consent and other forms, reporting of possible child abuse, and the like. An annual legal checkup may be as important for physicians as a physical checkup is for their patients.

              Future outcomes

              At the end of the Term, we will review the outcome of the cases noted above—and the possibility of follow-on cases. Whatever the Court does this Term, it will not be the end of the legal and political struggles over abortion and other reproductive issues. These questions deeply divide our society, and the cases and controversies reflect that continuing division. ●

              References
              1. Buck v Bell, 274 U.S. 200 (1927).
              2. Id. at 207.
              3. Skinner v State of Oklahoma, ex rel. Williamson, 316 U.S. 535 (1942).
              4. Griswold v Connecticut, 381 U.S. 479 (1965)
              5. Eisenstadt v Baird, 405 U.S. 438 (1972).
              6. Roe v Wade, 410 U.S. 113 (1973).
              7. Harris v McRae, 448 U.S. 297 (1980).
              8. Williams v Zbaraz, 448 U.S 358 (1980).
              9. Webster v Reproductive Health Services, 492 U.S. 490 (1989).
              10. Rust v Sullivan, 500 U.S. 173 (1991).
              11. Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U.S. 833 (1992).
              12.  Carey v Population Services, 431 U.S. 678 (1977).
              13. Bellotti v Baird, 443 U.S. 622 (1979).
              14. Planned Parenthood of Kansas City v Ashcroft, 462 U.S. 476 (1983).
              15. Planned Parenthood of Northern New England v Ayotte, 546 U.S. 320 (2006).
              16. H.L. v Matheson, 450 U.S. 398 (1981).
              17. Hodgson v Minnesota, 497 U.S. 417 (1990).
              18. Ohio v Akron Center for Reproductive Health, 497 U.S. 502 (1990).
              19. Lambert v Wicklund, 520 U.S. 292 (1997).
              20. June Medical Services v Russo, 591 U.S. ___ (2020), https:// www.supremecourt.gov/opinions/19pdf/18-1323_c07d.pdf.
              21. Whole Woman’s Health v Hellerstedt, 579 U.S. 582 (2016).
              22. AMA v Becerra, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/american-medical -association-v-cochran.
              23. Becerra v Baltimore, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/cochran-v-mayor-and-city-council-of-baltimore.
              24. Oregon v Becerra, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/oregon-v-cochran.
              25. Cameron v EMW Women’s Surgical Center, 20-601. https:// www.scotusblog.com/case-files/cases/cameron-v-emw -womens-surgical-center-p-s-c.
              26. Ex parte Young, 209 U.S. 123 (1908).
              27. Whole Woman’s Health v Jackson, 21-463. https://www .scotusblog.com/case-files/cases/whole-womans-health-v -jackson.
              28. U.S. v Texas, 21-588. https://www.scotusblog.com/case-files /cases/united-states-v-texas-3.
              29. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.scotusblog.com/case-files/cases/dobbs-v -jackson-womens-health-organization.
              30. Brief of Amici Curiae American College of Obstetricians and Gynecologists et al., Dobbs v Jackson Women’s Health Organization (Sep. 2021). https://www.acog.org/ -/media/project/acog/acogorg/files/advocacy/amicus -briefs/2021/20210920-dobbs-v-jwho-amicus-brief.pdf?la=e n&hash=717DFDD07A03B93A04490E66835BB8C5.
              31. Brief Amicus Curiae of International Federation of Gynecology and Obstetrics, Dobbs v Jackson Women’s Health Organization (Sep. 20, 2021). https://www.supremecourt. gov/DocketPDF/19/19-1392/193019/20210920155508744 _41426%20pdf%20Chen.pdf.
              32. Brief Amicus Curiae of American Association of Pro-Life Obstetricians and Gynecologists. Dobbs v Jackson Women’s Health Organization (Sep. 2021). https://www.supremecourt .gov/DocketPDF/19/19-1392/185350/20210729163532595 _No.%2019-1392%20-%20American%20Association %20of%20Pro-Life%20Obstetricians%20and%20 Gynecologists%20-%20Amicus%20Brief%20in%20Support %20of%20Petitioner%20-%207-29-21.pdf.
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              Mr. Smith is Professor Emeritus, Dean Emeritus, California Western School of Law, San Diego, California.

              Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh; Director, Reproductive Endocrinology and Infertility, Magee-Womens Hospital, Pittsburgh, Pennsylvania. He serves on the OBG Management Board of Editors.

              The authors report no financial relationships relevant to this article.

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              Author and Disclosure Information

              Mr. Smith is Professor Emeritus, Dean Emeritus, California Western School of Law, San Diego, California.

              Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh; Director, Reproductive Endocrinology and Infertility, Magee-Womens Hospital, Pittsburgh, Pennsylvania. He serves on the OBG Management Board of Editors.

              The authors report no financial relationships relevant to this article.

              Author and Disclosure Information

              Mr. Smith is Professor Emeritus, Dean Emeritus, California Western School of Law, San Diego, California.

              Dr. Sanfilippo is Professor, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh; Director, Reproductive Endocrinology and Infertility, Magee-Womens Hospital, Pittsburgh, Pennsylvania. He serves on the OBG Management Board of Editors.

              The authors report no financial relationships relevant to this article.

              Article PDF
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              DIGITAL ILLUSTRATION BY JOHN J. DENAPOLI/DREW ANGERER/ALEX WONG/STONE RF / GETTY IMAGES

              There is now great interest in the Supreme Court’s handling of cases that involve a woman’s ability to have an abortion. Recent decisions, and those planned in the next few months will be the source of intense scrutiny. But the Court’s involvement in reproductive rights did not begin with abortion. In fact, the Supreme Court has a long history of controversial decisions dealing with reproductive rights.

              Involuntary sterilization

              A notable, even infamous, case was Buck v Bell (1927)—later discredited—in which the Court reviewed a state law that provided for the involuntary sterilization of the “feeble minded.”1 The 8-1 decision was that the state could choose to have such a law to protect the so-called genetic health of the state. The law was based on a theory of eugenics. The opinion by the highly respected Justice Oliver Wendell Holmes included the unfortunate conclusion, “Three generations of imbeciles are enough.”2 As mentioned, the law has since been thoroughly discredited. In 1942, the Court did come to a different result, holding in Skinner v Oklahoma that it was unconstitutional for a state to involuntarily sterilize “habitual criminals.”3

              Contraception

              Forty years after Buck, in Griswold v Connecticut, the Court reviewed a state law that prohibited the distribution of any drug or device used for contraception (even for married couples).4 In a 7-2 decision, the Supreme Court struck down the state law as violating a marital right of privacy. Beyond its specific holding, Griswold was important in several ways. First, a physician was raising the rights of patients (not specifically his own rights). This is notable because, ordinarily in court, litigants may argue their own rights, not the rights of others. This has been important in later reproductive rights cases because often it has been physicians raising and arguing the rights of patients.

              A second interesting part of Griswold was the source of this constitutional right of privacy. The Constitution contains no express privacy provision. In Griswold, the Court found that the 1st, 3rd, 4th, and 9th Amendments create the right to privacy in marital relations. Writing for the majority, Justice Douglas found that “emanations” from these amendments have “penumbras” that create a right of marital privacy.

              Although Griswold was based on marital privacy, a few years later, in 1972, the Court essentially converted that right to one of reproductive privacy (“the decision whether to bear or beget a child.”) In Eisenstadt v Baird, the Court held that it was a violation of equal protection (the 14th Amendment) for a state to allow contraception to the married but deny it to an unmarried person.5

              Continue to: Abortion...

               

               

              Abortion

              In 1971, the Court had heard arguments in 2 cases that raised issues regarding whether state laws prohibiting abortion were constitutional. The first oral argument in Roe v Wade is widely considered one of the worst oral arguments in modern history, and for several reasons the Court set the case for rehearing the following Term (October 1972). In January 1973, the Court decided Roe v Wade.6 The 7-2 decision was written by Justice Blackmun, who had at one point been the attorney for the Mayo Clinic and might be considered one of the first “health lawyers.” The Court held that the Constitution (perhaps in the 14th or 9th Amendment) includes a right of privacy that includes the right of a woman to choose to have, or not to have, an abortion. In implementing the right, the Court held that a state may impose only modest medical safeguards for the mother (eg, requiring that abortions be performed by a licensed physician). In the second trimester, to the point of viability, a state could impose only limitations on abortion that were reasonably directed to ensure the health of the mother. After a fetus was viable (could live outside the mother’s body), the state was free to regulate or prohibit abortions and protect the fetus. At the time, viability was approximately the beginning of the third trimester.6

              The clear majority of the Court in Roe (7-2) may have suggested that there was not strong opposition to the decision. That, of course, was not the case. Legal and political conflict surrounding the case has been, and remains, intense. Since 1973, the Court has been called upon to decide many abortion cases, and each case seems to beget more controversy and still more cases.

              Some of the legal objections to Roe and other abortion decisions are that the constitutional basis for the decision remains unclear—a specific right of privacy is not contained in the text of the Constitution. Several locations of a possible right of privacy have been mentioned by various justices, but “substantive due process” became the common constitutional basis for the right. Critics note that “substantive” due process (as opposed to procedural due process) is not mentioned in the Constitution, and it is short on clear guiding principles. Beyond those jurisprudential issues, of course, there were strong religious and philosophical objections to abortion. What followed Roe has been a long series of efforts to limit or discourage access to abortion, and the Supreme Court has had to decide a great many abortion cases (and a few contraception cases) over the last 50 years. Most years (except from 2008‒2013) the Court has heard, on average, at least one abortion case.

              By way of examples, here are some of the issues related to abortion that the Court has decided:

              • Payment and facilities. States and the federal government are not required to pay for abortions for women who cannot afford them or to provide facilities for abortion.7-10
              • Informed consent. Some states’ special informed consent requirements for abortion were upheld, but complex consents that required the father’s participation were not.
              • Ability to advertise. Prohibitions on advertisement of abortion services were struck down.
              • Location. Requirements for hospital-only abortions (or similar regulations) were struck down.
              • Anti-abortion protests. Several cases addressed guidelines involving demonstrations near abortion clinics.

              Of particular importance was the case of Planned Parenthood of Southeastern Pennsylvania v Casey“Casey.”11 In 1992 that case reaffirmed the “essential” holding of Roe v Wade. A plurality in that case de-emphasized the trimester framework and applied an “undue burden” test on limitations on abortion. In the more recent cases argued before the Court, Casey is frequently referred to as specifically reaffirming, and therefore solidifying, Roe.

              Consent for minors

              There have been several cases since 1973 that involved contraceptives or abortions and “minors” (generally, adolescents aged <18 years, although there are some state-defined exceptions). These cases typically involve 2 issues: the right of minors to consent to treatment and the obligation of the physician to provide information to parents about treatment to their minor daughter. In 1977 the Court struck down a New York law that prohibited the distribution of contraceptives to minors.12 However, abortion issues involving minors have been more complicated. While the Court has struck down “2-parent” consent statutes,13 it has generally upheld 1-parent consent statutes, but only if those statutes contain a “judicial bypass” provision and an emergency medical provision.11,14,15 (This bypass allows a minor to “bypass” parental consent to abortion in some circumstances, and instead seek judicial authorization for an abortion.) Generally, the Court has upheld parental notification for abortions, with exceptions where it would be harmful to the minor who is seeking the abortion.16-19

              Continue to: Who can perform an abortion...

               

               

              Who can perform an abortion

              Over the years there have also been several cases raising questions about the professionals who can perform abortions, their hospital privileges, and what facilities can perform abortions. Two of those cases in recent years have, for example, seen the Court strike down state statutes that required the physicians who perform abortions to have admitting privileges at least in 1 nearby hospital.20,21 The basis for these decisions is that the admitting qualification is an “undue burden” because it serves almost no health purpose, while significantly limiting the number of professionals who can perform abortions.

              Cases this Term

              The current Term of the Court (officially the “October 2021 Term”) may be one of the most significant for reproductive rights in recent history. The Court accepted 6 abortion-related cases to hear. It dismissed 3 of those cases, which had become “moot” because the Biden administration changed the rules that had been legally challenged.22-24 It has heard arguments in the 3 (technically 4) remaining cases, in which decisions will be announced over the next several months.

              The first of these cases (involving the Texas Heartbeat Act) raises very important, but vexing, procedural issues about a Texas abortion law. The second (Whole Woman’s Health v Jackson) is a direct challenge to Roe v Wade. The third case (Cameron v EMW Women’s Surgical Center) involves the narrow question of whether a state attorney general can intervene in a case to uphold a state abortion law when another state official refuses to defend the law.25 It is worthwhile taking a look at the first 2 of these cases.

              Texas Heartbeat Act

              In the first case (technically, it is 2 cases, as we will see), the Texas legislature adopted a law that prohibits abortions after there is a discernable heartbeat (around 6 weeks of pregnancy). The law precludes state officials from enforcing the law. Instead, it allows almost any private citizen to seek monetary damages ($10,000 plus fees) from anyone who performs an abortion or “aids and abets” an abortion. (This is in some ways similar to “private attorney general” actions found in the False Claims Act, and in some civil rights and labor laws.) This statute is clearly inconsistent with Roe in that it prohibits abortions before the end of the second trimester. If it were a usual law—a Texas law being enforced by state officials—federal courts would issue injunctions to state officials against enforcing the law. The difficulty with the Texas law (and its very purpose) is that there are procedural limitations in federal law that make it very difficult to find a path for federal courts to review the Texas statute quickly. For example, would federal courts enjoin every private citizen of the state? There is a longstanding Constitutional doctrine that precludes federal courts from enjoining state courts.26 Therefore, it is difficult to challenge the law before someone performing or aiding an abortion has been ordered to pay the private citizen who is enforcing it. In the interim, which could be months or even years, health care providers face uncertainty about continuing to provide abortion services. Some providers would stop providing abortion services, reducing the availability of those services.

              Two cases challenge this Texas procedure. In the first, Whole Woman’s Health v Jackson, 27 abortion providers seek to find some way through the procedural thicket to allow an immediate challenge to the statute. It is important because this technique of exclusive private enforcement could be used in any number of ways by the state to chill important constitutional rights (beyond abortion—to speech, to bear arms). In the second case involving the Texas law, U.S. v Texas, the federal government seeks to intervene in the case, which is another unusual procedure.28 The Court found these questions so important and difficult that it allowed 3 hours of argument (and 4 sets of lawyers). It seems likely that the Court will find a mechanism for allowing some early federal court review of individual enforcement of state laws, while minimizing harm to the state-national federalism that is at the heart of the Constitution.

              For the recent procedural decisions in the Texas cases, see the “Current Court Decisions” box below.

              Current Court decisions

              On December 10, 2021, the Court handed down two decisions in reproductive freedom (abortion) cases, both involving the Texas abortion law (which prohibits most abortions after a fetal heartbeat can be detected and allows only private individuals to enforce the law). The more significant of the two cases, Whole Woman’s Health v Jackson,1 was the request of abortion providers (and others) to allow them to challenge the constitutionality of the Texas law by suing various state officials or a private individual, before the enforcement of the new Texas law.

              The decision of the Court was somewhat complex because of the split among justices. Overall:

              • The Court held 8-1 that before the law is enforced, providers have the ability to sue executives of medical licensing boards. This was based on the possibility that there could be licensure discipline for professionals who violate the new abortion law. Only Justice Thomas dissented from this part of the decision, which was written by Justice Gorsuch.
              • The Court unanimously held that state-court judges could not be sued to stop enforcement of the law, and dismissed them from the suit.
              • In a 5-4 split the Court held that state court clerks (and the state attorney general) could not be brought into federal court as a way of challenging the law. This was based on the 11th Amendment, sovereign immunity, and an important precedent from 1908.2 Chief Justice Roberts wrote from the justices who were essentially in dissent (Justices Bryer, Kagan, and Sotomayor). Justice Sotomayor also wrote a dissent (joined by Justices Breyer and Kagan) urging that there should be some way for providers to test the constitutionality of the law before enforcement. Allowing an action against state court clerks would be a good way to do that. She also expressly noted the problem of the Texas law approach being used by other states to attack any number of constitutional rights.
              • The Court unanimously dismissed (for lack of standing) the one private citizen who had been sued. He had signed a sworn statement that he did not intend to seek the damages against abortion providers under the Texas law.
              • The Court declined again to stay the Texas law while it is being challenged. That is, it left standing the 5th Circuit order allowing the law to go into effect.
              • In a second, related case, the Court dismissed, without deciding, the Biden administration’s request to become a party in the Texas abortion case.3

              References

              1. Whole Woman’s Health v Jackson, No. 21–463 (Dec. 10, 2021). https://www.supremecourt.gov /opinions/21pdf/21-463_new_8o6b.pdf.
              2. Ex parte Young, 209 U.S. 123 (1908).
              3. U.S. v Texas, 21-588 (Dec. 10, 2021). https://www.supremecourt.gov/opinions/21pdf/21-588 _c07d.pdf

              Continue to: Re-evaluating the viability standard...

               

               

              Re-evaluating the viability standard

              The substantive abortion issue in Dobbs v Jackson Women’s Health Organization is the constitutionality of the Mississippi Gestational Age Act, which allows abortions after 15 weeks of pregnancy only for medical emergencies or severe fetal abnormality.29 This case is likely the most watched and controversial case of the Term. Many medical organizations have filed amicus curiae briefs, including the American College of Obstetricians and Gynecologists joined by the American Medical Association,30 the International Federation of Gynecology and Obstetrics,31 and the American Association of Pro-Life Obstetricians and Gynecologists.32 The reason for all this attention is that the Court has accepted to resolve “whether all pre-viability prohibitions on elective abortions are unconstitutional.” Thus, it represents a direct challenge to the trimester/viability structure of Roe.

              It appears that there are 3 justices ready to outright overrule Roe, 3 that would uphold it as is, and 3 who are not in favor of Roe, but feel bound by precedent or are not in favor of a traumatic move. For that reason, there may be a narrow decision in this case. For example, the Court might find a procedural way to avoid directly deciding the abortion issue in this case, or it might uphold the right to abortion but change the viability standard. It is also true that predicting what the Court will do in controversial cases is a fool’s errand.

              The complexity of reproductive rights and the ObGyn practice

              These cases and policies affect the day-to-day practice of obstetrics. It is the most legally complex area of medical practice for several reasons. The law varies considerably from state to state. The clinician who practices both in California and across the border in Arizona will face substantially different laws, especially regarding the treatment of adolescents. And the reproductive rights laws in many states are a complicated mix of state statutes and state court decisions, with an overlay of federal statutes and court decisions, and a series of both state and federal regulations. This article demonstrates an additional complexity for practitioners—the continuous change in the law surrounding reproductive rights—and practice involving adolescent patients is especially difficult.

              There are some good state-by-state reviews of laws related to abortion and contraception. We find the Guttmacher Institute particularly helpful. (See “State-by-state reviews of laws related to abortion and contraception”.) Although these are good resources, they are not the basis for legal practice with the current law in a state. The complexity and ever-changing nature of reproductive rights is one of the reasons we believe that it is important that anyone in active ObGyn practice maintain an ongoing professional relationship with a lawyer with expertise in this area of practice. This relationship should establish and update policies and procedures consistent with local law, consent and other forms, reporting of possible child abuse, and the like. An annual legal checkup may be as important for physicians as a physical checkup is for their patients.

              Future outcomes

              At the end of the Term, we will review the outcome of the cases noted above—and the possibility of follow-on cases. Whatever the Court does this Term, it will not be the end of the legal and political struggles over abortion and other reproductive issues. These questions deeply divide our society, and the cases and controversies reflect that continuing division. ●

              DIGITAL ILLUSTRATION BY JOHN J. DENAPOLI/DREW ANGERER/ALEX WONG/STONE RF / GETTY IMAGES

              There is now great interest in the Supreme Court’s handling of cases that involve a woman’s ability to have an abortion. Recent decisions, and those planned in the next few months will be the source of intense scrutiny. But the Court’s involvement in reproductive rights did not begin with abortion. In fact, the Supreme Court has a long history of controversial decisions dealing with reproductive rights.

              Involuntary sterilization

              A notable, even infamous, case was Buck v Bell (1927)—later discredited—in which the Court reviewed a state law that provided for the involuntary sterilization of the “feeble minded.”1 The 8-1 decision was that the state could choose to have such a law to protect the so-called genetic health of the state. The law was based on a theory of eugenics. The opinion by the highly respected Justice Oliver Wendell Holmes included the unfortunate conclusion, “Three generations of imbeciles are enough.”2 As mentioned, the law has since been thoroughly discredited. In 1942, the Court did come to a different result, holding in Skinner v Oklahoma that it was unconstitutional for a state to involuntarily sterilize “habitual criminals.”3

              Contraception

              Forty years after Buck, in Griswold v Connecticut, the Court reviewed a state law that prohibited the distribution of any drug or device used for contraception (even for married couples).4 In a 7-2 decision, the Supreme Court struck down the state law as violating a marital right of privacy. Beyond its specific holding, Griswold was important in several ways. First, a physician was raising the rights of patients (not specifically his own rights). This is notable because, ordinarily in court, litigants may argue their own rights, not the rights of others. This has been important in later reproductive rights cases because often it has been physicians raising and arguing the rights of patients.

              A second interesting part of Griswold was the source of this constitutional right of privacy. The Constitution contains no express privacy provision. In Griswold, the Court found that the 1st, 3rd, 4th, and 9th Amendments create the right to privacy in marital relations. Writing for the majority, Justice Douglas found that “emanations” from these amendments have “penumbras” that create a right of marital privacy.

              Although Griswold was based on marital privacy, a few years later, in 1972, the Court essentially converted that right to one of reproductive privacy (“the decision whether to bear or beget a child.”) In Eisenstadt v Baird, the Court held that it was a violation of equal protection (the 14th Amendment) for a state to allow contraception to the married but deny it to an unmarried person.5

              Continue to: Abortion...

               

               

              Abortion

              In 1971, the Court had heard arguments in 2 cases that raised issues regarding whether state laws prohibiting abortion were constitutional. The first oral argument in Roe v Wade is widely considered one of the worst oral arguments in modern history, and for several reasons the Court set the case for rehearing the following Term (October 1972). In January 1973, the Court decided Roe v Wade.6 The 7-2 decision was written by Justice Blackmun, who had at one point been the attorney for the Mayo Clinic and might be considered one of the first “health lawyers.” The Court held that the Constitution (perhaps in the 14th or 9th Amendment) includes a right of privacy that includes the right of a woman to choose to have, or not to have, an abortion. In implementing the right, the Court held that a state may impose only modest medical safeguards for the mother (eg, requiring that abortions be performed by a licensed physician). In the second trimester, to the point of viability, a state could impose only limitations on abortion that were reasonably directed to ensure the health of the mother. After a fetus was viable (could live outside the mother’s body), the state was free to regulate or prohibit abortions and protect the fetus. At the time, viability was approximately the beginning of the third trimester.6

              The clear majority of the Court in Roe (7-2) may have suggested that there was not strong opposition to the decision. That, of course, was not the case. Legal and political conflict surrounding the case has been, and remains, intense. Since 1973, the Court has been called upon to decide many abortion cases, and each case seems to beget more controversy and still more cases.

              Some of the legal objections to Roe and other abortion decisions are that the constitutional basis for the decision remains unclear—a specific right of privacy is not contained in the text of the Constitution. Several locations of a possible right of privacy have been mentioned by various justices, but “substantive due process” became the common constitutional basis for the right. Critics note that “substantive” due process (as opposed to procedural due process) is not mentioned in the Constitution, and it is short on clear guiding principles. Beyond those jurisprudential issues, of course, there were strong religious and philosophical objections to abortion. What followed Roe has been a long series of efforts to limit or discourage access to abortion, and the Supreme Court has had to decide a great many abortion cases (and a few contraception cases) over the last 50 years. Most years (except from 2008‒2013) the Court has heard, on average, at least one abortion case.

              By way of examples, here are some of the issues related to abortion that the Court has decided:

              • Payment and facilities. States and the federal government are not required to pay for abortions for women who cannot afford them or to provide facilities for abortion.7-10
              • Informed consent. Some states’ special informed consent requirements for abortion were upheld, but complex consents that required the father’s participation were not.
              • Ability to advertise. Prohibitions on advertisement of abortion services were struck down.
              • Location. Requirements for hospital-only abortions (or similar regulations) were struck down.
              • Anti-abortion protests. Several cases addressed guidelines involving demonstrations near abortion clinics.

              Of particular importance was the case of Planned Parenthood of Southeastern Pennsylvania v Casey“Casey.”11 In 1992 that case reaffirmed the “essential” holding of Roe v Wade. A plurality in that case de-emphasized the trimester framework and applied an “undue burden” test on limitations on abortion. In the more recent cases argued before the Court, Casey is frequently referred to as specifically reaffirming, and therefore solidifying, Roe.

              Consent for minors

              There have been several cases since 1973 that involved contraceptives or abortions and “minors” (generally, adolescents aged <18 years, although there are some state-defined exceptions). These cases typically involve 2 issues: the right of minors to consent to treatment and the obligation of the physician to provide information to parents about treatment to their minor daughter. In 1977 the Court struck down a New York law that prohibited the distribution of contraceptives to minors.12 However, abortion issues involving minors have been more complicated. While the Court has struck down “2-parent” consent statutes,13 it has generally upheld 1-parent consent statutes, but only if those statutes contain a “judicial bypass” provision and an emergency medical provision.11,14,15 (This bypass allows a minor to “bypass” parental consent to abortion in some circumstances, and instead seek judicial authorization for an abortion.) Generally, the Court has upheld parental notification for abortions, with exceptions where it would be harmful to the minor who is seeking the abortion.16-19

              Continue to: Who can perform an abortion...

               

               

              Who can perform an abortion

              Over the years there have also been several cases raising questions about the professionals who can perform abortions, their hospital privileges, and what facilities can perform abortions. Two of those cases in recent years have, for example, seen the Court strike down state statutes that required the physicians who perform abortions to have admitting privileges at least in 1 nearby hospital.20,21 The basis for these decisions is that the admitting qualification is an “undue burden” because it serves almost no health purpose, while significantly limiting the number of professionals who can perform abortions.

              Cases this Term

              The current Term of the Court (officially the “October 2021 Term”) may be one of the most significant for reproductive rights in recent history. The Court accepted 6 abortion-related cases to hear. It dismissed 3 of those cases, which had become “moot” because the Biden administration changed the rules that had been legally challenged.22-24 It has heard arguments in the 3 (technically 4) remaining cases, in which decisions will be announced over the next several months.

              The first of these cases (involving the Texas Heartbeat Act) raises very important, but vexing, procedural issues about a Texas abortion law. The second (Whole Woman’s Health v Jackson) is a direct challenge to Roe v Wade. The third case (Cameron v EMW Women’s Surgical Center) involves the narrow question of whether a state attorney general can intervene in a case to uphold a state abortion law when another state official refuses to defend the law.25 It is worthwhile taking a look at the first 2 of these cases.

              Texas Heartbeat Act

              In the first case (technically, it is 2 cases, as we will see), the Texas legislature adopted a law that prohibits abortions after there is a discernable heartbeat (around 6 weeks of pregnancy). The law precludes state officials from enforcing the law. Instead, it allows almost any private citizen to seek monetary damages ($10,000 plus fees) from anyone who performs an abortion or “aids and abets” an abortion. (This is in some ways similar to “private attorney general” actions found in the False Claims Act, and in some civil rights and labor laws.) This statute is clearly inconsistent with Roe in that it prohibits abortions before the end of the second trimester. If it were a usual law—a Texas law being enforced by state officials—federal courts would issue injunctions to state officials against enforcing the law. The difficulty with the Texas law (and its very purpose) is that there are procedural limitations in federal law that make it very difficult to find a path for federal courts to review the Texas statute quickly. For example, would federal courts enjoin every private citizen of the state? There is a longstanding Constitutional doctrine that precludes federal courts from enjoining state courts.26 Therefore, it is difficult to challenge the law before someone performing or aiding an abortion has been ordered to pay the private citizen who is enforcing it. In the interim, which could be months or even years, health care providers face uncertainty about continuing to provide abortion services. Some providers would stop providing abortion services, reducing the availability of those services.

              Two cases challenge this Texas procedure. In the first, Whole Woman’s Health v Jackson, 27 abortion providers seek to find some way through the procedural thicket to allow an immediate challenge to the statute. It is important because this technique of exclusive private enforcement could be used in any number of ways by the state to chill important constitutional rights (beyond abortion—to speech, to bear arms). In the second case involving the Texas law, U.S. v Texas, the federal government seeks to intervene in the case, which is another unusual procedure.28 The Court found these questions so important and difficult that it allowed 3 hours of argument (and 4 sets of lawyers). It seems likely that the Court will find a mechanism for allowing some early federal court review of individual enforcement of state laws, while minimizing harm to the state-national federalism that is at the heart of the Constitution.

              For the recent procedural decisions in the Texas cases, see the “Current Court Decisions” box below.

              Current Court decisions

              On December 10, 2021, the Court handed down two decisions in reproductive freedom (abortion) cases, both involving the Texas abortion law (which prohibits most abortions after a fetal heartbeat can be detected and allows only private individuals to enforce the law). The more significant of the two cases, Whole Woman’s Health v Jackson,1 was the request of abortion providers (and others) to allow them to challenge the constitutionality of the Texas law by suing various state officials or a private individual, before the enforcement of the new Texas law.

              The decision of the Court was somewhat complex because of the split among justices. Overall:

              • The Court held 8-1 that before the law is enforced, providers have the ability to sue executives of medical licensing boards. This was based on the possibility that there could be licensure discipline for professionals who violate the new abortion law. Only Justice Thomas dissented from this part of the decision, which was written by Justice Gorsuch.
              • The Court unanimously held that state-court judges could not be sued to stop enforcement of the law, and dismissed them from the suit.
              • In a 5-4 split the Court held that state court clerks (and the state attorney general) could not be brought into federal court as a way of challenging the law. This was based on the 11th Amendment, sovereign immunity, and an important precedent from 1908.2 Chief Justice Roberts wrote from the justices who were essentially in dissent (Justices Bryer, Kagan, and Sotomayor). Justice Sotomayor also wrote a dissent (joined by Justices Breyer and Kagan) urging that there should be some way for providers to test the constitutionality of the law before enforcement. Allowing an action against state court clerks would be a good way to do that. She also expressly noted the problem of the Texas law approach being used by other states to attack any number of constitutional rights.
              • The Court unanimously dismissed (for lack of standing) the one private citizen who had been sued. He had signed a sworn statement that he did not intend to seek the damages against abortion providers under the Texas law.
              • The Court declined again to stay the Texas law while it is being challenged. That is, it left standing the 5th Circuit order allowing the law to go into effect.
              • In a second, related case, the Court dismissed, without deciding, the Biden administration’s request to become a party in the Texas abortion case.3

              References

              1. Whole Woman’s Health v Jackson, No. 21–463 (Dec. 10, 2021). https://www.supremecourt.gov /opinions/21pdf/21-463_new_8o6b.pdf.
              2. Ex parte Young, 209 U.S. 123 (1908).
              3. U.S. v Texas, 21-588 (Dec. 10, 2021). https://www.supremecourt.gov/opinions/21pdf/21-588 _c07d.pdf

              Continue to: Re-evaluating the viability standard...

               

               

              Re-evaluating the viability standard

              The substantive abortion issue in Dobbs v Jackson Women’s Health Organization is the constitutionality of the Mississippi Gestational Age Act, which allows abortions after 15 weeks of pregnancy only for medical emergencies or severe fetal abnormality.29 This case is likely the most watched and controversial case of the Term. Many medical organizations have filed amicus curiae briefs, including the American College of Obstetricians and Gynecologists joined by the American Medical Association,30 the International Federation of Gynecology and Obstetrics,31 and the American Association of Pro-Life Obstetricians and Gynecologists.32 The reason for all this attention is that the Court has accepted to resolve “whether all pre-viability prohibitions on elective abortions are unconstitutional.” Thus, it represents a direct challenge to the trimester/viability structure of Roe.

              It appears that there are 3 justices ready to outright overrule Roe, 3 that would uphold it as is, and 3 who are not in favor of Roe, but feel bound by precedent or are not in favor of a traumatic move. For that reason, there may be a narrow decision in this case. For example, the Court might find a procedural way to avoid directly deciding the abortion issue in this case, or it might uphold the right to abortion but change the viability standard. It is also true that predicting what the Court will do in controversial cases is a fool’s errand.

              The complexity of reproductive rights and the ObGyn practice

              These cases and policies affect the day-to-day practice of obstetrics. It is the most legally complex area of medical practice for several reasons. The law varies considerably from state to state. The clinician who practices both in California and across the border in Arizona will face substantially different laws, especially regarding the treatment of adolescents. And the reproductive rights laws in many states are a complicated mix of state statutes and state court decisions, with an overlay of federal statutes and court decisions, and a series of both state and federal regulations. This article demonstrates an additional complexity for practitioners—the continuous change in the law surrounding reproductive rights—and practice involving adolescent patients is especially difficult.

              There are some good state-by-state reviews of laws related to abortion and contraception. We find the Guttmacher Institute particularly helpful. (See “State-by-state reviews of laws related to abortion and contraception”.) Although these are good resources, they are not the basis for legal practice with the current law in a state. The complexity and ever-changing nature of reproductive rights is one of the reasons we believe that it is important that anyone in active ObGyn practice maintain an ongoing professional relationship with a lawyer with expertise in this area of practice. This relationship should establish and update policies and procedures consistent with local law, consent and other forms, reporting of possible child abuse, and the like. An annual legal checkup may be as important for physicians as a physical checkup is for their patients.

              Future outcomes

              At the end of the Term, we will review the outcome of the cases noted above—and the possibility of follow-on cases. Whatever the Court does this Term, it will not be the end of the legal and political struggles over abortion and other reproductive issues. These questions deeply divide our society, and the cases and controversies reflect that continuing division. ●

              References
              1. Buck v Bell, 274 U.S. 200 (1927).
              2. Id. at 207.
              3. Skinner v State of Oklahoma, ex rel. Williamson, 316 U.S. 535 (1942).
              4. Griswold v Connecticut, 381 U.S. 479 (1965)
              5. Eisenstadt v Baird, 405 U.S. 438 (1972).
              6. Roe v Wade, 410 U.S. 113 (1973).
              7. Harris v McRae, 448 U.S. 297 (1980).
              8. Williams v Zbaraz, 448 U.S 358 (1980).
              9. Webster v Reproductive Health Services, 492 U.S. 490 (1989).
              10. Rust v Sullivan, 500 U.S. 173 (1991).
              11. Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U.S. 833 (1992).
              12.  Carey v Population Services, 431 U.S. 678 (1977).
              13. Bellotti v Baird, 443 U.S. 622 (1979).
              14. Planned Parenthood of Kansas City v Ashcroft, 462 U.S. 476 (1983).
              15. Planned Parenthood of Northern New England v Ayotte, 546 U.S. 320 (2006).
              16. H.L. v Matheson, 450 U.S. 398 (1981).
              17. Hodgson v Minnesota, 497 U.S. 417 (1990).
              18. Ohio v Akron Center for Reproductive Health, 497 U.S. 502 (1990).
              19. Lambert v Wicklund, 520 U.S. 292 (1997).
              20. June Medical Services v Russo, 591 U.S. ___ (2020), https:// www.supremecourt.gov/opinions/19pdf/18-1323_c07d.pdf.
              21. Whole Woman’s Health v Hellerstedt, 579 U.S. 582 (2016).
              22. AMA v Becerra, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/american-medical -association-v-cochran.
              23. Becerra v Baltimore, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/cochran-v-mayor-and-city-council-of-baltimore.
              24. Oregon v Becerra, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/oregon-v-cochran.
              25. Cameron v EMW Women’s Surgical Center, 20-601. https:// www.scotusblog.com/case-files/cases/cameron-v-emw -womens-surgical-center-p-s-c.
              26. Ex parte Young, 209 U.S. 123 (1908).
              27. Whole Woman’s Health v Jackson, 21-463. https://www .scotusblog.com/case-files/cases/whole-womans-health-v -jackson.
              28. U.S. v Texas, 21-588. https://www.scotusblog.com/case-files /cases/united-states-v-texas-3.
              29. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.scotusblog.com/case-files/cases/dobbs-v -jackson-womens-health-organization.
              30. Brief of Amici Curiae American College of Obstetricians and Gynecologists et al., Dobbs v Jackson Women’s Health Organization (Sep. 2021). https://www.acog.org/ -/media/project/acog/acogorg/files/advocacy/amicus -briefs/2021/20210920-dobbs-v-jwho-amicus-brief.pdf?la=e n&hash=717DFDD07A03B93A04490E66835BB8C5.
              31. Brief Amicus Curiae of International Federation of Gynecology and Obstetrics, Dobbs v Jackson Women’s Health Organization (Sep. 20, 2021). https://www.supremecourt. gov/DocketPDF/19/19-1392/193019/20210920155508744 _41426%20pdf%20Chen.pdf.
              32. Brief Amicus Curiae of American Association of Pro-Life Obstetricians and Gynecologists. Dobbs v Jackson Women’s Health Organization (Sep. 2021). https://www.supremecourt .gov/DocketPDF/19/19-1392/185350/20210729163532595 _No.%2019-1392%20-%20American%20Association %20of%20Pro-Life%20Obstetricians%20and%20 Gynecologists%20-%20Amicus%20Brief%20in%20Support %20of%20Petitioner%20-%207-29-21.pdf.
              References
              1. Buck v Bell, 274 U.S. 200 (1927).
              2. Id. at 207.
              3. Skinner v State of Oklahoma, ex rel. Williamson, 316 U.S. 535 (1942).
              4. Griswold v Connecticut, 381 U.S. 479 (1965)
              5. Eisenstadt v Baird, 405 U.S. 438 (1972).
              6. Roe v Wade, 410 U.S. 113 (1973).
              7. Harris v McRae, 448 U.S. 297 (1980).
              8. Williams v Zbaraz, 448 U.S 358 (1980).
              9. Webster v Reproductive Health Services, 492 U.S. 490 (1989).
              10. Rust v Sullivan, 500 U.S. 173 (1991).
              11. Planned Parenthood of Southeastern Pennsylvania v Casey, 505 U.S. 833 (1992).
              12.  Carey v Population Services, 431 U.S. 678 (1977).
              13. Bellotti v Baird, 443 U.S. 622 (1979).
              14. Planned Parenthood of Kansas City v Ashcroft, 462 U.S. 476 (1983).
              15. Planned Parenthood of Northern New England v Ayotte, 546 U.S. 320 (2006).
              16. H.L. v Matheson, 450 U.S. 398 (1981).
              17. Hodgson v Minnesota, 497 U.S. 417 (1990).
              18. Ohio v Akron Center for Reproductive Health, 497 U.S. 502 (1990).
              19. Lambert v Wicklund, 520 U.S. 292 (1997).
              20. June Medical Services v Russo, 591 U.S. ___ (2020), https:// www.supremecourt.gov/opinions/19pdf/18-1323_c07d.pdf.
              21. Whole Woman’s Health v Hellerstedt, 579 U.S. 582 (2016).
              22. AMA v Becerra, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/american-medical -association-v-cochran.
              23. Becerra v Baltimore, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/cochran-v-mayor-and-city-council-of-baltimore.
              24. Oregon v Becerra, dismissed May 17, 2021, https://www .scotusblog.com/case-files/cases/oregon-v-cochran.
              25. Cameron v EMW Women’s Surgical Center, 20-601. https:// www.scotusblog.com/case-files/cases/cameron-v-emw -womens-surgical-center-p-s-c.
              26. Ex parte Young, 209 U.S. 123 (1908).
              27. Whole Woman’s Health v Jackson, 21-463. https://www .scotusblog.com/case-files/cases/whole-womans-health-v -jackson.
              28. U.S. v Texas, 21-588. https://www.scotusblog.com/case-files /cases/united-states-v-texas-3.
              29. Dobbs v Jackson Women’s Health Organization, 19-1392. https://www.scotusblog.com/case-files/cases/dobbs-v -jackson-womens-health-organization.
              30. Brief of Amici Curiae American College of Obstetricians and Gynecologists et al., Dobbs v Jackson Women’s Health Organization (Sep. 2021). https://www.acog.org/ -/media/project/acog/acogorg/files/advocacy/amicus -briefs/2021/20210920-dobbs-v-jwho-amicus-brief.pdf?la=e n&hash=717DFDD07A03B93A04490E66835BB8C5.
              31. Brief Amicus Curiae of International Federation of Gynecology and Obstetrics, Dobbs v Jackson Women’s Health Organization (Sep. 20, 2021). https://www.supremecourt. gov/DocketPDF/19/19-1392/193019/20210920155508744 _41426%20pdf%20Chen.pdf.
              32. Brief Amicus Curiae of American Association of Pro-Life Obstetricians and Gynecologists. Dobbs v Jackson Women’s Health Organization (Sep. 2021). https://www.supremecourt .gov/DocketPDF/19/19-1392/185350/20210729163532595 _No.%2019-1392%20-%20American%20Association %20of%20Pro-Life%20Obstetricians%20and%20 Gynecologists%20-%20Amicus%20Brief%20in%20Support %20of%20Petitioner%20-%207-29-21.pdf.
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              The troubling trend of repackaging feminine hygiene products for the next generation

              Article Type
              Changed
              Wed, 01/26/2022 - 13:03

              Feminine hygiene products have been commercially available for decades. They are commonly marketed to reduce odor or clean vaginal discharge and menses. Multiple formulas are available as topical washes, wipes, creams, sprays, powders, deodorants, and douches.1 Products on the market range from those used externally on the vulva, such as wipes and sprays, to liquid solutions used intravaginally, such as washes and douches.

              Who uses feminine hygiene products?

              According to a 2006 study, the majority of women who use douches started using them between age 15 and 19 years, but some women initiate this practice habit as early as age 10 to 14.1 Predictably, women who douche are more likely to perceive douche products as safe.1

              Demographic data on douche utilization are mixed: Some studies show that there are no significant racial differences in douching practices,2 while others have found that Black and African American women are more likely to practice douching than White and Hispanic women.1,3 Studies have shown a significant difference in attitudes toward douching and knowledge of normal vaginal symptoms among US racial demographics, although this must be examined through the historical context of racism and the lens of medical anthropology.4

              Women cite that common reasons they use feminine hygiene products are to feel clean, to control odor, and to use after menses and intercourse.1,2

              Modern marketing approaches

              From wipes to soaps to douches, feminine hygiene products often are advertised to promote “funk-free periods”5 and “freshness,” fostering an environment in which women and men develop unrealistic standards for what is considered normal genital odor and resulting in poor body image.6

              Recently, Vagisil (Combe Incorporated) marketing efforts faced backlash from the ObGyn community for targeting younger populations with a specific product line for adolescents called OMV! In addition, attention has been drawn to VCF vaginal odor eliminating film (Apothecus Pharmaceutical Corp), small stamp-sized dissolving films that are placed in the vaginal canal in contact with the epithelium. This product has entered the market of feminine hygiene products accompanied by slogans of eliminating “feminine odor” and providing “confidence for women to be intimate.”

              Continue to: Effects of feminine hygiene products on the vaginal microbiome...

               

               

              Effects of feminine hygiene products on the vaginal microbiome

              Frequent use of feminine hygiene products has been associated with recurrent vaginitis, bacterial vaginosis, and general irritation/itch,7,8 which can cause more discharge and odor. Ironically, this may result in women using the product more frequently since they often seek out these products to eliminate odor and discharge.1,2

              The pH of the vagina changes during a woman’s lifetime, but in the reproductive years, the normal pH range is typically 3.8 to 4.4.9 This range allows for a normal vaginal flora to form with bacteria such as Lactobacillus species and Gardnerella vaginalis, while feminine hygiene products have a wide range of pH.9,10

              Regardless of the formulation, most feminine hygiene products contain ingredients and compositions that potentially are detrimental to the health of the vulva and vagina. Many products contain acidic ingredients, such as citric acid, lactic acid, and dehydroacetic acid, that can alter the vaginal pH and weaken the vaginal barrier by wiping out normal vaginal flora10 despite being advertised for use on “sensitive areas” (TABLE). Lactic acid also has been found to increase diverse anaerobic bacteria in the vaginal microbiome.11 Some feminine hygiene products have been shown to suppress Lactobacillus growth at 2 hours after use and to kill all lactobacilli at 24 hours.10 Shifts in microbiota numbers often occur when the vaginal pH has been altered, as is frequently the case with feminine hygiene products. In the absence of microbiome bacteria, the presence of vaginal hygiene products has been shown to increase interleukin-8 (IL-8), suggesting a proinflammatory reaction.10

              A study in the United Kingdom found that women who used bubble bath, antiseptics, or douche products had a higher incidence of bacterial vaginosis compared with women who did not use such products.7 Women in Canada who used feminine hygiene products were more likely to report adverse conditions, including yeast infections, bacterial vaginosis, urinary tract infections, and sexually transmitted diseases.8 Furthermore, a significant association exists between vaginal douching and endometrial infection by bacterial vaginosis–associated organisms.12

              Additionally, a study that analyzed volatile organic compound levels in the blood with the use of feminine hygiene products revealed a significant positive dose-exposure relationship between the frequency of vaginal douching in the last 6 months and concentrations of 1,4-dichloromethane, one of the volatile organic compounds.3 This points to the issue of not only disruption of pH and vaginal flora but also to the introduction of harmful substances that can further disrupt the vaginal barrier.

              Understand the products to help educate patients

              Use of feminine hygiene products is common among women. While women depend on the market to filter out products that are considered unsafe or may have harmful side effects,1 unfortunately that is not necessarily the case. With increasingly more feminine products on the market and the target demographic becoming younger, women of all ages are susceptible to misinformation that could affect their vaginal health long term.

              It is vital that clinicians understand the topical effects of these products in order to properly educate and counsel patients. Ultimately, research on feminine hygiene products is limited and, as more products come to market, we must continue to reassess the effects of topical products on the vaginal epithelium and vulvar tissues. ●

              References
              1. Grimley DM, Annang L, Foushee HR, et al. Vaginal douches and other feminine hygiene products: women’s practices and perceptions of product safety. Matern Child Health J. 2006;10:303-310. doi: 10.1007/s10995-005-0054-y.
              2. Foch BJ, McDaniel ND, Chacko MR. Racial differences in vaginal douching knowledge, attitude, and practices among sexually active adolescents. J Pediatr Adolesc Gynecol. 2001;14:29-33. doi: 10.1016/S1083-3188(00)00080-2.
              3. Lin N, Ding N, Meza-Wilson E, et al. Volatile organic compounds in feminine hygiene products sold in the US market: a survey of products and health risks. Environ Int. 2020;144:105740. doi: 10.1016/j.envint.2020.105740.
              4. Wayne State University Digital Commons. Guy-Lee AK. Rituals reproducing race: African American women’s feminine hygiene practices, shared experiences, and power. 2017. http://digitalcommons.wayne.edu/oa_dissertations/1806. Accessed December 13, 2021.
              5. YouTube. OMV! by Vagisil—Intimate care products designed by teens. July 10, 2020. www.youtube.com/ watch?v=VkVsCagrAw0. Accessed December 13, 2021.
              6. Jenkins A, O’Doherty KC. The clean vagina, the healthy vagina, and the dirty vagina: exploring women’s portrayals of the vagina in relation to vaginal cleansing product use. Fem Psychol. 2021;31:192-211. doi: 10.1177/0959353520944144.
              7. Rajamanoharan S, Low N, Jones SB, et al. Bacterial vaginosis, ethnicity, and the use of genital cleansing agents: a case control study. Sex Transm Dis. 1999;26:404-409.
              8. Crann SE, Cunningham S, Albert A, et al. Vaginal health and hygiene practices and product use in Canada: a national cross-sectional survey. BMC Womens Health. 2018;18:52. doi: 10.1186/s12905-018-0543-y.
              9. Chen Y, Bruning E, Rubino J, et al. Role of female intimate hygiene in vulvovaginal health: global hygiene practices and product usage. Womens Health (London). 2017;13:58-67. doi: 10.1177/1745505717731011.
              10. Fashemi B, Delaney ML, Onderdonk AB, et al. Effects of feminine hygiene products on the vaginal mucosal biome. Microb Ecol Health Dis. 2013;24. doi: 10.3402/mehd. v24i0.19703.
              11. Van der Veer C, Bruisten SM, Van Houdt R, et al. Effects of an over-the-counter lactic-acid containing intra-vaginal douching product on the vaginal microbiota. BMC Microbiol. 2019;19:168. doi: 10.1186/s12866-019-1545-0.
              12. Gondwe T, Ness R, Totten PA, et al. Novel bacterial vaginosis-associated organisms mediate the relationship between vaginal douching and pelvic inflammatory disease. Sex Transm Infect. 2020;96:439-444. doi: 10.1136/ sextrans-2019-054191.
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              Dr. Guirguis is a Fellow, Female Pelvic Medicine and Reconstructive Surgery, Magee-Womens Hospital at University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

              Dr. Fitzgerald is an Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Urogynecology and Reconstructive Pelvic Surgery, University of Pittsburgh School of Medicine/ Magee-Women’s Hospital at University of Pittsburgh Medical Center.

              The authors report no financial relationships relevant to this article.

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              Dr. Guirguis is a Fellow, Female Pelvic Medicine and Reconstructive Surgery, Magee-Womens Hospital at University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

              Dr. Fitzgerald is an Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Urogynecology and Reconstructive Pelvic Surgery, University of Pittsburgh School of Medicine/ Magee-Women’s Hospital at University of Pittsburgh Medical Center.

              The authors report no financial relationships relevant to this article.

              Author and Disclosure Information

              Dr. Guirguis is a Fellow, Female Pelvic Medicine and Reconstructive Surgery, Magee-Womens Hospital at University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.

              Dr. Fitzgerald is an Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Division of Urogynecology and Reconstructive Pelvic Surgery, University of Pittsburgh School of Medicine/ Magee-Women’s Hospital at University of Pittsburgh Medical Center.

              The authors report no financial relationships relevant to this article.

              Article PDF
              Article PDF

              Feminine hygiene products have been commercially available for decades. They are commonly marketed to reduce odor or clean vaginal discharge and menses. Multiple formulas are available as topical washes, wipes, creams, sprays, powders, deodorants, and douches.1 Products on the market range from those used externally on the vulva, such as wipes and sprays, to liquid solutions used intravaginally, such as washes and douches.

              Who uses feminine hygiene products?

              According to a 2006 study, the majority of women who use douches started using them between age 15 and 19 years, but some women initiate this practice habit as early as age 10 to 14.1 Predictably, women who douche are more likely to perceive douche products as safe.1

              Demographic data on douche utilization are mixed: Some studies show that there are no significant racial differences in douching practices,2 while others have found that Black and African American women are more likely to practice douching than White and Hispanic women.1,3 Studies have shown a significant difference in attitudes toward douching and knowledge of normal vaginal symptoms among US racial demographics, although this must be examined through the historical context of racism and the lens of medical anthropology.4

              Women cite that common reasons they use feminine hygiene products are to feel clean, to control odor, and to use after menses and intercourse.1,2

              Modern marketing approaches

              From wipes to soaps to douches, feminine hygiene products often are advertised to promote “funk-free periods”5 and “freshness,” fostering an environment in which women and men develop unrealistic standards for what is considered normal genital odor and resulting in poor body image.6

              Recently, Vagisil (Combe Incorporated) marketing efforts faced backlash from the ObGyn community for targeting younger populations with a specific product line for adolescents called OMV! In addition, attention has been drawn to VCF vaginal odor eliminating film (Apothecus Pharmaceutical Corp), small stamp-sized dissolving films that are placed in the vaginal canal in contact with the epithelium. This product has entered the market of feminine hygiene products accompanied by slogans of eliminating “feminine odor” and providing “confidence for women to be intimate.”

              Continue to: Effects of feminine hygiene products on the vaginal microbiome...

               

               

              Effects of feminine hygiene products on the vaginal microbiome

              Frequent use of feminine hygiene products has been associated with recurrent vaginitis, bacterial vaginosis, and general irritation/itch,7,8 which can cause more discharge and odor. Ironically, this may result in women using the product more frequently since they often seek out these products to eliminate odor and discharge.1,2

              The pH of the vagina changes during a woman’s lifetime, but in the reproductive years, the normal pH range is typically 3.8 to 4.4.9 This range allows for a normal vaginal flora to form with bacteria such as Lactobacillus species and Gardnerella vaginalis, while feminine hygiene products have a wide range of pH.9,10

              Regardless of the formulation, most feminine hygiene products contain ingredients and compositions that potentially are detrimental to the health of the vulva and vagina. Many products contain acidic ingredients, such as citric acid, lactic acid, and dehydroacetic acid, that can alter the vaginal pH and weaken the vaginal barrier by wiping out normal vaginal flora10 despite being advertised for use on “sensitive areas” (TABLE). Lactic acid also has been found to increase diverse anaerobic bacteria in the vaginal microbiome.11 Some feminine hygiene products have been shown to suppress Lactobacillus growth at 2 hours after use and to kill all lactobacilli at 24 hours.10 Shifts in microbiota numbers often occur when the vaginal pH has been altered, as is frequently the case with feminine hygiene products. In the absence of microbiome bacteria, the presence of vaginal hygiene products has been shown to increase interleukin-8 (IL-8), suggesting a proinflammatory reaction.10

              A study in the United Kingdom found that women who used bubble bath, antiseptics, or douche products had a higher incidence of bacterial vaginosis compared with women who did not use such products.7 Women in Canada who used feminine hygiene products were more likely to report adverse conditions, including yeast infections, bacterial vaginosis, urinary tract infections, and sexually transmitted diseases.8 Furthermore, a significant association exists between vaginal douching and endometrial infection by bacterial vaginosis–associated organisms.12

              Additionally, a study that analyzed volatile organic compound levels in the blood with the use of feminine hygiene products revealed a significant positive dose-exposure relationship between the frequency of vaginal douching in the last 6 months and concentrations of 1,4-dichloromethane, one of the volatile organic compounds.3 This points to the issue of not only disruption of pH and vaginal flora but also to the introduction of harmful substances that can further disrupt the vaginal barrier.

              Understand the products to help educate patients

              Use of feminine hygiene products is common among women. While women depend on the market to filter out products that are considered unsafe or may have harmful side effects,1 unfortunately that is not necessarily the case. With increasingly more feminine products on the market and the target demographic becoming younger, women of all ages are susceptible to misinformation that could affect their vaginal health long term.

              It is vital that clinicians understand the topical effects of these products in order to properly educate and counsel patients. Ultimately, research on feminine hygiene products is limited and, as more products come to market, we must continue to reassess the effects of topical products on the vaginal epithelium and vulvar tissues. ●

              Feminine hygiene products have been commercially available for decades. They are commonly marketed to reduce odor or clean vaginal discharge and menses. Multiple formulas are available as topical washes, wipes, creams, sprays, powders, deodorants, and douches.1 Products on the market range from those used externally on the vulva, such as wipes and sprays, to liquid solutions used intravaginally, such as washes and douches.

              Who uses feminine hygiene products?

              According to a 2006 study, the majority of women who use douches started using them between age 15 and 19 years, but some women initiate this practice habit as early as age 10 to 14.1 Predictably, women who douche are more likely to perceive douche products as safe.1

              Demographic data on douche utilization are mixed: Some studies show that there are no significant racial differences in douching practices,2 while others have found that Black and African American women are more likely to practice douching than White and Hispanic women.1,3 Studies have shown a significant difference in attitudes toward douching and knowledge of normal vaginal symptoms among US racial demographics, although this must be examined through the historical context of racism and the lens of medical anthropology.4

              Women cite that common reasons they use feminine hygiene products are to feel clean, to control odor, and to use after menses and intercourse.1,2

              Modern marketing approaches

              From wipes to soaps to douches, feminine hygiene products often are advertised to promote “funk-free periods”5 and “freshness,” fostering an environment in which women and men develop unrealistic standards for what is considered normal genital odor and resulting in poor body image.6

              Recently, Vagisil (Combe Incorporated) marketing efforts faced backlash from the ObGyn community for targeting younger populations with a specific product line for adolescents called OMV! In addition, attention has been drawn to VCF vaginal odor eliminating film (Apothecus Pharmaceutical Corp), small stamp-sized dissolving films that are placed in the vaginal canal in contact with the epithelium. This product has entered the market of feminine hygiene products accompanied by slogans of eliminating “feminine odor” and providing “confidence for women to be intimate.”

              Continue to: Effects of feminine hygiene products on the vaginal microbiome...

               

               

              Effects of feminine hygiene products on the vaginal microbiome

              Frequent use of feminine hygiene products has been associated with recurrent vaginitis, bacterial vaginosis, and general irritation/itch,7,8 which can cause more discharge and odor. Ironically, this may result in women using the product more frequently since they often seek out these products to eliminate odor and discharge.1,2

              The pH of the vagina changes during a woman’s lifetime, but in the reproductive years, the normal pH range is typically 3.8 to 4.4.9 This range allows for a normal vaginal flora to form with bacteria such as Lactobacillus species and Gardnerella vaginalis, while feminine hygiene products have a wide range of pH.9,10

              Regardless of the formulation, most feminine hygiene products contain ingredients and compositions that potentially are detrimental to the health of the vulva and vagina. Many products contain acidic ingredients, such as citric acid, lactic acid, and dehydroacetic acid, that can alter the vaginal pH and weaken the vaginal barrier by wiping out normal vaginal flora10 despite being advertised for use on “sensitive areas” (TABLE). Lactic acid also has been found to increase diverse anaerobic bacteria in the vaginal microbiome.11 Some feminine hygiene products have been shown to suppress Lactobacillus growth at 2 hours after use and to kill all lactobacilli at 24 hours.10 Shifts in microbiota numbers often occur when the vaginal pH has been altered, as is frequently the case with feminine hygiene products. In the absence of microbiome bacteria, the presence of vaginal hygiene products has been shown to increase interleukin-8 (IL-8), suggesting a proinflammatory reaction.10

              A study in the United Kingdom found that women who used bubble bath, antiseptics, or douche products had a higher incidence of bacterial vaginosis compared with women who did not use such products.7 Women in Canada who used feminine hygiene products were more likely to report adverse conditions, including yeast infections, bacterial vaginosis, urinary tract infections, and sexually transmitted diseases.8 Furthermore, a significant association exists between vaginal douching and endometrial infection by bacterial vaginosis–associated organisms.12

              Additionally, a study that analyzed volatile organic compound levels in the blood with the use of feminine hygiene products revealed a significant positive dose-exposure relationship between the frequency of vaginal douching in the last 6 months and concentrations of 1,4-dichloromethane, one of the volatile organic compounds.3 This points to the issue of not only disruption of pH and vaginal flora but also to the introduction of harmful substances that can further disrupt the vaginal barrier.

              Understand the products to help educate patients

              Use of feminine hygiene products is common among women. While women depend on the market to filter out products that are considered unsafe or may have harmful side effects,1 unfortunately that is not necessarily the case. With increasingly more feminine products on the market and the target demographic becoming younger, women of all ages are susceptible to misinformation that could affect their vaginal health long term.

              It is vital that clinicians understand the topical effects of these products in order to properly educate and counsel patients. Ultimately, research on feminine hygiene products is limited and, as more products come to market, we must continue to reassess the effects of topical products on the vaginal epithelium and vulvar tissues. ●

              References
              1. Grimley DM, Annang L, Foushee HR, et al. Vaginal douches and other feminine hygiene products: women’s practices and perceptions of product safety. Matern Child Health J. 2006;10:303-310. doi: 10.1007/s10995-005-0054-y.
              2. Foch BJ, McDaniel ND, Chacko MR. Racial differences in vaginal douching knowledge, attitude, and practices among sexually active adolescents. J Pediatr Adolesc Gynecol. 2001;14:29-33. doi: 10.1016/S1083-3188(00)00080-2.
              3. Lin N, Ding N, Meza-Wilson E, et al. Volatile organic compounds in feminine hygiene products sold in the US market: a survey of products and health risks. Environ Int. 2020;144:105740. doi: 10.1016/j.envint.2020.105740.
              4. Wayne State University Digital Commons. Guy-Lee AK. Rituals reproducing race: African American women’s feminine hygiene practices, shared experiences, and power. 2017. http://digitalcommons.wayne.edu/oa_dissertations/1806. Accessed December 13, 2021.
              5. YouTube. OMV! by Vagisil—Intimate care products designed by teens. July 10, 2020. www.youtube.com/ watch?v=VkVsCagrAw0. Accessed December 13, 2021.
              6. Jenkins A, O’Doherty KC. The clean vagina, the healthy vagina, and the dirty vagina: exploring women’s portrayals of the vagina in relation to vaginal cleansing product use. Fem Psychol. 2021;31:192-211. doi: 10.1177/0959353520944144.
              7. Rajamanoharan S, Low N, Jones SB, et al. Bacterial vaginosis, ethnicity, and the use of genital cleansing agents: a case control study. Sex Transm Dis. 1999;26:404-409.
              8. Crann SE, Cunningham S, Albert A, et al. Vaginal health and hygiene practices and product use in Canada: a national cross-sectional survey. BMC Womens Health. 2018;18:52. doi: 10.1186/s12905-018-0543-y.
              9. Chen Y, Bruning E, Rubino J, et al. Role of female intimate hygiene in vulvovaginal health: global hygiene practices and product usage. Womens Health (London). 2017;13:58-67. doi: 10.1177/1745505717731011.
              10. Fashemi B, Delaney ML, Onderdonk AB, et al. Effects of feminine hygiene products on the vaginal mucosal biome. Microb Ecol Health Dis. 2013;24. doi: 10.3402/mehd. v24i0.19703.
              11. Van der Veer C, Bruisten SM, Van Houdt R, et al. Effects of an over-the-counter lactic-acid containing intra-vaginal douching product on the vaginal microbiota. BMC Microbiol. 2019;19:168. doi: 10.1186/s12866-019-1545-0.
              12. Gondwe T, Ness R, Totten PA, et al. Novel bacterial vaginosis-associated organisms mediate the relationship between vaginal douching and pelvic inflammatory disease. Sex Transm Infect. 2020;96:439-444. doi: 10.1136/ sextrans-2019-054191.
              References
              1. Grimley DM, Annang L, Foushee HR, et al. Vaginal douches and other feminine hygiene products: women’s practices and perceptions of product safety. Matern Child Health J. 2006;10:303-310. doi: 10.1007/s10995-005-0054-y.
              2. Foch BJ, McDaniel ND, Chacko MR. Racial differences in vaginal douching knowledge, attitude, and practices among sexually active adolescents. J Pediatr Adolesc Gynecol. 2001;14:29-33. doi: 10.1016/S1083-3188(00)00080-2.
              3. Lin N, Ding N, Meza-Wilson E, et al. Volatile organic compounds in feminine hygiene products sold in the US market: a survey of products and health risks. Environ Int. 2020;144:105740. doi: 10.1016/j.envint.2020.105740.
              4. Wayne State University Digital Commons. Guy-Lee AK. Rituals reproducing race: African American women’s feminine hygiene practices, shared experiences, and power. 2017. http://digitalcommons.wayne.edu/oa_dissertations/1806. Accessed December 13, 2021.
              5. YouTube. OMV! by Vagisil—Intimate care products designed by teens. July 10, 2020. www.youtube.com/ watch?v=VkVsCagrAw0. Accessed December 13, 2021.
              6. Jenkins A, O’Doherty KC. The clean vagina, the healthy vagina, and the dirty vagina: exploring women’s portrayals of the vagina in relation to vaginal cleansing product use. Fem Psychol. 2021;31:192-211. doi: 10.1177/0959353520944144.
              7. Rajamanoharan S, Low N, Jones SB, et al. Bacterial vaginosis, ethnicity, and the use of genital cleansing agents: a case control study. Sex Transm Dis. 1999;26:404-409.
              8. Crann SE, Cunningham S, Albert A, et al. Vaginal health and hygiene practices and product use in Canada: a national cross-sectional survey. BMC Womens Health. 2018;18:52. doi: 10.1186/s12905-018-0543-y.
              9. Chen Y, Bruning E, Rubino J, et al. Role of female intimate hygiene in vulvovaginal health: global hygiene practices and product usage. Womens Health (London). 2017;13:58-67. doi: 10.1177/1745505717731011.
              10. Fashemi B, Delaney ML, Onderdonk AB, et al. Effects of feminine hygiene products on the vaginal mucosal biome. Microb Ecol Health Dis. 2013;24. doi: 10.3402/mehd. v24i0.19703.
              11. Van der Veer C, Bruisten SM, Van Houdt R, et al. Effects of an over-the-counter lactic-acid containing intra-vaginal douching product on the vaginal microbiota. BMC Microbiol. 2019;19:168. doi: 10.1186/s12866-019-1545-0.
              12. Gondwe T, Ness R, Totten PA, et al. Novel bacterial vaginosis-associated organisms mediate the relationship between vaginal douching and pelvic inflammatory disease. Sex Transm Infect. 2020;96:439-444. doi: 10.1136/ sextrans-2019-054191.
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              Prior authorization abuse: It’s time for health insurance CEOs and their proxies to cease and desist the practice once and for all!

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              Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

              • Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

              While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

              • A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.1
              • While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.2

              The potential significance of the generated delays

              While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

              Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,3 meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.3 Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

              Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

              1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
              2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
              3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
              4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
              5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

              Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

              And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

              • The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.4 To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.4
              • About 86% of practices reported an increased burden of prior authorizations in the last 5 years.5

               

              Continue to: What is to be done?

               

               

              What is to be done?

              I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.6

              A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

              Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

              Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

               

              References
              1. Corder JC. Streamlining the insurance prior authorization debacle. Mo Med. 2018;115:312-314.
              2. Prior authorization hurdles have led to serious adverse events. American Medical Association website. February 5, 2019. https://www.ama-assn .org/press-center/press-releases/prior-author ization-hurdles-have-led-serious-adverse -events. Accessed November 29, 2021.
              3. Council for Affordable Quality Healthcare. 2020 CAQH INDEX. https://www.caqh.org/sites /default/files/explorations/index/2020-caqh -index.pdf. Accessed November 22, 2021.
              4. Most physicians had little relief from prior authorization as COVID cases soared. American Medical Association website. April 7, 2021. https:// www.ama-assn.org/press-center/press-releases /most-physicians-had-little-relief-prior-author ization-covid-cases. Accessed November 29, 2021.
              5. Robeznieks A. 1 in 4 doctors say prior authorization has led to a serious adverse event. American Medical Association website. February 5, 2019. https://www .ama-assn.org/practice-management/sustainability /1-4-doctors-say-prior-authorization-has-led-serious -adverse. Accessed November 29, 2021.
              6. Physicians call on Congress to address prior authorization reform. American Medical Association website. May 14, 2021. https://www .ama-assn.org/press-center/press-releases /physicians-call-congress-address-prior-author ization-reform. Accessed November 29, 2021.
              Article PDF
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              James A. Simon, MD

              Dr. Simon is Clinical Professor, Department of Obstetrics and Gynecology, George Washington University, and Medical Director, IntimMedicine® Specialists, Washington, DC.

              Dr. Simon reports receiving grant/research support from: AbbVie, Inc.; Bayer Healthcare LLC.; Dare´ Bioscience; Ipsen; Myovant Sciences; ObsEva SA; Sebela Pharmaceuticals Inc.; and Viveve Medical; being a consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc.; Besins Healthcare; California Institute of Integral Studies (CIIS); Camargo Pharmaceutical Services, LLC; Covance Inc.; Dare´ Bioscience; DEKA M.E.L.A S.r.l.; Femasys Inc.; KaNDy/NeRRe Therapeutics Ltd.; Madorra Pty Ltd.; Mitsubishi Tanabe Pharma Development America, Inc.; QUE Oncology Pty; Limited; Sebela Pharmaceuticals, Inc.; Sprout Pharmaceuticals, Inc.; and Vella Bioscience Inc.; serving on the speaker’s bureaus of: Mayne Pharma, Inc.; Myovant Sciences, Inc.; Pfizer Inc. (New York, NY); Pharmavite LLC.; and TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals.

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              James A. Simon, MD

              Dr. Simon is Clinical Professor, Department of Obstetrics and Gynecology, George Washington University, and Medical Director, IntimMedicine® Specialists, Washington, DC.

              Dr. Simon reports receiving grant/research support from: AbbVie, Inc.; Bayer Healthcare LLC.; Dare´ Bioscience; Ipsen; Myovant Sciences; ObsEva SA; Sebela Pharmaceuticals Inc.; and Viveve Medical; being a consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc.; Besins Healthcare; California Institute of Integral Studies (CIIS); Camargo Pharmaceutical Services, LLC; Covance Inc.; Dare´ Bioscience; DEKA M.E.L.A S.r.l.; Femasys Inc.; KaNDy/NeRRe Therapeutics Ltd.; Madorra Pty Ltd.; Mitsubishi Tanabe Pharma Development America, Inc.; QUE Oncology Pty; Limited; Sebela Pharmaceuticals, Inc.; Sprout Pharmaceuticals, Inc.; and Vella Bioscience Inc.; serving on the speaker’s bureaus of: Mayne Pharma, Inc.; Myovant Sciences, Inc.; Pfizer Inc. (New York, NY); Pharmavite LLC.; and TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals.

              Author and Disclosure Information

              James A. Simon, MD

              Dr. Simon is Clinical Professor, Department of Obstetrics and Gynecology, George Washington University, and Medical Director, IntimMedicine® Specialists, Washington, DC.

              Dr. Simon reports receiving grant/research support from: AbbVie, Inc.; Bayer Healthcare LLC.; Dare´ Bioscience; Ipsen; Myovant Sciences; ObsEva SA; Sebela Pharmaceuticals Inc.; and Viveve Medical; being a consultant/advisory board member for: Bayer HealthCare Pharmaceuticals Inc.; Besins Healthcare; California Institute of Integral Studies (CIIS); Camargo Pharmaceutical Services, LLC; Covance Inc.; Dare´ Bioscience; DEKA M.E.L.A S.r.l.; Femasys Inc.; KaNDy/NeRRe Therapeutics Ltd.; Madorra Pty Ltd.; Mitsubishi Tanabe Pharma Development America, Inc.; QUE Oncology Pty; Limited; Sebela Pharmaceuticals, Inc.; Sprout Pharmaceuticals, Inc.; and Vella Bioscience Inc.; serving on the speaker’s bureaus of: Mayne Pharma, Inc.; Myovant Sciences, Inc.; Pfizer Inc. (New York, NY); Pharmavite LLC.; and TherapeuticsMD; and being a stockholder (direct purchase) in: Sermonix Pharmaceuticals.

              Article PDF
              Article PDF

              Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

              • Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

              While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

              • A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.1
              • While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.2

              The potential significance of the generated delays

              While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

              Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,3 meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.3 Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

              Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

              1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
              2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
              3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
              4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
              5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

              Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

              And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

              • The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.4 To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.4
              • About 86% of practices reported an increased burden of prior authorizations in the last 5 years.5

               

              Continue to: What is to be done?

               

               

              What is to be done?

              I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.6

              A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

              Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

              Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

               

              Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

              • Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

              While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

              • A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.1
              • While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.2

              The potential significance of the generated delays

              While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

              Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,3 meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.3 Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

              Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

              1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
              2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
              3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
              4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
              5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

              Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

              And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

              • The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.4 To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.4
              • About 86% of practices reported an increased burden of prior authorizations in the last 5 years.5

               

              Continue to: What is to be done?

               

               

              What is to be done?

              I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.6

              A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

              Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

              Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

               

              References
              1. Corder JC. Streamlining the insurance prior authorization debacle. Mo Med. 2018;115:312-314.
              2. Prior authorization hurdles have led to serious adverse events. American Medical Association website. February 5, 2019. https://www.ama-assn .org/press-center/press-releases/prior-author ization-hurdles-have-led-serious-adverse -events. Accessed November 29, 2021.
              3. Council for Affordable Quality Healthcare. 2020 CAQH INDEX. https://www.caqh.org/sites /default/files/explorations/index/2020-caqh -index.pdf. Accessed November 22, 2021.
              4. Most physicians had little relief from prior authorization as COVID cases soared. American Medical Association website. April 7, 2021. https:// www.ama-assn.org/press-center/press-releases /most-physicians-had-little-relief-prior-author ization-covid-cases. Accessed November 29, 2021.
              5. Robeznieks A. 1 in 4 doctors say prior authorization has led to a serious adverse event. American Medical Association website. February 5, 2019. https://www .ama-assn.org/practice-management/sustainability /1-4-doctors-say-prior-authorization-has-led-serious -adverse. Accessed November 29, 2021.
              6. Physicians call on Congress to address prior authorization reform. American Medical Association website. May 14, 2021. https://www .ama-assn.org/press-center/press-releases /physicians-call-congress-address-prior-author ization-reform. Accessed November 29, 2021.
              References
              1. Corder JC. Streamlining the insurance prior authorization debacle. Mo Med. 2018;115:312-314.
              2. Prior authorization hurdles have led to serious adverse events. American Medical Association website. February 5, 2019. https://www.ama-assn .org/press-center/press-releases/prior-author ization-hurdles-have-led-serious-adverse -events. Accessed November 29, 2021.
              3. Council for Affordable Quality Healthcare. 2020 CAQH INDEX. https://www.caqh.org/sites /default/files/explorations/index/2020-caqh -index.pdf. Accessed November 22, 2021.
              4. Most physicians had little relief from prior authorization as COVID cases soared. American Medical Association website. April 7, 2021. https:// www.ama-assn.org/press-center/press-releases /most-physicians-had-little-relief-prior-author ization-covid-cases. Accessed November 29, 2021.
              5. Robeznieks A. 1 in 4 doctors say prior authorization has led to a serious adverse event. American Medical Association website. February 5, 2019. https://www .ama-assn.org/practice-management/sustainability /1-4-doctors-say-prior-authorization-has-led-serious -adverse. Accessed November 29, 2021.
              6. Physicians call on Congress to address prior authorization reform. American Medical Association website. May 14, 2021. https://www .ama-assn.org/press-center/press-releases /physicians-call-congress-address-prior-author ization-reform. Accessed November 29, 2021.
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              Are there perinatal benefits to pregnant patients after bariatric surgery?

              Article Type
              Changed
              Wed, 01/26/2022 - 13:19

              Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

              EXPERT COMMENTARY

              Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.1 Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,2 and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

              Details of the study

              Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m2 with no comorbidities or a BMI between 35 and 40 kg/m2 with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

              Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

              These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

              Study strengths and limitations

              Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity1 and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

              Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

              Benefits of bariatric surgery extend to perinatal outcomes

              This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE

              An important, modifiable risk factor for adverse perinatal outcomes is the patient’s prepregnancy BMI at the time of pregnancy. Bariatric surgery is an effective procedure for weight loss. There are many perinatal benefits for eligible patients who have bariatric surgery before pregnancy. Clinicians should counsel their obese patients who are considering or planning pregnancy about the benefits of bariatric surgery.

              RODNEY A. MCLAREN, JR, MD, AND VINCENZO BERGHELLA, MD

              References
              1. Driscoll AK, Gregory ECW. Increases in prepregnancy obesity: United States, 2016-2019. NCHS Data Brief. 2020 Nov;(392):1-8.
              2. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724- 1737. doi: 10.1001/jama.292.14.1724.
              3. Maggard MA, Yermilov I, Li Z, et al. Pregnancy and fertility following bariatric surgery: a systematic review. JAMA. 2008;300:2286-2296. doi: 10.1001/jama.2008.641.
              4. Watanabe A, Seki Y, Haruta H, et al. Maternal impacts and perinatal outcomes after three types of bariatric surgery at a single institution. Arch Gynecol Obstet. 2019;300:145-152. doi: 10.1007/s00404-019-05195-9.
              5. Balestrin B, Urbanetz AA, Barbieri MM, et al. Pregnancy after bariatric surgery: a comparative study of post-bariatric pregnant women versus non-bariatric obese pregnant women. Obes Surg. 2019;29:3142-3148. doi: 10.1007/s11695- 019-03961-x.
              Article PDF
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              Rodney A. McLaren, Jr, MD, Assistant Professor of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania.

              Vincenzo Berghella, MD, Professor of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia.

              The authors report no financial relationships relevant to this article.

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              Rodney A. McLaren, Jr, MD, Assistant Professor of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania.

              Vincenzo Berghella, MD, Professor of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia.

              The authors report no financial relationships relevant to this article.

              Author and Disclosure Information

              Rodney A. McLaren, Jr, MD, Assistant Professor of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia, Pennsylvania.

              Vincenzo Berghella, MD, Professor of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Thomas Jefferson University, Philadelphia.

              The authors report no financial relationships relevant to this article.

              Article PDF
              Article PDF

              Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

              EXPERT COMMENTARY

              Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.1 Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,2 and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

              Details of the study

              Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m2 with no comorbidities or a BMI between 35 and 40 kg/m2 with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

              Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

              These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

              Study strengths and limitations

              Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity1 and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

              Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

              Benefits of bariatric surgery extend to perinatal outcomes

              This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE

              An important, modifiable risk factor for adverse perinatal outcomes is the patient’s prepregnancy BMI at the time of pregnancy. Bariatric surgery is an effective procedure for weight loss. There are many perinatal benefits for eligible patients who have bariatric surgery before pregnancy. Clinicians should counsel their obese patients who are considering or planning pregnancy about the benefits of bariatric surgery.

              RODNEY A. MCLAREN, JR, MD, AND VINCENZO BERGHELLA, MD

              Getahun D, Fassett MJ, Jacobsen SJ, et al. Perinatal outcomes after bariatric surgery. Am J Obstet Gynecol. 2021;S0002-9378(21)00771-7. doi: 10.1016/j.ajog.2021 .06.087.

              EXPERT COMMENTARY

              Prepregnancy obesity continues to rise in the United States, with a prevalence of 29% among reproductive-age women in 2019, an 11% increase from 2016.1 Pregnant patients with obesity are at increased risk for multiple adverse perinatal outcomes, including gestational diabetes and preeclampsia. Bariatric surgery is effective for weight loss and has been shown to improve comorbidities associated with obesity,2 and it may have potential benefits for pregnancy outcomes, such as reducing rates of gestational diabetes and preeclampsia.3-5 However, little was known about other outcomes as well as other potential factors before a recent study in which investigators examined perinatal outcomes after bariatric surgery.

              Details of the study

              Getahun and colleagues conducted a population-based, retrospective study of pregnant patients who were eligible for bariatric surgery (body mass index [BMI] ≥40 kg/m2 with no comorbidities or a BMI between 35 and 40 kg/m2 with obesity-related comorbidities, such as diabetes). They aimed to evaluate the association of bariatric surgery with adverse perinatal outcomes.

              Results. In a large sample of pregnant patients eligible for bariatric surgery (N = 20,213), the authors found that patients who had bariatric surgery (n = 1,886) had a reduced risk of macrosomia (aOR, 0.24), preeclampsia (aOR, 0.53), gestational diabetes (aOR, 0.60), and cesarean delivery (aOR, 0.65) compared with those who did not have bariatric surgery (n = 18,327). They also found that patients who had bariatric surgery had an increased risk of small-for-gestational age neonates (aOR, 2.46) and postpartum hemorrhage (aOR, 1.79).

              These results remained after adjusting for other potential confounders. The authors evaluated the outcomes based on the timing of surgery and the patients’ pregnancy (<1 year, 1-1.5 years, 1.5-2 years, >2 years). The outcomes were more favorable among the patients who had the bariatric surgery regardless of the time interval of surgery to pregnancy than those who did not have the surgery. In addition, the benefits of bariatric surgery did not differ between the 2 most common types of bariatric surgery (Roux-en-Y gastric bypass and vertical sleeve gastrectomy) performed in this study, and both had better outcomes than those who did not have the surgery. Finally, patients with chronic hypertension and pregestational diabetes who had bariatric surgery also had lower risks of adverse outcomes than those without bariatric surgery.

              Study strengths and limitations

              Given the study’s retrospective design, uncertainties and important confounders could not be addressed, such as why certain eligible patients had the surgery and others did not. However, with its large sample size and an appropriate comparison group, the study findings further support the perinatal benefits of bariatric surgery in obese patients. Of note, this study also had a large sample of Black and Hispanic patients, populations known to have higher rates of obesity1 and pregnancy complications. Subgroup analyses within each racial/ethnic group revealed that those who had the surgery had lower risks of adverse perinatal outcomes than those who did not.

              Patients who had the bariatric surgery had an increased risk of postpartum hemorrhage; however, there is no physiologic basis or theory to explain this finding, so further studies are needed. Lastly, although patients who had bariatric surgery had an increased risk of small-for-gestational-age babies and the study was not powered for the risk of stillbirth, the patients who had the surgery had a reduced risk of neonates admitted to the neonatal intensive care unit. More data would have been beneficial to assess if these small-for-gestational-age babies were healthy. In general, obese patients tend to have larger and unhealthy babies; thus, healthier babies, even if small for gestational age, would not be an adverse outcome.

              Benefits of bariatric surgery extend to perinatal outcomes

              This study reinforces current practice that includes eligible patients being counseled about the health-related benefits of bariatric surgery, which now includes more perinatal outcomes. The finding of the increased risk of small-for-gestational-age fetuses supports the practice of a screening growth ultrasound exam in patients who had bariatric surgery. ●

               

              WHAT THIS EVIDENCE MEANS FOR PRACTICE

              An important, modifiable risk factor for adverse perinatal outcomes is the patient’s prepregnancy BMI at the time of pregnancy. Bariatric surgery is an effective procedure for weight loss. There are many perinatal benefits for eligible patients who have bariatric surgery before pregnancy. Clinicians should counsel their obese patients who are considering or planning pregnancy about the benefits of bariatric surgery.

              RODNEY A. MCLAREN, JR, MD, AND VINCENZO BERGHELLA, MD

              References
              1. Driscoll AK, Gregory ECW. Increases in prepregnancy obesity: United States, 2016-2019. NCHS Data Brief. 2020 Nov;(392):1-8.
              2. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724- 1737. doi: 10.1001/jama.292.14.1724.
              3. Maggard MA, Yermilov I, Li Z, et al. Pregnancy and fertility following bariatric surgery: a systematic review. JAMA. 2008;300:2286-2296. doi: 10.1001/jama.2008.641.
              4. Watanabe A, Seki Y, Haruta H, et al. Maternal impacts and perinatal outcomes after three types of bariatric surgery at a single institution. Arch Gynecol Obstet. 2019;300:145-152. doi: 10.1007/s00404-019-05195-9.
              5. Balestrin B, Urbanetz AA, Barbieri MM, et al. Pregnancy after bariatric surgery: a comparative study of post-bariatric pregnant women versus non-bariatric obese pregnant women. Obes Surg. 2019;29:3142-3148. doi: 10.1007/s11695- 019-03961-x.
              References
              1. Driscoll AK, Gregory ECW. Increases in prepregnancy obesity: United States, 2016-2019. NCHS Data Brief. 2020 Nov;(392):1-8.
              2. Buchwald H, Avidor Y, Braunwald E, et al. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004;292:1724- 1737. doi: 10.1001/jama.292.14.1724.
              3. Maggard MA, Yermilov I, Li Z, et al. Pregnancy and fertility following bariatric surgery: a systematic review. JAMA. 2008;300:2286-2296. doi: 10.1001/jama.2008.641.
              4. Watanabe A, Seki Y, Haruta H, et al. Maternal impacts and perinatal outcomes after three types of bariatric surgery at a single institution. Arch Gynecol Obstet. 2019;300:145-152. doi: 10.1007/s00404-019-05195-9.
              5. Balestrin B, Urbanetz AA, Barbieri MM, et al. Pregnancy after bariatric surgery: a comparative study of post-bariatric pregnant women versus non-bariatric obese pregnant women. Obes Surg. 2019;29:3142-3148. doi: 10.1007/s11695- 019-03961-x.
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