Sherry Boschert

SAN FRANCISCO – A large randomized, double-blind placebo-controlled study in the Netherlands supports earlier studies that found no benefit from routine maintenance tocolysis using nifedipine in women with arrested preterm labor.

What to do when preterm labor stops is "a million dollar question that many of us have faced," Dr. Deirdre J. Lyell said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco. Surveys suggest that more than a quarter of maternal-fetal medicine specialists routinely use maintenance tocolysis, most often with nifedipine, despite its questionable utility.

The Dutch study of 406 women "puts the question to bed," said Dr. Lyell, a maternal-fetal medicine ob.gyn. at Stanford (Calif.) University. She was not involved in the study.

The multicenter trial in these women was underpowered to show a statistically significant difference in its primary outcome – a composite of perinatal adverse outcomes – because of a lower-than-expected rate of adverse events in the control group, so it couldn’t exclude a possible benefit from nifedipine. However, "its use for maintenance tocolysis does not appear beneficial at this time," the investigators wrote (JAMA 2013;309:41-7).

Women in the study had arrested preterm labor at 24-34 weeks’ gestation. They were randomized to maintenance tocolysis with 20 mg nifedipine or placebo every 4-6 hours. Delivery occurred at 35 weeks in the nifedipine group and at 35 weeks and 2 days in the control group. The number of days of pregnancy after starting treatment was 34 and 33, respectively, and the two groups had similar rates of recurrent preterm labor. Twelve percent in the nifedipine group and 14% in the control group developed one of the problems in the primary composite outcome: perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage greater than grade 2, periventricular leukomalacia greater than grade 1, or necrotizing enterocolitis.

"There’s no evidence these medications were able to delay delivery," Dr. Lyell said.

Three previous randomized trials also found no benefit from maintenance tocolysis with nifedipine. One nonblinded study of 74 U.S. women found no difference in outcomes (Am. J. Obstet. Gynecol. 1999;181:822-7). Neither did a nonblinded Iranian study that randomized 73 women but did not report how the randomization was conducted (J. Perinat. Med. 2004;32:220-4). Dr. Lyell and her associates then conducted a double-blind placebo-controlled trial in 68 women, which again was negative (Obstet. Gynecol. 2008;112:1221-6).

These studies were small, "but we still haven’t seen anything robust to say this is something we should do," Dr. Lyell said.

Nifedipine can produce maternal side effects. In a trial comparing intravenous magnesium sulfate with oral nifedipine for acute tocolysis, nifedipine caused headache in 24% of women who received the drug, vomiting in 5%, hypotension in 5%, shortness of breath in 5%, and lethargy in 5% (Obstet. Gynecol. 2007;110:61-7).

Beta-mimetics such as terbutaline have a much longer list of maternal, fetal, and neonatal side effects, and two randomized controlled trials have shown that maintenance tocolysis using a terbutaline pump was not more effective than giving saline to prevent recurrent preterm labor, Dr. Lyell said.

A 2008 survey of 827 members of the Society of Maternal-Fetal Medicine found that 29% routinely use maintenance tocolysis and 31% will use it if the patient desires. Among members who employ maintenance tocolysis, nifedipine was the first choice of 79% (Obstet. Gynecol. 2008;112:42-7).

In an informal electronic survey of the physicians, nurses, and midwives at the meeting, 6% said they routinely use maintenance tocolysis, 67% occasionally use it, and 26% never use it. In a repeat survey after Dr. Lyell’s talk, none favored routine maintenance tocolysis, 53% said they would use it occasionally, and 47% said they would no longer use it.

The Netherlands Organization for Health Research and Development funded the study. Dr. Lyell reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A large randomized, double-blind placebo-controlled study in the Netherlands supports earlier studies that found no benefit from routine maintenance tocolysis using nifedipine in women with arrested preterm labor.

What to do when preterm labor stops is "a million dollar question that many of us have faced," Dr. Deirdre J. Lyell said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco. Surveys suggest that more than a quarter of maternal-fetal medicine specialists routinely use maintenance tocolysis, most often with nifedipine, despite its questionable utility.

The Dutch study of 406 women "puts the question to bed," said Dr. Lyell, a maternal-fetal medicine ob.gyn. at Stanford (Calif.) University. She was not involved in the study.

The multicenter trial in these women was underpowered to show a statistically significant difference in its primary outcome – a composite of perinatal adverse outcomes – because of a lower-than-expected rate of adverse events in the control group, so it couldn’t exclude a possible benefit from nifedipine. However, "its use for maintenance tocolysis does not appear beneficial at this time," the investigators wrote (JAMA 2013;309:41-7).

Women in the study had arrested preterm labor at 24-34 weeks’ gestation. They were randomized to maintenance tocolysis with 20 mg nifedipine or placebo every 4-6 hours. Delivery occurred at 35 weeks in the nifedipine group and at 35 weeks and 2 days in the control group. The number of days of pregnancy after starting treatment was 34 and 33, respectively, and the two groups had similar rates of recurrent preterm labor. Twelve percent in the nifedipine group and 14% in the control group developed one of the problems in the primary composite outcome: perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage greater than grade 2, periventricular leukomalacia greater than grade 1, or necrotizing enterocolitis.

"There’s no evidence these medications were able to delay delivery," Dr. Lyell said.

Three previous randomized trials also found no benefit from maintenance tocolysis with nifedipine. One nonblinded study of 74 U.S. women found no difference in outcomes (Am. J. Obstet. Gynecol. 1999;181:822-7). Neither did a nonblinded Iranian study that randomized 73 women but did not report how the randomization was conducted (J. Perinat. Med. 2004;32:220-4). Dr. Lyell and her associates then conducted a double-blind placebo-controlled trial in 68 women, which again was negative (Obstet. Gynecol. 2008;112:1221-6).

These studies were small, "but we still haven’t seen anything robust to say this is something we should do," Dr. Lyell said.

Nifedipine can produce maternal side effects. In a trial comparing intravenous magnesium sulfate with oral nifedipine for acute tocolysis, nifedipine caused headache in 24% of women who received the drug, vomiting in 5%, hypotension in 5%, shortness of breath in 5%, and lethargy in 5% (Obstet. Gynecol. 2007;110:61-7).

Beta-mimetics such as terbutaline have a much longer list of maternal, fetal, and neonatal side effects, and two randomized controlled trials have shown that maintenance tocolysis using a terbutaline pump was not more effective than giving saline to prevent recurrent preterm labor, Dr. Lyell said.

A 2008 survey of 827 members of the Society of Maternal-Fetal Medicine found that 29% routinely use maintenance tocolysis and 31% will use it if the patient desires. Among members who employ maintenance tocolysis, nifedipine was the first choice of 79% (Obstet. Gynecol. 2008;112:42-7).

In an informal electronic survey of the physicians, nurses, and midwives at the meeting, 6% said they routinely use maintenance tocolysis, 67% occasionally use it, and 26% never use it. In a repeat survey after Dr. Lyell’s talk, none favored routine maintenance tocolysis, 53% said they would use it occasionally, and 47% said they would no longer use it.

The Netherlands Organization for Health Research and Development funded the study. Dr. Lyell reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A large randomized, double-blind placebo-controlled study in the Netherlands supports earlier studies that found no benefit from routine maintenance tocolysis using nifedipine in women with arrested preterm labor.

What to do when preterm labor stops is "a million dollar question that many of us have faced," Dr. Deirdre J. Lyell said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco. Surveys suggest that more than a quarter of maternal-fetal medicine specialists routinely use maintenance tocolysis, most often with nifedipine, despite its questionable utility.

The Dutch study of 406 women "puts the question to bed," said Dr. Lyell, a maternal-fetal medicine ob.gyn. at Stanford (Calif.) University. She was not involved in the study.

The multicenter trial in these women was underpowered to show a statistically significant difference in its primary outcome – a composite of perinatal adverse outcomes – because of a lower-than-expected rate of adverse events in the control group, so it couldn’t exclude a possible benefit from nifedipine. However, "its use for maintenance tocolysis does not appear beneficial at this time," the investigators wrote (JAMA 2013;309:41-7).

Women in the study had arrested preterm labor at 24-34 weeks’ gestation. They were randomized to maintenance tocolysis with 20 mg nifedipine or placebo every 4-6 hours. Delivery occurred at 35 weeks in the nifedipine group and at 35 weeks and 2 days in the control group. The number of days of pregnancy after starting treatment was 34 and 33, respectively, and the two groups had similar rates of recurrent preterm labor. Twelve percent in the nifedipine group and 14% in the control group developed one of the problems in the primary composite outcome: perinatal death, chronic lung disease, neonatal sepsis, intraventricular hemorrhage greater than grade 2, periventricular leukomalacia greater than grade 1, or necrotizing enterocolitis.

"There’s no evidence these medications were able to delay delivery," Dr. Lyell said.

Three previous randomized trials also found no benefit from maintenance tocolysis with nifedipine. One nonblinded study of 74 U.S. women found no difference in outcomes (Am. J. Obstet. Gynecol. 1999;181:822-7). Neither did a nonblinded Iranian study that randomized 73 women but did not report how the randomization was conducted (J. Perinat. Med. 2004;32:220-4). Dr. Lyell and her associates then conducted a double-blind placebo-controlled trial in 68 women, which again was negative (Obstet. Gynecol. 2008;112:1221-6).

These studies were small, "but we still haven’t seen anything robust to say this is something we should do," Dr. Lyell said.

Nifedipine can produce maternal side effects. In a trial comparing intravenous magnesium sulfate with oral nifedipine for acute tocolysis, nifedipine caused headache in 24% of women who received the drug, vomiting in 5%, hypotension in 5%, shortness of breath in 5%, and lethargy in 5% (Obstet. Gynecol. 2007;110:61-7).

Beta-mimetics such as terbutaline have a much longer list of maternal, fetal, and neonatal side effects, and two randomized controlled trials have shown that maintenance tocolysis using a terbutaline pump was not more effective than giving saline to prevent recurrent preterm labor, Dr. Lyell said.

A 2008 survey of 827 members of the Society of Maternal-Fetal Medicine found that 29% routinely use maintenance tocolysis and 31% will use it if the patient desires. Among members who employ maintenance tocolysis, nifedipine was the first choice of 79% (Obstet. Gynecol. 2008;112:42-7).

In an informal electronic survey of the physicians, nurses, and midwives at the meeting, 6% said they routinely use maintenance tocolysis, 67% occasionally use it, and 26% never use it. In a repeat survey after Dr. Lyell’s talk, none favored routine maintenance tocolysis, 53% said they would use it occasionally, and 47% said they would no longer use it.

The Netherlands Organization for Health Research and Development funded the study. Dr. Lyell reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Pregnant women, more than anyone, face a challenge that Rachel Carson described in her 1962 book "Silent Spring": "What we have to face is not an occasional dose of poison which has accidentally got into some article of food, but a persistent and continuous poisoning of the whole human environment."

Modern science suggests that this is truer than ever, and that the danger especially applies to fetuses, Dr. Marya G. Zlatnik said.

Courtesy Wikimedia Commons/alanthebox/Creative Commons License

One study reported that 43 of 163 (26%) unwanted chemicals could be detected in 99% of pregnant women in the United States, even though some chemicals had been banned for years (Environ. Health Perspect. 2011;119:878-85).

What’s a woman – and her physician – to do? Physicians can recommend 10 relatively simple steps that their pregnant patients can take today to protect themselves and their babies, she said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

• Buy organic. It’s not cheap, but buying organic foods such as fruit and produce make a big difference in reducing exposure to pesticides, said Dr. Zlatnik, a high-risk ob.gyn. and perinatologist at the university. One study of 23 schoolchildren substituted organic food for their conventional diets and found a dramatic drop in organophosphorus pesticide levels in their urine while eating organically, but not before or after (Environ. Health Perspect. 2006;114:260-3).

• Don’t microwave plastic. Taking that plastic tub of leftovers directly from the refrigerator to the microwave oven may be convenient, but it can contaminate your food with bisphenol A (BPA) or other endocrine disrupting chemicals that may be in the plastic container. Why does that matter? A growing number of studies suggest that fetal exposure to BPA increases the risks for multiple health problems.

One study of 244 mothers and their children showed that each 10-fold increase in maternal serum BPA levels was associated with more anxious and depressed behavior in the children by age 3 years (Pediatrics 2011;128:873-882). Another study in mice found that BPA may increase the risk for metabolic disorders and diabetes and that the fetal development stage was the critical window of susceptibility to BPA exposure (PLoS One 2013;8:e64143). Swedish investigators showed in a separate study that BPA increases angiogenesis in human endometrial cells in vitro, suggesting that the chemical could disturb normal endometrial functioning related to pregnancy and fertility.

• Avoid plastic contact with food/drinks. Plastic storage containers for food aren’t the only problem. Even without heating in a microwave, plastic can leach BPA or other endocrine-disrupting chemicals into your food or drinks. And plastic is ubiquitous – it’s in the linings of most canned foods, in polycarbonate water bottles, and in the plastic pouches or soft-box linings of wet foods. Try to avoid any food item with substantial plastic content.

• Don’t accept the receipt. Carbonless receipts – the kind you get at the ATM or in any store where you pay by credit card – commonly contain BPA, phthalates, or other endocrine disruptors. In response to concerns about BPA, some stores have started to use BPA-free receipts, "but many times when the BPA is removed, another phthalate gets added, so don’t even take the receipts," Dr. Zlatnik advised. Workers who have to handle carbonless receipts should wear gloves and/or wash their hands frequently, she added.

• Limit pesticide use around the home. A good principle in general, this is especially important during pregnancy.

• Be thoughtful about personal care products. Cosmetics and other personal care products can contain BPA or other endocrine disruptors. Skip the lipstick during pregnancy if you can’t verify that it’s free of harmful chemicals, for example.

• Mop daily. Dust mopping or damp mopping to remove dust that may contain lead or potentially harmful chemicals. "Along those lines, don’t wear shoes in the house," because they track these substances into the home, Dr. Zlatnik said.

• Replace foam furniture. Ubiquitous laws require furniture or mattresses containing foam to be treated with flame-retardant chemicals to reduce fire risk, but now it’s becoming clear that polybrominated diphenyl ethers (PBDEs) in the those chemicals can pose health risks.

Maternal prenatal PBDE concentrations were associated with impaired attention in children at age 5 years, poorer fine-motor coordination at ages 5 and 7 years, and lower scores on some sections of IQ tests at age 7 years in a study of 323 mothers and children (Environ. Health Perspect. 2013;121:257-62). A separate study of 210 cord blood samples found lower scores on tests of mental and physical development (including IQ) at 12-72 months of age in children who had higher concentrations of PBDEs at birth (Environ. Health Perspect. 2010;118:712-9). Serum levels of PBDE in the second trimester of pregnancy were associated with thyroid-stimulating hormone levels in a study of 25 pregnant Californians (Environ. Sci. Technol. 2011;45:7896-905).

• Quit smoking. Avoid second-hand smoke. Remind patients that toxins in cigarette smoke increase the risk for miscarriage, infertility, and preterm birth, among other problems.

• Avoid lead. This can be simple and inexpensive, such as dust mopping daily and avoiding lead-containing lipsticks, or complicated and expensive, such as staying away from jobs or hobbies with exposure to lead, or lead paint–abatement remedies. Women with a history of lead exposure can take calcium supplements to minimize the release of lead stored in bone.

"This is not a comprehensive list, but these are some relatively simple things to do" to avoid troublesome environmental chemicals during pregnancy, Dr. Zlatnik said.

She reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Pregnant women, more than anyone, face a challenge that Rachel Carson described in her 1962 book "Silent Spring": "What we have to face is not an occasional dose of poison which has accidentally got into some article of food, but a persistent and continuous poisoning of the whole human environment."

Modern science suggests that this is truer than ever, and that the danger especially applies to fetuses, Dr. Marya G. Zlatnik said.

Courtesy Wikimedia Commons/alanthebox/Creative Commons License

One study reported that 43 of 163 (26%) unwanted chemicals could be detected in 99% of pregnant women in the United States, even though some chemicals had been banned for years (Environ. Health Perspect. 2011;119:878-85).

What’s a woman – and her physician – to do? Physicians can recommend 10 relatively simple steps that their pregnant patients can take today to protect themselves and their babies, she said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

• Buy organic. It’s not cheap, but buying organic foods such as fruit and produce make a big difference in reducing exposure to pesticides, said Dr. Zlatnik, a high-risk ob.gyn. and perinatologist at the university. One study of 23 schoolchildren substituted organic food for their conventional diets and found a dramatic drop in organophosphorus pesticide levels in their urine while eating organically, but not before or after (Environ. Health Perspect. 2006;114:260-3).

• Don’t microwave plastic. Taking that plastic tub of leftovers directly from the refrigerator to the microwave oven may be convenient, but it can contaminate your food with bisphenol A (BPA) or other endocrine disrupting chemicals that may be in the plastic container. Why does that matter? A growing number of studies suggest that fetal exposure to BPA increases the risks for multiple health problems.

One study of 244 mothers and their children showed that each 10-fold increase in maternal serum BPA levels was associated with more anxious and depressed behavior in the children by age 3 years (Pediatrics 2011;128:873-882). Another study in mice found that BPA may increase the risk for metabolic disorders and diabetes and that the fetal development stage was the critical window of susceptibility to BPA exposure (PLoS One 2013;8:e64143). Swedish investigators showed in a separate study that BPA increases angiogenesis in human endometrial cells in vitro, suggesting that the chemical could disturb normal endometrial functioning related to pregnancy and fertility.

• Avoid plastic contact with food/drinks. Plastic storage containers for food aren’t the only problem. Even without heating in a microwave, plastic can leach BPA or other endocrine-disrupting chemicals into your food or drinks. And plastic is ubiquitous – it’s in the linings of most canned foods, in polycarbonate water bottles, and in the plastic pouches or soft-box linings of wet foods. Try to avoid any food item with substantial plastic content.

• Don’t accept the receipt. Carbonless receipts – the kind you get at the ATM or in any store where you pay by credit card – commonly contain BPA, phthalates, or other endocrine disruptors. In response to concerns about BPA, some stores have started to use BPA-free receipts, "but many times when the BPA is removed, another phthalate gets added, so don’t even take the receipts," Dr. Zlatnik advised. Workers who have to handle carbonless receipts should wear gloves and/or wash their hands frequently, she added.

• Limit pesticide use around the home. A good principle in general, this is especially important during pregnancy.

• Be thoughtful about personal care products. Cosmetics and other personal care products can contain BPA or other endocrine disruptors. Skip the lipstick during pregnancy if you can’t verify that it’s free of harmful chemicals, for example.

• Mop daily. Dust mopping or damp mopping to remove dust that may contain lead or potentially harmful chemicals. "Along those lines, don’t wear shoes in the house," because they track these substances into the home, Dr. Zlatnik said.

• Replace foam furniture. Ubiquitous laws require furniture or mattresses containing foam to be treated with flame-retardant chemicals to reduce fire risk, but now it’s becoming clear that polybrominated diphenyl ethers (PBDEs) in the those chemicals can pose health risks.

Maternal prenatal PBDE concentrations were associated with impaired attention in children at age 5 years, poorer fine-motor coordination at ages 5 and 7 years, and lower scores on some sections of IQ tests at age 7 years in a study of 323 mothers and children (Environ. Health Perspect. 2013;121:257-62). A separate study of 210 cord blood samples found lower scores on tests of mental and physical development (including IQ) at 12-72 months of age in children who had higher concentrations of PBDEs at birth (Environ. Health Perspect. 2010;118:712-9). Serum levels of PBDE in the second trimester of pregnancy were associated with thyroid-stimulating hormone levels in a study of 25 pregnant Californians (Environ. Sci. Technol. 2011;45:7896-905).

• Quit smoking. Avoid second-hand smoke. Remind patients that toxins in cigarette smoke increase the risk for miscarriage, infertility, and preterm birth, among other problems.

• Avoid lead. This can be simple and inexpensive, such as dust mopping daily and avoiding lead-containing lipsticks, or complicated and expensive, such as staying away from jobs or hobbies with exposure to lead, or lead paint–abatement remedies. Women with a history of lead exposure can take calcium supplements to minimize the release of lead stored in bone.

"This is not a comprehensive list, but these are some relatively simple things to do" to avoid troublesome environmental chemicals during pregnancy, Dr. Zlatnik said.

She reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Pregnant women, more than anyone, face a challenge that Rachel Carson described in her 1962 book "Silent Spring": "What we have to face is not an occasional dose of poison which has accidentally got into some article of food, but a persistent and continuous poisoning of the whole human environment."

Modern science suggests that this is truer than ever, and that the danger especially applies to fetuses, Dr. Marya G. Zlatnik said.

Courtesy Wikimedia Commons/alanthebox/Creative Commons License

One study reported that 43 of 163 (26%) unwanted chemicals could be detected in 99% of pregnant women in the United States, even though some chemicals had been banned for years (Environ. Health Perspect. 2011;119:878-85).

What’s a woman – and her physician – to do? Physicians can recommend 10 relatively simple steps that their pregnant patients can take today to protect themselves and their babies, she said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

• Buy organic. It’s not cheap, but buying organic foods such as fruit and produce make a big difference in reducing exposure to pesticides, said Dr. Zlatnik, a high-risk ob.gyn. and perinatologist at the university. One study of 23 schoolchildren substituted organic food for their conventional diets and found a dramatic drop in organophosphorus pesticide levels in their urine while eating organically, but not before or after (Environ. Health Perspect. 2006;114:260-3).

• Don’t microwave plastic. Taking that plastic tub of leftovers directly from the refrigerator to the microwave oven may be convenient, but it can contaminate your food with bisphenol A (BPA) or other endocrine disrupting chemicals that may be in the plastic container. Why does that matter? A growing number of studies suggest that fetal exposure to BPA increases the risks for multiple health problems.

One study of 244 mothers and their children showed that each 10-fold increase in maternal serum BPA levels was associated with more anxious and depressed behavior in the children by age 3 years (Pediatrics 2011;128:873-882). Another study in mice found that BPA may increase the risk for metabolic disorders and diabetes and that the fetal development stage was the critical window of susceptibility to BPA exposure (PLoS One 2013;8:e64143). Swedish investigators showed in a separate study that BPA increases angiogenesis in human endometrial cells in vitro, suggesting that the chemical could disturb normal endometrial functioning related to pregnancy and fertility.

• Avoid plastic contact with food/drinks. Plastic storage containers for food aren’t the only problem. Even without heating in a microwave, plastic can leach BPA or other endocrine-disrupting chemicals into your food or drinks. And plastic is ubiquitous – it’s in the linings of most canned foods, in polycarbonate water bottles, and in the plastic pouches or soft-box linings of wet foods. Try to avoid any food item with substantial plastic content.

• Don’t accept the receipt. Carbonless receipts – the kind you get at the ATM or in any store where you pay by credit card – commonly contain BPA, phthalates, or other endocrine disruptors. In response to concerns about BPA, some stores have started to use BPA-free receipts, "but many times when the BPA is removed, another phthalate gets added, so don’t even take the receipts," Dr. Zlatnik advised. Workers who have to handle carbonless receipts should wear gloves and/or wash their hands frequently, she added.

• Limit pesticide use around the home. A good principle in general, this is especially important during pregnancy.

• Be thoughtful about personal care products. Cosmetics and other personal care products can contain BPA or other endocrine disruptors. Skip the lipstick during pregnancy if you can’t verify that it’s free of harmful chemicals, for example.

• Mop daily. Dust mopping or damp mopping to remove dust that may contain lead or potentially harmful chemicals. "Along those lines, don’t wear shoes in the house," because they track these substances into the home, Dr. Zlatnik said.

• Replace foam furniture. Ubiquitous laws require furniture or mattresses containing foam to be treated with flame-retardant chemicals to reduce fire risk, but now it’s becoming clear that polybrominated diphenyl ethers (PBDEs) in the those chemicals can pose health risks.

Maternal prenatal PBDE concentrations were associated with impaired attention in children at age 5 years, poorer fine-motor coordination at ages 5 and 7 years, and lower scores on some sections of IQ tests at age 7 years in a study of 323 mothers and children (Environ. Health Perspect. 2013;121:257-62). A separate study of 210 cord blood samples found lower scores on tests of mental and physical development (including IQ) at 12-72 months of age in children who had higher concentrations of PBDEs at birth (Environ. Health Perspect. 2010;118:712-9). Serum levels of PBDE in the second trimester of pregnancy were associated with thyroid-stimulating hormone levels in a study of 25 pregnant Californians (Environ. Sci. Technol. 2011;45:7896-905).

• Quit smoking. Avoid second-hand smoke. Remind patients that toxins in cigarette smoke increase the risk for miscarriage, infertility, and preterm birth, among other problems.

• Avoid lead. This can be simple and inexpensive, such as dust mopping daily and avoiding lead-containing lipsticks, or complicated and expensive, such as staying away from jobs or hobbies with exposure to lead, or lead paint–abatement remedies. Women with a history of lead exposure can take calcium supplements to minimize the release of lead stored in bone.

"This is not a comprehensive list, but these are some relatively simple things to do" to avoid troublesome environmental chemicals during pregnancy, Dr. Zlatnik said.

She reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Only 29% of pregnant women who were taking complementary and alternative medication products, such as dietary supplements, had discussed them with their doctor, judging from the findings of one recent study of 500 patients.

"This is really important. We should talk to our patients about their use of integrative medicine," Margaret A. Chesney, Ph.D. said.

The safety of most complementary and alternative medication (CAM) products on the market is assumed, not proved. The products are not standardized, their labeling may not be accurate, and some products are contaminated, particularly dietary supplement products from China, she said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The study found that 28% of 250 obstetric patients in a faculty-led practice and 9% of 250 obstetric patients in a resident-led practice were using CAM products. Of the women using the products, 29% said they had spoken with their health care provider about their use (J. Reprod. Med. 2012;57:390-6). Older women and whites were more likely to use CAM products, which may be related to socioeconomic status, said Dr. Chesney, director of the university’s Osher Center for Integrative Medicine.

Published studies of the utility of CAM during pregnancy are few and preliminary, but their findings suggest that ginger may help nausea in pregnancy, yoga might help reduce pain and discomfort, and mindfulness-based stress reduction techniques could reduce pregnancy-related anxiety and depression. Acupuncture, on the other hand, did not seem to help with infertility, and there’s no evidence to support claims of it helping labor pain, she said.

Ginger was effective as vitamin B₆ in reducing first-trimester nausea, retching, and vomiting in a randomized, controlled trial involving 291 patients who were less than 16-weeks pregnant. The women took either 350 mg ginger or 25 mg vitamin B₆ three times per day for 3 weeks. Nausea and vomiting were assessed at 7, 14, and 21 days (Obstet. Gynecol. 103:639-45). The investigators made their own ginger pills by loading capsules with crystallized ginger, Dr. Chesney noted.

The findings need to be replicated, "but there are not a lot of bad side effects from ginger, so it’s something to consider" for patients experiencing nausea in pregnancy, she said.

A review of three poorly designed randomized, controlled trials of yoga in 298 pregnancy women suggests that yoga might significantly reduce pain, discomfort, and perceived stress and improve scores for physical domain in quality of life measures during pregnancy, but the studies’ designs did not meet guidelines from the Consolidated Standard of Reporting Trials.

Despite claims that acupuncture can help improve fertility, there was no difference in pregnancy rates in 160 women who were undergoing in vitro fertilization who were randomized to treatment with acupuncture or a sham procedure, a randomized, double-blind study found (Fertil. Steril. 2011;95:583-7). No good evidence is available to support separate claims that acupuncture can reduce labor pain, Dr. Chesney added.

A pilot study of 27 pregnant women who participated in nine weekly classes and a retreat to learn mindfulness-based stress reduction techniques found that their scores for mindfulness and positive affect significantly increased, with decreases in scores for pregnancy anxiety, depression, and negative affect at the end of the trial compared with the start (J. Child Fam. Stud. 2010;19:190-202).

That preliminary evidence was good enough that the National Institutes of Health are funding a larger study of mindfulness-based stress reduction in pregnancy, she said.

Dr. Chesney reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Only 29% of pregnant women who were taking complementary and alternative medication products, such as dietary supplements, had discussed them with their doctor, judging from the findings of one recent study of 500 patients.

"This is really important. We should talk to our patients about their use of integrative medicine," Margaret A. Chesney, Ph.D. said.

The safety of most complementary and alternative medication (CAM) products on the market is assumed, not proved. The products are not standardized, their labeling may not be accurate, and some products are contaminated, particularly dietary supplement products from China, she said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The study found that 28% of 250 obstetric patients in a faculty-led practice and 9% of 250 obstetric patients in a resident-led practice were using CAM products. Of the women using the products, 29% said they had spoken with their health care provider about their use (J. Reprod. Med. 2012;57:390-6). Older women and whites were more likely to use CAM products, which may be related to socioeconomic status, said Dr. Chesney, director of the university’s Osher Center for Integrative Medicine.

Published studies of the utility of CAM during pregnancy are few and preliminary, but their findings suggest that ginger may help nausea in pregnancy, yoga might help reduce pain and discomfort, and mindfulness-based stress reduction techniques could reduce pregnancy-related anxiety and depression. Acupuncture, on the other hand, did not seem to help with infertility, and there’s no evidence to support claims of it helping labor pain, she said.

Ginger was effective as vitamin B₆ in reducing first-trimester nausea, retching, and vomiting in a randomized, controlled trial involving 291 patients who were less than 16-weeks pregnant. The women took either 350 mg ginger or 25 mg vitamin B₆ three times per day for 3 weeks. Nausea and vomiting were assessed at 7, 14, and 21 days (Obstet. Gynecol. 103:639-45). The investigators made their own ginger pills by loading capsules with crystallized ginger, Dr. Chesney noted.

The findings need to be replicated, "but there are not a lot of bad side effects from ginger, so it’s something to consider" for patients experiencing nausea in pregnancy, she said.

A review of three poorly designed randomized, controlled trials of yoga in 298 pregnancy women suggests that yoga might significantly reduce pain, discomfort, and perceived stress and improve scores for physical domain in quality of life measures during pregnancy, but the studies’ designs did not meet guidelines from the Consolidated Standard of Reporting Trials.

Despite claims that acupuncture can help improve fertility, there was no difference in pregnancy rates in 160 women who were undergoing in vitro fertilization who were randomized to treatment with acupuncture or a sham procedure, a randomized, double-blind study found (Fertil. Steril. 2011;95:583-7). No good evidence is available to support separate claims that acupuncture can reduce labor pain, Dr. Chesney added.

A pilot study of 27 pregnant women who participated in nine weekly classes and a retreat to learn mindfulness-based stress reduction techniques found that their scores for mindfulness and positive affect significantly increased, with decreases in scores for pregnancy anxiety, depression, and negative affect at the end of the trial compared with the start (J. Child Fam. Stud. 2010;19:190-202).

That preliminary evidence was good enough that the National Institutes of Health are funding a larger study of mindfulness-based stress reduction in pregnancy, she said.

Dr. Chesney reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Only 29% of pregnant women who were taking complementary and alternative medication products, such as dietary supplements, had discussed them with their doctor, judging from the findings of one recent study of 500 patients.

"This is really important. We should talk to our patients about their use of integrative medicine," Margaret A. Chesney, Ph.D. said.

The safety of most complementary and alternative medication (CAM) products on the market is assumed, not proved. The products are not standardized, their labeling may not be accurate, and some products are contaminated, particularly dietary supplement products from China, she said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The study found that 28% of 250 obstetric patients in a faculty-led practice and 9% of 250 obstetric patients in a resident-led practice were using CAM products. Of the women using the products, 29% said they had spoken with their health care provider about their use (J. Reprod. Med. 2012;57:390-6). Older women and whites were more likely to use CAM products, which may be related to socioeconomic status, said Dr. Chesney, director of the university’s Osher Center for Integrative Medicine.

Published studies of the utility of CAM during pregnancy are few and preliminary, but their findings suggest that ginger may help nausea in pregnancy, yoga might help reduce pain and discomfort, and mindfulness-based stress reduction techniques could reduce pregnancy-related anxiety and depression. Acupuncture, on the other hand, did not seem to help with infertility, and there’s no evidence to support claims of it helping labor pain, she said.

Ginger was effective as vitamin B₆ in reducing first-trimester nausea, retching, and vomiting in a randomized, controlled trial involving 291 patients who were less than 16-weeks pregnant. The women took either 350 mg ginger or 25 mg vitamin B₆ three times per day for 3 weeks. Nausea and vomiting were assessed at 7, 14, and 21 days (Obstet. Gynecol. 103:639-45). The investigators made their own ginger pills by loading capsules with crystallized ginger, Dr. Chesney noted.

The findings need to be replicated, "but there are not a lot of bad side effects from ginger, so it’s something to consider" for patients experiencing nausea in pregnancy, she said.

A review of three poorly designed randomized, controlled trials of yoga in 298 pregnancy women suggests that yoga might significantly reduce pain, discomfort, and perceived stress and improve scores for physical domain in quality of life measures during pregnancy, but the studies’ designs did not meet guidelines from the Consolidated Standard of Reporting Trials.

Despite claims that acupuncture can help improve fertility, there was no difference in pregnancy rates in 160 women who were undergoing in vitro fertilization who were randomized to treatment with acupuncture or a sham procedure, a randomized, double-blind study found (Fertil. Steril. 2011;95:583-7). No good evidence is available to support separate claims that acupuncture can reduce labor pain, Dr. Chesney added.

A pilot study of 27 pregnant women who participated in nine weekly classes and a retreat to learn mindfulness-based stress reduction techniques found that their scores for mindfulness and positive affect significantly increased, with decreases in scores for pregnancy anxiety, depression, and negative affect at the end of the trial compared with the start (J. Child Fam. Stud. 2010;19:190-202).

That preliminary evidence was good enough that the National Institutes of Health are funding a larger study of mindfulness-based stress reduction in pregnancy, she said.

Dr. Chesney reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.

These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.

Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety, said Dr. Elliott K. Main, who cochaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.

Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries, he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The U.S. rates of pregnancy-related deaths from hemorrhage or hypertensive disorders of pregnancy decreased from the periods of 1987-1990 to 1998-2005, but increased for deaths associated with cardiomyopathy or other cardiovascular conditions, one study showed (Obstet. Gynecol. 2010;116:1302-9). Other data suggest that hemorrhage and preeclampsia cause the lion’s share of morbidity.

The Joint Commission in 2010 issued Sentinel Alert #44 to suggest ways that birthing centers might better improve maternal morbidity and mortality, and Dr. Main directed ongoing work by the California Maternal Quality Care Collaborative (CMQCC) to identify and address common causes of pregnancy-related deaths that have a good chance of being altered to improve outcomes.Free "toolkits" of best practices with guidelines, protocols, sample policies, and more are available on the CMQCC website .

Representatives of more than 30 organizations participated in the May consensus meeting, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians, the Society for Maternal-Fetal Medicine, the American Hospital Association, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Main, director of maternal-fetal medicine at California Pacific Medical Center, San Francisco, described some of the "safety bundles" that emerged from the consensus meeting and will be recommended nationally. "We’re not expecting you to implement all of these at once, but these are what you want to be working toward," he said.

• Hemorrhage: Be ready for obstetric hemorrhage by having a hemorrhage cart of equipment with instructions for newer procedures such as intrauterine balloons and compression sutures. Partner with your local blood bank to make sure that blood products at the right ratios are available rapidly and reliably, he said. Hold hemorrhage-response drills regularly with post-drill debriefs or "huddles." Ensure rapid availability of medications, establish easy availability of special care resources, and educate the unit staff about hemorrhage protocols.

To better recognize obstetric hemorrhage, assess a patient’s risk on admission and late in labor. Use the Early Warning Tool (see below) for vital signs and symptoms, and get semiquantitative assessments of cumulative blood loss, with the emphasis on cumulative, Dr. Main said.

Response to obstetric hemorrhage should rely on a protocol standardized for your unit with checklists. Universal use of active management in the third stage of labor is important for hemorrhage prevention. To promote learning, establish a culture of post-hemorrhage debrief/huddles, and review all serious cases for systems issues.

In an informal poll of the physicians and nurses in the audience, 58% said they have a comprehensive, standardized protocol for obstetric hemorrhage in their hospital, 23% have one that could be improved, 11% don’t have one, and 8% had no clue.

• Hypertension: Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic, Dr. Main said.

Meanwhile, key elements of a "safety bundle" for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose, he said. The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues.

The CMQCC is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals, he added.

A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don’t have one, and 11% had not a clue.(The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)

• Thromboembolism: The keys to preventing venous thromboembolism are to have protocols for use of a sequential compression device, pharmacologic prophylaxis for higher-risk mothers, and antenatal prophylaxis, Dr. Main said.

A draft safety bundle for prevention of venous thromboembolism during cesarean section calls for applying a sequential compression device prior to delivery. Add chemoprophylaxis to all who already are receiving prophylaxis or full anticoagulation, patients with a history of thromboembolism who are not already on chemoprophylaxis, mothers with a family history of venous thromboembolism and any thrombophilia, mothers who are morbidly obese, or any patients with a score of two or more for other, more minor risk factors.

Obesity is "the big risk factor in California," he said. Two-thirds of pregnant Californians who die from thomboembolism have a body mass index greater then 40 kg/m².

An unexpectedly high proportion of the audience – 29% said that their hospital has a standardized protocol for using Lovenox (enoxaparin) for obstetric patients at higher risk for venous thromboembolism. Few local hospitals will have such protocols, Dr. Main noted, and if they have them, they’re usually very complicated. Another 18% at the meeting said they have such a protocol but it could be improved; 38% said they don’t have a protocol, and 15% had no clue.

• Warnings: Draft criteria for an Early Warning Tool that should trigger an evaluation of maternal safety include specific vital signs and important symptoms. Troubling vital signs include a systolic blood pressure below 90 mm Hg or above 160 mm Hg; diastolic blood pressure higher than 100 mm Hg; sustained heart rate below 50 or above 120 beats per minute; respiratory rate slower than 10 or faster than 30 breaths/minute; oxygen saturation less than 95% room air (at sea level); or oliguria less than 30 mL/hour for 2 hours.

Among symptoms, maternal agitation, confusion or unresponsiveness often is a sign of low oxygen saturation, Dr. Main said. A patient with hypertension who reports an unremitting headache is a red flag. Shortness of breath in a patient with preeclampsia or hypertension should raise big concerns about the development of pulmonary edema and cardiovascular problems.

As a core safety principal, however, the bedside clinician should always feel comfortable escalating concern at any point, because these criteria can’t address all scenarios, he added. These warning criteria are being rolled out in New York State hospitals for a trial, he said.

• Cardiovascular: There are not enough data yet to identify opportunities for safety improvements related to cardiovascular or cardiomyopathy risks in pregnancy, so instead of a safety bundle Dr. Main presented three clinical pearls from California’s work on maternal safety.

Morbid obesity plus hypertension equals high risk for cardiomyopathy, especially if the patient is African American and older than 35 years, he said. There are not many pregnant women with known underlying cardiovascular disease, but this group should be followed closely by a multidisciplinary team, perhaps in a tertiary care center. The third pearl was new to Dr. Main: the onset of wheezing in the third trimester, which is not likely to be asthma but cardiac in origin and deserves a patient referral for evaluation.

Dr. Main reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.

These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.

Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety, said Dr. Elliott K. Main, who cochaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.

Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries, he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The U.S. rates of pregnancy-related deaths from hemorrhage or hypertensive disorders of pregnancy decreased from the periods of 1987-1990 to 1998-2005, but increased for deaths associated with cardiomyopathy or other cardiovascular conditions, one study showed (Obstet. Gynecol. 2010;116:1302-9). Other data suggest that hemorrhage and preeclampsia cause the lion’s share of morbidity.

The Joint Commission in 2010 issued Sentinel Alert #44 to suggest ways that birthing centers might better improve maternal morbidity and mortality, and Dr. Main directed ongoing work by the California Maternal Quality Care Collaborative (CMQCC) to identify and address common causes of pregnancy-related deaths that have a good chance of being altered to improve outcomes.Free "toolkits" of best practices with guidelines, protocols, sample policies, and more are available on the CMQCC website .

Representatives of more than 30 organizations participated in the May consensus meeting, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians, the Society for Maternal-Fetal Medicine, the American Hospital Association, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Main, director of maternal-fetal medicine at California Pacific Medical Center, San Francisco, described some of the "safety bundles" that emerged from the consensus meeting and will be recommended nationally. "We’re not expecting you to implement all of these at once, but these are what you want to be working toward," he said.

• Hemorrhage: Be ready for obstetric hemorrhage by having a hemorrhage cart of equipment with instructions for newer procedures such as intrauterine balloons and compression sutures. Partner with your local blood bank to make sure that blood products at the right ratios are available rapidly and reliably, he said. Hold hemorrhage-response drills regularly with post-drill debriefs or "huddles." Ensure rapid availability of medications, establish easy availability of special care resources, and educate the unit staff about hemorrhage protocols.

To better recognize obstetric hemorrhage, assess a patient’s risk on admission and late in labor. Use the Early Warning Tool (see below) for vital signs and symptoms, and get semiquantitative assessments of cumulative blood loss, with the emphasis on cumulative, Dr. Main said.

Response to obstetric hemorrhage should rely on a protocol standardized for your unit with checklists. Universal use of active management in the third stage of labor is important for hemorrhage prevention. To promote learning, establish a culture of post-hemorrhage debrief/huddles, and review all serious cases for systems issues.

In an informal poll of the physicians and nurses in the audience, 58% said they have a comprehensive, standardized protocol for obstetric hemorrhage in their hospital, 23% have one that could be improved, 11% don’t have one, and 8% had no clue.

• Hypertension: Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic, Dr. Main said.

Meanwhile, key elements of a "safety bundle" for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose, he said. The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues.

The CMQCC is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals, he added.

A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don’t have one, and 11% had not a clue.(The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)

• Thromboembolism: The keys to preventing venous thromboembolism are to have protocols for use of a sequential compression device, pharmacologic prophylaxis for higher-risk mothers, and antenatal prophylaxis, Dr. Main said.

A draft safety bundle for prevention of venous thromboembolism during cesarean section calls for applying a sequential compression device prior to delivery. Add chemoprophylaxis to all who already are receiving prophylaxis or full anticoagulation, patients with a history of thromboembolism who are not already on chemoprophylaxis, mothers with a family history of venous thromboembolism and any thrombophilia, mothers who are morbidly obese, or any patients with a score of two or more for other, more minor risk factors.

Obesity is "the big risk factor in California," he said. Two-thirds of pregnant Californians who die from thomboembolism have a body mass index greater then 40 kg/m².

An unexpectedly high proportion of the audience – 29% said that their hospital has a standardized protocol for using Lovenox (enoxaparin) for obstetric patients at higher risk for venous thromboembolism. Few local hospitals will have such protocols, Dr. Main noted, and if they have them, they’re usually very complicated. Another 18% at the meeting said they have such a protocol but it could be improved; 38% said they don’t have a protocol, and 15% had no clue.

• Warnings: Draft criteria for an Early Warning Tool that should trigger an evaluation of maternal safety include specific vital signs and important symptoms. Troubling vital signs include a systolic blood pressure below 90 mm Hg or above 160 mm Hg; diastolic blood pressure higher than 100 mm Hg; sustained heart rate below 50 or above 120 beats per minute; respiratory rate slower than 10 or faster than 30 breaths/minute; oxygen saturation less than 95% room air (at sea level); or oliguria less than 30 mL/hour for 2 hours.

Among symptoms, maternal agitation, confusion or unresponsiveness often is a sign of low oxygen saturation, Dr. Main said. A patient with hypertension who reports an unremitting headache is a red flag. Shortness of breath in a patient with preeclampsia or hypertension should raise big concerns about the development of pulmonary edema and cardiovascular problems.

As a core safety principal, however, the bedside clinician should always feel comfortable escalating concern at any point, because these criteria can’t address all scenarios, he added. These warning criteria are being rolled out in New York State hospitals for a trial, he said.

• Cardiovascular: There are not enough data yet to identify opportunities for safety improvements related to cardiovascular or cardiomyopathy risks in pregnancy, so instead of a safety bundle Dr. Main presented three clinical pearls from California’s work on maternal safety.

Morbid obesity plus hypertension equals high risk for cardiomyopathy, especially if the patient is African American and older than 35 years, he said. There are not many pregnant women with known underlying cardiovascular disease, but this group should be followed closely by a multidisciplinary team, perhaps in a tertiary care center. The third pearl was new to Dr. Main: the onset of wheezing in the third trimester, which is not likely to be asthma but cardiac in origin and deserves a patient referral for evaluation.

Dr. Main reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Every birthing facility in the United States should have specific practices and equipment to optimize maternal safety in pregnancy, according to a recent consensus meeting of national medical organizations.

These include so-called "safety bundles," or safety initiatives, of protocols and equipment for preventing and managing obstetric hemorrhage, venous thromboembolism, and severe hypertension, as well as for supporting patients, families, and staff. Specific early-warning criteria should trigger a maternal evaluation, and facilities should regularly review severe maternal morbidity from a systems perspective.

Motivated by climbing maternal mortality rates in the United States in recent decades, the recommendations build on preliminary success from California efforts to improve maternal safety, said Dr. Elliott K. Main, who cochaired the "National Maternal Health Initiative: Strategies to Improve Maternal Health and Safety" consensus meeting in New Orleans in May 2013.

Maternal mortality rates declined in California since 1970, but started increasing again around 2000, so that by 2005, the rate of 17 maternal deaths/100,000 live births was similar to rates in the early 1970s. Nationally, U.S. maternal mortality rates increased from 1980 to 2008, in contrast with decreases in many other developed countries, he said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

The U.S. rates of pregnancy-related deaths from hemorrhage or hypertensive disorders of pregnancy decreased from the periods of 1987-1990 to 1998-2005, but increased for deaths associated with cardiomyopathy or other cardiovascular conditions, one study showed (Obstet. Gynecol. 2010;116:1302-9). Other data suggest that hemorrhage and preeclampsia cause the lion’s share of morbidity.

The Joint Commission in 2010 issued Sentinel Alert #44 to suggest ways that birthing centers might better improve maternal morbidity and mortality, and Dr. Main directed ongoing work by the California Maternal Quality Care Collaborative (CMQCC) to identify and address common causes of pregnancy-related deaths that have a good chance of being altered to improve outcomes.Free "toolkits" of best practices with guidelines, protocols, sample policies, and more are available on the CMQCC website .

Representatives of more than 30 organizations participated in the May consensus meeting, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Family Physicians, the Society for Maternal-Fetal Medicine, the American Hospital Association, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Main, director of maternal-fetal medicine at California Pacific Medical Center, San Francisco, described some of the "safety bundles" that emerged from the consensus meeting and will be recommended nationally. "We’re not expecting you to implement all of these at once, but these are what you want to be working toward," he said.

• Hemorrhage: Be ready for obstetric hemorrhage by having a hemorrhage cart of equipment with instructions for newer procedures such as intrauterine balloons and compression sutures. Partner with your local blood bank to make sure that blood products at the right ratios are available rapidly and reliably, he said. Hold hemorrhage-response drills regularly with post-drill debriefs or "huddles." Ensure rapid availability of medications, establish easy availability of special care resources, and educate the unit staff about hemorrhage protocols.

To better recognize obstetric hemorrhage, assess a patient’s risk on admission and late in labor. Use the Early Warning Tool (see below) for vital signs and symptoms, and get semiquantitative assessments of cumulative blood loss, with the emphasis on cumulative, Dr. Main said.

Response to obstetric hemorrhage should rely on a protocol standardized for your unit with checklists. Universal use of active management in the third stage of labor is important for hemorrhage prevention. To promote learning, establish a culture of post-hemorrhage debrief/huddles, and review all serious cases for systems issues.

In an informal poll of the physicians and nurses in the audience, 58% said they have a comprehensive, standardized protocol for obstetric hemorrhage in their hospital, 23% have one that could be improved, 11% don’t have one, and 8% had no clue.

• Hypertension: Debate continues about the definition of severe preeclampsia, and ACOG should be issuing a presidential task force statement later this year on the topic, Dr. Main said.

Meanwhile, key elements of a "safety bundle" for hypertension in pregnancy include having unit-standard protocols and policies for the treatment of severe hypertension and eclampsia, safe use of magnesium therapy, and managing magnesium overdose, he said. The birthing unit also should have an agreed-upon definition of severe preeclampsia, early warning tools employing vital signs and symptoms, and regular review of all hypertension cases with severe morbidity to look for systems issues.

The CMQCC is expected soon to publish a California Preeclampsia QI Toolkit for quality improvement, which will be tested in 26 hospitals, he added.

A poll of the audience found that 31% have a comprehensive, standardized protocol for severe pregnancy hypertension in their hospital, 22% have one that could be improved, 35% don’t have one, and 11% had not a clue.(The percentages added up to 99% rather than 100% when the survey results were displayed at the meeting.)

• Thromboembolism: The keys to preventing venous thromboembolism are to have protocols for use of a sequential compression device, pharmacologic prophylaxis for higher-risk mothers, and antenatal prophylaxis, Dr. Main said.

A draft safety bundle for prevention of venous thromboembolism during cesarean section calls for applying a sequential compression device prior to delivery. Add chemoprophylaxis to all who already are receiving prophylaxis or full anticoagulation, patients with a history of thromboembolism who are not already on chemoprophylaxis, mothers with a family history of venous thromboembolism and any thrombophilia, mothers who are morbidly obese, or any patients with a score of two or more for other, more minor risk factors.

Obesity is "the big risk factor in California," he said. Two-thirds of pregnant Californians who die from thomboembolism have a body mass index greater then 40 kg/m².

An unexpectedly high proportion of the audience – 29% said that their hospital has a standardized protocol for using Lovenox (enoxaparin) for obstetric patients at higher risk for venous thromboembolism. Few local hospitals will have such protocols, Dr. Main noted, and if they have them, they’re usually very complicated. Another 18% at the meeting said they have such a protocol but it could be improved; 38% said they don’t have a protocol, and 15% had no clue.

• Warnings: Draft criteria for an Early Warning Tool that should trigger an evaluation of maternal safety include specific vital signs and important symptoms. Troubling vital signs include a systolic blood pressure below 90 mm Hg or above 160 mm Hg; diastolic blood pressure higher than 100 mm Hg; sustained heart rate below 50 or above 120 beats per minute; respiratory rate slower than 10 or faster than 30 breaths/minute; oxygen saturation less than 95% room air (at sea level); or oliguria less than 30 mL/hour for 2 hours.

Among symptoms, maternal agitation, confusion or unresponsiveness often is a sign of low oxygen saturation, Dr. Main said. A patient with hypertension who reports an unremitting headache is a red flag. Shortness of breath in a patient with preeclampsia or hypertension should raise big concerns about the development of pulmonary edema and cardiovascular problems.

As a core safety principal, however, the bedside clinician should always feel comfortable escalating concern at any point, because these criteria can’t address all scenarios, he added. These warning criteria are being rolled out in New York State hospitals for a trial, he said.

• Cardiovascular: There are not enough data yet to identify opportunities for safety improvements related to cardiovascular or cardiomyopathy risks in pregnancy, so instead of a safety bundle Dr. Main presented three clinical pearls from California’s work on maternal safety.

Morbid obesity plus hypertension equals high risk for cardiomyopathy, especially if the patient is African American and older than 35 years, he said. There are not many pregnant women with known underlying cardiovascular disease, but this group should be followed closely by a multidisciplinary team, perhaps in a tertiary care center. The third pearl was new to Dr. Main: the onset of wheezing in the third trimester, which is not likely to be asthma but cardiac in origin and deserves a patient referral for evaluation.

Dr. Main reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Measuring plasma copeptin levels may provide an accurate and easier way to identify the cause of severe hyponatremia, compared with measuring arginine vasopressin levels, preliminary data on 175 patients suggested.

A plasma copeptin level greater than 70 pmol/L correlated with a diagnosis of hypovolemic or diuretic-induced hyponatremia requiring saline infusion with 91% specificity. A copeptin/urinary sodium ratio greater than 1.84 identified patients who clearly needed saline infusion with a specificity of 90%, Dr. Nicole Nigro reported at the annual meeting of the Endocrine Society.

"The differential diagnosis of hyponatremia is not easy to make" and often relies on detecting adequate or inadequate plasma levels of arginine vasopressin (AVP), she said in an interview. Blood samples for AVP measurements must be kept on ice, making handling and transportation to the lab more difficult. AVP mostly attaches to platelets, it clears rapidly, and AVP levels are known to be very unstable.

Copeptin, on the other hand, is very stable in plasma, easy to measure, and released by the body in an equimolar ratio with AVP, said Dr. Nigro of University Hospital, Basel, Switzerland.

She presented data on the first 175 patients in an ongoing study that has enrolled 290 of an expected 300 consecutive patients who present with severe hypo-osmolar hyponatremia at the emergency departments of two Swiss tertiary referral centers. All patients had a sodium level below 125 mmol/L. Three experts who were blinded to patients’ copeptin levels made the final diagnoses based on a clinical algorithm, a chart review, and response to therapy.

The median plasma copeptin level was 2.8 pmol/L in 17 patients diagnosed with primary polydipsia, 13.2 pmol/L in 45 patients with diuretic-induced hyponatremia, 13 pmol/L in 56 patients with syndrome of inappropriate antidiuretic hormone, 28 pmol/L in 25 patients with hypervolemic hyponatremia, and 55 pmol/L in 32 patients with hypovolemic hyponatremia, Dr. Nigro reported in an oral presentation and a featured poster at the meeting.

The 77 patients who required saline infusion had significantly higher copeptin levels (27 pmol/L), than patients who did not need saline (12 pmol/L).

Dr. Nigro’s hospital routinely measures copeptin levels but is not yet using them to guide the differential diagnosis of hyponatremia. If the current study produces clear findings when it’s finished, the investigators next may conduct a study that uses copeptin levels to guide treatment of patients with severe hyponatremia.

Ultimately, "copeptin may help us to guide the therapy and management of these patients with severe hyponatremia," she suggested.

Some of Dr. Nigro’s associates in the study have been speakers for B.R.A.H.M.S./Thermo Fisher Scientific. She reported having no other relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Measuring plasma copeptin levels may provide an accurate and easier way to identify the cause of severe hyponatremia, compared with measuring arginine vasopressin levels, preliminary data on 175 patients suggested.

A plasma copeptin level greater than 70 pmol/L correlated with a diagnosis of hypovolemic or diuretic-induced hyponatremia requiring saline infusion with 91% specificity. A copeptin/urinary sodium ratio greater than 1.84 identified patients who clearly needed saline infusion with a specificity of 90%, Dr. Nicole Nigro reported at the annual meeting of the Endocrine Society.

"The differential diagnosis of hyponatremia is not easy to make" and often relies on detecting adequate or inadequate plasma levels of arginine vasopressin (AVP), she said in an interview. Blood samples for AVP measurements must be kept on ice, making handling and transportation to the lab more difficult. AVP mostly attaches to platelets, it clears rapidly, and AVP levels are known to be very unstable.

Copeptin, on the other hand, is very stable in plasma, easy to measure, and released by the body in an equimolar ratio with AVP, said Dr. Nigro of University Hospital, Basel, Switzerland.

She presented data on the first 175 patients in an ongoing study that has enrolled 290 of an expected 300 consecutive patients who present with severe hypo-osmolar hyponatremia at the emergency departments of two Swiss tertiary referral centers. All patients had a sodium level below 125 mmol/L. Three experts who were blinded to patients’ copeptin levels made the final diagnoses based on a clinical algorithm, a chart review, and response to therapy.

The median plasma copeptin level was 2.8 pmol/L in 17 patients diagnosed with primary polydipsia, 13.2 pmol/L in 45 patients with diuretic-induced hyponatremia, 13 pmol/L in 56 patients with syndrome of inappropriate antidiuretic hormone, 28 pmol/L in 25 patients with hypervolemic hyponatremia, and 55 pmol/L in 32 patients with hypovolemic hyponatremia, Dr. Nigro reported in an oral presentation and a featured poster at the meeting.

The 77 patients who required saline infusion had significantly higher copeptin levels (27 pmol/L), than patients who did not need saline (12 pmol/L).

Dr. Nigro’s hospital routinely measures copeptin levels but is not yet using them to guide the differential diagnosis of hyponatremia. If the current study produces clear findings when it’s finished, the investigators next may conduct a study that uses copeptin levels to guide treatment of patients with severe hyponatremia.

Ultimately, "copeptin may help us to guide the therapy and management of these patients with severe hyponatremia," she suggested.

Some of Dr. Nigro’s associates in the study have been speakers for B.R.A.H.M.S./Thermo Fisher Scientific. She reported having no other relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Measuring plasma copeptin levels may provide an accurate and easier way to identify the cause of severe hyponatremia, compared with measuring arginine vasopressin levels, preliminary data on 175 patients suggested.

A plasma copeptin level greater than 70 pmol/L correlated with a diagnosis of hypovolemic or diuretic-induced hyponatremia requiring saline infusion with 91% specificity. A copeptin/urinary sodium ratio greater than 1.84 identified patients who clearly needed saline infusion with a specificity of 90%, Dr. Nicole Nigro reported at the annual meeting of the Endocrine Society.

"The differential diagnosis of hyponatremia is not easy to make" and often relies on detecting adequate or inadequate plasma levels of arginine vasopressin (AVP), she said in an interview. Blood samples for AVP measurements must be kept on ice, making handling and transportation to the lab more difficult. AVP mostly attaches to platelets, it clears rapidly, and AVP levels are known to be very unstable.

Copeptin, on the other hand, is very stable in plasma, easy to measure, and released by the body in an equimolar ratio with AVP, said Dr. Nigro of University Hospital, Basel, Switzerland.

She presented data on the first 175 patients in an ongoing study that has enrolled 290 of an expected 300 consecutive patients who present with severe hypo-osmolar hyponatremia at the emergency departments of two Swiss tertiary referral centers. All patients had a sodium level below 125 mmol/L. Three experts who were blinded to patients’ copeptin levels made the final diagnoses based on a clinical algorithm, a chart review, and response to therapy.

The median plasma copeptin level was 2.8 pmol/L in 17 patients diagnosed with primary polydipsia, 13.2 pmol/L in 45 patients with diuretic-induced hyponatremia, 13 pmol/L in 56 patients with syndrome of inappropriate antidiuretic hormone, 28 pmol/L in 25 patients with hypervolemic hyponatremia, and 55 pmol/L in 32 patients with hypovolemic hyponatremia, Dr. Nigro reported in an oral presentation and a featured poster at the meeting.

The 77 patients who required saline infusion had significantly higher copeptin levels (27 pmol/L), than patients who did not need saline (12 pmol/L).

Dr. Nigro’s hospital routinely measures copeptin levels but is not yet using them to guide the differential diagnosis of hyponatremia. If the current study produces clear findings when it’s finished, the investigators next may conduct a study that uses copeptin levels to guide treatment of patients with severe hyponatremia.

Ultimately, "copeptin may help us to guide the therapy and management of these patients with severe hyponatremia," she suggested.

Some of Dr. Nigro’s associates in the study have been speakers for B.R.A.H.M.S./Thermo Fisher Scientific. She reported having no other relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

There’s a growing recognition that inadequate sleep may contribute to overeating and, thus, to our massive obesity epidemic. Now there’s a prime suspect to help explain why that may be so.

It’s the endocannabinoids, man.

You’ve heard of them. They’re like the cannabinoids in marijuana that make eating so pleasurable and trigger the "munchies," except these are natural appetite stimulants in the body that control the pleasurable aspects of eating. A study presented at the annual meeting of the Endocrine Society showed that nine healthy, lean, young adults had higher blood levels of the endocannabinoid molecule 2-arachidonoylglycerol (2-AG) after only 4.5 hours of sleep compared with a normal night’s sleep when they got 8.5 hours in bed.

Researchers controlled what the participants ate and did during 6 nights in a sleep lab, testing their blood levels every hour for 24 hours after the second night of sleep.

They randomized participants to the normal-sleep or partial-sleep-restriction groups and had them return a month later in a crossover design to spend another 6 nights in the sleep lab experiencing whichever sleep pattern they hadn’t been randomized to initially.

The results showed a circadian rhythm to endocannabinoid levels, with 2-AG peaking in the early afternoon in both groups but being significantly higher in the sleep-restriction group, reported Erin C. Hanlon, Ph.D. and her associates.

Previous studies of the relationship between sleep and endocannabinoids had looked at only single time points or narrower time intervals, she said. The current results extend findings from at least a dozen previous studies in the last 5 years on related topics. In three studies, researchers reported an association between shortened sleep duration and increased eating of snacks and high-energy foods, such as in this study: Am. J. Clin. Nutr. 2012;95:818-24. Two other studies showed that decreased sleep was associated with increased risk for obesity. And seven other carefully controlled laboratory studies found that sleep restriction impaired glucose metabolism, altered peripherally secreted hormones that modulate feeding behavior, and increased participants’ ratings of appetite and hunger, said Dr. Hanlon of the University of Chicago.

Is lack of sleep the only cause of the obesity epidemic? Of course not. But a quick look at national data suggests that it could be a major factor, if these preliminary studies are on to something.

According to the Centers for Disease Control and Prevention, 35% of nearly 75,000 U.S. adults in 12 states reported in 2009 that they get less than 7 hours of sleep in a typical 24-hour period. Want to guess how many Americans reported being overweight in 2012? That would be 36%, according to a Gallup poll, with another 26% saying that they’re obese.

And are endocannabinoids the only endogenous players that affect overeating? Unlikely. But the endocannabinoid system is a target for development of potential pharmaceutical treatments for obesity, Dr. Hanlon said. Someday soon, I suppose, you may be able to buy a pill to counteract the munchie effects of excessive endocannabinoids. Or, we could all just get a good night’s sleep.

Dr. Hanlon reported having no financial disclosures. Her research was funded by the National Institutes of Health, the Department of Defense, and the Medical College of Wisconsin.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

There’s a growing recognition that inadequate sleep may contribute to overeating and, thus, to our massive obesity epidemic. Now there’s a prime suspect to help explain why that may be so.

It’s the endocannabinoids, man.

You’ve heard of them. They’re like the cannabinoids in marijuana that make eating so pleasurable and trigger the "munchies," except these are natural appetite stimulants in the body that control the pleasurable aspects of eating. A study presented at the annual meeting of the Endocrine Society showed that nine healthy, lean, young adults had higher blood levels of the endocannabinoid molecule 2-arachidonoylglycerol (2-AG) after only 4.5 hours of sleep compared with a normal night’s sleep when they got 8.5 hours in bed.

Researchers controlled what the participants ate and did during 6 nights in a sleep lab, testing their blood levels every hour for 24 hours after the second night of sleep.

They randomized participants to the normal-sleep or partial-sleep-restriction groups and had them return a month later in a crossover design to spend another 6 nights in the sleep lab experiencing whichever sleep pattern they hadn’t been randomized to initially.

The results showed a circadian rhythm to endocannabinoid levels, with 2-AG peaking in the early afternoon in both groups but being significantly higher in the sleep-restriction group, reported Erin C. Hanlon, Ph.D. and her associates.

Previous studies of the relationship between sleep and endocannabinoids had looked at only single time points or narrower time intervals, she said. The current results extend findings from at least a dozen previous studies in the last 5 years on related topics. In three studies, researchers reported an association between shortened sleep duration and increased eating of snacks and high-energy foods, such as in this study: Am. J. Clin. Nutr. 2012;95:818-24. Two other studies showed that decreased sleep was associated with increased risk for obesity. And seven other carefully controlled laboratory studies found that sleep restriction impaired glucose metabolism, altered peripherally secreted hormones that modulate feeding behavior, and increased participants’ ratings of appetite and hunger, said Dr. Hanlon of the University of Chicago.

Is lack of sleep the only cause of the obesity epidemic? Of course not. But a quick look at national data suggests that it could be a major factor, if these preliminary studies are on to something.

According to the Centers for Disease Control and Prevention, 35% of nearly 75,000 U.S. adults in 12 states reported in 2009 that they get less than 7 hours of sleep in a typical 24-hour period. Want to guess how many Americans reported being overweight in 2012? That would be 36%, according to a Gallup poll, with another 26% saying that they’re obese.

And are endocannabinoids the only endogenous players that affect overeating? Unlikely. But the endocannabinoid system is a target for development of potential pharmaceutical treatments for obesity, Dr. Hanlon said. Someday soon, I suppose, you may be able to buy a pill to counteract the munchie effects of excessive endocannabinoids. Or, we could all just get a good night’s sleep.

Dr. Hanlon reported having no financial disclosures. Her research was funded by the National Institutes of Health, the Department of Defense, and the Medical College of Wisconsin.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

There’s a growing recognition that inadequate sleep may contribute to overeating and, thus, to our massive obesity epidemic. Now there’s a prime suspect to help explain why that may be so.

It’s the endocannabinoids, man.

You’ve heard of them. They’re like the cannabinoids in marijuana that make eating so pleasurable and trigger the "munchies," except these are natural appetite stimulants in the body that control the pleasurable aspects of eating. A study presented at the annual meeting of the Endocrine Society showed that nine healthy, lean, young adults had higher blood levels of the endocannabinoid molecule 2-arachidonoylglycerol (2-AG) after only 4.5 hours of sleep compared with a normal night’s sleep when they got 8.5 hours in bed.

Researchers controlled what the participants ate and did during 6 nights in a sleep lab, testing their blood levels every hour for 24 hours after the second night of sleep.

They randomized participants to the normal-sleep or partial-sleep-restriction groups and had them return a month later in a crossover design to spend another 6 nights in the sleep lab experiencing whichever sleep pattern they hadn’t been randomized to initially.

The results showed a circadian rhythm to endocannabinoid levels, with 2-AG peaking in the early afternoon in both groups but being significantly higher in the sleep-restriction group, reported Erin C. Hanlon, Ph.D. and her associates.

Previous studies of the relationship between sleep and endocannabinoids had looked at only single time points or narrower time intervals, she said. The current results extend findings from at least a dozen previous studies in the last 5 years on related topics. In three studies, researchers reported an association between shortened sleep duration and increased eating of snacks and high-energy foods, such as in this study: Am. J. Clin. Nutr. 2012;95:818-24. Two other studies showed that decreased sleep was associated with increased risk for obesity. And seven other carefully controlled laboratory studies found that sleep restriction impaired glucose metabolism, altered peripherally secreted hormones that modulate feeding behavior, and increased participants’ ratings of appetite and hunger, said Dr. Hanlon of the University of Chicago.

Is lack of sleep the only cause of the obesity epidemic? Of course not. But a quick look at national data suggests that it could be a major factor, if these preliminary studies are on to something.

According to the Centers for Disease Control and Prevention, 35% of nearly 75,000 U.S. adults in 12 states reported in 2009 that they get less than 7 hours of sleep in a typical 24-hour period. Want to guess how many Americans reported being overweight in 2012? That would be 36%, according to a Gallup poll, with another 26% saying that they’re obese.

And are endocannabinoids the only endogenous players that affect overeating? Unlikely. But the endocannabinoid system is a target for development of potential pharmaceutical treatments for obesity, Dr. Hanlon said. Someday soon, I suppose, you may be able to buy a pill to counteract the munchie effects of excessive endocannabinoids. Or, we could all just get a good night’s sleep.

Dr. Hanlon reported having no financial disclosures. Her research was funded by the National Institutes of Health, the Department of Defense, and the Medical College of Wisconsin.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A new type of scale for determining remission from depression performed well, compared with conventional measures in a study of 153 outpatients being treated for depression.

At baseline and after 3-4 months of treatment, patients completed the experimental Remission From Depression Questionnaire (RDQ) and the commonly used Quick Inventory of Depressive Symptomatology (QIDS). They were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D). The QIDS and HAM-D focus on symptomatology, while the 41-item RDQ is a broader measure that includes other factors that patients have identified in previous studies as being important elements of remission, Dr. Mark Zimmerman said at the annual meeting of the American Psychiatric Association.

The effect size for all three scales were the same, meaning that the three tools were equally sensitive to change in depression, reported Dr. Zimmerman of Brown University, Providence, R.I.

Each of the seven subscales of the RDQ were sensitive to change, including subscales for symptoms of depression, other symptoms (such as anxiety or irritability), coping ability, positive mental health, functioning, life satisfaction, and general sense of well-being.

The RDQ scores were associated with self-perceived remission even after controlling for QIDS scores. In contrast, QIDS scores were associated with self-perceived remission, but not after controlling for the RDQ scores. "The RDQ is picking up variance in whether or not patients believe they are in remission above and beyond that accounted for by symptoms alone," said Dr. Zimmerman, also director of outpatient psychiatry at Rhode Island Hospital, Providence.

Historically, studies have found wide variability in the definition of remission from depression and in the terms used to describe it. A 1991 consensus conference defined remission as a score of 7 or less on the 17-item HAM-D. One of the limits of this and other definitions of remission is that they are completely symptom based with no consideration of other factors that might be important in determining how patients are doing during treatment, he said.

Dr. Zimmerman and his associates have been studying a broader concept of depression remission in studies over the past decade. "Just what this field needs – another measure to assess depression, because there aren’t enough of them already," he said sarcastically.

They initially surveyed 535 depressed outpatients to find out what they consider to be important aspects in determining remission. Among the 16 items they rated, symptom resolution didn’t make the top 4. The top factors rated by patients as important were the presence of positive mental health (selected by 77% of participants), feeling like one’s usual, normal self (76%); return to one’s usual level of functioning (74%); and feeling in emotional control (72%). When asked to choose the most important factor determining remission, 17% chose the presence of positive mental health, 14% chose feeling like one’s usual self, 11% picked a general sense of well-being, and only 10% pointed to the absence of symptoms of depression (Am. J. Psychiatry 2006;163:148-50).

"There seems to be a disconnect between what researchers have been doing all these years, which is defining remission purely in symptom terms, and what patients say are the most important considerations that they have in determining whether or not they’re in remission," he said.

Dr. Zimmerman and his associates next surveyed 514 outpatients being treated for major depressive disorder. They found that patients’ ratings of the severity of their depression, how much their symptoms have interfered with their lives or caused them difficulties, and their overall quality of life were significantly and independently associated with their view of whether or not they were in remission. (J. Psychiatr. Res. 2008;42:797-801).

The findings of these first two studies and subsequent focus groups led the investigators to develop the RDQ. In a study of 102 depressed outpatients, patients felt the RDQ was more accurate than was the symptom-based QIDS in assessing their goals and progress in treatment, and they preferred the RDQ, Dr. Zimmerman said (Ann. Clin. Psych. 2011;23:208-12).

He and his associates tested the RDQ’s reliability and validity in a study of 274 depressed outpatients in ongoing treatment, 60 of whom completed the RDQ twice to assess reliability. Patients filled out the RDQ and the QIDS, and were rated on the 17-item HAM-D and other measures. The RDQ proved to be reliable, with good internal consistency. Approximately 50% of patients were in self-reported remission according to the various measures. After researchers controlled for depression symptom severity, the RDQ identified patients who considered themselves to be in remission for reasons above and beyond symptoms status (J. Psychiatr. Res. 2013;47:78-82).

"It was capturing something unique" that the symptom-based QIDS and HAM-D scores missed, Dr. Zimmerman said. "Depressed patients’ perspective of remission goes beyond symptom resolution."

He is hopeful that the concept of remission is evolving, because outcomes in treatment trials increasingly are not being measured just in terms of symptom status alone. Investigators have begun to look at aspects of function and, less frequently, at quality of life, he said.

Dr. Zimmerman hopes to study whether a broader-based measure of remission, such as the RDQ, better predicts which patients are likely to relapse, compared with conventional remission measures. Another study could look at whether the RDQ is a superior outcome measure when treatment de-emphasizes symptomatic improvement, and instead focuses on functional improvement and quality of life, he said.

Dr. Zimmerman’s research was funded by Eli Lilly. He also reported financial associations with Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A new type of scale for determining remission from depression performed well, compared with conventional measures in a study of 153 outpatients being treated for depression.

At baseline and after 3-4 months of treatment, patients completed the experimental Remission From Depression Questionnaire (RDQ) and the commonly used Quick Inventory of Depressive Symptomatology (QIDS). They were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D). The QIDS and HAM-D focus on symptomatology, while the 41-item RDQ is a broader measure that includes other factors that patients have identified in previous studies as being important elements of remission, Dr. Mark Zimmerman said at the annual meeting of the American Psychiatric Association.

The effect size for all three scales were the same, meaning that the three tools were equally sensitive to change in depression, reported Dr. Zimmerman of Brown University, Providence, R.I.

Each of the seven subscales of the RDQ were sensitive to change, including subscales for symptoms of depression, other symptoms (such as anxiety or irritability), coping ability, positive mental health, functioning, life satisfaction, and general sense of well-being.

The RDQ scores were associated with self-perceived remission even after controlling for QIDS scores. In contrast, QIDS scores were associated with self-perceived remission, but not after controlling for the RDQ scores. "The RDQ is picking up variance in whether or not patients believe they are in remission above and beyond that accounted for by symptoms alone," said Dr. Zimmerman, also director of outpatient psychiatry at Rhode Island Hospital, Providence.

Historically, studies have found wide variability in the definition of remission from depression and in the terms used to describe it. A 1991 consensus conference defined remission as a score of 7 or less on the 17-item HAM-D. One of the limits of this and other definitions of remission is that they are completely symptom based with no consideration of other factors that might be important in determining how patients are doing during treatment, he said.

Dr. Zimmerman and his associates have been studying a broader concept of depression remission in studies over the past decade. "Just what this field needs – another measure to assess depression, because there aren’t enough of them already," he said sarcastically.

They initially surveyed 535 depressed outpatients to find out what they consider to be important aspects in determining remission. Among the 16 items they rated, symptom resolution didn’t make the top 4. The top factors rated by patients as important were the presence of positive mental health (selected by 77% of participants), feeling like one’s usual, normal self (76%); return to one’s usual level of functioning (74%); and feeling in emotional control (72%). When asked to choose the most important factor determining remission, 17% chose the presence of positive mental health, 14% chose feeling like one’s usual self, 11% picked a general sense of well-being, and only 10% pointed to the absence of symptoms of depression (Am. J. Psychiatry 2006;163:148-50).

"There seems to be a disconnect between what researchers have been doing all these years, which is defining remission purely in symptom terms, and what patients say are the most important considerations that they have in determining whether or not they’re in remission," he said.

Dr. Zimmerman and his associates next surveyed 514 outpatients being treated for major depressive disorder. They found that patients’ ratings of the severity of their depression, how much their symptoms have interfered with their lives or caused them difficulties, and their overall quality of life were significantly and independently associated with their view of whether or not they were in remission. (J. Psychiatr. Res. 2008;42:797-801).

The findings of these first two studies and subsequent focus groups led the investigators to develop the RDQ. In a study of 102 depressed outpatients, patients felt the RDQ was more accurate than was the symptom-based QIDS in assessing their goals and progress in treatment, and they preferred the RDQ, Dr. Zimmerman said (Ann. Clin. Psych. 2011;23:208-12).

He and his associates tested the RDQ’s reliability and validity in a study of 274 depressed outpatients in ongoing treatment, 60 of whom completed the RDQ twice to assess reliability. Patients filled out the RDQ and the QIDS, and were rated on the 17-item HAM-D and other measures. The RDQ proved to be reliable, with good internal consistency. Approximately 50% of patients were in self-reported remission according to the various measures. After researchers controlled for depression symptom severity, the RDQ identified patients who considered themselves to be in remission for reasons above and beyond symptoms status (J. Psychiatr. Res. 2013;47:78-82).

"It was capturing something unique" that the symptom-based QIDS and HAM-D scores missed, Dr. Zimmerman said. "Depressed patients’ perspective of remission goes beyond symptom resolution."

He is hopeful that the concept of remission is evolving, because outcomes in treatment trials increasingly are not being measured just in terms of symptom status alone. Investigators have begun to look at aspects of function and, less frequently, at quality of life, he said.

Dr. Zimmerman hopes to study whether a broader-based measure of remission, such as the RDQ, better predicts which patients are likely to relapse, compared with conventional remission measures. Another study could look at whether the RDQ is a superior outcome measure when treatment de-emphasizes symptomatic improvement, and instead focuses on functional improvement and quality of life, he said.

Dr. Zimmerman’s research was funded by Eli Lilly. He also reported financial associations with Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A new type of scale for determining remission from depression performed well, compared with conventional measures in a study of 153 outpatients being treated for depression.

At baseline and after 3-4 months of treatment, patients completed the experimental Remission From Depression Questionnaire (RDQ) and the commonly used Quick Inventory of Depressive Symptomatology (QIDS). They were assessed using the 17-item Hamilton Depression Rating Scale (HAM-D). The QIDS and HAM-D focus on symptomatology, while the 41-item RDQ is a broader measure that includes other factors that patients have identified in previous studies as being important elements of remission, Dr. Mark Zimmerman said at the annual meeting of the American Psychiatric Association.

The effect size for all three scales were the same, meaning that the three tools were equally sensitive to change in depression, reported Dr. Zimmerman of Brown University, Providence, R.I.

Each of the seven subscales of the RDQ were sensitive to change, including subscales for symptoms of depression, other symptoms (such as anxiety or irritability), coping ability, positive mental health, functioning, life satisfaction, and general sense of well-being.

The RDQ scores were associated with self-perceived remission even after controlling for QIDS scores. In contrast, QIDS scores were associated with self-perceived remission, but not after controlling for the RDQ scores. "The RDQ is picking up variance in whether or not patients believe they are in remission above and beyond that accounted for by symptoms alone," said Dr. Zimmerman, also director of outpatient psychiatry at Rhode Island Hospital, Providence.

Historically, studies have found wide variability in the definition of remission from depression and in the terms used to describe it. A 1991 consensus conference defined remission as a score of 7 or less on the 17-item HAM-D. One of the limits of this and other definitions of remission is that they are completely symptom based with no consideration of other factors that might be important in determining how patients are doing during treatment, he said.

Dr. Zimmerman and his associates have been studying a broader concept of depression remission in studies over the past decade. "Just what this field needs – another measure to assess depression, because there aren’t enough of them already," he said sarcastically.

They initially surveyed 535 depressed outpatients to find out what they consider to be important aspects in determining remission. Among the 16 items they rated, symptom resolution didn’t make the top 4. The top factors rated by patients as important were the presence of positive mental health (selected by 77% of participants), feeling like one’s usual, normal self (76%); return to one’s usual level of functioning (74%); and feeling in emotional control (72%). When asked to choose the most important factor determining remission, 17% chose the presence of positive mental health, 14% chose feeling like one’s usual self, 11% picked a general sense of well-being, and only 10% pointed to the absence of symptoms of depression (Am. J. Psychiatry 2006;163:148-50).

"There seems to be a disconnect between what researchers have been doing all these years, which is defining remission purely in symptom terms, and what patients say are the most important considerations that they have in determining whether or not they’re in remission," he said.

Dr. Zimmerman and his associates next surveyed 514 outpatients being treated for major depressive disorder. They found that patients’ ratings of the severity of their depression, how much their symptoms have interfered with their lives or caused them difficulties, and their overall quality of life were significantly and independently associated with their view of whether or not they were in remission. (J. Psychiatr. Res. 2008;42:797-801).

The findings of these first two studies and subsequent focus groups led the investigators to develop the RDQ. In a study of 102 depressed outpatients, patients felt the RDQ was more accurate than was the symptom-based QIDS in assessing their goals and progress in treatment, and they preferred the RDQ, Dr. Zimmerman said (Ann. Clin. Psych. 2011;23:208-12).

He and his associates tested the RDQ’s reliability and validity in a study of 274 depressed outpatients in ongoing treatment, 60 of whom completed the RDQ twice to assess reliability. Patients filled out the RDQ and the QIDS, and were rated on the 17-item HAM-D and other measures. The RDQ proved to be reliable, with good internal consistency. Approximately 50% of patients were in self-reported remission according to the various measures. After researchers controlled for depression symptom severity, the RDQ identified patients who considered themselves to be in remission for reasons above and beyond symptoms status (J. Psychiatr. Res. 2013;47:78-82).

"It was capturing something unique" that the symptom-based QIDS and HAM-D scores missed, Dr. Zimmerman said. "Depressed patients’ perspective of remission goes beyond symptom resolution."

He is hopeful that the concept of remission is evolving, because outcomes in treatment trials increasingly are not being measured just in terms of symptom status alone. Investigators have begun to look at aspects of function and, less frequently, at quality of life, he said.

Dr. Zimmerman hopes to study whether a broader-based measure of remission, such as the RDQ, better predicts which patients are likely to relapse, compared with conventional remission measures. Another study could look at whether the RDQ is a superior outcome measure when treatment de-emphasizes symptomatic improvement, and instead focuses on functional improvement and quality of life, he said.

Dr. Zimmerman’s research was funded by Eli Lilly. He also reported financial associations with Bristol-Myers Squibb.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A threshold of 6-cm cervical dilation is more accurate than the conventional 4 cm to determine when a woman enters the active phase of labor, a reevaluation of evidence suggests.

The historical evidence behind the commonly used assumption that 4-cm dilation signals the start of active labor contains methodological flaws, doesn’t match today’s population of pregnant women, and is contradicted by more recent studies supporting the 6-cm threshold, Tekoa King, C.N.M, Ph.D., said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Using the 4-cm threshold, a woman "may just be in the normal latent phase of labor," she said.

Switching to the 6-cm threshold should delay or reduce the use of epidural anesthesia and might lower the high rate of cesarean sections in the United States. "Six centimeters is the new four centimeters," said Dr. King, a certified nurse-midwife and clinical professor of nursing at the university.

The 4-cm threshold for active labor arose out of two studies in the 1950s by Friedman et al. One study plotted the course of labor in centimeters of dilation over time in 500 nulliparous pregnant women. The same investigators profiled 200 women who were considered in the 1950s to have "ideal labor" – meaning term, vertex, singleton pregnancies – but the women commonly received considerable amounts of morphine and may or may not have had instrumented deliveries using outlet forceps. "They wouldn’t be what we would consider ideal today," Dr. King said.

Comparing the two cohorts, investigators in the 1950s found that the "ideal" group had shorter labors. They concluded that women who had been contracting more than 24 hours had a prolonged latent phase, and that the slowest rate of dilation in the active phase of labor was 1.2 cm/hr. Thus was born the "Friedman curve" that underpinned the decades-long dogma that women need to dilate about 1 cm/hr in the active phase of labor.

More recently, other data show that "the Friedman curve was really codified by the way we examined women every 2 hours. If you examine them more frequently, you’re going to get a different curve. Probably what we should be doing is examining them a lot less frequently until they’re 6 cm, and perhaps a little more frequently from 6 cm to complete" dilation, depending on whether or not there are other indications for examination, she said.

A 2002 study by Zhang et al. of 1,329 nulliparous, term, singleton, vertex pregnancies with normal-weight babies, spontaneous onset of labor, and vaginal delivery used a different approach from the Friedman studies. It measured the time between each centimeter change in dilation instead of the time it took to go from 4-cm to 10-cm dilation and then calculating an interval average. The newer study found that it was common to have very slow progress before 7 cm, there was no deceleration phase, and the slowest but still normal rate of cervical dilation was less than 1 cm/hr, with a wide range of variability (Am. J. Obstet. Gynecol. 2002;187:824-8).

To go from 6-cm to 7-cm dilation, for example, took little more than half an hour on average, but it ranged from 0.2 hours to more than 2 hours. "This makes sense," Dr. King said. "What’s really happening between 6 and 7 or 7 and 8 cm? Internal rotation. We often forget that internal rotation and descent station are progress. We just get ourselves fixated on cervical dilation" and end up performing a cesarean section in women for "arrested labor" at a time when they’re having normal progress.

The same investigators followed that with a 2010 study analyzing data on more than 50,000 singleton, vertex pregnancies with spontaneous onset of labor, vaginal delivery and "normal outcome." Again, they used the "repeated measures" approach to estimate the labor curves and to "redefine normal," Dr. King said. They found that the median rate of change was about 2 cm/hr and the slowest rate of normal change was 0.4 cm/hr (Obstet. Gynecol. 2010;116:1281-7).

On Friedman’s curve, what he called the point of inflection (or the beginning of the active phase of labor) was at 4-cm cervical dilation. But Zhang’s curve suggests that the point of inflection when labor starts to progress faster is at 6-cm dilation. "That’s our real world today, and here we are, using 4 cm. Basically, we’re treating women who are in the latent phase of labor as though they were active," she said.

The other insight from the work of Zhang et al. is that dilation progresses faster as the cervix becomes more dilated, not at a steady rate of 1 cm/hr.

Zhang et al. also reported that 40% of women who undergo induction of labor get a cesarean section when they are 4 cm dilated. "That’s probably where we really need to start paying some attention to what we’re doing," Dr. King said. Too many cesarean sections are being done at cervical dilations of 6 cm or less, she said.

Other recent data show that women with induced labor need significantly more time to reach 6-cm dilation compared with women with spontaneous labor, but after 6 cm the rate of progression is similar (Obstet. Gynecol. 2012;119:1113-8).

Greater patience with induced labor could reduce the rate of cesarean sections. "These are the women who are getting sectioned," she said.

A separate study suggests that women trying for a vaginal delivery after a prior cesarean section should be assessed by the same progression curves as women without a prior cesarean section (Obstet. Gynecol. 2012;119:732-6).

Clinical variables also have changed since the 1950s in ways that affect the progress of labor. Pregnant women in the United States today are more likely to be obese. A high body mass index prolongs the time it takes for cervical dilation in labor. "We may need a whole new labor curve for these women," Dr. King said.

She reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A threshold of 6-cm cervical dilation is more accurate than the conventional 4 cm to determine when a woman enters the active phase of labor, a reevaluation of evidence suggests.

The historical evidence behind the commonly used assumption that 4-cm dilation signals the start of active labor contains methodological flaws, doesn’t match today’s population of pregnant women, and is contradicted by more recent studies supporting the 6-cm threshold, Tekoa King, C.N.M, Ph.D., said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Using the 4-cm threshold, a woman "may just be in the normal latent phase of labor," she said.

Switching to the 6-cm threshold should delay or reduce the use of epidural anesthesia and might lower the high rate of cesarean sections in the United States. "Six centimeters is the new four centimeters," said Dr. King, a certified nurse-midwife and clinical professor of nursing at the university.

The 4-cm threshold for active labor arose out of two studies in the 1950s by Friedman et al. One study plotted the course of labor in centimeters of dilation over time in 500 nulliparous pregnant women. The same investigators profiled 200 women who were considered in the 1950s to have "ideal labor" – meaning term, vertex, singleton pregnancies – but the women commonly received considerable amounts of morphine and may or may not have had instrumented deliveries using outlet forceps. "They wouldn’t be what we would consider ideal today," Dr. King said.

Comparing the two cohorts, investigators in the 1950s found that the "ideal" group had shorter labors. They concluded that women who had been contracting more than 24 hours had a prolonged latent phase, and that the slowest rate of dilation in the active phase of labor was 1.2 cm/hr. Thus was born the "Friedman curve" that underpinned the decades-long dogma that women need to dilate about 1 cm/hr in the active phase of labor.

More recently, other data show that "the Friedman curve was really codified by the way we examined women every 2 hours. If you examine them more frequently, you’re going to get a different curve. Probably what we should be doing is examining them a lot less frequently until they’re 6 cm, and perhaps a little more frequently from 6 cm to complete" dilation, depending on whether or not there are other indications for examination, she said.

A 2002 study by Zhang et al. of 1,329 nulliparous, term, singleton, vertex pregnancies with normal-weight babies, spontaneous onset of labor, and vaginal delivery used a different approach from the Friedman studies. It measured the time between each centimeter change in dilation instead of the time it took to go from 4-cm to 10-cm dilation and then calculating an interval average. The newer study found that it was common to have very slow progress before 7 cm, there was no deceleration phase, and the slowest but still normal rate of cervical dilation was less than 1 cm/hr, with a wide range of variability (Am. J. Obstet. Gynecol. 2002;187:824-8).

To go from 6-cm to 7-cm dilation, for example, took little more than half an hour on average, but it ranged from 0.2 hours to more than 2 hours. "This makes sense," Dr. King said. "What’s really happening between 6 and 7 or 7 and 8 cm? Internal rotation. We often forget that internal rotation and descent station are progress. We just get ourselves fixated on cervical dilation" and end up performing a cesarean section in women for "arrested labor" at a time when they’re having normal progress.

The same investigators followed that with a 2010 study analyzing data on more than 50,000 singleton, vertex pregnancies with spontaneous onset of labor, vaginal delivery and "normal outcome." Again, they used the "repeated measures" approach to estimate the labor curves and to "redefine normal," Dr. King said. They found that the median rate of change was about 2 cm/hr and the slowest rate of normal change was 0.4 cm/hr (Obstet. Gynecol. 2010;116:1281-7).

On Friedman’s curve, what he called the point of inflection (or the beginning of the active phase of labor) was at 4-cm cervical dilation. But Zhang’s curve suggests that the point of inflection when labor starts to progress faster is at 6-cm dilation. "That’s our real world today, and here we are, using 4 cm. Basically, we’re treating women who are in the latent phase of labor as though they were active," she said.

The other insight from the work of Zhang et al. is that dilation progresses faster as the cervix becomes more dilated, not at a steady rate of 1 cm/hr.

Zhang et al. also reported that 40% of women who undergo induction of labor get a cesarean section when they are 4 cm dilated. "That’s probably where we really need to start paying some attention to what we’re doing," Dr. King said. Too many cesarean sections are being done at cervical dilations of 6 cm or less, she said.

Other recent data show that women with induced labor need significantly more time to reach 6-cm dilation compared with women with spontaneous labor, but after 6 cm the rate of progression is similar (Obstet. Gynecol. 2012;119:1113-8).

Greater patience with induced labor could reduce the rate of cesarean sections. "These are the women who are getting sectioned," she said.

A separate study suggests that women trying for a vaginal delivery after a prior cesarean section should be assessed by the same progression curves as women without a prior cesarean section (Obstet. Gynecol. 2012;119:732-6).

Clinical variables also have changed since the 1950s in ways that affect the progress of labor. Pregnant women in the United States today are more likely to be obese. A high body mass index prolongs the time it takes for cervical dilation in labor. "We may need a whole new labor curve for these women," Dr. King said.

She reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – A threshold of 6-cm cervical dilation is more accurate than the conventional 4 cm to determine when a woman enters the active phase of labor, a reevaluation of evidence suggests.

The historical evidence behind the commonly used assumption that 4-cm dilation signals the start of active labor contains methodological flaws, doesn’t match today’s population of pregnant women, and is contradicted by more recent studies supporting the 6-cm threshold, Tekoa King, C.N.M, Ph.D., said at a meeting on antepartum and intrapartum management sponsored by the University of California, San Francisco.

Using the 4-cm threshold, a woman "may just be in the normal latent phase of labor," she said.

Switching to the 6-cm threshold should delay or reduce the use of epidural anesthesia and might lower the high rate of cesarean sections in the United States. "Six centimeters is the new four centimeters," said Dr. King, a certified nurse-midwife and clinical professor of nursing at the university.

The 4-cm threshold for active labor arose out of two studies in the 1950s by Friedman et al. One study plotted the course of labor in centimeters of dilation over time in 500 nulliparous pregnant women. The same investigators profiled 200 women who were considered in the 1950s to have "ideal labor" – meaning term, vertex, singleton pregnancies – but the women commonly received considerable amounts of morphine and may or may not have had instrumented deliveries using outlet forceps. "They wouldn’t be what we would consider ideal today," Dr. King said.

Comparing the two cohorts, investigators in the 1950s found that the "ideal" group had shorter labors. They concluded that women who had been contracting more than 24 hours had a prolonged latent phase, and that the slowest rate of dilation in the active phase of labor was 1.2 cm/hr. Thus was born the "Friedman curve" that underpinned the decades-long dogma that women need to dilate about 1 cm/hr in the active phase of labor.

More recently, other data show that "the Friedman curve was really codified by the way we examined women every 2 hours. If you examine them more frequently, you’re going to get a different curve. Probably what we should be doing is examining them a lot less frequently until they’re 6 cm, and perhaps a little more frequently from 6 cm to complete" dilation, depending on whether or not there are other indications for examination, she said.

A 2002 study by Zhang et al. of 1,329 nulliparous, term, singleton, vertex pregnancies with normal-weight babies, spontaneous onset of labor, and vaginal delivery used a different approach from the Friedman studies. It measured the time between each centimeter change in dilation instead of the time it took to go from 4-cm to 10-cm dilation and then calculating an interval average. The newer study found that it was common to have very slow progress before 7 cm, there was no deceleration phase, and the slowest but still normal rate of cervical dilation was less than 1 cm/hr, with a wide range of variability (Am. J. Obstet. Gynecol. 2002;187:824-8).

To go from 6-cm to 7-cm dilation, for example, took little more than half an hour on average, but it ranged from 0.2 hours to more than 2 hours. "This makes sense," Dr. King said. "What’s really happening between 6 and 7 or 7 and 8 cm? Internal rotation. We often forget that internal rotation and descent station are progress. We just get ourselves fixated on cervical dilation" and end up performing a cesarean section in women for "arrested labor" at a time when they’re having normal progress.

The same investigators followed that with a 2010 study analyzing data on more than 50,000 singleton, vertex pregnancies with spontaneous onset of labor, vaginal delivery and "normal outcome." Again, they used the "repeated measures" approach to estimate the labor curves and to "redefine normal," Dr. King said. They found that the median rate of change was about 2 cm/hr and the slowest rate of normal change was 0.4 cm/hr (Obstet. Gynecol. 2010;116:1281-7).

On Friedman’s curve, what he called the point of inflection (or the beginning of the active phase of labor) was at 4-cm cervical dilation. But Zhang’s curve suggests that the point of inflection when labor starts to progress faster is at 6-cm dilation. "That’s our real world today, and here we are, using 4 cm. Basically, we’re treating women who are in the latent phase of labor as though they were active," she said.

The other insight from the work of Zhang et al. is that dilation progresses faster as the cervix becomes more dilated, not at a steady rate of 1 cm/hr.

Zhang et al. also reported that 40% of women who undergo induction of labor get a cesarean section when they are 4 cm dilated. "That’s probably where we really need to start paying some attention to what we’re doing," Dr. King said. Too many cesarean sections are being done at cervical dilations of 6 cm or less, she said.

Other recent data show that women with induced labor need significantly more time to reach 6-cm dilation compared with women with spontaneous labor, but after 6 cm the rate of progression is similar (Obstet. Gynecol. 2012;119:1113-8).

Greater patience with induced labor could reduce the rate of cesarean sections. "These are the women who are getting sectioned," she said.

A separate study suggests that women trying for a vaginal delivery after a prior cesarean section should be assessed by the same progression curves as women without a prior cesarean section (Obstet. Gynecol. 2012;119:732-6).

Clinical variables also have changed since the 1950s in ways that affect the progress of labor. Pregnant women in the United States today are more likely to be obese. A high body mass index prolongs the time it takes for cervical dilation in labor. "We may need a whole new labor curve for these women," Dr. King said.

She reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Thirty-seven percent of 175 hospitalized adolescents diagnosed with bipolar disorder met criteria for a new disorder listed in the DSM-5 – disruptive mood dysregulation disorder.

Nearly all of the patients (96%) had been diagnosed with bipolar I disorder "not otherwise specified" (NOS) at the time of admission, a retrospective study found. Three other bipolar diagnoses were applied to two patients each: bipolar depression, bipolar mania, or mixed-episode bipolar disorder, David L. Pogge, Ph.D., reported at the annual meeting of the American Psychiatric Association.

The findings suggest that a substantial proportion of adolescent inpatients diagnosed with bipolar disorder may instead meet criteria for disruptive mood dysregulation disorder, and that clinicians should be more careful in diagnosing bipolar disorder, especially bipolar NOS, said Dr. Pogge of the department of psychology and counseling at Fairleigh Dickinson University, Teaneck, N.J. He also serves as director of psychology at Four Winds Hospital, which operates four campuses in New York state.

The study included records for all 1,505 patients aged 13-17 years who were admitted to a private psychiatric hospital over a 2-year period. At the time of admission, clinicians rated 1,351 patients as having at least moderate depression and 368 as also having severe symptoms of hostility and explosiveness. They diagnosed bipolar disorder in 259 cases. The investigators analyzed records for 174 patients with complete records or who had at least moderate depression and severe symptoms of hostility and explosiveness but no signs of elation or euphoria at the time of admission.

Disruptive mood dysregulation disorder is marked by intense temper outbursts superimposed on a background of persistent depressed or irritable mood. Temper outbursts and aggression are common reasons for inpatient admissions of children and adolescents, Dr. Pogge noted in his poster presentation.

Compared with the 63% of patients who did not meet criteria for disruptive mood dysregulation disorder (DMDD), patients who met the DMDD criteria were significantly more likely to experience restraint or seclusion while hospitalized (30% vs. 20%), receive a significantly higher number of restraints or seclusions (2.2 vs. 0.8), and remain hospitalized significantly longer (25 days vs. 21 days), he reported. At the time of discharge, clinicians’ ratings on the Global Assessment of Functioning (GAF) scale indicated significantly greater global psychopathology in patients with DMDD (a mean GAF score of 44), compared with patients who did not meet DMDD criteria (a mean GAF score of 50).

The two groups did not differ significantly by age, clinician ratings of depression severity, or clinical ratings of global psychopathology at admission.

The study identified a subgroup of adolescent inpatients diagnosed with bipolar disorder without euphoric symptoms who exhibited explosiveness, hostility, and concurrent depression, comprising roughly a third of bipolar disorder diagnoses in the cohort. The findings suggest that these patients who lack signs of elevated mood and meet DMDD criteria routinely get diagnosed with bipolar I disorder, have a more problematic hospital stay, and have more symptoms at discharge, Dr. Pogge and his coinvestigators concluded.

The bipolar diagnoses might be incorrect, or there might be a substantial rate of comorbidity between DMDD and bipolar disease, he said.

The results also suggest that DMDD might be a common reason for psychiatric hospitalization of adolescents.

The study excluded patients whose records suggested other confounding factors or were missing any data on outcome measures.

Dr. Pogge reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Thirty-seven percent of 175 hospitalized adolescents diagnosed with bipolar disorder met criteria for a new disorder listed in the DSM-5 – disruptive mood dysregulation disorder.

Nearly all of the patients (96%) had been diagnosed with bipolar I disorder "not otherwise specified" (NOS) at the time of admission, a retrospective study found. Three other bipolar diagnoses were applied to two patients each: bipolar depression, bipolar mania, or mixed-episode bipolar disorder, David L. Pogge, Ph.D., reported at the annual meeting of the American Psychiatric Association.

The findings suggest that a substantial proportion of adolescent inpatients diagnosed with bipolar disorder may instead meet criteria for disruptive mood dysregulation disorder, and that clinicians should be more careful in diagnosing bipolar disorder, especially bipolar NOS, said Dr. Pogge of the department of psychology and counseling at Fairleigh Dickinson University, Teaneck, N.J. He also serves as director of psychology at Four Winds Hospital, which operates four campuses in New York state.

The study included records for all 1,505 patients aged 13-17 years who were admitted to a private psychiatric hospital over a 2-year period. At the time of admission, clinicians rated 1,351 patients as having at least moderate depression and 368 as also having severe symptoms of hostility and explosiveness. They diagnosed bipolar disorder in 259 cases. The investigators analyzed records for 174 patients with complete records or who had at least moderate depression and severe symptoms of hostility and explosiveness but no signs of elation or euphoria at the time of admission.

Disruptive mood dysregulation disorder is marked by intense temper outbursts superimposed on a background of persistent depressed or irritable mood. Temper outbursts and aggression are common reasons for inpatient admissions of children and adolescents, Dr. Pogge noted in his poster presentation.

Compared with the 63% of patients who did not meet criteria for disruptive mood dysregulation disorder (DMDD), patients who met the DMDD criteria were significantly more likely to experience restraint or seclusion while hospitalized (30% vs. 20%), receive a significantly higher number of restraints or seclusions (2.2 vs. 0.8), and remain hospitalized significantly longer (25 days vs. 21 days), he reported. At the time of discharge, clinicians’ ratings on the Global Assessment of Functioning (GAF) scale indicated significantly greater global psychopathology in patients with DMDD (a mean GAF score of 44), compared with patients who did not meet DMDD criteria (a mean GAF score of 50).

The two groups did not differ significantly by age, clinician ratings of depression severity, or clinical ratings of global psychopathology at admission.

The study identified a subgroup of adolescent inpatients diagnosed with bipolar disorder without euphoric symptoms who exhibited explosiveness, hostility, and concurrent depression, comprising roughly a third of bipolar disorder diagnoses in the cohort. The findings suggest that these patients who lack signs of elevated mood and meet DMDD criteria routinely get diagnosed with bipolar I disorder, have a more problematic hospital stay, and have more symptoms at discharge, Dr. Pogge and his coinvestigators concluded.

The bipolar diagnoses might be incorrect, or there might be a substantial rate of comorbidity between DMDD and bipolar disease, he said.

The results also suggest that DMDD might be a common reason for psychiatric hospitalization of adolescents.

The study excluded patients whose records suggested other confounding factors or were missing any data on outcome measures.

Dr. Pogge reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SAN FRANCISCO – Thirty-seven percent of 175 hospitalized adolescents diagnosed with bipolar disorder met criteria for a new disorder listed in the DSM-5 – disruptive mood dysregulation disorder.

Nearly all of the patients (96%) had been diagnosed with bipolar I disorder "not otherwise specified" (NOS) at the time of admission, a retrospective study found. Three other bipolar diagnoses were applied to two patients each: bipolar depression, bipolar mania, or mixed-episode bipolar disorder, David L. Pogge, Ph.D., reported at the annual meeting of the American Psychiatric Association.

The findings suggest that a substantial proportion of adolescent inpatients diagnosed with bipolar disorder may instead meet criteria for disruptive mood dysregulation disorder, and that clinicians should be more careful in diagnosing bipolar disorder, especially bipolar NOS, said Dr. Pogge of the department of psychology and counseling at Fairleigh Dickinson University, Teaneck, N.J. He also serves as director of psychology at Four Winds Hospital, which operates four campuses in New York state.

The study included records for all 1,505 patients aged 13-17 years who were admitted to a private psychiatric hospital over a 2-year period. At the time of admission, clinicians rated 1,351 patients as having at least moderate depression and 368 as also having severe symptoms of hostility and explosiveness. They diagnosed bipolar disorder in 259 cases. The investigators analyzed records for 174 patients with complete records or who had at least moderate depression and severe symptoms of hostility and explosiveness but no signs of elation or euphoria at the time of admission.

Disruptive mood dysregulation disorder is marked by intense temper outbursts superimposed on a background of persistent depressed or irritable mood. Temper outbursts and aggression are common reasons for inpatient admissions of children and adolescents, Dr. Pogge noted in his poster presentation.

Compared with the 63% of patients who did not meet criteria for disruptive mood dysregulation disorder (DMDD), patients who met the DMDD criteria were significantly more likely to experience restraint or seclusion while hospitalized (30% vs. 20%), receive a significantly higher number of restraints or seclusions (2.2 vs. 0.8), and remain hospitalized significantly longer (25 days vs. 21 days), he reported. At the time of discharge, clinicians’ ratings on the Global Assessment of Functioning (GAF) scale indicated significantly greater global psychopathology in patients with DMDD (a mean GAF score of 44), compared with patients who did not meet DMDD criteria (a mean GAF score of 50).

The two groups did not differ significantly by age, clinician ratings of depression severity, or clinical ratings of global psychopathology at admission.

The study identified a subgroup of adolescent inpatients diagnosed with bipolar disorder without euphoric symptoms who exhibited explosiveness, hostility, and concurrent depression, comprising roughly a third of bipolar disorder diagnoses in the cohort. The findings suggest that these patients who lack signs of elevated mood and meet DMDD criteria routinely get diagnosed with bipolar I disorder, have a more problematic hospital stay, and have more symptoms at discharge, Dr. Pogge and his coinvestigators concluded.

The bipolar diagnoses might be incorrect, or there might be a substantial rate of comorbidity between DMDD and bipolar disease, he said.

The results also suggest that DMDD might be a common reason for psychiatric hospitalization of adolescents.

The study excluded patients whose records suggested other confounding factors or were missing any data on outcome measures.

Dr. Pogge reported having no relevant financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert