OBG Management

Ferrara A, Hedderson MM, Zhu Y, et al. Perinatal complications in individuals in California with or without SARS-CoV-2 infection during pregnancy. JAMA Intern Med. 2022;182:503-512. doi:10.1001/jamainternmed.2022.0330

Expert Commentary

SARS-CoV-2 infection is associated with several adverse outcomes, with the magnitude of specific risks varying by population studied and study design used. Early Centers for Disease Control and Prevention (CDC) data demonstrated that pregnant women were at increased risk for severe illness, including risks of intensive care unit (ICU) admission, invasive ventilation, and extracorporeal membrane oxygenation, compared with non–pregnant women.¹ Since then, other groups have confirmed the increased risks of severe COVID-19, and also identified pregnancy-specific risks, such as preeclampsia, cesarean delivery (CD), prematurity, venous thromboembolic (VTE) disease, and stillbirth.^2-6

The recent study by Ferrara and colleagues adds more granular data to help refine understanding of COVID-19 in pregnancy and counsel patients.

Details of the study

The authors conducted a retrospective cohort study between March 1, 2020, and March 16, 2021, using the electronic health records (EHRs) from Kaiser Permanente Northern California, an integrated managed care organization that serves 4.5 million patients annually. Universal testing for SARS-CoV-2 upon admission for delivery began December 1, 2020; prior to this date, asymptomatic pregnant women were tested only for certain criteria (such as being a health care worker or having high-risk medical conditions).

Pregnant women were identified with SARS-CoV-2 based on 1) a positive polymerase chain reaction test result between 30 days prior to the last menstrual period up to 7 days after delivery or 2) an ICD-10 diagnosis of SARS-CoV-2 infection. Pregnant women not meeting these criteria were classified as SARS-CoV-2 negative. Women were followed through pregnancy to understand if they experienced preterm birth (spontaneous and medically indicated), gestational hypertension, preeclampsia/eclampsia, VTE disease, gestational diabetes, severe maternal morbidity (as defined by the CDC), hospitalization, and livebirth (or stillbirth), in order to consider the timing of SARS-CoV-2 infection relative to each of these outcomes (and ascertain whether SARS-CoV-2 infection preceded any of these outcomes more commonly than not). Management of pregnancies with COVID-19 across this large organization and multiple hospitals was not specified.

Identified perinatal risks

Among 43,886 pregnant women included in the cohort, 1,332 (3.0%) were diagnosed with SARS-CoV-2, with the vast majority of positive tests in the third trimester. Significant sociodemographic differences were noted between those with and without SARS-CoV-2, including differences in age, self-reported race/ethnicity, neighborhood deprivation index, and pre-pregnancy body mass index; no differences were noted for other pre-existing comorbidities, gestational week at delivery, or smoking in pregnancy.

In multivariable models, SARS-CoV-2 infection in pregnancy was associated with severe maternal morbidity, preterm birth, and VTE disease. It was not associated with stillbirth, any hypertensive disorder of pregnancy, CD, or any neonatal complication.

The prevalence of SARS-CoV-2 was 1.3% prior to and 8.0% after implementation of universal testing in pregnancy for SARS-CoV-2. No differences were noted in the risks of severe maternal morbidity or preterm birth relative to the implementation of universal testing, with risks remaining comparably high even after universal testing.

A total of 307 of the 1,332 pregant women with SARS-CoV-2 were admitted to the hospital for symptomatic infection; 3 required noninvasive positive-pressure ventilation, and 1 required mechanical ventilation.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

Strengths include the large, EHR-based dataset from a single organization, allowing for granular analysis on patient comorbidities and outcomes (rather than only based on diagnosis codes, as is true of many other large databases), as well as focus on relevant perinatal outcomes and thoughtful statistical modeling. However, a significant challenge with this, and many other studies, is ascertainment of SARS-CoV-2 infections throughout pregnancy. Asymptomatic and mildly symptomatic women, who may not be as likely to have adverse pregnancy outcomes, can often be counted in the unaffected population, biasing study results toward increased risks of SARS-CoV-2. Although the findings stratified by implementation of universal testing (which captures a greater fraction of asymptomatic patients at admission for delivery), do not suggest risk mitigation with asymptomatic status, this analysis did not capture asymptomatic infections earlier in pregnancy, many of which might not be associated with perinatal risk.

Another challenge with such a dataset is that one cannot determine the severity of illness of each patient without manual review of each chart; however, other data that are easily abstracted from the EHR may serve as a proxy. For instance, of the 307 women with symptomatic COVID-19, 4 required respiratory support above nasal cannula. This suggests a low rate of severely ill women, and may explain some of the findings in the study, such as no differences in the rate of CD, hypertensive disorders of pregnancy, or stillbirth, but does not explain the increased risk of both medically indicated and spontaneous preterm birth, or the rates of acute respiratory distress syndrome and sepsis that drive the increased risk of severe maternal morbidity.

The CDC has published data on the risks of stillbirth from a large hospital-based administrative database for COVID-19 from Premier Healthcare.² In a cohort of over 1.2 million women admitted for delivery, including the timeframe of Ferrara et al’s study, COVID-19 was associated with a 2-fold increased risk of stillbirth, with higher risks noted with the delta variant. A rare outcome, stillbirth occurs in 6/1,000 births,⁷ which was the rate seen in Ferrara’s publication for both women with and without SARS-CoV-2 infection. The rare nature of the outcome may explain why a signal was not noted in the article of interest.

Translating data to patient counseling

Ferrara and colleagues’ study clearly confirms that COVID-19 infection has risks. Although many women with a COVID-19 infection in pregnancy may have an uncomplicated course, a favorable outcome is hard to predict with certainty. Risks of prematurity, VTE, organ dysfunction, and stillbirth from COVID-19 are rare but devastating complications. However, vaccinated women tend to incur far fewer adverse outcomes of COVID-19 in pregnancy, namely a 90% risk reduction in severe or critical COVID-19, with lower rates of ICU admissions and stillbirths.⁸ While these data strongly favor vaccination, we remain ill-advised on management strategies specifically to mitigate risk for the pregnancy once affected by COVID-19 infection. Thus, prevention with vaccination, mask wearing, and physical distancing remains a cornerstone of prenatal care in the current day. ●

Ferrara A, Hedderson MM, Zhu Y, et al. Perinatal complications in individuals in California with or without SARS-CoV-2 infection during pregnancy. JAMA Intern Med. 2022;182:503-512. doi:10.1001/jamainternmed.2022.0330

Expert Commentary

SARS-CoV-2 infection is associated with several adverse outcomes, with the magnitude of specific risks varying by population studied and study design used. Early Centers for Disease Control and Prevention (CDC) data demonstrated that pregnant women were at increased risk for severe illness, including risks of intensive care unit (ICU) admission, invasive ventilation, and extracorporeal membrane oxygenation, compared with non–pregnant women.¹ Since then, other groups have confirmed the increased risks of severe COVID-19, and also identified pregnancy-specific risks, such as preeclampsia, cesarean delivery (CD), prematurity, venous thromboembolic (VTE) disease, and stillbirth.^2-6

The recent study by Ferrara and colleagues adds more granular data to help refine understanding of COVID-19 in pregnancy and counsel patients.

Details of the study

The authors conducted a retrospective cohort study between March 1, 2020, and March 16, 2021, using the electronic health records (EHRs) from Kaiser Permanente Northern California, an integrated managed care organization that serves 4.5 million patients annually. Universal testing for SARS-CoV-2 upon admission for delivery began December 1, 2020; prior to this date, asymptomatic pregnant women were tested only for certain criteria (such as being a health care worker or having high-risk medical conditions).

Pregnant women were identified with SARS-CoV-2 based on 1) a positive polymerase chain reaction test result between 30 days prior to the last menstrual period up to 7 days after delivery or 2) an ICD-10 diagnosis of SARS-CoV-2 infection. Pregnant women not meeting these criteria were classified as SARS-CoV-2 negative. Women were followed through pregnancy to understand if they experienced preterm birth (spontaneous and medically indicated), gestational hypertension, preeclampsia/eclampsia, VTE disease, gestational diabetes, severe maternal morbidity (as defined by the CDC), hospitalization, and livebirth (or stillbirth), in order to consider the timing of SARS-CoV-2 infection relative to each of these outcomes (and ascertain whether SARS-CoV-2 infection preceded any of these outcomes more commonly than not). Management of pregnancies with COVID-19 across this large organization and multiple hospitals was not specified.

Identified perinatal risks

Among 43,886 pregnant women included in the cohort, 1,332 (3.0%) were diagnosed with SARS-CoV-2, with the vast majority of positive tests in the third trimester. Significant sociodemographic differences were noted between those with and without SARS-CoV-2, including differences in age, self-reported race/ethnicity, neighborhood deprivation index, and pre-pregnancy body mass index; no differences were noted for other pre-existing comorbidities, gestational week at delivery, or smoking in pregnancy.

In multivariable models, SARS-CoV-2 infection in pregnancy was associated with severe maternal morbidity, preterm birth, and VTE disease. It was not associated with stillbirth, any hypertensive disorder of pregnancy, CD, or any neonatal complication.

The prevalence of SARS-CoV-2 was 1.3% prior to and 8.0% after implementation of universal testing in pregnancy for SARS-CoV-2. No differences were noted in the risks of severe maternal morbidity or preterm birth relative to the implementation of universal testing, with risks remaining comparably high even after universal testing.

A total of 307 of the 1,332 pregant women with SARS-CoV-2 were admitted to the hospital for symptomatic infection; 3 required noninvasive positive-pressure ventilation, and 1 required mechanical ventilation.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

Strengths include the large, EHR-based dataset from a single organization, allowing for granular analysis on patient comorbidities and outcomes (rather than only based on diagnosis codes, as is true of many other large databases), as well as focus on relevant perinatal outcomes and thoughtful statistical modeling. However, a significant challenge with this, and many other studies, is ascertainment of SARS-CoV-2 infections throughout pregnancy. Asymptomatic and mildly symptomatic women, who may not be as likely to have adverse pregnancy outcomes, can often be counted in the unaffected population, biasing study results toward increased risks of SARS-CoV-2. Although the findings stratified by implementation of universal testing (which captures a greater fraction of asymptomatic patients at admission for delivery), do not suggest risk mitigation with asymptomatic status, this analysis did not capture asymptomatic infections earlier in pregnancy, many of which might not be associated with perinatal risk.

Another challenge with such a dataset is that one cannot determine the severity of illness of each patient without manual review of each chart; however, other data that are easily abstracted from the EHR may serve as a proxy. For instance, of the 307 women with symptomatic COVID-19, 4 required respiratory support above nasal cannula. This suggests a low rate of severely ill women, and may explain some of the findings in the study, such as no differences in the rate of CD, hypertensive disorders of pregnancy, or stillbirth, but does not explain the increased risk of both medically indicated and spontaneous preterm birth, or the rates of acute respiratory distress syndrome and sepsis that drive the increased risk of severe maternal morbidity.

The CDC has published data on the risks of stillbirth from a large hospital-based administrative database for COVID-19 from Premier Healthcare.² In a cohort of over 1.2 million women admitted for delivery, including the timeframe of Ferrara et al’s study, COVID-19 was associated with a 2-fold increased risk of stillbirth, with higher risks noted with the delta variant. A rare outcome, stillbirth occurs in 6/1,000 births,⁷ which was the rate seen in Ferrara’s publication for both women with and without SARS-CoV-2 infection. The rare nature of the outcome may explain why a signal was not noted in the article of interest.

Translating data to patient counseling

Ferrara and colleagues’ study clearly confirms that COVID-19 infection has risks. Although many women with a COVID-19 infection in pregnancy may have an uncomplicated course, a favorable outcome is hard to predict with certainty. Risks of prematurity, VTE, organ dysfunction, and stillbirth from COVID-19 are rare but devastating complications. However, vaccinated women tend to incur far fewer adverse outcomes of COVID-19 in pregnancy, namely a 90% risk reduction in severe or critical COVID-19, with lower rates of ICU admissions and stillbirths.⁸ While these data strongly favor vaccination, we remain ill-advised on management strategies specifically to mitigate risk for the pregnancy once affected by COVID-19 infection. Thus, prevention with vaccination, mask wearing, and physical distancing remains a cornerstone of prenatal care in the current day. ●

Ferrara A, Hedderson MM, Zhu Y, et al. Perinatal complications in individuals in California with or without SARS-CoV-2 infection during pregnancy. JAMA Intern Med. 2022;182:503-512. doi:10.1001/jamainternmed.2022.0330

Expert Commentary

SARS-CoV-2 infection is associated with several adverse outcomes, with the magnitude of specific risks varying by population studied and study design used. Early Centers for Disease Control and Prevention (CDC) data demonstrated that pregnant women were at increased risk for severe illness, including risks of intensive care unit (ICU) admission, invasive ventilation, and extracorporeal membrane oxygenation, compared with non–pregnant women.¹ Since then, other groups have confirmed the increased risks of severe COVID-19, and also identified pregnancy-specific risks, such as preeclampsia, cesarean delivery (CD), prematurity, venous thromboembolic (VTE) disease, and stillbirth.^2-6

The recent study by Ferrara and colleagues adds more granular data to help refine understanding of COVID-19 in pregnancy and counsel patients.

Details of the study

The authors conducted a retrospective cohort study between March 1, 2020, and March 16, 2021, using the electronic health records (EHRs) from Kaiser Permanente Northern California, an integrated managed care organization that serves 4.5 million patients annually. Universal testing for SARS-CoV-2 upon admission for delivery began December 1, 2020; prior to this date, asymptomatic pregnant women were tested only for certain criteria (such as being a health care worker or having high-risk medical conditions).

Pregnant women were identified with SARS-CoV-2 based on 1) a positive polymerase chain reaction test result between 30 days prior to the last menstrual period up to 7 days after delivery or 2) an ICD-10 diagnosis of SARS-CoV-2 infection. Pregnant women not meeting these criteria were classified as SARS-CoV-2 negative. Women were followed through pregnancy to understand if they experienced preterm birth (spontaneous and medically indicated), gestational hypertension, preeclampsia/eclampsia, VTE disease, gestational diabetes, severe maternal morbidity (as defined by the CDC), hospitalization, and livebirth (or stillbirth), in order to consider the timing of SARS-CoV-2 infection relative to each of these outcomes (and ascertain whether SARS-CoV-2 infection preceded any of these outcomes more commonly than not). Management of pregnancies with COVID-19 across this large organization and multiple hospitals was not specified.

Identified perinatal risks

Among 43,886 pregnant women included in the cohort, 1,332 (3.0%) were diagnosed with SARS-CoV-2, with the vast majority of positive tests in the third trimester. Significant sociodemographic differences were noted between those with and without SARS-CoV-2, including differences in age, self-reported race/ethnicity, neighborhood deprivation index, and pre-pregnancy body mass index; no differences were noted for other pre-existing comorbidities, gestational week at delivery, or smoking in pregnancy.

In multivariable models, SARS-CoV-2 infection in pregnancy was associated with severe maternal morbidity, preterm birth, and VTE disease. It was not associated with stillbirth, any hypertensive disorder of pregnancy, CD, or any neonatal complication.

The prevalence of SARS-CoV-2 was 1.3% prior to and 8.0% after implementation of universal testing in pregnancy for SARS-CoV-2. No differences were noted in the risks of severe maternal morbidity or preterm birth relative to the implementation of universal testing, with risks remaining comparably high even after universal testing.

A total of 307 of the 1,332 pregant women with SARS-CoV-2 were admitted to the hospital for symptomatic infection; 3 required noninvasive positive-pressure ventilation, and 1 required mechanical ventilation.

Continue to: Study strengths and weaknesses...

Study strengths and weaknesses

Strengths include the large, EHR-based dataset from a single organization, allowing for granular analysis on patient comorbidities and outcomes (rather than only based on diagnosis codes, as is true of many other large databases), as well as focus on relevant perinatal outcomes and thoughtful statistical modeling. However, a significant challenge with this, and many other studies, is ascertainment of SARS-CoV-2 infections throughout pregnancy. Asymptomatic and mildly symptomatic women, who may not be as likely to have adverse pregnancy outcomes, can often be counted in the unaffected population, biasing study results toward increased risks of SARS-CoV-2. Although the findings stratified by implementation of universal testing (which captures a greater fraction of asymptomatic patients at admission for delivery), do not suggest risk mitigation with asymptomatic status, this analysis did not capture asymptomatic infections earlier in pregnancy, many of which might not be associated with perinatal risk.

Another challenge with such a dataset is that one cannot determine the severity of illness of each patient without manual review of each chart; however, other data that are easily abstracted from the EHR may serve as a proxy. For instance, of the 307 women with symptomatic COVID-19, 4 required respiratory support above nasal cannula. This suggests a low rate of severely ill women, and may explain some of the findings in the study, such as no differences in the rate of CD, hypertensive disorders of pregnancy, or stillbirth, but does not explain the increased risk of both medically indicated and spontaneous preterm birth, or the rates of acute respiratory distress syndrome and sepsis that drive the increased risk of severe maternal morbidity.

The CDC has published data on the risks of stillbirth from a large hospital-based administrative database for COVID-19 from Premier Healthcare.² In a cohort of over 1.2 million women admitted for delivery, including the timeframe of Ferrara et al’s study, COVID-19 was associated with a 2-fold increased risk of stillbirth, with higher risks noted with the delta variant. A rare outcome, stillbirth occurs in 6/1,000 births,⁷ which was the rate seen in Ferrara’s publication for both women with and without SARS-CoV-2 infection. The rare nature of the outcome may explain why a signal was not noted in the article of interest.

Translating data to patient counseling

Ferrara and colleagues’ study clearly confirms that COVID-19 infection has risks. Although many women with a COVID-19 infection in pregnancy may have an uncomplicated course, a favorable outcome is hard to predict with certainty. Risks of prematurity, VTE, organ dysfunction, and stillbirth from COVID-19 are rare but devastating complications. However, vaccinated women tend to incur far fewer adverse outcomes of COVID-19 in pregnancy, namely a 90% risk reduction in severe or critical COVID-19, with lower rates of ICU admissions and stillbirths.⁸ While these data strongly favor vaccination, we remain ill-advised on management strategies specifically to mitigate risk for the pregnancy once affected by COVID-19 infection. Thus, prevention with vaccination, mask wearing, and physical distancing remains a cornerstone of prenatal care in the current day. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

The 1973 Supreme Court of the United States (SCOTUS) decision in Roe v Wade was a landmark ruling,¹ establishing that the United States Constitution provides a fundamental “right to privacy,” protecting pregnant people’s freedom to access all available reproductive health care options. Recognizing that the right to abortion was not absolute, the majority of justices supported a trimester system. In the first trimester, decisions about abortion care are fully controlled by patients and clinicians, and no government could place restrictions on access to abortion. In the second trimester, SCOTUS ruled that states may choose to regulate abortion to protect maternal health. (As an example of such state restrictions, in Massachusetts, for many years, but no longer, the state required that abortions occur in a hospital when the patient was between 18 and 24 weeks’ gestation in order to facilitate comprehensive emergency care for complications.) Beginning in the third trimester, a point at which a fetus could be viable, the Court ruled that a government could prohibit abortion except when an abortion was necessary to protect the life or health of the pregnant person. In 1992, the SCOTUS decision in Planned Parenthood v Casey² rejected the trimester system, reaffirming the right to an abortion before fetal viability, and adopting a new standard that states may not create an undue burden on a person seeking an abortion before fetal viability. SCOTUS ruled that an undue burden exists if the purpose of a regulation is to place substantial obstacles in the path of a person seeking an abortion.

If, as anticipated, the 2022 SCOTUS decision in Dobbs v Jackson Women’s Health Organization³ overturns the precedents set in Roe v Wade and Planned Parenthood v Casey, decisions on abortion law will be relegated to elected legislators and state courts.⁴ It is expected that at least 26 state legislatures and governors will enact stringent new restrictions on access to abortion. This cataclysmic reversal of judicial opinion creates a historic challenge to obstetrician-gynecologists and their patients and could threaten access to other vital reproductive services beyond abortion, like contraception. We will be fighting, state by state, for people’s right to access all available reproductive health procedures. This will also significantly affect the ability for providers in women’s reproductive health to obtain appropriate and necessary education and training in a critical skills. If access to safe abortion is restricted, we fear patients may be forced to consider unsafe abortion, raising the specter of a return to the 1960s, when an epidemic of unsafe abortion caused countless injuries and deaths.^5,6

How do we best prepare for these challenges?

• We will need to be flexible and continually evolve our clinical practices to be adherent with state and local legislation and regulation.
• To reduce unintended pregnancies, we need to strengthen our efforts to ensure that every patient has ready access to all available contraceptive options with no out-of-pocket cost.
• When a contraceptive is desired, we will focus on educating people about effectiveness, and offering them highly reliable contraception, such as the implant or intrauterine devices.
• We need to ensure timely access to abortion if state-based laws permit abortion before 6 or 7 weeks’ gestation. Providing medication abortion without an in-person visit using a telehealth option would be one option to expand rapid access to early first trimester abortion.
• Clinicians in states with access to abortion services will need to collaborate with colleagues in states with restrictions on abortion services to improve patient access across state borders.

On a national level, advancing our effective advocacy in Congress may lead to national legislation passed and signed by the President. This could supersede most state laws prohibiting access to comprehensive women’s reproductive health and create a unified, national approach to abortion care, allowing for the appropriate training of all obstetrician-gynecologists. We will also need to develop teams in every state capable of advocating for laws that ensure access to all reproductive health care options. The American College of Obstetricians and Gynecologists has leaders trained and tasked with legislative advocacy in every state.⁷ This network will be a foundation upon which to build additional advocacy efforts.

As women’s health care professionals, our responsibility to our patients, is to work to ensure universal access to safe and effective comprehensive reproductive options, and to ensure that our workforce is prepared to meet the needs of our patients by defending the patient-clinician relationship. Abortion care saves lives of pregnant patients and reduces maternal morbidity.⁸ Access to safe abortion care as part of comprehensive reproductive services is an important component of health care. ●

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).¹ It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.² In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.³

Although delivery at a specialized PAS center has been associated with improved patient outcomes,⁴ not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,⁵ and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.⁶ Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.^7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.⁸

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,¹⁰ patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.¹¹ This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).¹ It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.² In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.³

Although delivery at a specialized PAS center has been associated with improved patient outcomes,⁴ not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,⁵ and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.⁶ Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.^7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.⁸

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,¹⁰ patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.¹¹ This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

CASE Placenta accreta spectrum following uncomplicated vaginal delivery

Imagine you are an obstetric hospitalist taking call at a level II maternal level of care hospital. Your patient is a 35-year-old woman, gravida 2, para 1, with a past history of retained placenta requiring dilation and curettage and intravenous antibiotics for endomyometritis. This is an in vitro fertilization pregnancy that has progressed normally, and the patient labored spontaneously at 38 weeks’ gestation. Following an uncomplicated vaginal delivery, the placenta has not delivered, and you attempt a manual placental extraction after a 40-minute third stage. While there is epidural analgesia and you can reach the uterine fundus, you are unable to create a separation plane between the placenta and uterus.

What do you do next?

Placenta accreta spectrum (PAS) includes a broad range of clinical scenarios with abnormal placental attachment as their common denominator. The condition has classically been defined pathologically, with chorionic villi attaching directly to the myometrium (“accreta”) or extending more deeply into the myometrium (“increta”) or attaching to surrounding tissues and structures (“percreta”).¹ It is most commonly encountered in patients with low placental implantation on a prior cesarean section scar; indeed, placenta previa, particularly with a history of cesarean delivery, is the strongest risk factor for the development of PAS.² In addition to abnormal placental attachment, these placental attachments are often hypervascular and can lead to catastrophic hemorrhage if not managed appropriately. For this reason, patients with sonographic or radiologic signs of PAS should be referred to specialized centers for further workup, counseling, and delivery planning.³

Although delivery at a specialized PAS center has been associated with improved patient outcomes,⁴ not all patients with PAS will be identified in the antepartum period. Ultrasonography may miss up to 40% to 50% of PAS cases, particularly when the sonologist has not been advised to look for the condition,⁵ and not all patients with PAS will have a previa implanted in a prior cesarean scar. A recent study found that these patients with nonprevia PAS were identified by imaging less than 40% of the time and were significantly less likely to be managed by a specialized team of clinicians.⁶ Thus, it falls upon every obstetric care provider to be aware of this diagnosis, promptly recognize its unanticipated presentations, and have a plan to optimize patient safety.

Step 1: Recognition

While PAS is classically defined as a pathologic condition, no clinician has the luxury of histology in the delivery room. Researchers have variously defined PAS clinically, with the common trait of abnormal placental adherence.^7-9 The TABLE compares published definitions that have been used in the literature. While some definitions include hemorrhage, no clinician wants to induce significant hemorrhage to confirm their patient’s diagnosis. Thus, practically, the clinical PAS diagnosis comes down to abnormal placental attachment: If it is apparent that some or all of the placenta will not separate from the uterine wall with digital manipulation or careful curettage, then PAS should be suspected, and appropriate steps should be taken before further removal attempts.

At cesarean delivery, the PAS diagnosis may be aided by visual cues. With placenta previa, the lower uterine segment may bulge and take on a bluish hue, distinctly different from the upper healthy myometrium. PAS may also manifest with neovascularization, particularly behind the bladder. As with vaginal births, the placenta will fail to separate after the delivery, and controlled traction on the umbilical cord can produce a “dimple sign,” or visible myometrial retraction at the site of implantation (FIGURE 1). Finally, if the diagnosis is still in doubt, attempts to gently form a cleavage plane between the placenta and myometrium will be unsuccessful if PAS is present.⁸

Step 2: Initial management—pause, plan

Most importantly, do not attempt to forcibly remove the placenta. It can be left attached to the uterus until appropriate resources are secured. Efforts to forcibly remove an adherent placenta may well lead to major hemorrhage, and thus it falls on the patient’s care team to pause and plan for PAS care at this point. FIGURE 2 displays an algorithm for patient management. Further steps depend primarily on whether or not the patient is already hemorrhaging. In a stable situation, the patient should be counseled regarding the abnormal findings and the suspected PAS diagnosis. This includes the possibility of further procedures, blood transfusion, and hysterectomy. Local resources, including nursing, anesthesia, and the blood bank, should be notified about the situation and for the potential to call in specialized services. If on-site experienced specialists are not available, then patient transfer to a PAS specialty center should be strongly considered. While awaiting additional help or transport, the patient requires close monitoring for gross and physiologic signs of hemorrhage. If pursued, transport to a PAS specialty center should be expedited.

If the patient is already hemorrhaging or unstable, then appropriate local resources must be activated. At a minimum, this requires an obstetrician and anesthesiologist at the bedside and activation of hemorrhage protocols (eg, a massive transfusion protocol). If blood products are unavailable, consider whether they can be transported from other nearby blood banks, and start that process promptly. Next, contact backup services. Based on local resources and clinical severity, this may include maternal-fetal medicine specialists, pelvic surgeons, general and trauma surgeons, intensivists, interventional radiologists, and transfusion specialists. Even if the patient cannot be safely transferred to another hospital, the obstetrician can call an outside PAS specialist to discuss next steps in care and begin transfer plans, assuming the patient can be stabilized. Based on the Maternal Levels of Care definitions published by the American College of Obstetricians and Gynecologists and the Society of Maternal-Fetal Medicine,¹⁰ patients with PAS should be managed at level III or level IV centers. However, delivery units at every level of maternal care should have a protocol for securing local help and reaching an appropriate consultant if a PAS case is encountered. Know which center in your area specializes in PAS so that when an unanticipated case arises, you know who to call.

Continue to: Step 3: Ultimate management—mobilize and prepare for bleeding...

Step 3: Ultimate management—mobilize and prepare for bleeding

If diagnosis occurs intraoperatively at a PAS specialty center, or if safe transport is not possible, then the team should mobilize for the possibility of hysterectomy and prepare for massive bleeding, which can occur regardless of the treatment chosen. Many patients require or will opt for hysterectomy. For example, a patient who has finished childbearing may consent to a hysterectomy upon hearing she likely has PAS. In patients with suspected PAS who are actively hemorrhaging or are unstable, hysterectomy is required.

Uterine conservation may be considered in stable patients who strongly desire future childbearing or uterine retention. This often requires leaving densely adherent placental tissue in situ and thus requires thorough counseling regarding the risks of delayed hemorrhage, infection, and emergent hysterectomy.¹¹ This may not be desirable or safe for some patients, so informed consent is crucial. In such cases, we strongly recommend consultation with a PAS specialist, even if that requires immediate control of the placental blood supply (such as with arterial embolization), and transfer to a PAS specialty center.

Clinical scenarios

Vaginal delivery

The patient in the opening case was never expected to have PAS given her normal placental location and absence of a uterine scar. Even though she had some possible PAS risk factors (past retained placenta with instrumentation and in vitro fertilization), her absolute risk for the condition was low. Nevertheless, inability to create a separation plane should be considered PAS until proven otherwise. Although at this point many obstetricians would move to an operating room for uterine curettage, we recommend that the care team pause and put measures in place for possible PAS and hemorrhage. This involves notification of the blood bank, crossmatching of blood products, alerting the anesthesia team, and having a clear plan in place should a major hemorrhage ensue. This may involve use of balloon tamponade, activation of an interventional radiology team, or possible laparotomy with arterial ligations or hysterectomy. Avoidance of a prolonged third stage should be balanced against the need for preparation with these cases.

It is important for clinicians to bear in mind, and communicate to the patient, that hysterectomy is the standard of care for PAS. Significant delays in performing an indicated hysterectomy can lead to coagulopathy and patient instability. Timeliness is key; we find that delays in the decision to perform an indicated hysterectomy are often at the root of the cause for worsened morbidity in patients with unanticipated PAS. With an unscarred uterus and no placenta previa, a postpartum hysterectomy can be performed by many obstetrician-gynecologists experienced in this abdominal procedure.

Cesarean delivery

Undiagnosed PAS may present at cesarean delivery with or without placenta previa and a prior uterine scar. With this combination, PAS is often visually apparent upon opening the abdominal cavity (TABLE and FIGURE 1). Such surgical findings call for a clinical pause, as further actions at this point can lead to catastrophic hemorrhage. The obstetrician should consider a series of questions:

1. Are appropriate surgical and transfusion resources immediately available? If yes, they should be notified in case they are needed urgently. If not, then the obstetrician should ask whether the delivery must occur now.

2. Is this a scheduled delivery with a stable patient and fetus? If so, then closing the abdominal incision, monitoring the patient and fetus, and either transferring the patient to a PAS center or awaiting appropriate local specialists may be a lifesaving step.

3. Is immediate delivery required? If the fetus must be delivered, then it is imperative to create a hysterotomy out of the way of the placenta. Disrupting the adherent placenta with either an incision or manual manipulation may trigger a massive hemorrhage and should be avoided. This may require rectus muscle transection or creating a “T” incision on the skin to reach the uterine fundus and creating a hysterotomy over the top or even the back of the uterus. Once the fetus is delivered and lack of uterine hemorrhage confirmed (both abdominally and vaginally), the hysterotomy and abdomen can be closed with anticipation of urgent patient transfer to a PAS team or center.

4. Is the patient hemorrhaging? If the patient is hemorrhaging and closure is not an option, then recruitment of local emergent surgical teams is warranted, even if that requires packing the abdomen until an appropriate surgeon can arrive.

Diagnosis at cesarean delivery requires expedited and complex patient counseling. A patient who is unstable or hemorrhaging needs to be told that hysterectomy is lifesaving in this situation. For patients who are stable, it may be appropriate to close the abdomen and leave the placenta in situ, perform comprehensive counseling, and assess the possibility of transfer to a specialty center.

Summary

All obstetric care providers should be familiar with the clinical presentation of undiagnosed accreta spectrum. While hemorrhage is often part of the diagnosis, recognition of abnormal placental adherence and PAS-focused management should ideally be undertaken before this occurs. Once PAS is suspected, avoidance of further placental disruption may save significant morbidity, even if that means leaving the placenta attached until appropriate resources can be obtained. A local protocol for consultation, emergency transfer, and deployment of local resources should be part of every delivery unit’s emergency preparedness plan.

CASE Outcome

This patient is stabilized, with an adherent, retained placenta and no signs of hemorrhage. You administer uterotonics and notify your anesthesiologist and backup obstetrician that you have a likely case of accreta spectrum. A second intravenous line is placed, and blood products are crossmatched. The closest level III hospital is called, and they accept your patient for transfer. There, she is counseled about PAS, and she expresses no desire for future childbearing. After again confirming no placental separation in the operating room, the patient is moved immediately to perform laparotomy and total abdominal hysterectomy through a Pfannenstiel incision. She does not require a blood transfusion, and the pathology returns with grade I placenta accreta spectrum. ●

Technology has revolutionized how we access information. One example is the increased use of mobile applications (apps). On the surface, building a new app may seem a daunting and intimidating task. However, new software—such as Glide (glideapps.com)—make it easy for anyone to design, build, and launch a custom web app within hours. This software is free for basic apps but does offer an upgrade for those wanting more professional services (glide-apps.com/pro). Here, by way of example, we identify an area of need and walk the reader
through the process of making an app. 

Although there are many apps aimed at educating users on different aspects of obstetrics and gynecology, few are focused on undergraduate medical education (UME). With the assistance of Glide app  building software, we created an app focused on providing rapid access to resources aimed at fulfilling medical student objectives from the Association of Professors of Gynecology and Obstetrics (APGO).¹ We included 16 of the APGO objectives. On clicking an objective, the user is taken to a screen with links to associated APGO Educational Topic Video and Basic Science Videos. Basic Science Video links were included in order to provide longitudinal learning between the pre-clinical and clinical years of UME. We also created a tab for additional educational resources (including excerpts from the APGO Basic Clinical Skills Curriculum).² We eventually added two other tabs: one for clerkship schedules that allows students to organize their daily schedule and another that facilitates quick contact with members of the clerkship team. As expected, the app was well-received by our students.

The steps needed for you to make your own app are listed in the FIGURE along with accompanying images for easy navigation. ●

Technology has revolutionized how we access information. One example is the increased use of mobile applications (apps). On the surface, building a new app may seem a daunting and intimidating task. However, new software—such as Glide (glideapps.com)—make it easy for anyone to design, build, and launch a custom web app within hours. This software is free for basic apps but does offer an upgrade for those wanting more professional services (glide-apps.com/pro). Here, by way of example, we identify an area of need and walk the reader
through the process of making an app. 

Although there are many apps aimed at educating users on different aspects of obstetrics and gynecology, few are focused on undergraduate medical education (UME). With the assistance of Glide app  building software, we created an app focused on providing rapid access to resources aimed at fulfilling medical student objectives from the Association of Professors of Gynecology and Obstetrics (APGO).¹ We included 16 of the APGO objectives. On clicking an objective, the user is taken to a screen with links to associated APGO Educational Topic Video and Basic Science Videos. Basic Science Video links were included in order to provide longitudinal learning between the pre-clinical and clinical years of UME. We also created a tab for additional educational resources (including excerpts from the APGO Basic Clinical Skills Curriculum).² We eventually added two other tabs: one for clerkship schedules that allows students to organize their daily schedule and another that facilitates quick contact with members of the clerkship team. As expected, the app was well-received by our students.

The steps needed for you to make your own app are listed in the FIGURE along with accompanying images for easy navigation. ●

Technology has revolutionized how we access information. One example is the increased use of mobile applications (apps). On the surface, building a new app may seem a daunting and intimidating task. However, new software—such as Glide (glideapps.com)—make it easy for anyone to design, build, and launch a custom web app within hours. This software is free for basic apps but does offer an upgrade for those wanting more professional services (glide-apps.com/pro). Here, by way of example, we identify an area of need and walk the reader
through the process of making an app. 

Although there are many apps aimed at educating users on different aspects of obstetrics and gynecology, few are focused on undergraduate medical education (UME). With the assistance of Glide app  building software, we created an app focused on providing rapid access to resources aimed at fulfilling medical student objectives from the Association of Professors of Gynecology and Obstetrics (APGO).¹ We included 16 of the APGO objectives. On clicking an objective, the user is taken to a screen with links to associated APGO Educational Topic Video and Basic Science Videos. Basic Science Video links were included in order to provide longitudinal learning between the pre-clinical and clinical years of UME. We also created a tab for additional educational resources (including excerpts from the APGO Basic Clinical Skills Curriculum).² We eventually added two other tabs: one for clerkship schedules that allows students to organize their daily schedule and another that facilitates quick contact with members of the clerkship team. As expected, the app was well-received by our students.

The steps needed for you to make your own app are listed in the FIGURE along with accompanying images for easy navigation. ●

It was such a pleasure at the 48th Annual Meeting of the Society of Gynecologic Surgeons (SGS) to witness record meeting attendance and strong enthusiasm after 2 depressing years with the COVID-19 pandemic. Evidently, everyone was tired of virtual gatherings and presentations. As a dedicated surgical educator and a passionate vaginal surgeon, SGS President Carl Zimmerman, MD, chose “Gynecologic surgery training: Lessons from the past, looking to the future” as the theme for this year’s meeting. Our keynote speakers, Patricia Turner, MD, MBA, Executive Director of the American College of Surgeons, and Marta Crispens, MD, MBA, Professor and Division Director of Gynecologic Oncology at Vanderbilt, were spot on. They reviewed the current status of surgical training eloquently with convincing statistics. They mapped out the path forward by stressing collaboration and proposing strategies that might produce competent surgeons in all fields.

The meeting featured 2 panel discussions. The first, titled “Innovations in training gynecologic surgeons,” reviewed tracking in residency, use of simulation for surgical proficiency, and European perspective on training. The panelists emphasized the dwindling numbers of surgical procedures, especially vaginal hysterectomies. Cecile Ferrando, MD, suggested that tracking might be part of the answer, based on their experience, which provided a structure for residents to obtain concentrated training in their areas of interest. Douglas Miyazaki, MD, presented the prospects for his innovative, federally funded vaginal surgery simulation model. Oliver Preyer, MD, presented Austrian trainees’ low case volumes, showing that the grass was not actually greener on the other side. Finally, this panel reinvigorated ongoing debate about separating Obstetrics and Gynecology.

The second panel, “Operating room safety and efficiency,” shed light on human and nontechnical factors that might be as critical as surgeons’ skills and experience, and it highlighted an innovative technology that monitored and analyzed all operating room parameters to improve operational processes and surgical technique. Points by Jason Wright, MD, on the relationship between surgical volume and outcomes complemented the meeting theme and the first panel discussion. He underlined how much surgical volume of individual surgeons and hospitals mattered, but he also indicated that restrictive credentialing strategies might lead to unintended consequences.

Importantly, the SGS Women’s Council held a panel on the “Impact of Texas legislation on the physician/patient relationship” to provide a platform for members who had mixed feelings about attending this meeting in Texas.

The SGS meeting also included several popular postgraduate courses on multidisciplinary management of Müllerian anomalies, pelvic fistula treatment, surgical simulation, management modalities for uterine fibroids, and medical innovation and entrepreneurship. In this special section and in the next issue of OBG Management, several of these topics are presented.

It was such a pleasure at the 48th Annual Meeting of the Society of Gynecologic Surgeons (SGS) to witness record meeting attendance and strong enthusiasm after 2 depressing years with the COVID-19 pandemic. Evidently, everyone was tired of virtual gatherings and presentations. As a dedicated surgical educator and a passionate vaginal surgeon, SGS President Carl Zimmerman, MD, chose “Gynecologic surgery training: Lessons from the past, looking to the future” as the theme for this year’s meeting. Our keynote speakers, Patricia Turner, MD, MBA, Executive Director of the American College of Surgeons, and Marta Crispens, MD, MBA, Professor and Division Director of Gynecologic Oncology at Vanderbilt, were spot on. They reviewed the current status of surgical training eloquently with convincing statistics. They mapped out the path forward by stressing collaboration and proposing strategies that might produce competent surgeons in all fields.

The meeting featured 2 panel discussions. The first, titled “Innovations in training gynecologic surgeons,” reviewed tracking in residency, use of simulation for surgical proficiency, and European perspective on training. The panelists emphasized the dwindling numbers of surgical procedures, especially vaginal hysterectomies. Cecile Ferrando, MD, suggested that tracking might be part of the answer, based on their experience, which provided a structure for residents to obtain concentrated training in their areas of interest. Douglas Miyazaki, MD, presented the prospects for his innovative, federally funded vaginal surgery simulation model. Oliver Preyer, MD, presented Austrian trainees’ low case volumes, showing that the grass was not actually greener on the other side. Finally, this panel reinvigorated ongoing debate about separating Obstetrics and Gynecology.

The second panel, “Operating room safety and efficiency,” shed light on human and nontechnical factors that might be as critical as surgeons’ skills and experience, and it highlighted an innovative technology that monitored and analyzed all operating room parameters to improve operational processes and surgical technique. Points by Jason Wright, MD, on the relationship between surgical volume and outcomes complemented the meeting theme and the first panel discussion. He underlined how much surgical volume of individual surgeons and hospitals mattered, but he also indicated that restrictive credentialing strategies might lead to unintended consequences.

Importantly, the SGS Women’s Council held a panel on the “Impact of Texas legislation on the physician/patient relationship” to provide a platform for members who had mixed feelings about attending this meeting in Texas.

The SGS meeting also included several popular postgraduate courses on multidisciplinary management of Müllerian anomalies, pelvic fistula treatment, surgical simulation, management modalities for uterine fibroids, and medical innovation and entrepreneurship. In this special section and in the next issue of OBG Management, several of these topics are presented.

It was such a pleasure at the 48th Annual Meeting of the Society of Gynecologic Surgeons (SGS) to witness record meeting attendance and strong enthusiasm after 2 depressing years with the COVID-19 pandemic. Evidently, everyone was tired of virtual gatherings and presentations. As a dedicated surgical educator and a passionate vaginal surgeon, SGS President Carl Zimmerman, MD, chose “Gynecologic surgery training: Lessons from the past, looking to the future” as the theme for this year’s meeting. Our keynote speakers, Patricia Turner, MD, MBA, Executive Director of the American College of Surgeons, and Marta Crispens, MD, MBA, Professor and Division Director of Gynecologic Oncology at Vanderbilt, were spot on. They reviewed the current status of surgical training eloquently with convincing statistics. They mapped out the path forward by stressing collaboration and proposing strategies that might produce competent surgeons in all fields.

The meeting featured 2 panel discussions. The first, titled “Innovations in training gynecologic surgeons,” reviewed tracking in residency, use of simulation for surgical proficiency, and European perspective on training. The panelists emphasized the dwindling numbers of surgical procedures, especially vaginal hysterectomies. Cecile Ferrando, MD, suggested that tracking might be part of the answer, based on their experience, which provided a structure for residents to obtain concentrated training in their areas of interest. Douglas Miyazaki, MD, presented the prospects for his innovative, federally funded vaginal surgery simulation model. Oliver Preyer, MD, presented Austrian trainees’ low case volumes, showing that the grass was not actually greener on the other side. Finally, this panel reinvigorated ongoing debate about separating Obstetrics and Gynecology.

The second panel, “Operating room safety and efficiency,” shed light on human and nontechnical factors that might be as critical as surgeons’ skills and experience, and it highlighted an innovative technology that monitored and analyzed all operating room parameters to improve operational processes and surgical technique. Points by Jason Wright, MD, on the relationship between surgical volume and outcomes complemented the meeting theme and the first panel discussion. He underlined how much surgical volume of individual surgeons and hospitals mattered, but he also indicated that restrictive credentialing strategies might lead to unintended consequences.

Importantly, the SGS Women’s Council held a panel on the “Impact of Texas legislation on the physician/patient relationship” to provide a platform for members who had mixed feelings about attending this meeting in Texas.

The SGS meeting also included several popular postgraduate courses on multidisciplinary management of Müllerian anomalies, pelvic fistula treatment, surgical simulation, management modalities for uterine fibroids, and medical innovation and entrepreneurship. In this special section and in the next issue of OBG Management, several of these topics are presented.

Vaginal surgery, including vaginal hysterectomy, is slowly becoming a dying art. According to the National Inpatient Sample and the Nationwide Ambulatory Surgery Sample from 2018, only 11.8% of all hysterectomies were performed vaginally.¹ The combination of uterine-sparing surgeries, advances in conservative therapies for benign uterine conditions, and the diversification of minimally invasive routes (laparoscopic and robotic) has resulted in a continued downtrend in vaginal surgical volumes. This shift has led to fewer operative learning opportunities and declining graduating resident surgical volume.² According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15, which represents only the minimum accepted exposure and does not imply competency.

In response, surgical simulation has been used for skill acquisition and maintenance outside of the operating room in a learning environment that is safe for the learners and does not expose patients to additional risk. Educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency. Although vaginal surgery, specifically vaginal hysterectomy, continues to decline, it can be resuscitated with the assistance of surgical simulation.

In this article, we provide a broad overview of vaginal surgical simulation. We discuss the basic tenets of simulation, review how to teach and evaluate vaginal surgical skills, and present some of the commonly available vaginal surgery simulation models and their associated resources, cost, setup time, fidelity, and limitations.

Simulation principles relevant for vaginal hysterectomy simulation

Here, we review simulation-based learning principles that will help place specific simulation models into perspective.

One size does not fit all

Simulation, like many educational interventions, does not work via a “one-size-fits-all” approach. While the American College of Obstetricians and Gynecologists (ACOG) Simulations Working Group (SWG) has created a toolkit (available online at https://www.acog.org/education-and-events/simulations/about/curriculum) with many ready-to-use how-to simulation descriptions and lesson plans that cover common topics, what works in one setting may not work in another. The SWG created those modules to help educators save time and resources and to avoid reinventing the wheel for each simulation session. However, these simulations need to be adapted to the local needs of trainees and resources, such as faculty time, space, models, and funding.

Cost vs fidelity

It is important to distinguish between cost and fidelity. “Low cost” is often incorrectly used interchangeably with “low fidelity” when referring to models and simulations. The most basic principle of fidelity is that it is associated with situational realism that in turn, drives learning.^3,4 For example, the term high fidelity does apply to a virtual reality robotic surgery simulator, which also is high cost. However, a low-cost beef tongue model of fourth-degree laceration⁵ is high fidelity, while more expensive commercial models are less realistic, which makes them high cost and low fidelity.⁶ When selecting simulation models, educators need to consider cost based on their available resources and the level of fidelity needed for their learners.

Continue to: Task breakdown...

Task breakdown

As surgeon-educators, we love to teach! And while educators are passionate about imparting vaginal hysterectomy skills to the next generation of surgeons, it is important to assess where the learners are technically. Vaginal hysterectomy is a high-complexity procedure, with each step involving a unique skill set that is new to residents as learners; this is where the science of learning can help us teach more effectively.⁷ Focusing on doing the entire procedure all at once is more likely to result in cognitive overload, while a better approach is to break the procedure down into several components and practice those parts until goal proficiency is reached.

Deliberate practice

The idea of deliberate practice was popularized by Malcolm Gladwell in his book titled Outliers, in which he gives examples of how 10,000 hours of practice leads to mastery of complex skills. This concept was deepened by the work of cognitive psychologist Anders Ericsson, who emphasized that not only the duration but also the quality of practice—which involves concentration, analysis, and problem-solving—leads to the most effective training.⁸

In surgical education, this concept translates into many domains. For example, an individualized learning plan includes frequent low-stakes assessments, video recording for later viewing and analysis, surgical coaching, and detailed planning of future training sessions to incorporate past performance. “Just doing” surgery on a simulator (or in the operating room) results in missed learning opportunities.

Logistics and implementation: Who, where, when

The simulation “formula” takes into account multiple factors but should start with learning objectives and then an assessment of what resources are available to address them. For example, if one surgeon-educator and one resident-learner are available for 30 minutes in between cases in the operating room, and the goal is to teach the resident clamp-and-tie technique on pedicles, the “milk carton” model⁹ and a few instruments from the vaginal hysterectomy tray are ideal for this training. On the other hand, if it is important to achieve competency for an entire procedure prior to operating room debut and a group of surgeon-educators is available to share the time commitment of 2-hour sessions per each resident, then the PROMPT (PRactical Obstetric Multi-Professional Training) shoulder dystocia model could be used (TABLE).^10-14

Learning curves

Ideally, educators would like to know how many simulated training sessions are needed for a learner to reach a proficiency level and become operating room ready. Such information about learning curves, unfortunately, is not available yet for vaginal hysterectomies. The first step in the process is to establish a baseline for performance to know a starting point, with assessment tools specific to each simulator; the next step is to study how many “takes” are needed for learners to move through their learning curve.¹⁵ The use of assessment tools can help assess each learner’s progression.

Continue to: Evaluation, assessment, and feedback...

With more emphasis being placed on patient safety and transparency in every aspect of health care, including surgical training, graduate medical education leaders increasingly highlight the importance of objective assessment tools and outcome-based standards for certification of competency in surgery.^16,17 Commonly used assessment tools that have reliability and validity evidence include surgical checklists and global rating scales. Checklists for common gynecologic procedures, including vaginal hysterectomy, as well as a global rating scale specifically developed for vaginal surgery (Vaginal Surgical Skills Index, VSSI)¹⁸ are accessible on the ACOG Simulations Working Group Surgical Curriculum in Obstetrics and Gynecology website.¹⁹

While checklists contain the main steps of each procedure, these lists do not assess for how well each step of the procedure is performed. By contrast, global rating scales, such as the VSSI, can discriminate between surgeons with different skill levels both in the simulation and operating room settings; each metric within the global rating scale (for example, time and motion) does not pertain to the performance of a procedure’s specific step but rather to the overall performance of the entire procedure.^18,20 Hence, to provide detailed feedback, especially for formative assessment, both checklists and global rating scales often are used together.

Although standardized, checklists and global rating scales ultimately are still subjective (not objective) assessment tools. Recently, more attention has been to use surgical data science, particularly artificial intelligence methods, to objectively assess surgical performance by analyzing data generated during the performance of surgery, such as instrumental motion and video.²¹ These methods have been applied to a wide range of surgical techniques, including open, laparoscopic, robotic, endoscopic, and microsurgical approaches. Most of these types of studies have used assessment of surgical skill as the main outcome, with fewer studies correlating skill with clinically relevant metrics, such as patient outcomes.^22-25 Although this is an area of active research, these methods are still being developed, and their validity and utility are not well established. For now, educators should continue to use validated checklists and global rating skills to help assess any type of surgical performance, particularly vaginal surgery.

Vaginal surgical simulation models

Vaginal surgery requires a surgeon to operate in a narrow, deep space. This requires ambidexterity, accurate depth perception, understanding of how to handle tissues, and use of movements that are efficient, fluid, and rhythmic. Multiple proposed simulation models are relevant to vaginal surgery, and these vary based on level of fidelity, cost, feasibility, ability to maintain standardization, ease of construction (if required), and generalizability to all of pelvic surgery (that is, procedure specific vs basic skills focused).^{10,11,13,26-31}

Below, we describe various simulation models that are available for teaching vaginal surgical skills.

Vaginal hysterectomy simulation model

One commercially available simulation model for vaginal hysterectomy (as well as other vaginal surgical procedures, such as midurethral sling and anterior and posterior colporrhaphy) is the Miya Model (Miyazaki Enterprises) (FIGURE 1) and its accompanying MiyaMODEL App. In a multi-institutional study funded by the National Institutes of Health (NIH), the Miya Model, when used with the VSSI, was shown to be a valid assessment tool in terms of ability to differentiate a competent from a noncompetent surgeon.²⁰ Currently, an ongoing NIH-sponsored multi-institutional study is assessing the Miya Model as a teaching tool and whether skills acquired on the Miya Model are transferable to the operating room.

Continue to: Low-cost vaginal hysterectomy models...

Multiple low-cost vaginal hysterectomy simulation models are described. Two models developed many years ago include the ACOG SWG flowerpot model¹⁴ and the PROMPT shoulder dystocia pelvic trainer model.^10,11,14 The former model is low cost as it can be constructed from easily obtained household materials, but its downside is that it takes time and effort to obtain the materials and to assemble them. The latter model is faster to assemble but requires one to use a PROMPT pelvis for shoulder dystocia training, which has a considerable upfront cost. However, it is available in most hospitals with considerable obstetrical volume, and it allows for the most realistic perineum, which is helpful in recreating the feel of vaginal surgery, including retraction and exposure.

Many models created and described in the literature are variations of the models mentioned above, and many use commercially available low-cost bony pelvis models and polyvinyl chloride (PVC) pipes as a foundation for the soft tissue inserts to attach.^12,13,31-33 Each model varies on what it “teaches best” regarding realism—for example, teaching anatomy, working in a tight space, dissection, or clamp placement and suture ligature.

Furthermore, since vaginal hysterectomy is a high-complexity procedure in terms of skills (working in confined space, limited view, “upside-down” anatomy, and need to direct assistants for retraction and exposure), task breakdown is important for simulation learning, as it is not efficient to repeat the entire procedure until proficiency is reached. Two trainers have been described to address that need: the milk carton and the vaginal suturing trainer. The latter allows learners to practice clamp placement and pedicle ligation multiple times, including in confined space (FIGURE 2), and the former allows them to do the same in a procedural matter as the clamp placement moves caudad to cephalad during the procedure (FIGURE 3).

Native tissue pelvic floor surgery simulation

While there are few publications regarding surgical simulation models for native tissue pelvic floor surgeries, a low-cost anterior and posterior repair model was developed for the ACOG SWG Simulation Toolkit and published online in 2017, after their peer-review process. The fidelity is moderate for this low-cost model, which costs less than $5 per use. The simulation model requires a new vaginal insert for each learner, which is fast and easy to make and requires only a few components; however, the bony pelvis (for example, the flowerpot model) needs to be purchased or created. The stage of the anterior wall prolapse can be adjusted by the amount of fluid placed in the balloon, which is used to simulate the bladder. The more fluid that is placed in the “bladder,” the more severe the anterior wall prolapse appears. The vaginal caliber can be adjusted, if needed, by increasing or decreasing the size of the components to create the vagina, but the suggested sizes simulate a significantly widened vaginal caliber that would benefit from a posterior repair with perineorrhaphy. Although there is no validity evidence for this model, a skills assessment is available through the ACOG Simulation Surgical Curriculum. Of note, native tissue colpopexy repairs are also possible with this model (or another high-fidelity model, such as the Miya Model), if the sacrospinous ligaments and/or uterosacral ligaments are available on the pelvic model in use. This model’s limitations include the absence of a high-fidelity plane of dissection of the vaginal muscularis, and that no bleeding is encountered, which is the case for many low-cost models.^19,34

Fundamentals of Vaginal Surgery (FVS) basic surgical skills simulation

The FVS simulation system, consisting of a task trainer paired with 6 selected surgical tasks, was developed to teach basic skills used in vaginal surgery.³⁵ The FVS task trainer is 3D printed and has 3 main components: a base piece that allows for different surgical materials to be secured, a depth extender, and a width reducer. In addition, it has a mobile phone mount and a window into the system to enable video capture of skills exercises.

The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication suturing, Heaney transfixion pedicle ligation, and free pedicle ligation (FIGURE 4). In a pilot study, the FVS simulation system was deemed representative of the intended surgical field, useful for inclusion in a training program, and favored as a tool for both training and testing. Additionally, an initial proficiency score of 400 was set, which discriminated between novice and expert surgeons.³⁵

An advantage of this simulation system is that it allows learners to focus on basic skills, rather than on an entire specific procedure. Further, the system is standardized, as it is commercially manufactured; this also allows for easy assembly. The disadvantage of this model is that it cannot be modified to teach specific vaginal procedures, and it must be purchased, rather than constructed on site. Further studies are needed to create generalizable proficiency scores and to assess its use in training and testing. For more information on the FVS simulation model, visit the Arbor Simulation website (http://arborsim.com).

Surgical simulation’s important role

Surgical skills can be learned and improved in the simulation setting in a low-stakes, low-pressure environment. Simulation can enable basic skills development and then higher-level learning of complex procedures. Skill assessment is important to aid in learning (via formative assessments) and for examination or certification (summative assessments).

With decreasing vaginal surgical volumes occurring nationally, it is becoming even more important to use surgical simulation to teach and maintain vaginal surgical skills. In this article, we reviewed various different simulation models that can be used for developing vaginal surgical skills and presented the advantages, limitations, and resources relevant for each simulation model. ●

Vaginal surgery, including vaginal hysterectomy, is slowly becoming a dying art. According to the National Inpatient Sample and the Nationwide Ambulatory Surgery Sample from 2018, only 11.8% of all hysterectomies were performed vaginally.¹ The combination of uterine-sparing surgeries, advances in conservative therapies for benign uterine conditions, and the diversification of minimally invasive routes (laparoscopic and robotic) has resulted in a continued downtrend in vaginal surgical volumes. This shift has led to fewer operative learning opportunities and declining graduating resident surgical volume.² According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15, which represents only the minimum accepted exposure and does not imply competency.

In response, surgical simulation has been used for skill acquisition and maintenance outside of the operating room in a learning environment that is safe for the learners and does not expose patients to additional risk. Educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency. Although vaginal surgery, specifically vaginal hysterectomy, continues to decline, it can be resuscitated with the assistance of surgical simulation.

In this article, we provide a broad overview of vaginal surgical simulation. We discuss the basic tenets of simulation, review how to teach and evaluate vaginal surgical skills, and present some of the commonly available vaginal surgery simulation models and their associated resources, cost, setup time, fidelity, and limitations.

Simulation principles relevant for vaginal hysterectomy simulation

Here, we review simulation-based learning principles that will help place specific simulation models into perspective.

One size does not fit all

Simulation, like many educational interventions, does not work via a “one-size-fits-all” approach. While the American College of Obstetricians and Gynecologists (ACOG) Simulations Working Group (SWG) has created a toolkit (available online at https://www.acog.org/education-and-events/simulations/about/curriculum) with many ready-to-use how-to simulation descriptions and lesson plans that cover common topics, what works in one setting may not work in another. The SWG created those modules to help educators save time and resources and to avoid reinventing the wheel for each simulation session. However, these simulations need to be adapted to the local needs of trainees and resources, such as faculty time, space, models, and funding.

Cost vs fidelity

It is important to distinguish between cost and fidelity. “Low cost” is often incorrectly used interchangeably with “low fidelity” when referring to models and simulations. The most basic principle of fidelity is that it is associated with situational realism that in turn, drives learning.^3,4 For example, the term high fidelity does apply to a virtual reality robotic surgery simulator, which also is high cost. However, a low-cost beef tongue model of fourth-degree laceration⁵ is high fidelity, while more expensive commercial models are less realistic, which makes them high cost and low fidelity.⁶ When selecting simulation models, educators need to consider cost based on their available resources and the level of fidelity needed for their learners.

Continue to: Task breakdown...

Task breakdown

As surgeon-educators, we love to teach! And while educators are passionate about imparting vaginal hysterectomy skills to the next generation of surgeons, it is important to assess where the learners are technically. Vaginal hysterectomy is a high-complexity procedure, with each step involving a unique skill set that is new to residents as learners; this is where the science of learning can help us teach more effectively.⁷ Focusing on doing the entire procedure all at once is more likely to result in cognitive overload, while a better approach is to break the procedure down into several components and practice those parts until goal proficiency is reached.

Deliberate practice

The idea of deliberate practice was popularized by Malcolm Gladwell in his book titled Outliers, in which he gives examples of how 10,000 hours of practice leads to mastery of complex skills. This concept was deepened by the work of cognitive psychologist Anders Ericsson, who emphasized that not only the duration but also the quality of practice—which involves concentration, analysis, and problem-solving—leads to the most effective training.⁸

In surgical education, this concept translates into many domains. For example, an individualized learning plan includes frequent low-stakes assessments, video recording for later viewing and analysis, surgical coaching, and detailed planning of future training sessions to incorporate past performance. “Just doing” surgery on a simulator (or in the operating room) results in missed learning opportunities.

Logistics and implementation: Who, where, when

The simulation “formula” takes into account multiple factors but should start with learning objectives and then an assessment of what resources are available to address them. For example, if one surgeon-educator and one resident-learner are available for 30 minutes in between cases in the operating room, and the goal is to teach the resident clamp-and-tie technique on pedicles, the “milk carton” model⁹ and a few instruments from the vaginal hysterectomy tray are ideal for this training. On the other hand, if it is important to achieve competency for an entire procedure prior to operating room debut and a group of surgeon-educators is available to share the time commitment of 2-hour sessions per each resident, then the PROMPT (PRactical Obstetric Multi-Professional Training) shoulder dystocia model could be used (TABLE).^10-14

Learning curves

Ideally, educators would like to know how many simulated training sessions are needed for a learner to reach a proficiency level and become operating room ready. Such information about learning curves, unfortunately, is not available yet for vaginal hysterectomies. The first step in the process is to establish a baseline for performance to know a starting point, with assessment tools specific to each simulator; the next step is to study how many “takes” are needed for learners to move through their learning curve.¹⁵ The use of assessment tools can help assess each learner’s progression.

Continue to: Evaluation, assessment, and feedback...

With more emphasis being placed on patient safety and transparency in every aspect of health care, including surgical training, graduate medical education leaders increasingly highlight the importance of objective assessment tools and outcome-based standards for certification of competency in surgery.^16,17 Commonly used assessment tools that have reliability and validity evidence include surgical checklists and global rating scales. Checklists for common gynecologic procedures, including vaginal hysterectomy, as well as a global rating scale specifically developed for vaginal surgery (Vaginal Surgical Skills Index, VSSI)¹⁸ are accessible on the ACOG Simulations Working Group Surgical Curriculum in Obstetrics and Gynecology website.¹⁹

While checklists contain the main steps of each procedure, these lists do not assess for how well each step of the procedure is performed. By contrast, global rating scales, such as the VSSI, can discriminate between surgeons with different skill levels both in the simulation and operating room settings; each metric within the global rating scale (for example, time and motion) does not pertain to the performance of a procedure’s specific step but rather to the overall performance of the entire procedure.^18,20 Hence, to provide detailed feedback, especially for formative assessment, both checklists and global rating scales often are used together.

Although standardized, checklists and global rating scales ultimately are still subjective (not objective) assessment tools. Recently, more attention has been to use surgical data science, particularly artificial intelligence methods, to objectively assess surgical performance by analyzing data generated during the performance of surgery, such as instrumental motion and video.²¹ These methods have been applied to a wide range of surgical techniques, including open, laparoscopic, robotic, endoscopic, and microsurgical approaches. Most of these types of studies have used assessment of surgical skill as the main outcome, with fewer studies correlating skill with clinically relevant metrics, such as patient outcomes.^22-25 Although this is an area of active research, these methods are still being developed, and their validity and utility are not well established. For now, educators should continue to use validated checklists and global rating skills to help assess any type of surgical performance, particularly vaginal surgery.

Vaginal surgical simulation models

Vaginal surgery requires a surgeon to operate in a narrow, deep space. This requires ambidexterity, accurate depth perception, understanding of how to handle tissues, and use of movements that are efficient, fluid, and rhythmic. Multiple proposed simulation models are relevant to vaginal surgery, and these vary based on level of fidelity, cost, feasibility, ability to maintain standardization, ease of construction (if required), and generalizability to all of pelvic surgery (that is, procedure specific vs basic skills focused).^{10,11,13,26-31}

Below, we describe various simulation models that are available for teaching vaginal surgical skills.

Vaginal hysterectomy simulation model

One commercially available simulation model for vaginal hysterectomy (as well as other vaginal surgical procedures, such as midurethral sling and anterior and posterior colporrhaphy) is the Miya Model (Miyazaki Enterprises) (FIGURE 1) and its accompanying MiyaMODEL App. In a multi-institutional study funded by the National Institutes of Health (NIH), the Miya Model, when used with the VSSI, was shown to be a valid assessment tool in terms of ability to differentiate a competent from a noncompetent surgeon.²⁰ Currently, an ongoing NIH-sponsored multi-institutional study is assessing the Miya Model as a teaching tool and whether skills acquired on the Miya Model are transferable to the operating room.

Continue to: Low-cost vaginal hysterectomy models...

Multiple low-cost vaginal hysterectomy simulation models are described. Two models developed many years ago include the ACOG SWG flowerpot model¹⁴ and the PROMPT shoulder dystocia pelvic trainer model.^10,11,14 The former model is low cost as it can be constructed from easily obtained household materials, but its downside is that it takes time and effort to obtain the materials and to assemble them. The latter model is faster to assemble but requires one to use a PROMPT pelvis for shoulder dystocia training, which has a considerable upfront cost. However, it is available in most hospitals with considerable obstetrical volume, and it allows for the most realistic perineum, which is helpful in recreating the feel of vaginal surgery, including retraction and exposure.

Many models created and described in the literature are variations of the models mentioned above, and many use commercially available low-cost bony pelvis models and polyvinyl chloride (PVC) pipes as a foundation for the soft tissue inserts to attach.^12,13,31-33 Each model varies on what it “teaches best” regarding realism—for example, teaching anatomy, working in a tight space, dissection, or clamp placement and suture ligature.

Furthermore, since vaginal hysterectomy is a high-complexity procedure in terms of skills (working in confined space, limited view, “upside-down” anatomy, and need to direct assistants for retraction and exposure), task breakdown is important for simulation learning, as it is not efficient to repeat the entire procedure until proficiency is reached. Two trainers have been described to address that need: the milk carton and the vaginal suturing trainer. The latter allows learners to practice clamp placement and pedicle ligation multiple times, including in confined space (FIGURE 2), and the former allows them to do the same in a procedural matter as the clamp placement moves caudad to cephalad during the procedure (FIGURE 3).

Native tissue pelvic floor surgery simulation

While there are few publications regarding surgical simulation models for native tissue pelvic floor surgeries, a low-cost anterior and posterior repair model was developed for the ACOG SWG Simulation Toolkit and published online in 2017, after their peer-review process. The fidelity is moderate for this low-cost model, which costs less than $5 per use. The simulation model requires a new vaginal insert for each learner, which is fast and easy to make and requires only a few components; however, the bony pelvis (for example, the flowerpot model) needs to be purchased or created. The stage of the anterior wall prolapse can be adjusted by the amount of fluid placed in the balloon, which is used to simulate the bladder. The more fluid that is placed in the “bladder,” the more severe the anterior wall prolapse appears. The vaginal caliber can be adjusted, if needed, by increasing or decreasing the size of the components to create the vagina, but the suggested sizes simulate a significantly widened vaginal caliber that would benefit from a posterior repair with perineorrhaphy. Although there is no validity evidence for this model, a skills assessment is available through the ACOG Simulation Surgical Curriculum. Of note, native tissue colpopexy repairs are also possible with this model (or another high-fidelity model, such as the Miya Model), if the sacrospinous ligaments and/or uterosacral ligaments are available on the pelvic model in use. This model’s limitations include the absence of a high-fidelity plane of dissection of the vaginal muscularis, and that no bleeding is encountered, which is the case for many low-cost models.^19,34

Fundamentals of Vaginal Surgery (FVS) basic surgical skills simulation

The FVS simulation system, consisting of a task trainer paired with 6 selected surgical tasks, was developed to teach basic skills used in vaginal surgery.³⁵ The FVS task trainer is 3D printed and has 3 main components: a base piece that allows for different surgical materials to be secured, a depth extender, and a width reducer. In addition, it has a mobile phone mount and a window into the system to enable video capture of skills exercises.

The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication suturing, Heaney transfixion pedicle ligation, and free pedicle ligation (FIGURE 4). In a pilot study, the FVS simulation system was deemed representative of the intended surgical field, useful for inclusion in a training program, and favored as a tool for both training and testing. Additionally, an initial proficiency score of 400 was set, which discriminated between novice and expert surgeons.³⁵

An advantage of this simulation system is that it allows learners to focus on basic skills, rather than on an entire specific procedure. Further, the system is standardized, as it is commercially manufactured; this also allows for easy assembly. The disadvantage of this model is that it cannot be modified to teach specific vaginal procedures, and it must be purchased, rather than constructed on site. Further studies are needed to create generalizable proficiency scores and to assess its use in training and testing. For more information on the FVS simulation model, visit the Arbor Simulation website (http://arborsim.com).

Surgical simulation’s important role

Surgical skills can be learned and improved in the simulation setting in a low-stakes, low-pressure environment. Simulation can enable basic skills development and then higher-level learning of complex procedures. Skill assessment is important to aid in learning (via formative assessments) and for examination or certification (summative assessments).

With decreasing vaginal surgical volumes occurring nationally, it is becoming even more important to use surgical simulation to teach and maintain vaginal surgical skills. In this article, we reviewed various different simulation models that can be used for developing vaginal surgical skills and presented the advantages, limitations, and resources relevant for each simulation model. ●

Vaginal surgery, including vaginal hysterectomy, is slowly becoming a dying art. According to the National Inpatient Sample and the Nationwide Ambulatory Surgery Sample from 2018, only 11.8% of all hysterectomies were performed vaginally.¹ The combination of uterine-sparing surgeries, advances in conservative therapies for benign uterine conditions, and the diversification of minimally invasive routes (laparoscopic and robotic) has resulted in a continued downtrend in vaginal surgical volumes. This shift has led to fewer operative learning opportunities and declining graduating resident surgical volume.² According to the Accreditation Council for Graduate Medical Education (ACGME), the minimum number of vaginal hysterectomies is 15, which represents only the minimum accepted exposure and does not imply competency.

In response, surgical simulation has been used for skill acquisition and maintenance outside of the operating room in a learning environment that is safe for the learners and does not expose patients to additional risk. Educators are uniquely poised to use simulation to teach residents and to evaluate their procedural competency. Although vaginal surgery, specifically vaginal hysterectomy, continues to decline, it can be resuscitated with the assistance of surgical simulation.

In this article, we provide a broad overview of vaginal surgical simulation. We discuss the basic tenets of simulation, review how to teach and evaluate vaginal surgical skills, and present some of the commonly available vaginal surgery simulation models and their associated resources, cost, setup time, fidelity, and limitations.

Simulation principles relevant for vaginal hysterectomy simulation

Here, we review simulation-based learning principles that will help place specific simulation models into perspective.

One size does not fit all

Simulation, like many educational interventions, does not work via a “one-size-fits-all” approach. While the American College of Obstetricians and Gynecologists (ACOG) Simulations Working Group (SWG) has created a toolkit (available online at https://www.acog.org/education-and-events/simulations/about/curriculum) with many ready-to-use how-to simulation descriptions and lesson plans that cover common topics, what works in one setting may not work in another. The SWG created those modules to help educators save time and resources and to avoid reinventing the wheel for each simulation session. However, these simulations need to be adapted to the local needs of trainees and resources, such as faculty time, space, models, and funding.

Cost vs fidelity

It is important to distinguish between cost and fidelity. “Low cost” is often incorrectly used interchangeably with “low fidelity” when referring to models and simulations. The most basic principle of fidelity is that it is associated with situational realism that in turn, drives learning.^3,4 For example, the term high fidelity does apply to a virtual reality robotic surgery simulator, which also is high cost. However, a low-cost beef tongue model of fourth-degree laceration⁵ is high fidelity, while more expensive commercial models are less realistic, which makes them high cost and low fidelity.⁶ When selecting simulation models, educators need to consider cost based on their available resources and the level of fidelity needed for their learners.

Continue to: Task breakdown...

Task breakdown

As surgeon-educators, we love to teach! And while educators are passionate about imparting vaginal hysterectomy skills to the next generation of surgeons, it is important to assess where the learners are technically. Vaginal hysterectomy is a high-complexity procedure, with each step involving a unique skill set that is new to residents as learners; this is where the science of learning can help us teach more effectively.⁷ Focusing on doing the entire procedure all at once is more likely to result in cognitive overload, while a better approach is to break the procedure down into several components and practice those parts until goal proficiency is reached.

Deliberate practice

The idea of deliberate practice was popularized by Malcolm Gladwell in his book titled Outliers, in which he gives examples of how 10,000 hours of practice leads to mastery of complex skills. This concept was deepened by the work of cognitive psychologist Anders Ericsson, who emphasized that not only the duration but also the quality of practice—which involves concentration, analysis, and problem-solving—leads to the most effective training.⁸

In surgical education, this concept translates into many domains. For example, an individualized learning plan includes frequent low-stakes assessments, video recording for later viewing and analysis, surgical coaching, and detailed planning of future training sessions to incorporate past performance. “Just doing” surgery on a simulator (or in the operating room) results in missed learning opportunities.

Logistics and implementation: Who, where, when

The simulation “formula” takes into account multiple factors but should start with learning objectives and then an assessment of what resources are available to address them. For example, if one surgeon-educator and one resident-learner are available for 30 minutes in between cases in the operating room, and the goal is to teach the resident clamp-and-tie technique on pedicles, the “milk carton” model⁹ and a few instruments from the vaginal hysterectomy tray are ideal for this training. On the other hand, if it is important to achieve competency for an entire procedure prior to operating room debut and a group of surgeon-educators is available to share the time commitment of 2-hour sessions per each resident, then the PROMPT (PRactical Obstetric Multi-Professional Training) shoulder dystocia model could be used (TABLE).^10-14

Learning curves

Ideally, educators would like to know how many simulated training sessions are needed for a learner to reach a proficiency level and become operating room ready. Such information about learning curves, unfortunately, is not available yet for vaginal hysterectomies. The first step in the process is to establish a baseline for performance to know a starting point, with assessment tools specific to each simulator; the next step is to study how many “takes” are needed for learners to move through their learning curve.¹⁵ The use of assessment tools can help assess each learner’s progression.

Continue to: Evaluation, assessment, and feedback...

With more emphasis being placed on patient safety and transparency in every aspect of health care, including surgical training, graduate medical education leaders increasingly highlight the importance of objective assessment tools and outcome-based standards for certification of competency in surgery.^16,17 Commonly used assessment tools that have reliability and validity evidence include surgical checklists and global rating scales. Checklists for common gynecologic procedures, including vaginal hysterectomy, as well as a global rating scale specifically developed for vaginal surgery (Vaginal Surgical Skills Index, VSSI)¹⁸ are accessible on the ACOG Simulations Working Group Surgical Curriculum in Obstetrics and Gynecology website.¹⁹

While checklists contain the main steps of each procedure, these lists do not assess for how well each step of the procedure is performed. By contrast, global rating scales, such as the VSSI, can discriminate between surgeons with different skill levels both in the simulation and operating room settings; each metric within the global rating scale (for example, time and motion) does not pertain to the performance of a procedure’s specific step but rather to the overall performance of the entire procedure.^18,20 Hence, to provide detailed feedback, especially for formative assessment, both checklists and global rating scales often are used together.

Although standardized, checklists and global rating scales ultimately are still subjective (not objective) assessment tools. Recently, more attention has been to use surgical data science, particularly artificial intelligence methods, to objectively assess surgical performance by analyzing data generated during the performance of surgery, such as instrumental motion and video.²¹ These methods have been applied to a wide range of surgical techniques, including open, laparoscopic, robotic, endoscopic, and microsurgical approaches. Most of these types of studies have used assessment of surgical skill as the main outcome, with fewer studies correlating skill with clinically relevant metrics, such as patient outcomes.^22-25 Although this is an area of active research, these methods are still being developed, and their validity and utility are not well established. For now, educators should continue to use validated checklists and global rating skills to help assess any type of surgical performance, particularly vaginal surgery.

Vaginal surgical simulation models

Vaginal surgery requires a surgeon to operate in a narrow, deep space. This requires ambidexterity, accurate depth perception, understanding of how to handle tissues, and use of movements that are efficient, fluid, and rhythmic. Multiple proposed simulation models are relevant to vaginal surgery, and these vary based on level of fidelity, cost, feasibility, ability to maintain standardization, ease of construction (if required), and generalizability to all of pelvic surgery (that is, procedure specific vs basic skills focused).^{10,11,13,26-31}

Below, we describe various simulation models that are available for teaching vaginal surgical skills.

Vaginal hysterectomy simulation model

One commercially available simulation model for vaginal hysterectomy (as well as other vaginal surgical procedures, such as midurethral sling and anterior and posterior colporrhaphy) is the Miya Model (Miyazaki Enterprises) (FIGURE 1) and its accompanying MiyaMODEL App. In a multi-institutional study funded by the National Institutes of Health (NIH), the Miya Model, when used with the VSSI, was shown to be a valid assessment tool in terms of ability to differentiate a competent from a noncompetent surgeon.²⁰ Currently, an ongoing NIH-sponsored multi-institutional study is assessing the Miya Model as a teaching tool and whether skills acquired on the Miya Model are transferable to the operating room.

Continue to: Low-cost vaginal hysterectomy models...

Multiple low-cost vaginal hysterectomy simulation models are described. Two models developed many years ago include the ACOG SWG flowerpot model¹⁴ and the PROMPT shoulder dystocia pelvic trainer model.^10,11,14 The former model is low cost as it can be constructed from easily obtained household materials, but its downside is that it takes time and effort to obtain the materials and to assemble them. The latter model is faster to assemble but requires one to use a PROMPT pelvis for shoulder dystocia training, which has a considerable upfront cost. However, it is available in most hospitals with considerable obstetrical volume, and it allows for the most realistic perineum, which is helpful in recreating the feel of vaginal surgery, including retraction and exposure.

Many models created and described in the literature are variations of the models mentioned above, and many use commercially available low-cost bony pelvis models and polyvinyl chloride (PVC) pipes as a foundation for the soft tissue inserts to attach.^12,13,31-33 Each model varies on what it “teaches best” regarding realism—for example, teaching anatomy, working in a tight space, dissection, or clamp placement and suture ligature.

Furthermore, since vaginal hysterectomy is a high-complexity procedure in terms of skills (working in confined space, limited view, “upside-down” anatomy, and need to direct assistants for retraction and exposure), task breakdown is important for simulation learning, as it is not efficient to repeat the entire procedure until proficiency is reached. Two trainers have been described to address that need: the milk carton and the vaginal suturing trainer. The latter allows learners to practice clamp placement and pedicle ligation multiple times, including in confined space (FIGURE 2), and the former allows them to do the same in a procedural matter as the clamp placement moves caudad to cephalad during the procedure (FIGURE 3).

Native tissue pelvic floor surgery simulation

While there are few publications regarding surgical simulation models for native tissue pelvic floor surgeries, a low-cost anterior and posterior repair model was developed for the ACOG SWG Simulation Toolkit and published online in 2017, after their peer-review process. The fidelity is moderate for this low-cost model, which costs less than $5 per use. The simulation model requires a new vaginal insert for each learner, which is fast and easy to make and requires only a few components; however, the bony pelvis (for example, the flowerpot model) needs to be purchased or created. The stage of the anterior wall prolapse can be adjusted by the amount of fluid placed in the balloon, which is used to simulate the bladder. The more fluid that is placed in the “bladder,” the more severe the anterior wall prolapse appears. The vaginal caliber can be adjusted, if needed, by increasing or decreasing the size of the components to create the vagina, but the suggested sizes simulate a significantly widened vaginal caliber that would benefit from a posterior repair with perineorrhaphy. Although there is no validity evidence for this model, a skills assessment is available through the ACOG Simulation Surgical Curriculum. Of note, native tissue colpopexy repairs are also possible with this model (or another high-fidelity model, such as the Miya Model), if the sacrospinous ligaments and/or uterosacral ligaments are available on the pelvic model in use. This model’s limitations include the absence of a high-fidelity plane of dissection of the vaginal muscularis, and that no bleeding is encountered, which is the case for many low-cost models.^19,34

Fundamentals of Vaginal Surgery (FVS) basic surgical skills simulation

The FVS simulation system, consisting of a task trainer paired with 6 selected surgical tasks, was developed to teach basic skills used in vaginal surgery.³⁵ The FVS task trainer is 3D printed and has 3 main components: a base piece that allows for different surgical materials to be secured, a depth extender, and a width reducer. In addition, it has a mobile phone mount and a window into the system to enable video capture of skills exercises.

The FVS simulator is designed to enable 6 surgical tasks, including one-handed knot tying, two-handed knot tying, running suturing, plication suturing, Heaney transfixion pedicle ligation, and free pedicle ligation (FIGURE 4). In a pilot study, the FVS simulation system was deemed representative of the intended surgical field, useful for inclusion in a training program, and favored as a tool for both training and testing. Additionally, an initial proficiency score of 400 was set, which discriminated between novice and expert surgeons.³⁵

An advantage of this simulation system is that it allows learners to focus on basic skills, rather than on an entire specific procedure. Further, the system is standardized, as it is commercially manufactured; this also allows for easy assembly. The disadvantage of this model is that it cannot be modified to teach specific vaginal procedures, and it must be purchased, rather than constructed on site. Further studies are needed to create generalizable proficiency scores and to assess its use in training and testing. For more information on the FVS simulation model, visit the Arbor Simulation website (http://arborsim.com).

Surgical simulation’s important role

Surgical skills can be learned and improved in the simulation setting in a low-stakes, low-pressure environment. Simulation can enable basic skills development and then higher-level learning of complex procedures. Skill assessment is important to aid in learning (via formative assessments) and for examination or certification (summative assessments).

With decreasing vaginal surgical volumes occurring nationally, it is becoming even more important to use surgical simulation to teach and maintain vaginal surgical skills. In this article, we reviewed various different simulation models that can be used for developing vaginal surgical skills and presented the advantages, limitations, and resources relevant for each simulation model. ●