Obstetrics

Most infants are vulnerable to measles, mumps, and rubella viruses between the disappearance of antibodies acquired during gestation and their first MMR vaccination, according to results of a study in Vaccine.

Yarinca/istockphoto

María José Cilleruelo, PhD, of Hospital Universitario Puerta de Hierro in Majadahonda, Spain, and colleagues showed that, although most infants acquire some protective antibodies against MMR from their mothers during gestation, most have lost this protection as early as 3 months of age. This single-center, observational, prospective study was conducted between October 2013 and December 2014, and it began with 146 mother-child pairs, with 99 remaining in follow-up at 3 months, 77 at 6 months, 63 at 9 months, and 30 at 12 months. For measles, 88% of newborns were seropositive, but only 19% were at 3 months; for mumps, 70% of newborns were seropositive, but only 11% were at 3 months; and for rubella, 91% of newborns were seropositive, but only 13% were at 3 months. No infants were seropositive for mumps or rubella at 9 months, and only 2% were for measles. No infants were seropositive for any of these viruses by 12 months of age.

The investigators noted that, given Spain (where the study was conducted) is a country that gives the first MMR vaccine at 12 months of life, these declining titers can leave most infants vulnerable to those viruses before then.

“We suggest that it may be worth considering administering the first dose of MMR vaccine before 12 months of age,” the investigators concluded, although they advised studies be undertaken into the efficacy and safety of administration of that vaccine in infants younger than 12 months. They noted that the biggest limitation of this study was the high percentage of loss to follow-up, which limited the statistical power to make comparisons.

The study was funded by the Fondo de Investigación Sanitaria, and one of the authors was funded by CIBER de Epidemiología y Salud Pública. The authors declared that there are no conflicts of interest.

[email protected]

SOURCE: Cilleruelo MJ et al. Vaccine. 2019;37:4164-71.

Most infants are vulnerable to measles, mumps, and rubella viruses between the disappearance of antibodies acquired during gestation and their first MMR vaccination, according to results of a study in Vaccine.

Yarinca/istockphoto

María José Cilleruelo, PhD, of Hospital Universitario Puerta de Hierro in Majadahonda, Spain, and colleagues showed that, although most infants acquire some protective antibodies against MMR from their mothers during gestation, most have lost this protection as early as 3 months of age. This single-center, observational, prospective study was conducted between October 2013 and December 2014, and it began with 146 mother-child pairs, with 99 remaining in follow-up at 3 months, 77 at 6 months, 63 at 9 months, and 30 at 12 months. For measles, 88% of newborns were seropositive, but only 19% were at 3 months; for mumps, 70% of newborns were seropositive, but only 11% were at 3 months; and for rubella, 91% of newborns were seropositive, but only 13% were at 3 months. No infants were seropositive for mumps or rubella at 9 months, and only 2% were for measles. No infants were seropositive for any of these viruses by 12 months of age.

The investigators noted that, given Spain (where the study was conducted) is a country that gives the first MMR vaccine at 12 months of life, these declining titers can leave most infants vulnerable to those viruses before then.

“We suggest that it may be worth considering administering the first dose of MMR vaccine before 12 months of age,” the investigators concluded, although they advised studies be undertaken into the efficacy and safety of administration of that vaccine in infants younger than 12 months. They noted that the biggest limitation of this study was the high percentage of loss to follow-up, which limited the statistical power to make comparisons.

The study was funded by the Fondo de Investigación Sanitaria, and one of the authors was funded by CIBER de Epidemiología y Salud Pública. The authors declared that there are no conflicts of interest.

[email protected]

SOURCE: Cilleruelo MJ et al. Vaccine. 2019;37:4164-71.

Most infants are vulnerable to measles, mumps, and rubella viruses between the disappearance of antibodies acquired during gestation and their first MMR vaccination, according to results of a study in Vaccine.

Yarinca/istockphoto

María José Cilleruelo, PhD, of Hospital Universitario Puerta de Hierro in Majadahonda, Spain, and colleagues showed that, although most infants acquire some protective antibodies against MMR from their mothers during gestation, most have lost this protection as early as 3 months of age. This single-center, observational, prospective study was conducted between October 2013 and December 2014, and it began with 146 mother-child pairs, with 99 remaining in follow-up at 3 months, 77 at 6 months, 63 at 9 months, and 30 at 12 months. For measles, 88% of newborns were seropositive, but only 19% were at 3 months; for mumps, 70% of newborns were seropositive, but only 11% were at 3 months; and for rubella, 91% of newborns were seropositive, but only 13% were at 3 months. No infants were seropositive for mumps or rubella at 9 months, and only 2% were for measles. No infants were seropositive for any of these viruses by 12 months of age.

The investigators noted that, given Spain (where the study was conducted) is a country that gives the first MMR vaccine at 12 months of life, these declining titers can leave most infants vulnerable to those viruses before then.

“We suggest that it may be worth considering administering the first dose of MMR vaccine before 12 months of age,” the investigators concluded, although they advised studies be undertaken into the efficacy and safety of administration of that vaccine in infants younger than 12 months. They noted that the biggest limitation of this study was the high percentage of loss to follow-up, which limited the statistical power to make comparisons.

The study was funded by the Fondo de Investigación Sanitaria, and one of the authors was funded by CIBER de Epidemiología y Salud Pública. The authors declared that there are no conflicts of interest.

[email protected]

SOURCE: Cilleruelo MJ et al. Vaccine. 2019;37:4164-71.

The Food and Drug Administration has revised its 2017 guidance on fish consumption.

Lynda Banzi/MDedge News

The revision touts the health benefits of fish and shellfish and promotes safer fish choices for those who should limit mercury exposure – including women who are or might become pregnant, women who are breastfeeding, and young children.

Those individuals should avoid commercial fish with the highest levels of mercury and should instead choose from “the many types of fish that are lower in mercury – including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish, and cod,” according to an FDA press statement.

The potential health benefits of eating fish were highlighted in the U.S. Department of Health and Human Services/Department of Agriculture 2015-2020 Dietary Guidelines for Americans, and in 2017 the FDA and the Environmental Protection Agency released advice on fish consumption, including a user-friendly reference chart regarding mercury levels in various types of fish.

Although the information in the chart has not changed, the FDA revised its advice to expand on the “information about the benefits of fish as part of healthy eating patterns by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans.”

The advice calls for consumption of at least 8 ounces of seafood per week for adults (less for children) based on a 2,000 calorie diet, and for women who are pregnant or breastfeeding, 8-12 ounces of a variety of seafood per week selected from choices lower in mercury.

“The FDA’s revised advice highlights the many nutrients found in fish, several of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for improving heart health and lowering the risk of obesity,” the press release states.

Despite these benefits – and the recommendations for intake – concerns about mercury in fish have led many pregnant women in the United States to consume far less than the recommended amount of seafood, according to Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.

“Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat,” Dr. Mayne said in the FDA statement.

In response to the revised guidance, John S. Cullen, MD, president of the American Academy of Family Physicians, said that all women should be counseled to eat a well-balanced and varied diet including meats, dairy products, fruits, vegetables, and grains, and pregnant women should limit their intake of fish and seafood products to 8-12 ounces, or about 2-3 fish meals, per week.

Pregnant women may eat salmon in moderation, but should avoid raw seafood of any type because of possible contamination with parasites and Norwalk-like viruses, he said, adding that seafood like shark, swordfish, king mackerel, tilefish, Bigeye (Ahi) tuna steaks, and other long-lived fish high on the food chain should be avoided completely because of high mercury levels.

“While the AAFP did not review the revised advice to the dietary guidelines, family physicians are on the front lines encouraging healthy nutrition for pregnant and breastfeeding women and young children. It’s an ongoing, important part of the patient-physician conversation that begins with the initial prenatal visit,” Dr. Cullen said in a statement.

Similarly, Christopher M. Zahn, MD, vice president of practice activities for the American College of Obstetricians and Gynecologists, said the FDA/EPA updated guidance is in line with ACOG recommendations.

“The guidance continues to underscore the value of eating seafood 2-3 times per week during pregnancy and the importance of avoiding fish products that are high in mercury. The additional emphasis on healthy eating patterns mirrors ACOG’s long-standing guidance on the importance of a well-balanced, varied, nutritional diet that is consistent with a woman’s access to food and food preferences,” he said in a statement, noting that “seafood is a nutrient-rich food that has proven beneficial to women and in aiding the development of a fetus throughout pregnancy.”

[email protected]

The Food and Drug Administration has revised its 2017 guidance on fish consumption.

Lynda Banzi/MDedge News

The revision touts the health benefits of fish and shellfish and promotes safer fish choices for those who should limit mercury exposure – including women who are or might become pregnant, women who are breastfeeding, and young children.

Those individuals should avoid commercial fish with the highest levels of mercury and should instead choose from “the many types of fish that are lower in mercury – including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish, and cod,” according to an FDA press statement.

The potential health benefits of eating fish were highlighted in the U.S. Department of Health and Human Services/Department of Agriculture 2015-2020 Dietary Guidelines for Americans, and in 2017 the FDA and the Environmental Protection Agency released advice on fish consumption, including a user-friendly reference chart regarding mercury levels in various types of fish.

Although the information in the chart has not changed, the FDA revised its advice to expand on the “information about the benefits of fish as part of healthy eating patterns by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans.”

The advice calls for consumption of at least 8 ounces of seafood per week for adults (less for children) based on a 2,000 calorie diet, and for women who are pregnant or breastfeeding, 8-12 ounces of a variety of seafood per week selected from choices lower in mercury.

“The FDA’s revised advice highlights the many nutrients found in fish, several of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for improving heart health and lowering the risk of obesity,” the press release states.

Despite these benefits – and the recommendations for intake – concerns about mercury in fish have led many pregnant women in the United States to consume far less than the recommended amount of seafood, according to Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.

“Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat,” Dr. Mayne said in the FDA statement.

In response to the revised guidance, John S. Cullen, MD, president of the American Academy of Family Physicians, said that all women should be counseled to eat a well-balanced and varied diet including meats, dairy products, fruits, vegetables, and grains, and pregnant women should limit their intake of fish and seafood products to 8-12 ounces, or about 2-3 fish meals, per week.

Pregnant women may eat salmon in moderation, but should avoid raw seafood of any type because of possible contamination with parasites and Norwalk-like viruses, he said, adding that seafood like shark, swordfish, king mackerel, tilefish, Bigeye (Ahi) tuna steaks, and other long-lived fish high on the food chain should be avoided completely because of high mercury levels.

“While the AAFP did not review the revised advice to the dietary guidelines, family physicians are on the front lines encouraging healthy nutrition for pregnant and breastfeeding women and young children. It’s an ongoing, important part of the patient-physician conversation that begins with the initial prenatal visit,” Dr. Cullen said in a statement.

Similarly, Christopher M. Zahn, MD, vice president of practice activities for the American College of Obstetricians and Gynecologists, said the FDA/EPA updated guidance is in line with ACOG recommendations.

“The guidance continues to underscore the value of eating seafood 2-3 times per week during pregnancy and the importance of avoiding fish products that are high in mercury. The additional emphasis on healthy eating patterns mirrors ACOG’s long-standing guidance on the importance of a well-balanced, varied, nutritional diet that is consistent with a woman’s access to food and food preferences,” he said in a statement, noting that “seafood is a nutrient-rich food that has proven beneficial to women and in aiding the development of a fetus throughout pregnancy.”

[email protected]

The Food and Drug Administration has revised its 2017 guidance on fish consumption.

Lynda Banzi/MDedge News

The revision touts the health benefits of fish and shellfish and promotes safer fish choices for those who should limit mercury exposure – including women who are or might become pregnant, women who are breastfeeding, and young children.

Those individuals should avoid commercial fish with the highest levels of mercury and should instead choose from “the many types of fish that are lower in mercury – including ones commonly found in grocery stores, such as salmon, shrimp, pollock, canned light tuna, tilapia, catfish, and cod,” according to an FDA press statement.

The potential health benefits of eating fish were highlighted in the U.S. Department of Health and Human Services/Department of Agriculture 2015-2020 Dietary Guidelines for Americans, and in 2017 the FDA and the Environmental Protection Agency released advice on fish consumption, including a user-friendly reference chart regarding mercury levels in various types of fish.

Although the information in the chart has not changed, the FDA revised its advice to expand on the “information about the benefits of fish as part of healthy eating patterns by promoting the science-based recommendations of the 2015-2020 Dietary Guidelines for Americans.”

The advice calls for consumption of at least 8 ounces of seafood per week for adults (less for children) based on a 2,000 calorie diet, and for women who are pregnant or breastfeeding, 8-12 ounces of a variety of seafood per week selected from choices lower in mercury.

“The FDA’s revised advice highlights the many nutrients found in fish, several of which have important roles in growth and development during pregnancy and early childhood. It also highlights the potential health benefits of eating fish as part of a healthy eating pattern, particularly for improving heart health and lowering the risk of obesity,” the press release states.

Despite these benefits – and the recommendations for intake – concerns about mercury in fish have led many pregnant women in the United States to consume far less than the recommended amount of seafood, according to Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition.

“Our goal is to make sure Americans are equipped with this knowledge so that they can reap the benefits of eating fish, while choosing types of fish that are safe for them and their families to eat,” Dr. Mayne said in the FDA statement.

In response to the revised guidance, John S. Cullen, MD, president of the American Academy of Family Physicians, said that all women should be counseled to eat a well-balanced and varied diet including meats, dairy products, fruits, vegetables, and grains, and pregnant women should limit their intake of fish and seafood products to 8-12 ounces, or about 2-3 fish meals, per week.

Pregnant women may eat salmon in moderation, but should avoid raw seafood of any type because of possible contamination with parasites and Norwalk-like viruses, he said, adding that seafood like shark, swordfish, king mackerel, tilefish, Bigeye (Ahi) tuna steaks, and other long-lived fish high on the food chain should be avoided completely because of high mercury levels.

“While the AAFP did not review the revised advice to the dietary guidelines, family physicians are on the front lines encouraging healthy nutrition for pregnant and breastfeeding women and young children. It’s an ongoing, important part of the patient-physician conversation that begins with the initial prenatal visit,” Dr. Cullen said in a statement.

Similarly, Christopher M. Zahn, MD, vice president of practice activities for the American College of Obstetricians and Gynecologists, said the FDA/EPA updated guidance is in line with ACOG recommendations.

“The guidance continues to underscore the value of eating seafood 2-3 times per week during pregnancy and the importance of avoiding fish products that are high in mercury. The additional emphasis on healthy eating patterns mirrors ACOG’s long-standing guidance on the importance of a well-balanced, varied, nutritional diet that is consistent with a woman’s access to food and food preferences,” he said in a statement, noting that “seafood is a nutrient-rich food that has proven beneficial to women and in aiding the development of a fetus throughout pregnancy.”

[email protected]

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

The Affordable Care Act (ACA) was enacted on March 23, 2010. Controversies, complaints, and detractors have and continue to abound. But the ACA’s landmark women’s health gains are unmistakable. Contraceptive coverage, maternity coverage, Medicaid coverage of low-income women, coverage for individuals with preexisting conditions, and gender-neutral premiums are now a part of the fabric of our society. For most.

Many physicians and patients—many lawmakers, too—do not remember the serious problems people had with their insurance companies before the ACA. Maternity coverage was usually a free-standing rider to an insurance policy, making it very expensive. Insurance plans did not have to, and often did not, cover contraceptives, and none did without copays or deductibles. Women were routinely denied coverage if they had ever had a cesarean delivery, had once been the victim of domestic violence, or had any one of many common conditions, like diabetes. The many exclusionary conditions are so common, in fact, that one study estimated that around 52 million adults in the United States (27% of those younger than age 65 years) have preexisting conditions that would potentially make them uninsurable without the ACA’s protections.¹

Before the ACA, it also was common for women with insurance policies to find their coverage rescinded, often with no explanation, even though they paid their premiums every month. And women with serious medical conditions often saw their coverage ended midway through their course of treatment. That placed their ObGyns in a terrible situation, too.

The insurance industry as a whole was running rough-shod over its customers, and making a lot of money by creatively and routinely denying coverage and payment for care. People were often insured, but not covered. The ACA halted many of these practices, and required insurers to meet high medical loss ratios, guaranteeing that 80% of the premiums’ for individual and small market insurers (and 85% for large insurers) are returned to patients in care payments or even in checks. In fact, nearly $4 billion in premiums have been rebated to insured individuals over the last 7 years under the ACA.²

The commitment of the American College of Obstetricians and Gynecologists (ACOG) to women’s health and to our members’ ability to provide the best care has centered on preserving the critical gains of the ACA for women, improving them when we can, and making sure politicians don’t turn back the clock on women’s health. We have been busy.

In this article, we will look at what has happened to these landmark gains and promises of improved women’s health, specifically preexisting condition protections and contraceptive coverage, under a new Administration. What happens when good health care policy and political enmity collide?

Preexisting coverage protections

The 1996 Health Insurance Portability and Accountability Act (HIPAA) defines a preexisting condition exclusionas a “limitation or exclusion of benefits relating to a condition based on the fact that the condition was present before the date of enrollment for the coverage, whether or not any medical advice, diagnosis, care, or treatment was recommended or received before that date.” HIPPA prohibited employer-sponsored health plans from discriminating against individuals through denying them coverage or charging them more based on their or their family members’ health problems. The ACA expanded protections to prohibit the insurance practice of denying coverage altogether to an individual with a preexisting condition.³

Continue to: Under Congress...

Under Congress

Republicans held the majority in both chambers of the 115th Congress (2017–2018), and hoped to use their majority status to get an ACA repeal bill to the Republican President’s desk for speedy enactment. It was not easy, and they were not successful. Four major bills—the American Health Care Act, the Better Care Reconciliation Act, the Health Care Freedom Act, and the Graham-Cassidy Amendment—never made it over the finish line, with some not even making it to a vote. The Health Care Freedom Act was voted down in the Senate 51-49 when Senator John McCain came back from brain surgery to cast his famous thumbs-down vote.⁴ These bills all would have repealed or hobbled guaranteed issue, community rating, and essential health benefits of the ACA. Of all the legislative attempts to undermine the ACA, only the 2017 Tax Cuts and Jobs Act (TCJA) was signed into law, repealing the ACA individual mandate.

Handling by the courts

The TCJA gave ACA opponents their opening in court. Twenty Republican state attorneys general and governors brought suit in February 2018 (Texas v Azar), arguing that because the ACA relies on the mandate, and the mandate has been repealed, the rest of the ACA also should be struck down. A federal district judge agreed, on December 15, 2018, declaring the entire ACA unconstitutional.⁵

That decision has been limited in its practical effect so far, and maybe it was not altogether unexpected. What was unexpected was that the US Department of Justice (DOJ) refused to defend a federal law, in this case, the ACA. In June 2018, the DOJ declined to defend the individual mandate, as well as guaranteed issue, community rating, the ban on preexisting condition exclusions, and discrimination based on health status in the ACA. The DOJ at that time, however, did not agree with the plaintiffs that without the mandate the entire ACA should be struck down. It said, “There is no reason why the ACA’s particular expansion of Medicaid hinges on the individual mandate.” Later, after the December 15 ruling, the DOJ changed its position and agreed with the judge, in a two-sentence letter to the court, that the ACA should be stricken altogether—shortly after which 3 career DOJ attorneys resigned.⁶

A legal expert observed: “The DOJ’s decision not to defend the ACA breaks with the Department’s long-standing bipartisan commitment to defend federal laws if reasonable arguments can be made in their defense. Decisions not to defend federal law are exceedingly rare. It seems even rarer to change the government’s position mid-appeal in such a high-profile lawsuit that risks disrupting the entire health care system and health insurance coverage for millions of Americans.”⁷

Regulatory tactics

What a policy maker cannot do by law, he or she can try to accomplish by regulation. The Administration is using 3 regulatory routes to undercut the ACA preexisting coverage protections and market stability.

Route 1: Short-Term Limited Duration (STLD) plans. These plans were created in the ACA to provide bridge coverage for up to 3 months for individuals in between health insurance plans. These plans do not have to comply with ACA patient protections, can deny coverage for preexisting conditions, and do not cover maternity care. In 2018, the Administration moved to allow these plans to be marketed broadly and renewed for up to 3 years. Because these plans provide less coverage and often come with high deductibles, they can be marketed with lower premiums, skimming off healthier younger people who do not expect to need much care, as well as lower-income families. This destabilizes the market and leaves people insured but not covered, exactly the situation before the ACA. Seven public health and medical groups sued to challenge the Administration’s STLD regulation; the lawsuit is presently pending.

Continue to: Route 2: Association Health Plans (AHPs)...

Route 2: Association Health Plans (AHPs). The Administration also has allowed the sale of AHPs, marketed to small employers and self-employed individuals. These plans also do not have to comply with ACA consumer protections. They often do not cover maternity care or other essential benefits, and can charge women higher premiums for the same insurance. This regulation, too, resulted in litigation and a federal judge enjoined the rule, but the case is now on appeal.

Route 3: ACA Section 1332 waivers. These waivers were created in the ACA to encourage state innovation to increase access to health coverage, under certain guardrails: states must ensure coverage is at least as comprehensive as the Essential Health Benefits; cost sharing protections must be at least as affordable as under the ACA; the plan must cover at least a comparable number of its residents; and the plan must not increase the federal deficit.

The Adminstration has come under fire for approving 1332 waiver plans that do not meet these guardrails, and allow insurers to exclude coverage for individuals with preexisting conditions, as well as skirt other important ACA patient protections. In response, Seema Verma, Administrator of the Centers for Medicare & Medicaid Services, promised as recently as April 23, that the Administration will not allow any weakening of the ACA preexisting coverage guarantee.⁸ So far, however, we do not know what action this means, and not surprisingly, House Democrats, now in the majority, are waiting to see those assurances come true. Consistent polling shows that a large majority of Americans, across political parties, think preexisting coverage protections are very important.⁹

Already, the House passed HR986, to repeal the Administration’s changes to the 1332 waiver rules. The bill won only 4 Republican votes in the House and now waits a Senate vote.

The House is ready to vote on HR1010, which returns the STLD rules to the original ACA version. The Congressional Budget Office has determined that this bill will reduce the federal deficit by $8.9 billion over 10 years, in part by reestablishing a large risk pool. Lower ACA premiums would mean lower federal subsidies and small federal outlays.

Contraceptive coverage

Since 2012, the ACA has required non-grandfathered individual and group health plans to cover, with no copays or deductibles, women’s preventive services, as determined by the Health Resources and Services Administration (HRSA). HRSA asked the National Academy of Medicine (the Institute of Medicine [IOM] at the time) to develop these coverage guidelines based on clinical and scientific relevance. The IOM relied heavily on ACOG’s testimony and women’s health guidelines. The guidelines are updated every 5 years, based on extensive review by the Women’s Preventive Services Initiative, led by ACOG. By law and regulation, covered services include:

• well-woman visits
• contraceptive methods and counseling, including all methods approved for women by the FDA
• breast and cervical cancer screening
• counseling for sexually transmitted infections
• counseling and screening for HIV
• screening for gestational diabetes
• breastfeeding support, supplies, and counseling
• screening and counseling for interpersonal and domestic violence.

Continue to: The previous administration offered a narrow exemption...

The previous administration offered a narrow exemption—an accommodation—for churches, religious orders, and integrated auxiliaries (organizations with financial support primarily from churches). That accommodation was expanded in the Supreme Court’s decision in Hobby Lobby, for closely held for-profit organizations that had religious objections to covering some or all contraceptives. Under the accommodation, the entity’s insurer or third-party administrator was responsible for providing contraceptive services to the entity’s plan participants and beneficiaries.

In October 2017, the Trump administration acted to greatly expand the ability of any employer, college or university, individual, or insurer to opt out of the ACA’s contraceptive coverage requirement. You will read more about this later.

ACOG’s business case for contraception

Early in the Trump Administration, the White House released a statement saying, “Ensuring affordable, accessible, and quality healthcare is critical to improving women’s health and ensuring that it fits their priorities at any stage of life.”¹⁰ ACOG could not agree more, and we encouraged the President to accomplish this important goal by protecting the landmark women’s health gains of the ACA. Our call to the President and the US Congress was: “Don’t turn back the clock on women’s health.”

We made a business case for continued contraceptive coverage:

Contraception reduces unintended pregnancies and saves federal dollars.

• Approximately 45% of US pregnancies are unintended.¹¹
• No-copay coverage of contraception has contributed to a dramatic decline in the unintended pregnancy rate in the United States, now at a 30-year low.¹²
• When cost is not a barrier, women choose more effective forms of contraception, such as intrauterine devices and implants.¹³
• Unintended pregnancies cost approximately $12.5 billion in government expenditures in 2008.¹⁴
• Private health plans spend as much as $4.6 billion annually in costs related to unintended pregnancies.¹⁵

Contraception means healthier women and healthier families.

• Under the ACA, the uninsured rate among women ages 18 to 64 almost halved, decreasing from 19.3% to 10.8%.¹⁶
• More than 55 million women gained access to preventive services, including contraception, without a copay or a deductible.¹⁶
• Women with unintended pregnancies are more likely to delay prenatal care. Infants are at greater risk of birth defects, low birth weight, and poor mental and physical functioning in early childhood.¹⁷

Increased access to contraception helps families and improves economic security.

• Women saved $1.4 billion in out-of-pocket costs for contraception in 1 year.¹⁸
• Before the ACA, women were spending between 30% and 44% of their total out-of-pocket health costs just on birth control.¹⁹
• The ability to plan a pregnancy increases engagement of women in the workforce and improves economic stability for women and their families.²⁰

Administration expands religious exemptions to contraception coverage

Still, on October 6, 2017, the Trump Administration moved to curtail women’s access to and coverage of contraception with the Religious Exemptions and Accommodations for Coverage of Certain Preventive Services under the Affordable Care Act and Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. In November 2018, the Administration published a revised rule, to take effect in January 2019.²¹ The rule immediately was taken to court by more than a dozen states and, 1 month later, was subject to an injunction by the US Court of Appeals for the Ninth Circuit, blocking the rules from going into effect in those states.

Continue to: The rule vastly expands the Obama Administration’s religious accommodation...

The rule vastly expands the Obama Administration’s religious accommodation to include “nonprofit organizations, small businesses, and individuals that have nonreligious moral convictions opposing services covered by the contraceptive mandate.” The covered entities include²¹:

• churches, integrated auxiliaries, and religious orders with religious objections
• nonprofit organizations with religious or moral objections
• for-profit entities that are not publicly traded, with religious or moral objections
• for-profit entities that are publicly traded, with religious objections
• other nongovernmental employers with religious objections
• nongovernmental institutions of higher education with religious or moral objections
• individuals with religious or moral objections, with employer sponsored or individual market coverage, where the plan sponsor and/or issuer (as applicable) are willing to offer them a plan omitting contraceptive coverage to which they object
• issuers with religious or moral objections, to the extent they provide coverage to a plan sponsor or individual that is also exempt.

The Administration says women losing coverage can get contraceptives through Title X clinics or other government programs. Of course, many women losing coverage are employed, and earn above the low income (100% of the federal poverty level) eligibility requirement for Title X assistance. To address that, the Administration, through its proposed Title X regulations, broadens the definition of “low income” in that program to include women who lose their contraceptive coverage through the employer-base health insurance plan. This move further limits the ability of the Title X program to adequately care for already-qualified individuals.

The Administration’s rule also relied on major inaccuracies, which ACOG corrected.²² First, ACOG pointed out that, in fact, FDA-approved contraceptive methods are not abortifacients, countering the Administration’s contention that contraception is an abortifacient, and that contraceptives cause abortions or miscarriages. Every FDA-approved contraceptive acts before implantation, does not interfere with a pregnancy, and is not effective after a fertilized egg has implanted successfully in the uterus.²³ No credible research supports the false statement that birth control causes miscarriages.²⁴

Second, ACOG offered data proving that increased access to contraception is not associated with increased unsafe sexual behavior or increased sexual activity.^25,26 The facts are that:

• The percentage of teens who are having sex has declined significantly, by 14% for female and 22% for male teenagers, over the past 25 years.²⁷
• More women are using contraception the first time they have sex. Young women who do not use birth control at first sexual intercourse are twice as likely to become teen mothers.²⁸
• Increased access to and use of contraception has contributed to a dramatic decline in rates of adolescent pregnancy.²⁹
• School-based health centers that provide access to contraceptives are proven to increase use of contraceptives by already sexually active students, not to increase onset of sexual activity.^30,31

Third, ACOG made clear the benefits to women’s health from contraception. ACOG asserted: As with any medication, certain types of contraception may be contraindicated for patients with certain medical conditions, including high blood pressure, lupus, or a history of breast cancer.^32,33 For these and many other reasons, access to the full range of FDA-approved contraception, with no cost sharing or other barriers, is critical to women’s health. Regarding VTE, the risk among oral contraceptive users is very low. In fact, it is much lower than the risk of VTE during pregnancy or in the immediate postpartum period.³⁴

Continue to: Regarding breast cancer: there is no proven increased risk...

Regarding breast cancer: there is no proven increased risk of breast cancer among contraceptive users, particularly among those younger than age 40. For women older than 40, health care providers must consider both the risks of becoming pregnant at advanced reproductive age and the risks of continuing contraception use until menopause.³⁵

ACOG has 2 clear messages for politicians

ACOG has remained steadfast in its opposition to the Administration’s proposals to block access to contraception. ACOG expressed its strong opposition to political interference in medical care, saying “Every woman, regardless of her insurer, employer, state of residence, or income, should have affordable, seamless access to the right form of contraception for her, free from interference from her employer or politicians.”²²

ACOG’s voice has been joined by 5 other major medical associations—American Academy of Family Physicians, American Academy of Pediatrics, American Psychiatric Association, American Academy of Pediatrics, and American Osteopathic Association—together representing more than 560,000 physicians and medical students, in urging the Administration to immediately withdraw its proposals. This broad coalition unequivocally stated³⁶:

Contraception is an integral part of preventive care and a medical necessity for women during approximately 30 years of their lives. Access to no-copay contraception leads to healthier women and families. Changes to our healthcare system come with very high stakes – impacting tens of millions of our patients. Access to contraception allows women to achieve, lead and reach their full potentials, becoming key drivers of our Nation’s economic success. These rules would create a new standard whereby employers can deny their employees coverage, based on their own moral objections. This interferes in the personal health care decisions of our patients, and inappropriately inserts a patient’s employer into the physician-patient relationship. In addition, these rules open the door to moral exemptions for other essential health care, including vaccinations.

These are challenging days for women’s health policy and legislation federally, and in many states. ACOG has two clear messages for politicians: Don’t turn back the clock on women’s health, and stay out of our exam rooms.

CASE Low-risk maternity patient wants fewer prenatal visits

A recently pregnant patient asks her obstetrician if she can schedule fewer prenatal visits given that she is at low risk, wants to minimize missing work, and lives an hour away from the clinic office. Her physician tells her that she needs the standard 13 to 15 visits to have a healthy pregnancy.

Obstetric care in the United States largely remains a “one-size fits all” approach despite compelling data that fewer visits for low-risk women are medically acceptable and may be more cost-effective.

Prenatal care: One size does not fit all

With nearly 4 million births annually in the United States, prenatal care is one of the most widely used preventive health care strategies.^1,2 The ideal method for providing prenatal care, however, remains controversial. At the inception of early 20th century prenatal care in the United States, preventive strategies focused in part on eclampsia-related maternal morbidity and mortality, which in turn informed the content and frequency of prenatal visits.² Despite the dramatic changes in medical practice over the last 100 years, the basic timing and quantity of prenatal care has not changed substantively.

The lack of change is not because we have not explored other models of prenatal care and sought to introduce evidence-based change. Several studies have assessed the impact of reduced prenatal care visits for low-risk women.^3-7 Systematic reviews evaluated 7 randomized trials, with more than 60,000 women enrolled, of prenatal care models with a reduced number of planned antenatal visits (4 to 9 visits vs the traditional 13 to 15 visits).^3,8 There were no demonstrable differences in maternal or perinatal morbidity or mortality, particularly in higher resource settings.

Despite strong safety data and the potential cost-effectiveness of a reduced schedule of prenatal visits, US prenatal care practices generally continue to have a one-size-fits-all approach. Several organizations, however, have called for a change in practice.

Endorsing a reduced number of prenatal visits for low-risk women, the US Department of Health and Human Services Expert Panel on Prenatal Care issued a report in 1989 that stated “the specific content and timing of prenatal visits, contacts, and education should vary depending on the risk status of the pregnant woman and her fetus.”⁹ Consistent with that recommendation, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (ACOG) jointly published guidelines that recommend a system of goal-oriented antenatal visits at specific gestational ages and that support a reduced schedule of prenatal visits, compared with traditional models, for low-risk, parous women.¹⁰ The World Health Organization also published recommendations for an 8 “contact” prenatal care system to reduce perinatal mortality and improve women’s prenatal experience.¹¹

Is obstetric dogma the reason for lack of change?

Concerns about patient satisfaction may play a role in limiting the use of a reduced prenatal care visit model. In trials that evaluated a model of reduced prenatal care visits, women were less satisfied with a reduced visit schedule and the gap between provider contacts.^3,8 Anecdotally, providers have expressed concerns about perceived liability. Most compelling, perhaps, is the idea that the traditional prenatal schedule has become obstetric dogma.

Continue to: Consciously or unconsciously, clinicians may feel...

Consciously or unconsciously, clinicians may feel uncomfortable diverging from a schedule of visits that is firmly entrenched in obstetric practice. Continuing the status quo is easier than restructuring prenatal care practice. Ultimately, a paradigm shift may be required to broadly adopt a model of fewer prenatal visits for low-risk pregnancies.¹² With these issues propelling the historic patterns of prenatal care, it is easy to see why we have not yet changed despite convincing reasons to do so.

In this article, we detail the reduced-visit prenatal care models developed at 3 institutions and how they incorporate use of today’s technology.

Approach #1: University of Utah Virtual Prenatal Care Program

The University of Utah Virtual Prenatal Care Program was conceived as a “baby step” toward developing a model of fewer total prenatal visits. Virtual visits were intended to reduce the number of prenatal face-to-face visits while maintaining the same total number of visits. Since large clinical trials had established the safety of reduced visits, the primary objectives were to retain patient satisfaction and to facilitate provider adoption.

Would women be satisfied with remote prenatal care? A prospective randomized controlled trial was designed in which 200 women were assigned to receive either a combination of telemedicine and 5 scheduled in-clinic prenatal visits (remote care group) or traditional in-clinic prenatal care (usual care group). Low-risk multigravida pregnant women who were between 6 0/7 and 16 0/7 weeks’ gestation were enrolled. The primary outcome was patient satisfaction.

The face-to-face visits were goal oriented, with scheduled physical examination, laboratory tests, or ultrasonography, and were conducted by the patient’s established obstetric provider (physician or nurse midwife) to maintain continuity of care. The remote care group self-collected measurements for weight, blood pressure, and fetal heart rate by handheld Doppler device prior to each telemedicine visit and entered the information into the electronic medical record. The purpose of the self-collected data was patient engagement and satisfaction, as well as increased provider comfort with the change in prenatal care schedule, rather than medical necessity.

The primary outcome of overall patient satisfaction with prenatal care was ascertained by questionnaire after delivery. The sample size calculation of 200 patients was based on noninferiority testing, and analysis was by intent-to-treat. The details of the trial are pending publication.

As expected, the remote care group had significantly fewer in-clinic prenatal care visits compared with the usual care group (7.2 vs 11.3 visits); the total number of prenatal visits was not different between groups. Overall satisfaction with prenatal care was very high in both the remote care and the usual care group (100% vs 97%).

The virtual prenatal care model for low-risk pregnancies, consisting of a novel remote monitoring strategy and a reduced number of in-clinic visits, was not associated with lower patient satisfaction compared with traditional care.

New care strategy gives patients a choice. The success of this clinical trial has led to its programmatic adoption at the University of Utah, and low-risk women currently are offered a choice between participating in the Virtual Prenatal Care Program or receiving traditional prenatal care. The University of Utah is moving on from the one-size-fits-all approach to adopt new strategies that provide personalized evidence-based prenatal care at the lowest cost, while retaining high patient satisfaction. Formal cost-effectiveness analyses are underway.

Continue to: Approach #2: Mayo Clinic OB Nest...

Approach #2: Mayo Clinic OB Nest

In 2011, the Mayo Clinic Obstetric Division partnered with 2 other Mayo Clinic divisions, the Center for Innovation and the Center for the Science of Health Care Delivery, to redesign prenatal care for low-risk expectant mothers.Pregnant women and their obstetric health care teams (including obstetricians, certified nurse midwives, registered nurses, and clinical support staff) were convened to develop a novel model of prenatal care.⁴ The goal of this collaboration centered on:

• creating an evidence-driven prenatal care model for low-risk expectant women designed by relevant stakeholders
• focusing on meeting the on-demand needs of expectant mothers
• integrating innovative 21st century technology, and
• reducing the burden of prescheduled, low-value office visits.

Exploratory efforts to develop a novel care program. Based on feedback from the collaboration and guided by these goals, 141 expectant mothers participated in 19 different experiments, enabling the health care team to understand the impact of changing various components of prenatal care.

The experiments included integration of home monitoring (home fetal Doppler devices, drop-in fetal Doppler stations, home blood pressure monitoring devices), technology-enhanced communication with obstetric team members (video chats, tummy photos, virtual prenatal clinic appointments, proactive calls), and social media engagement (secure online prenatal care community).

Recommendations for the final components of OB Nest were based on feasibility and the potential impact on care. The recommendations included decreasing scheduled clinic appointments from 14 to 8, providing home monitoring devices to measure maternal blood pressure and fetal heart rate, establishing OB Nest virtual connected care visits with a registered nurse, and offering a secure online community of expectant mothers.

Trial assessed program’s efficacy, safety, satisfaction. A mixed-methods randomized controlled trial subsequently was conducted to evaluate the components of OB Nest.⁶ The trial included 300 pregnant women who were randomly assigned to standard prenatal care as recommended by ACOG or to OB Nest care.

OB Nest care consisted of 8 scheduled clinic appointments, 6 planned virtual (phone or online) connected care visits with a registered nurse dedicated to OB Nest, home monitoring of blood pressure (with a home digital sphygmomanometer) and fetal heart rate, and access to an online prenatal care community designated for OB Nest participants.

While publication of the trial results currently is pending, the OB Nest program appears to safely and effectively decrease the number of scheduled prenatal care visits for low-risk expectant mothers while improving the overall patient experience. OB Nest care now is offered as one of several options for low-risk expectant mothers at Mayo Clinic.

Additional avenues of study. Studies evaluating the impact of OB Nest in various nonacademic settings are now underway. Also under review is the potential cost savings of OB Nest as related to the productive lives of expectant mothers, while prenatal care safety is maintained.

The focus shift from a sick to a wellness perspective, stakeholder inclusion in the program design, and the integration of home monitoring tools are all major contributing factors to the success of OB Nest.

Continue to: Approach #3: Prisma Health utilizes mobile app technology...

Approach #3: Prisma Health utilizes mobile app technology

A third approach to reducing unnecessary visits for routine maternity care is to employ mobile app technology. Technology companies have developed app platforms for providers to use to educate and connect with patients; such apps reduce the number of routine obstetric office visits while maintaining patient satisfaction.

One group’s app experience. In a pilot study at a Prisma Health practice (South Carolina), 100 patients were placed on a reduced appointment schedule of 9 prenatal visits; the women self-monitored their weight gain and blood pressure using a remote monitoring system via an app called Babyscripts.⁷ Patient feedback was collected, with 45 of 100 patients responding.

Ninety-five percent of patients were satisfied with the mobile app, 94% reported positivity around pregnancy readiness, 90% were satisfied with their health care team, and 89% were happy with remote monitoring. Patients visited the app 3 times per week on average, and the top categories of interest were travel, exercise, genetics, and eating right.

One patient using the Babyscripts mobile health app and schedule optimization platform commented, “I am on my second pregnancy and wish this had been available for the first! The app is easy to use and I love seeing my weight on a graph. And I very much like the quality of the cuff” (personal data generated from Babyscripts).

In with the new

As clinicians strive to provide more patient-centered care, offering expectant families more than one way to receive their prenatal care is appropriate. Beyond the traditional 14-visit care model, we should offer use of novel options like mobile health apps, which improve the patient experience while decreasing the cost of care by reducing unnecessary visits.¹² Note also that reducing visits for low-risk mothers opens space in the provider schedule for patients who need services more quickly.

Benefits for postpartum care. Traditionally, clinicians see the low-risk patient for a single follow-up appointment at 6 weeks postpartum. However, the World Health Organization recommends evaluating women at 3 days, 1 to 2 weeks, and 6 weeks postpartum.¹³ Further, the National Institute for Health and Care Excellence guidance recommends screening all women for resolution of postpartum blues at 10 to 14 days.¹⁴

ACOG also has made recommendations on optimizing postpartum care. In a committee opinion, ACOG recommends that all women have contact with their provider within the first 3 weeks postpartum.¹⁵ Recognizing that such an in-person visit may be difficult, ACOG has endorsed communication via text messaging, app-based support, and remote monitoring.¹⁵ An app such as Babyscripts would fill this need conveniently for both patient and provider.

In 2019, patients want choice. As maternity care providers, we should be open to considering novel, evidence-based options that may provide more cost-effective obstetric care.

CASE Low-risk maternity patient wants fewer prenatal visits

A recently pregnant patient asks her obstetrician if she can schedule fewer prenatal visits given that she is at low risk, wants to minimize missing work, and lives an hour away from the clinic office. Her physician tells her that she needs the standard 13 to 15 visits to have a healthy pregnancy.

Obstetric care in the United States largely remains a “one-size fits all” approach despite compelling data that fewer visits for low-risk women are medically acceptable and may be more cost-effective.

Prenatal care: One size does not fit all

With nearly 4 million births annually in the United States, prenatal care is one of the most widely used preventive health care strategies.^1,2 The ideal method for providing prenatal care, however, remains controversial. At the inception of early 20th century prenatal care in the United States, preventive strategies focused in part on eclampsia-related maternal morbidity and mortality, which in turn informed the content and frequency of prenatal visits.² Despite the dramatic changes in medical practice over the last 100 years, the basic timing and quantity of prenatal care has not changed substantively.

The lack of change is not because we have not explored other models of prenatal care and sought to introduce evidence-based change. Several studies have assessed the impact of reduced prenatal care visits for low-risk women.^3-7 Systematic reviews evaluated 7 randomized trials, with more than 60,000 women enrolled, of prenatal care models with a reduced number of planned antenatal visits (4 to 9 visits vs the traditional 13 to 15 visits).^3,8 There were no demonstrable differences in maternal or perinatal morbidity or mortality, particularly in higher resource settings.

Despite strong safety data and the potential cost-effectiveness of a reduced schedule of prenatal visits, US prenatal care practices generally continue to have a one-size-fits-all approach. Several organizations, however, have called for a change in practice.

Endorsing a reduced number of prenatal visits for low-risk women, the US Department of Health and Human Services Expert Panel on Prenatal Care issued a report in 1989 that stated “the specific content and timing of prenatal visits, contacts, and education should vary depending on the risk status of the pregnant woman and her fetus.”⁹ Consistent with that recommendation, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (ACOG) jointly published guidelines that recommend a system of goal-oriented antenatal visits at specific gestational ages and that support a reduced schedule of prenatal visits, compared with traditional models, for low-risk, parous women.¹⁰ The World Health Organization also published recommendations for an 8 “contact” prenatal care system to reduce perinatal mortality and improve women’s prenatal experience.¹¹

Is obstetric dogma the reason for lack of change?

Concerns about patient satisfaction may play a role in limiting the use of a reduced prenatal care visit model. In trials that evaluated a model of reduced prenatal care visits, women were less satisfied with a reduced visit schedule and the gap between provider contacts.^3,8 Anecdotally, providers have expressed concerns about perceived liability. Most compelling, perhaps, is the idea that the traditional prenatal schedule has become obstetric dogma.

Continue to: Consciously or unconsciously, clinicians may feel...

Consciously or unconsciously, clinicians may feel uncomfortable diverging from a schedule of visits that is firmly entrenched in obstetric practice. Continuing the status quo is easier than restructuring prenatal care practice. Ultimately, a paradigm shift may be required to broadly adopt a model of fewer prenatal visits for low-risk pregnancies.¹² With these issues propelling the historic patterns of prenatal care, it is easy to see why we have not yet changed despite convincing reasons to do so.

In this article, we detail the reduced-visit prenatal care models developed at 3 institutions and how they incorporate use of today’s technology.

Approach #1: University of Utah Virtual Prenatal Care Program

The University of Utah Virtual Prenatal Care Program was conceived as a “baby step” toward developing a model of fewer total prenatal visits. Virtual visits were intended to reduce the number of prenatal face-to-face visits while maintaining the same total number of visits. Since large clinical trials had established the safety of reduced visits, the primary objectives were to retain patient satisfaction and to facilitate provider adoption.

Would women be satisfied with remote prenatal care? A prospective randomized controlled trial was designed in which 200 women were assigned to receive either a combination of telemedicine and 5 scheduled in-clinic prenatal visits (remote care group) or traditional in-clinic prenatal care (usual care group). Low-risk multigravida pregnant women who were between 6 0/7 and 16 0/7 weeks’ gestation were enrolled. The primary outcome was patient satisfaction.

The face-to-face visits were goal oriented, with scheduled physical examination, laboratory tests, or ultrasonography, and were conducted by the patient’s established obstetric provider (physician or nurse midwife) to maintain continuity of care. The remote care group self-collected measurements for weight, blood pressure, and fetal heart rate by handheld Doppler device prior to each telemedicine visit and entered the information into the electronic medical record. The purpose of the self-collected data was patient engagement and satisfaction, as well as increased provider comfort with the change in prenatal care schedule, rather than medical necessity.

The primary outcome of overall patient satisfaction with prenatal care was ascertained by questionnaire after delivery. The sample size calculation of 200 patients was based on noninferiority testing, and analysis was by intent-to-treat. The details of the trial are pending publication.

As expected, the remote care group had significantly fewer in-clinic prenatal care visits compared with the usual care group (7.2 vs 11.3 visits); the total number of prenatal visits was not different between groups. Overall satisfaction with prenatal care was very high in both the remote care and the usual care group (100% vs 97%).

The virtual prenatal care model for low-risk pregnancies, consisting of a novel remote monitoring strategy and a reduced number of in-clinic visits, was not associated with lower patient satisfaction compared with traditional care.

New care strategy gives patients a choice. The success of this clinical trial has led to its programmatic adoption at the University of Utah, and low-risk women currently are offered a choice between participating in the Virtual Prenatal Care Program or receiving traditional prenatal care. The University of Utah is moving on from the one-size-fits-all approach to adopt new strategies that provide personalized evidence-based prenatal care at the lowest cost, while retaining high patient satisfaction. Formal cost-effectiveness analyses are underway.

Continue to: Approach #2: Mayo Clinic OB Nest...

Approach #2: Mayo Clinic OB Nest

In 2011, the Mayo Clinic Obstetric Division partnered with 2 other Mayo Clinic divisions, the Center for Innovation and the Center for the Science of Health Care Delivery, to redesign prenatal care for low-risk expectant mothers.Pregnant women and their obstetric health care teams (including obstetricians, certified nurse midwives, registered nurses, and clinical support staff) were convened to develop a novel model of prenatal care.⁴ The goal of this collaboration centered on:

• creating an evidence-driven prenatal care model for low-risk expectant women designed by relevant stakeholders
• focusing on meeting the on-demand needs of expectant mothers
• integrating innovative 21st century technology, and
• reducing the burden of prescheduled, low-value office visits.

Exploratory efforts to develop a novel care program. Based on feedback from the collaboration and guided by these goals, 141 expectant mothers participated in 19 different experiments, enabling the health care team to understand the impact of changing various components of prenatal care.

The experiments included integration of home monitoring (home fetal Doppler devices, drop-in fetal Doppler stations, home blood pressure monitoring devices), technology-enhanced communication with obstetric team members (video chats, tummy photos, virtual prenatal clinic appointments, proactive calls), and social media engagement (secure online prenatal care community).

Recommendations for the final components of OB Nest were based on feasibility and the potential impact on care. The recommendations included decreasing scheduled clinic appointments from 14 to 8, providing home monitoring devices to measure maternal blood pressure and fetal heart rate, establishing OB Nest virtual connected care visits with a registered nurse, and offering a secure online community of expectant mothers.

Trial assessed program’s efficacy, safety, satisfaction. A mixed-methods randomized controlled trial subsequently was conducted to evaluate the components of OB Nest.⁶ The trial included 300 pregnant women who were randomly assigned to standard prenatal care as recommended by ACOG or to OB Nest care.

OB Nest care consisted of 8 scheduled clinic appointments, 6 planned virtual (phone or online) connected care visits with a registered nurse dedicated to OB Nest, home monitoring of blood pressure (with a home digital sphygmomanometer) and fetal heart rate, and access to an online prenatal care community designated for OB Nest participants.

While publication of the trial results currently is pending, the OB Nest program appears to safely and effectively decrease the number of scheduled prenatal care visits for low-risk expectant mothers while improving the overall patient experience. OB Nest care now is offered as one of several options for low-risk expectant mothers at Mayo Clinic.

Additional avenues of study. Studies evaluating the impact of OB Nest in various nonacademic settings are now underway. Also under review is the potential cost savings of OB Nest as related to the productive lives of expectant mothers, while prenatal care safety is maintained.

The focus shift from a sick to a wellness perspective, stakeholder inclusion in the program design, and the integration of home monitoring tools are all major contributing factors to the success of OB Nest.

Continue to: Approach #3: Prisma Health utilizes mobile app technology...

Approach #3: Prisma Health utilizes mobile app technology

A third approach to reducing unnecessary visits for routine maternity care is to employ mobile app technology. Technology companies have developed app platforms for providers to use to educate and connect with patients; such apps reduce the number of routine obstetric office visits while maintaining patient satisfaction.

One group’s app experience. In a pilot study at a Prisma Health practice (South Carolina), 100 patients were placed on a reduced appointment schedule of 9 prenatal visits; the women self-monitored their weight gain and blood pressure using a remote monitoring system via an app called Babyscripts.⁷ Patient feedback was collected, with 45 of 100 patients responding.

Ninety-five percent of patients were satisfied with the mobile app, 94% reported positivity around pregnancy readiness, 90% were satisfied with their health care team, and 89% were happy with remote monitoring. Patients visited the app 3 times per week on average, and the top categories of interest were travel, exercise, genetics, and eating right.

One patient using the Babyscripts mobile health app and schedule optimization platform commented, “I am on my second pregnancy and wish this had been available for the first! The app is easy to use and I love seeing my weight on a graph. And I very much like the quality of the cuff” (personal data generated from Babyscripts).

In with the new

As clinicians strive to provide more patient-centered care, offering expectant families more than one way to receive their prenatal care is appropriate. Beyond the traditional 14-visit care model, we should offer use of novel options like mobile health apps, which improve the patient experience while decreasing the cost of care by reducing unnecessary visits.¹² Note also that reducing visits for low-risk mothers opens space in the provider schedule for patients who need services more quickly.

Benefits for postpartum care. Traditionally, clinicians see the low-risk patient for a single follow-up appointment at 6 weeks postpartum. However, the World Health Organization recommends evaluating women at 3 days, 1 to 2 weeks, and 6 weeks postpartum.¹³ Further, the National Institute for Health and Care Excellence guidance recommends screening all women for resolution of postpartum blues at 10 to 14 days.¹⁴

ACOG also has made recommendations on optimizing postpartum care. In a committee opinion, ACOG recommends that all women have contact with their provider within the first 3 weeks postpartum.¹⁵ Recognizing that such an in-person visit may be difficult, ACOG has endorsed communication via text messaging, app-based support, and remote monitoring.¹⁵ An app such as Babyscripts would fill this need conveniently for both patient and provider.

In 2019, patients want choice. As maternity care providers, we should be open to considering novel, evidence-based options that may provide more cost-effective obstetric care.

CASE Low-risk maternity patient wants fewer prenatal visits

A recently pregnant patient asks her obstetrician if she can schedule fewer prenatal visits given that she is at low risk, wants to minimize missing work, and lives an hour away from the clinic office. Her physician tells her that she needs the standard 13 to 15 visits to have a healthy pregnancy.

Obstetric care in the United States largely remains a “one-size fits all” approach despite compelling data that fewer visits for low-risk women are medically acceptable and may be more cost-effective.

Prenatal care: One size does not fit all

With nearly 4 million births annually in the United States, prenatal care is one of the most widely used preventive health care strategies.^1,2 The ideal method for providing prenatal care, however, remains controversial. At the inception of early 20th century prenatal care in the United States, preventive strategies focused in part on eclampsia-related maternal morbidity and mortality, which in turn informed the content and frequency of prenatal visits.² Despite the dramatic changes in medical practice over the last 100 years, the basic timing and quantity of prenatal care has not changed substantively.

The lack of change is not because we have not explored other models of prenatal care and sought to introduce evidence-based change. Several studies have assessed the impact of reduced prenatal care visits for low-risk women.^3-7 Systematic reviews evaluated 7 randomized trials, with more than 60,000 women enrolled, of prenatal care models with a reduced number of planned antenatal visits (4 to 9 visits vs the traditional 13 to 15 visits).^3,8 There were no demonstrable differences in maternal or perinatal morbidity or mortality, particularly in higher resource settings.

Despite strong safety data and the potential cost-effectiveness of a reduced schedule of prenatal visits, US prenatal care practices generally continue to have a one-size-fits-all approach. Several organizations, however, have called for a change in practice.

Endorsing a reduced number of prenatal visits for low-risk women, the US Department of Health and Human Services Expert Panel on Prenatal Care issued a report in 1989 that stated “the specific content and timing of prenatal visits, contacts, and education should vary depending on the risk status of the pregnant woman and her fetus.”⁹ Consistent with that recommendation, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (ACOG) jointly published guidelines that recommend a system of goal-oriented antenatal visits at specific gestational ages and that support a reduced schedule of prenatal visits, compared with traditional models, for low-risk, parous women.¹⁰ The World Health Organization also published recommendations for an 8 “contact” prenatal care system to reduce perinatal mortality and improve women’s prenatal experience.¹¹

Is obstetric dogma the reason for lack of change?

Concerns about patient satisfaction may play a role in limiting the use of a reduced prenatal care visit model. In trials that evaluated a model of reduced prenatal care visits, women were less satisfied with a reduced visit schedule and the gap between provider contacts.^3,8 Anecdotally, providers have expressed concerns about perceived liability. Most compelling, perhaps, is the idea that the traditional prenatal schedule has become obstetric dogma.

Continue to: Consciously or unconsciously, clinicians may feel...

Consciously or unconsciously, clinicians may feel uncomfortable diverging from a schedule of visits that is firmly entrenched in obstetric practice. Continuing the status quo is easier than restructuring prenatal care practice. Ultimately, a paradigm shift may be required to broadly adopt a model of fewer prenatal visits for low-risk pregnancies.¹² With these issues propelling the historic patterns of prenatal care, it is easy to see why we have not yet changed despite convincing reasons to do so.

In this article, we detail the reduced-visit prenatal care models developed at 3 institutions and how they incorporate use of today’s technology.

Approach #1: University of Utah Virtual Prenatal Care Program

The University of Utah Virtual Prenatal Care Program was conceived as a “baby step” toward developing a model of fewer total prenatal visits. Virtual visits were intended to reduce the number of prenatal face-to-face visits while maintaining the same total number of visits. Since large clinical trials had established the safety of reduced visits, the primary objectives were to retain patient satisfaction and to facilitate provider adoption.

Would women be satisfied with remote prenatal care? A prospective randomized controlled trial was designed in which 200 women were assigned to receive either a combination of telemedicine and 5 scheduled in-clinic prenatal visits (remote care group) or traditional in-clinic prenatal care (usual care group). Low-risk multigravida pregnant women who were between 6 0/7 and 16 0/7 weeks’ gestation were enrolled. The primary outcome was patient satisfaction.

The face-to-face visits were goal oriented, with scheduled physical examination, laboratory tests, or ultrasonography, and were conducted by the patient’s established obstetric provider (physician or nurse midwife) to maintain continuity of care. The remote care group self-collected measurements for weight, blood pressure, and fetal heart rate by handheld Doppler device prior to each telemedicine visit and entered the information into the electronic medical record. The purpose of the self-collected data was patient engagement and satisfaction, as well as increased provider comfort with the change in prenatal care schedule, rather than medical necessity.

The primary outcome of overall patient satisfaction with prenatal care was ascertained by questionnaire after delivery. The sample size calculation of 200 patients was based on noninferiority testing, and analysis was by intent-to-treat. The details of the trial are pending publication.

As expected, the remote care group had significantly fewer in-clinic prenatal care visits compared with the usual care group (7.2 vs 11.3 visits); the total number of prenatal visits was not different between groups. Overall satisfaction with prenatal care was very high in both the remote care and the usual care group (100% vs 97%).

The virtual prenatal care model for low-risk pregnancies, consisting of a novel remote monitoring strategy and a reduced number of in-clinic visits, was not associated with lower patient satisfaction compared with traditional care.

New care strategy gives patients a choice. The success of this clinical trial has led to its programmatic adoption at the University of Utah, and low-risk women currently are offered a choice between participating in the Virtual Prenatal Care Program or receiving traditional prenatal care. The University of Utah is moving on from the one-size-fits-all approach to adopt new strategies that provide personalized evidence-based prenatal care at the lowest cost, while retaining high patient satisfaction. Formal cost-effectiveness analyses are underway.

Continue to: Approach #2: Mayo Clinic OB Nest...

Approach #2: Mayo Clinic OB Nest

In 2011, the Mayo Clinic Obstetric Division partnered with 2 other Mayo Clinic divisions, the Center for Innovation and the Center for the Science of Health Care Delivery, to redesign prenatal care for low-risk expectant mothers.Pregnant women and their obstetric health care teams (including obstetricians, certified nurse midwives, registered nurses, and clinical support staff) were convened to develop a novel model of prenatal care.⁴ The goal of this collaboration centered on:

• creating an evidence-driven prenatal care model for low-risk expectant women designed by relevant stakeholders
• focusing on meeting the on-demand needs of expectant mothers
• integrating innovative 21st century technology, and
• reducing the burden of prescheduled, low-value office visits.

Exploratory efforts to develop a novel care program. Based on feedback from the collaboration and guided by these goals, 141 expectant mothers participated in 19 different experiments, enabling the health care team to understand the impact of changing various components of prenatal care.

The experiments included integration of home monitoring (home fetal Doppler devices, drop-in fetal Doppler stations, home blood pressure monitoring devices), technology-enhanced communication with obstetric team members (video chats, tummy photos, virtual prenatal clinic appointments, proactive calls), and social media engagement (secure online prenatal care community).

Recommendations for the final components of OB Nest were based on feasibility and the potential impact on care. The recommendations included decreasing scheduled clinic appointments from 14 to 8, providing home monitoring devices to measure maternal blood pressure and fetal heart rate, establishing OB Nest virtual connected care visits with a registered nurse, and offering a secure online community of expectant mothers.

Trial assessed program’s efficacy, safety, satisfaction. A mixed-methods randomized controlled trial subsequently was conducted to evaluate the components of OB Nest.⁶ The trial included 300 pregnant women who were randomly assigned to standard prenatal care as recommended by ACOG or to OB Nest care.

OB Nest care consisted of 8 scheduled clinic appointments, 6 planned virtual (phone or online) connected care visits with a registered nurse dedicated to OB Nest, home monitoring of blood pressure (with a home digital sphygmomanometer) and fetal heart rate, and access to an online prenatal care community designated for OB Nest participants.

While publication of the trial results currently is pending, the OB Nest program appears to safely and effectively decrease the number of scheduled prenatal care visits for low-risk expectant mothers while improving the overall patient experience. OB Nest care now is offered as one of several options for low-risk expectant mothers at Mayo Clinic.

Additional avenues of study. Studies evaluating the impact of OB Nest in various nonacademic settings are now underway. Also under review is the potential cost savings of OB Nest as related to the productive lives of expectant mothers, while prenatal care safety is maintained.

The focus shift from a sick to a wellness perspective, stakeholder inclusion in the program design, and the integration of home monitoring tools are all major contributing factors to the success of OB Nest.

Continue to: Approach #3: Prisma Health utilizes mobile app technology...

Approach #3: Prisma Health utilizes mobile app technology

A third approach to reducing unnecessary visits for routine maternity care is to employ mobile app technology. Technology companies have developed app platforms for providers to use to educate and connect with patients; such apps reduce the number of routine obstetric office visits while maintaining patient satisfaction.

One group’s app experience. In a pilot study at a Prisma Health practice (South Carolina), 100 patients were placed on a reduced appointment schedule of 9 prenatal visits; the women self-monitored their weight gain and blood pressure using a remote monitoring system via an app called Babyscripts.⁷ Patient feedback was collected, with 45 of 100 patients responding.

Ninety-five percent of patients were satisfied with the mobile app, 94% reported positivity around pregnancy readiness, 90% were satisfied with their health care team, and 89% were happy with remote monitoring. Patients visited the app 3 times per week on average, and the top categories of interest were travel, exercise, genetics, and eating right.

One patient using the Babyscripts mobile health app and schedule optimization platform commented, “I am on my second pregnancy and wish this had been available for the first! The app is easy to use and I love seeing my weight on a graph. And I very much like the quality of the cuff” (personal data generated from Babyscripts).

In with the new

As clinicians strive to provide more patient-centered care, offering expectant families more than one way to receive their prenatal care is appropriate. Beyond the traditional 14-visit care model, we should offer use of novel options like mobile health apps, which improve the patient experience while decreasing the cost of care by reducing unnecessary visits.¹² Note also that reducing visits for low-risk mothers opens space in the provider schedule for patients who need services more quickly.

Benefits for postpartum care. Traditionally, clinicians see the low-risk patient for a single follow-up appointment at 6 weeks postpartum. However, the World Health Organization recommends evaluating women at 3 days, 1 to 2 weeks, and 6 weeks postpartum.¹³ Further, the National Institute for Health and Care Excellence guidance recommends screening all women for resolution of postpartum blues at 10 to 14 days.¹⁴

ACOG also has made recommendations on optimizing postpartum care. In a committee opinion, ACOG recommends that all women have contact with their provider within the first 3 weeks postpartum.¹⁵ Recognizing that such an in-person visit may be difficult, ACOG has endorsed communication via text messaging, app-based support, and remote monitoring.¹⁵ An app such as Babyscripts would fill this need conveniently for both patient and provider.

In 2019, patients want choice. As maternity care providers, we should be open to considering novel, evidence-based options that may provide more cost-effective obstetric care.

WHAT IS YOUR APPROACH TO THE PERSISTENT OCCIPUT POSTERIOR MALPOSITION?

ROBERT L. BARBIERI, MD

(EDITORIAL; MARCH 2019)

A classic approach for managing fetal malposition

For those of us who trained and practiced obstetrics in the days of the 6% primary cesarean delivery (CD) rate, we never considered the management of the persistent occiput posterior (OP) position to be particularly difficult. I outline below a method that requires no unusual level of skill or dexterity.

1. The cervix must be fully dilated.
2. Dense regional anesthesia must be achieved.
3. The vertex must have reached +1 station.
4. The position must be clearly established, and this does not require anything other than the ability to palpate an ear, as it can be pointed only in one direction. If you feel ultrasonography is needed, be my guest.
5. Use an obstetric lubricant to reduce resistance and minimize lacerations.
6. While a trial of manual rotation is reasonable, it commonly will not succeed and requires that an operator’s hand be inserted rather than a slender and less traumatic device (forceps).
7. Next, palpate the sagittal suture to determine whether the position is straight OP versus left OP or right OP. This should not be difficult unless the poor woman has gone through 2 or 3 hours of unproductive pushing, thereby creating caput.
8. After proper forceps application is confirmed, gently apply upward pressure. This will make rotation easier.
9. Dr. Irving’s recommendations notwithstanding, the forceps handles are not carried in a wide sweep. One should use Kielland’s forceps, which do not have a pelvic curve and were invented for this precise indication. The forceps are simply rotated.
10. Try to avoid delivery as an OP, as this pulls a much larger diameter deflexed head through the pelvis and usually results in significant lacerations.
11. Episiotomy is not always required if rotation has succeeded.
12. Once descent to the outlet has been achieved, it is probably best to switch to a forceps with a pelvic curve to achieve easier extension.
13. This should complete the delivery, but as a general rule, if more than minimal resistance is met in any of the above steps, abandon the procedure and move to CD.
14. This process should result in at least a 70% success rate.

As is most likely understood by the current generation of obstetricians who appear to be satisfied with a 30% to 40% primary CD rate, the above reflects the views of a long-retired ObGyn (whose CD rate never exceeded 10%) and may be inappropriate for those who are not adequately trained in or comfortable with vaginal obstetrics.

David M. Priver, MD

San Diego, California

Continue to: HOW DO YOU FEEL ABOUT EXPECTANTLY MANAGING A WELL-DATED PREGNANCY PAST 41 WEEKS’ GESTATION?

HOW DO YOU FEEL ABOUT EXPECTANTLY MANAGING A WELL-DATED PREGNANCY PAST 41 WEEKS’ GESTATION?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019)

Membrane stripping can be problematic

The recent discussion on stripping membranes to facilitate the initiation of labor and delivery was intriguing. This practice was reviewed extensively during my training in the 1960s and abandoned when the results were disappointing or contradictory. Although the practice has been revitalized recently, I am concerned that potential risks and the absence of a recommended protocol of safeguards may allow new problems to develop.

In a metropolitan community where I provide consultative services, the only patients I see for evaluation of pregnancies beyond 40 to 41 weeks come from providers who are non-physicians. Apparently, they are concerned that they may have to turn their patients over to physician providers for interventions that they are not capable of doing. My advice to them is simply that nothing good happens after 40 to 41 weeks.

Well-grown babies may continue to grow if they are healthy, and they may incur greater risks of dystotic labor and delivery resulting in injury or the need for physician-administered surgical assistance. If, on the other hand, growth markedly diminishes or ceases, fetal harm or neonatal complications may occur through asphyxia, meconium aspiration, or trauma. In either event, physician-based assistance is strongly encouraged, as long as due diligence in determining gestational age has been done.

Promoting membrane stripping without having a protocol for ascertainment of risk factors is worrisome to me. In my opinion, large population studies that fail to demonstrate increased risks of infection may fail to demonstrate that membrane stripping may induce a degree of perinatal infection comparable to that of prolonged labor with multiple internal examinations with or without ultimate cesarean birth. Prior to considering membrane stripping as a strategy, one should recognize certain important considerations, namely:

• Patients most in need of active intervention may have the least favorable cervical findings, and as a result they are potentially at risk for the greatest discomfort.
• The frequency of group B streptococcal colonization of the vagina at term should be recognized, and a culture should be obtained immediately prior to intervention. When a culture is a positive, membrane stripping should be avoided, or at least a sober consideration of its use and appropriate antibiotic coverage should occur.
• Consider performing transvaginal ultrasonography prior to membrane stripping to exclude the possibility of a placental edge close enough to be encountered and compromised, with resultant hemorrhage in an outpatient venue ill equipped to provide adequate emergency support.
• The comparative effectiveness of other direct cervical conditioning therapies, including use of a Foley catheter or regional prostaglandin medication, has been well explored and found effective. Also, if one takes seriously the need for any intervention, admission to the hospital for overnight cervical conditioning allows for surveillance and avoids the patient experience of being sent home cramping, bleeding, brooding infection, and questioning her trust in the provider.

Continue to: I am concerned that the promotion...

I am concerned that the promotion of this potentially rather brutish practice by highly reputable advisors can result in its growing utilization by providers some of whom may be least qualified to apply proper judgment and sensitivity to its selection. In the most primitive of circumstances, it may have utility. Personally, however, I feel that medically based strategies initiated and monitored by professionals capable of dealing with any untoward departures from the expected results must be considered in the best traditions of what we do. The appeal of simplicity must not encourage the adoption of interventions that lack the proper application of thought and plan and whose only appeal is that of simplicity.

Richard P. Perkins, MD

Fort Myers, Florida; Stockton, California

Dr. Barbieri responds

I thank Dr. Priver for his excellent description of how to use forceps to resolve a persistent occiput posterior position. I also thank Dr. Perkins for his valuable comments and agree with him that in the United States among the options available for outpatient cervical ripening, misoprostol or a balloon are more commonly used than membrane stripping. Membrane stripping is an outpatient cervical ripening technique that is commonly used in the United Kingdom.

WHAT IS YOUR APPROACH TO THE PERSISTENT OCCIPUT POSTERIOR MALPOSITION?

ROBERT L. BARBIERI, MD

(EDITORIAL; MARCH 2019)

A classic approach for managing fetal malposition

For those of us who trained and practiced obstetrics in the days of the 6% primary cesarean delivery (CD) rate, we never considered the management of the persistent occiput posterior (OP) position to be particularly difficult. I outline below a method that requires no unusual level of skill or dexterity.

1. The cervix must be fully dilated.
2. Dense regional anesthesia must be achieved.
3. The vertex must have reached +1 station.
4. The position must be clearly established, and this does not require anything other than the ability to palpate an ear, as it can be pointed only in one direction. If you feel ultrasonography is needed, be my guest.
5. Use an obstetric lubricant to reduce resistance and minimize lacerations.
6. While a trial of manual rotation is reasonable, it commonly will not succeed and requires that an operator’s hand be inserted rather than a slender and less traumatic device (forceps).
7. Next, palpate the sagittal suture to determine whether the position is straight OP versus left OP or right OP. This should not be difficult unless the poor woman has gone through 2 or 3 hours of unproductive pushing, thereby creating caput.
8. After proper forceps application is confirmed, gently apply upward pressure. This will make rotation easier.
9. Dr. Irving’s recommendations notwithstanding, the forceps handles are not carried in a wide sweep. One should use Kielland’s forceps, which do not have a pelvic curve and were invented for this precise indication. The forceps are simply rotated.
10. Try to avoid delivery as an OP, as this pulls a much larger diameter deflexed head through the pelvis and usually results in significant lacerations.
11. Episiotomy is not always required if rotation has succeeded.
12. Once descent to the outlet has been achieved, it is probably best to switch to a forceps with a pelvic curve to achieve easier extension.
13. This should complete the delivery, but as a general rule, if more than minimal resistance is met in any of the above steps, abandon the procedure and move to CD.
14. This process should result in at least a 70% success rate.

As is most likely understood by the current generation of obstetricians who appear to be satisfied with a 30% to 40% primary CD rate, the above reflects the views of a long-retired ObGyn (whose CD rate never exceeded 10%) and may be inappropriate for those who are not adequately trained in or comfortable with vaginal obstetrics.

David M. Priver, MD

San Diego, California

Continue to: HOW DO YOU FEEL ABOUT EXPECTANTLY MANAGING A WELL-DATED PREGNANCY PAST 41 WEEKS’ GESTATION?

HOW DO YOU FEEL ABOUT EXPECTANTLY MANAGING A WELL-DATED PREGNANCY PAST 41 WEEKS’ GESTATION?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019)

Membrane stripping can be problematic

The recent discussion on stripping membranes to facilitate the initiation of labor and delivery was intriguing. This practice was reviewed extensively during my training in the 1960s and abandoned when the results were disappointing or contradictory. Although the practice has been revitalized recently, I am concerned that potential risks and the absence of a recommended protocol of safeguards may allow new problems to develop.

In a metropolitan community where I provide consultative services, the only patients I see for evaluation of pregnancies beyond 40 to 41 weeks come from providers who are non-physicians. Apparently, they are concerned that they may have to turn their patients over to physician providers for interventions that they are not capable of doing. My advice to them is simply that nothing good happens after 40 to 41 weeks.

Well-grown babies may continue to grow if they are healthy, and they may incur greater risks of dystotic labor and delivery resulting in injury or the need for physician-administered surgical assistance. If, on the other hand, growth markedly diminishes or ceases, fetal harm or neonatal complications may occur through asphyxia, meconium aspiration, or trauma. In either event, physician-based assistance is strongly encouraged, as long as due diligence in determining gestational age has been done.

Promoting membrane stripping without having a protocol for ascertainment of risk factors is worrisome to me. In my opinion, large population studies that fail to demonstrate increased risks of infection may fail to demonstrate that membrane stripping may induce a degree of perinatal infection comparable to that of prolonged labor with multiple internal examinations with or without ultimate cesarean birth. Prior to considering membrane stripping as a strategy, one should recognize certain important considerations, namely:

• Patients most in need of active intervention may have the least favorable cervical findings, and as a result they are potentially at risk for the greatest discomfort.
• The frequency of group B streptococcal colonization of the vagina at term should be recognized, and a culture should be obtained immediately prior to intervention. When a culture is a positive, membrane stripping should be avoided, or at least a sober consideration of its use and appropriate antibiotic coverage should occur.
• Consider performing transvaginal ultrasonography prior to membrane stripping to exclude the possibility of a placental edge close enough to be encountered and compromised, with resultant hemorrhage in an outpatient venue ill equipped to provide adequate emergency support.
• The comparative effectiveness of other direct cervical conditioning therapies, including use of a Foley catheter or regional prostaglandin medication, has been well explored and found effective. Also, if one takes seriously the need for any intervention, admission to the hospital for overnight cervical conditioning allows for surveillance and avoids the patient experience of being sent home cramping, bleeding, brooding infection, and questioning her trust in the provider.

Continue to: I am concerned that the promotion...

I am concerned that the promotion of this potentially rather brutish practice by highly reputable advisors can result in its growing utilization by providers some of whom may be least qualified to apply proper judgment and sensitivity to its selection. In the most primitive of circumstances, it may have utility. Personally, however, I feel that medically based strategies initiated and monitored by professionals capable of dealing with any untoward departures from the expected results must be considered in the best traditions of what we do. The appeal of simplicity must not encourage the adoption of interventions that lack the proper application of thought and plan and whose only appeal is that of simplicity.

Richard P. Perkins, MD

Fort Myers, Florida; Stockton, California

Dr. Barbieri responds

I thank Dr. Priver for his excellent description of how to use forceps to resolve a persistent occiput posterior position. I also thank Dr. Perkins for his valuable comments and agree with him that in the United States among the options available for outpatient cervical ripening, misoprostol or a balloon are more commonly used than membrane stripping. Membrane stripping is an outpatient cervical ripening technique that is commonly used in the United Kingdom.

WHAT IS YOUR APPROACH TO THE PERSISTENT OCCIPUT POSTERIOR MALPOSITION?

ROBERT L. BARBIERI, MD

(EDITORIAL; MARCH 2019)

A classic approach for managing fetal malposition

For those of us who trained and practiced obstetrics in the days of the 6% primary cesarean delivery (CD) rate, we never considered the management of the persistent occiput posterior (OP) position to be particularly difficult. I outline below a method that requires no unusual level of skill or dexterity.

1. The cervix must be fully dilated.
2. Dense regional anesthesia must be achieved.
3. The vertex must have reached +1 station.
4. The position must be clearly established, and this does not require anything other than the ability to palpate an ear, as it can be pointed only in one direction. If you feel ultrasonography is needed, be my guest.
5. Use an obstetric lubricant to reduce resistance and minimize lacerations.
6. While a trial of manual rotation is reasonable, it commonly will not succeed and requires that an operator’s hand be inserted rather than a slender and less traumatic device (forceps).
7. Next, palpate the sagittal suture to determine whether the position is straight OP versus left OP or right OP. This should not be difficult unless the poor woman has gone through 2 or 3 hours of unproductive pushing, thereby creating caput.
8. After proper forceps application is confirmed, gently apply upward pressure. This will make rotation easier.
9. Dr. Irving’s recommendations notwithstanding, the forceps handles are not carried in a wide sweep. One should use Kielland’s forceps, which do not have a pelvic curve and were invented for this precise indication. The forceps are simply rotated.
10. Try to avoid delivery as an OP, as this pulls a much larger diameter deflexed head through the pelvis and usually results in significant lacerations.
11. Episiotomy is not always required if rotation has succeeded.
12. Once descent to the outlet has been achieved, it is probably best to switch to a forceps with a pelvic curve to achieve easier extension.
13. This should complete the delivery, but as a general rule, if more than minimal resistance is met in any of the above steps, abandon the procedure and move to CD.
14. This process should result in at least a 70% success rate.

As is most likely understood by the current generation of obstetricians who appear to be satisfied with a 30% to 40% primary CD rate, the above reflects the views of a long-retired ObGyn (whose CD rate never exceeded 10%) and may be inappropriate for those who are not adequately trained in or comfortable with vaginal obstetrics.

David M. Priver, MD

San Diego, California

Continue to: HOW DO YOU FEEL ABOUT EXPECTANTLY MANAGING A WELL-DATED PREGNANCY PAST 41 WEEKS’ GESTATION?

HOW DO YOU FEEL ABOUT EXPECTANTLY MANAGING A WELL-DATED PREGNANCY PAST 41 WEEKS’ GESTATION?

ROBERT L. BARBIERI, MD

(EDITORIAL; FEBRUARY 2019)

Membrane stripping can be problematic

The recent discussion on stripping membranes to facilitate the initiation of labor and delivery was intriguing. This practice was reviewed extensively during my training in the 1960s and abandoned when the results were disappointing or contradictory. Although the practice has been revitalized recently, I am concerned that potential risks and the absence of a recommended protocol of safeguards may allow new problems to develop.

In a metropolitan community where I provide consultative services, the only patients I see for evaluation of pregnancies beyond 40 to 41 weeks come from providers who are non-physicians. Apparently, they are concerned that they may have to turn their patients over to physician providers for interventions that they are not capable of doing. My advice to them is simply that nothing good happens after 40 to 41 weeks.

Well-grown babies may continue to grow if they are healthy, and they may incur greater risks of dystotic labor and delivery resulting in injury or the need for physician-administered surgical assistance. If, on the other hand, growth markedly diminishes or ceases, fetal harm or neonatal complications may occur through asphyxia, meconium aspiration, or trauma. In either event, physician-based assistance is strongly encouraged, as long as due diligence in determining gestational age has been done.

Promoting membrane stripping without having a protocol for ascertainment of risk factors is worrisome to me. In my opinion, large population studies that fail to demonstrate increased risks of infection may fail to demonstrate that membrane stripping may induce a degree of perinatal infection comparable to that of prolonged labor with multiple internal examinations with or without ultimate cesarean birth. Prior to considering membrane stripping as a strategy, one should recognize certain important considerations, namely:

• Patients most in need of active intervention may have the least favorable cervical findings, and as a result they are potentially at risk for the greatest discomfort.
• The frequency of group B streptococcal colonization of the vagina at term should be recognized, and a culture should be obtained immediately prior to intervention. When a culture is a positive, membrane stripping should be avoided, or at least a sober consideration of its use and appropriate antibiotic coverage should occur.
• Consider performing transvaginal ultrasonography prior to membrane stripping to exclude the possibility of a placental edge close enough to be encountered and compromised, with resultant hemorrhage in an outpatient venue ill equipped to provide adequate emergency support.
• The comparative effectiveness of other direct cervical conditioning therapies, including use of a Foley catheter or regional prostaglandin medication, has been well explored and found effective. Also, if one takes seriously the need for any intervention, admission to the hospital for overnight cervical conditioning allows for surveillance and avoids the patient experience of being sent home cramping, bleeding, brooding infection, and questioning her trust in the provider.

Continue to: I am concerned that the promotion...

I am concerned that the promotion of this potentially rather brutish practice by highly reputable advisors can result in its growing utilization by providers some of whom may be least qualified to apply proper judgment and sensitivity to its selection. In the most primitive of circumstances, it may have utility. Personally, however, I feel that medically based strategies initiated and monitored by professionals capable of dealing with any untoward departures from the expected results must be considered in the best traditions of what we do. The appeal of simplicity must not encourage the adoption of interventions that lack the proper application of thought and plan and whose only appeal is that of simplicity.

Richard P. Perkins, MD

Fort Myers, Florida; Stockton, California

Dr. Barbieri responds

I thank Dr. Priver for his excellent description of how to use forceps to resolve a persistent occiput posterior position. I also thank Dr. Perkins for his valuable comments and agree with him that in the United States among the options available for outpatient cervical ripening, misoprostol or a balloon are more commonly used than membrane stripping. Membrane stripping is an outpatient cervical ripening technique that is commonly used in the United Kingdom.

Haas DM, Daggy J, Flannery KM, et al. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial. Am J Obstet Gynecol. 2019. doi:10.1016/j.ajog.2019.04.037.

EXPERT COMMENTARY

Cervical ripening is routine practice in women undergoing induction of labor who have an unfavorable cervical examination.¹ This is because generating contractions against a long thick cervix is more likely to lead to failed induction and cesarean delivery. Cervical ripening can be achieved using mechanical or pharmacologic methods.

Misoprostol (a prostaglandin E₁ [PGE₁] analog) is approved by the US Food and Drug Administration for the treatment of peptic ulcer disease, but it also is widely used off-label for cervical ripening, partly due to its low cost. Misoprostol’s optimal dosing regimen and route of administration are not known. The IMPROVE trial was designed to address this knowledge gap, specifically to compare the efficacy and safety of VM versus BM in women undergoing labor induction at term.

Details of the study

The IMPROVE trial was a prospective, randomized, noninferiority, triple-masked, placebo-controlled trial of 300 women with a singleton vertex fetus requiring cervical ripening for induction of labor at term.² Enrolled women were randomly assigned to VM or BM (same dosing regimen) and to a matching placebo administered via the opposite route.

Primary outcomes included time-to-vaginal-delivery from first dose, which was reduced in VM vs BM (20.1 vs 28.1 hours; P = .006), and urgent cesarean delivery for nonreassuring fetal testing, which was similarly reduced in VM (3.3% vs 9.5%; P = .33). These differences persisted after controlling for covariates. There was also a greater difference seen in multiparous versus nulliparous women.

Secondary outcomes also favored VM over BM, including more vaginal deliverieswithin 24 hours, fewer doses to achieve active labor, and a lower maximum dose of oxytocin.

Overall cesarean delivery rates were similar in the 2 groups (VM, 15.8%; BM, 22.3%; P = .15). There were no significant differences in other delivery characteristics or in maternal or fetal adverse events.

Continue to: Study strengths and limitations...

Study strengths and limitations

The IMPROVE trial had a triple-blinded study design with an intention-to-treat paradigm and good follow-up. There was also standardization of PGE₁ administration criteria, which was consistent with the American College of Obstetricians and Gynecologists standards of care. Results were similar to those of prior studies regarding rates of tachysystole, urgent cesarean delivery, and vaginal delivery.

The study has good generalizability as it included both elective and medically indicated inductions; however, patients with ruptured membranes were excluded. Although there was no difference in the overall cesarean delivery rates, the study was underpowered to look at this outcome. The authors included a patient satisfaction survey, but this is hard to interpret since study participants all received tablets orally and vaginally. The study did not address efficacy of VM versus BM administration at different doses or time intervals.

Haas DM, Daggy J, Flannery KM, et al. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial. Am J Obstet Gynecol. 2019. doi:10.1016/j.ajog.2019.04.037.

EXPERT COMMENTARY

Cervical ripening is routine practice in women undergoing induction of labor who have an unfavorable cervical examination.¹ This is because generating contractions against a long thick cervix is more likely to lead to failed induction and cesarean delivery. Cervical ripening can be achieved using mechanical or pharmacologic methods.

Misoprostol (a prostaglandin E₁ [PGE₁] analog) is approved by the US Food and Drug Administration for the treatment of peptic ulcer disease, but it also is widely used off-label for cervical ripening, partly due to its low cost. Misoprostol’s optimal dosing regimen and route of administration are not known. The IMPROVE trial was designed to address this knowledge gap, specifically to compare the efficacy and safety of VM versus BM in women undergoing labor induction at term.

Details of the study

The IMPROVE trial was a prospective, randomized, noninferiority, triple-masked, placebo-controlled trial of 300 women with a singleton vertex fetus requiring cervical ripening for induction of labor at term.² Enrolled women were randomly assigned to VM or BM (same dosing regimen) and to a matching placebo administered via the opposite route.

Primary outcomes included time-to-vaginal-delivery from first dose, which was reduced in VM vs BM (20.1 vs 28.1 hours; P = .006), and urgent cesarean delivery for nonreassuring fetal testing, which was similarly reduced in VM (3.3% vs 9.5%; P = .33). These differences persisted after controlling for covariates. There was also a greater difference seen in multiparous versus nulliparous women.

Secondary outcomes also favored VM over BM, including more vaginal deliverieswithin 24 hours, fewer doses to achieve active labor, and a lower maximum dose of oxytocin.

Overall cesarean delivery rates were similar in the 2 groups (VM, 15.8%; BM, 22.3%; P = .15). There were no significant differences in other delivery characteristics or in maternal or fetal adverse events.

Continue to: Study strengths and limitations...

Study strengths and limitations

The IMPROVE trial had a triple-blinded study design with an intention-to-treat paradigm and good follow-up. There was also standardization of PGE₁ administration criteria, which was consistent with the American College of Obstetricians and Gynecologists standards of care. Results were similar to those of prior studies regarding rates of tachysystole, urgent cesarean delivery, and vaginal delivery.

The study has good generalizability as it included both elective and medically indicated inductions; however, patients with ruptured membranes were excluded. Although there was no difference in the overall cesarean delivery rates, the study was underpowered to look at this outcome. The authors included a patient satisfaction survey, but this is hard to interpret since study participants all received tablets orally and vaginally. The study did not address efficacy of VM versus BM administration at different doses or time intervals.

Haas DM, Daggy J, Flannery KM, et al. A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple masked randomized controlled trial. Am J Obstet Gynecol. 2019. doi:10.1016/j.ajog.2019.04.037.

EXPERT COMMENTARY

Cervical ripening is routine practice in women undergoing induction of labor who have an unfavorable cervical examination.¹ This is because generating contractions against a long thick cervix is more likely to lead to failed induction and cesarean delivery. Cervical ripening can be achieved using mechanical or pharmacologic methods.

Misoprostol (a prostaglandin E₁ [PGE₁] analog) is approved by the US Food and Drug Administration for the treatment of peptic ulcer disease, but it also is widely used off-label for cervical ripening, partly due to its low cost. Misoprostol’s optimal dosing regimen and route of administration are not known. The IMPROVE trial was designed to address this knowledge gap, specifically to compare the efficacy and safety of VM versus BM in women undergoing labor induction at term.

Details of the study

The IMPROVE trial was a prospective, randomized, noninferiority, triple-masked, placebo-controlled trial of 300 women with a singleton vertex fetus requiring cervical ripening for induction of labor at term.² Enrolled women were randomly assigned to VM or BM (same dosing regimen) and to a matching placebo administered via the opposite route.

Primary outcomes included time-to-vaginal-delivery from first dose, which was reduced in VM vs BM (20.1 vs 28.1 hours; P = .006), and urgent cesarean delivery for nonreassuring fetal testing, which was similarly reduced in VM (3.3% vs 9.5%; P = .33). These differences persisted after controlling for covariates. There was also a greater difference seen in multiparous versus nulliparous women.

Secondary outcomes also favored VM over BM, including more vaginal deliverieswithin 24 hours, fewer doses to achieve active labor, and a lower maximum dose of oxytocin.

Overall cesarean delivery rates were similar in the 2 groups (VM, 15.8%; BM, 22.3%; P = .15). There were no significant differences in other delivery characteristics or in maternal or fetal adverse events.

Continue to: Study strengths and limitations...

Study strengths and limitations

The IMPROVE trial had a triple-blinded study design with an intention-to-treat paradigm and good follow-up. There was also standardization of PGE₁ administration criteria, which was consistent with the American College of Obstetricians and Gynecologists standards of care. Results were similar to those of prior studies regarding rates of tachysystole, urgent cesarean delivery, and vaginal delivery.

The study has good generalizability as it included both elective and medically indicated inductions; however, patients with ruptured membranes were excluded. Although there was no difference in the overall cesarean delivery rates, the study was underpowered to look at this outcome. The authors included a patient satisfaction survey, but this is hard to interpret since study participants all received tablets orally and vaginally. The study did not address efficacy of VM versus BM administration at different doses or time intervals.

Postpartum blood loss greater than 1,000 mL occurs in approximately 7% of cesarean delivery (CD) procedures with the administration of oxytocin alone or oxytocin plus misoprostol.¹ Rapid identification and control of hemorrhage is essential to avoid escalating coagulopathy and maternal instability. In cases of excess blood loss, clinicians request assistance from colleagues, endeavor to identify the cause of the bleeding, utilize additional uterotonics (methylergonovine, carboprost, misoprostol), perform uterine massage, warm the uterus, repair lacerations and replace blood products. If blood loss continues after these initial measures, obstetricians may consider uterine artery embolization (UAE) or hysterectomy. While UAE is a highly effective measure to control postpartum hemorrhage, it is not available at all obstetric hospitals. Even when available, there may be a significant time delay from the decision to consult an interventional radiologist to completion of the embolization procedure.

To avoid the permanent sterilization of a hysterectomy, or to obtain time for UAE or correction of coagulopathy, additional uterus-sparing surgical interventions should be considered. These include: 1) progressive uterine devascularization, 2) uterine compression sutures, and 3) intrauterine balloon tamponade. One caveat is that there is very little high-quality evidence from randomized trials to compare the efficacy or outcome of these uterine-sparing surgical interventions. Most of our evidence is based on limited case series and expert recommendations.

Uterine devascularization

Many techniques have been described for performing progressive uterine devascularization. Most experts recommend first performing an O’Leary suture, ligating both ascending uterine arteries and accompanying veins at a point approximately 2 cm closer to the cervix than the uterine incision (FIGURE 1). An absorbable suture is passed through the myometrium, being sure to remain medial to the ascending uterine vessels. Clear visualization of the vessels posteriorly is essential, usually necessitating exteriorization of the uterus. The needle is then driven through an avascular space in the broad ligament close to the uterine vessels, and the suture is tied down. Ureteral injury can be avoided by extending the bladder flap laterally to the level of the round ligament and mobilizing the vesicouterine peritoneum inferiorly, with the suture placed directly on endopelvic fascia. If necessary, the utero-ovarian ligament can be ligated in a second step, just below the uterine-tubal junction. The progressive devascularization intervention can be limited to the first or second steps if bleeding is well controlled.

In our experience, bilateral O’Leary sutures are highly effective at controlling ongoing uterine bleeding, particularly from the lower uterine segment. In the event that they are not successful, placement does not preclude later use of UAE.

Uterine compression sutures

Compression sutures are most often used in the setting of refractory uterine atony. They also may be helpful for controlling focal atony or bleeding from a placental implantation site. More than a dozen different types of uterine compression sutures have been reported in the literature; the B-Lynch, Hyman, and Pereira sutures are most commonly performed.²

Continue to: The B-Lynch suture³ is performed with...

1. Take bites on either side of the right edge of the hysterotomy incision (A and B). Place these bites approximately 3 cm from the edge of the hysterotomy incision.
2. Loop the suture around the fundus and reenter the uterus through the posterior uterine wall at point C, which is directly posterior to point B.
3. Exit the posterior wall of the uterus through point D.
4. Loop the suture over the uterine fundus.
5. Anchor the suture in the lower uterine segment by taking bites on either side of the left edge of the uterine hysterotomy incision (points E and F).
6. Pull the two ends of the suture tight while an assistant squeezes the uterus to aid compression.
7. Place a surgical knot to secure the suture.
8. Close the hysterotomy incision.

The B-Lynch suture was described with an open hysterotomy incision,³ which avoids closing off the lower uterine segment. We have successfully performed a modific tion on a closed uterus, taking care to not drive the lower uterine sutures through both the anterior and posterior walls.

The Hayman suture⁴ was proposed with two important modifications: The suture is placed through-and-through the lower uterine segment with a closed hysterotomy, and the suture can be fixed to the uterine fundus to avoid slippage. This vertical compression suture (FIGURE 3) is performed by placing two to four vertical #2 chromic sutures directly through the anterior to posterior uterine wall, tying the suture on the fundus using a 3-throw technique to minimize slippage of the first knot. In the original description, Hayman also described injecting carboprost into the uterine fundus to stimulate uterine contraction and regularly inspecting the vagina to evaluate the extent of continued bleeding.⁴

Intrauterine balloon tamponade

Many types of balloon tamponade devices have been developed, ranging from the humble condom tied to a Foley urinary catheter to the sophisticated Bakri^6,7 and Belfort-Dildy⁸ balloon tamponade devices. Intrauterine balloon tamponade is highly effective in controlling excess bleeding following vaginal delivery and less effective when used following a CD. In one study of 226 women with postpartum hemorrhage treated with a Bakri balloon the success rate was 89% and 66% following vaginal delivery and CD, respectively.⁹

Continue to: When using balloon tamponade during a CD...

When using balloon tamponade during a CD, some experts recommend partially closing the transverse hysterotomy incision by placing sutures to close edges of the hysterotomy, followed by insertion of the balloon into the uterus and the stem through the cervix into the vagina. Attachment of the stem to a collection bag should help to quickly assess the rate of blood loss. The balloon is inflated after the hysterotomy is closed. Following inflation of an intrauterine balloon, blood loss should decrease almost immediately.¹⁰ If excessive blood loss continues for more than 10 minutes, additional uterus-sparing interventions or hysterectomy may be required. Following successful balloon tamponade, the balloon may be deflated 12 to 24 hours postpartum when maternal stabilization and normal coagulation have been achieved. If bleeding resumes, the balloon may be reinflated and UAE should be considered.

Combined interventions: Uterine devascularization plus uterine compression sutures

There are no high-quality randomized trials comparing the devascularization plus compression sutures versus a single intervention alone, and case series and case reports on this topic are lacking. If uterine devascularization alone does not sufficiently control bleeding, adding a uterine compression stitch might resolve the hemorrhage. Both procedures require only suture material, which is immediately available in all operating rooms. Hence, this combination of interventions can be executed quickly.

Uterine sandwich: Intrauterine balloon tamponade plus uterine compression sutures

CD for placenta previa is associated with an increased risk of postpartum hemorrhage, with bleeding from the lower uterine segment greatly contributing to total blood loss. While O’Leary sutures can stem the flow of bleeding in this area, the use of both an intrauterine balloon tamponade plus uterine compression sutures—a so-called uterine sandwich—may result in maximal reduction in blood loss.^11,12

In one randomized trial, 106 women undergoing CD for a placenta previa were randomly assigned to uterine devascularization alone or double transverse compression suture at the lower uterine segment plus intrauterine Foley catheter balloon. Compared with women receiving devascularization alone, the combination of compression suture plus intrauterine balloon significantly reduced blood loss (1,350 mL vs 750 mL, respectively; P = .0001).¹³

Underutilization of uterine-sparing interventions

In a nationwide study of 50 consecutive Danish peripartum hysterectomy cases, an audit committee concluded that 24% of the hysterectomies could have been avoided, and an additional 30% of hysterectomies might have been avoided, if uterine-sparing surgical interventions had been utilized.¹⁴ In a recent survey of senior ObGyn residents in France, greater than 70% of respondents reported that they had not mastered uterine-sparing techniques of uterine devascularization and compression sutures, nor peripartum hysterectomy.¹⁵ Together, these studies suggest that uterine-sparing interventions are underutilized and that with more training and practice clinicians would become facile with these interventions.

The cornerstones of uterine-sparing surgical interventions are simplicity, safety, and efficacy. If a combination of pharmacologic and multiple uterine-sparing surgical interventions do not control the bleeding, the patient may need an emergency hysterectomy or, if stable, a UAE. While devascularization and compression sutures are described during CD, it is reasonable to use them after vaginal delivery if the next reasonable step would be a laparotomy. When you next face the clinical challenge of a postpartum hemorrhage, rapid recognition of excess blood loss, early identification of the cause, swift pharmacologic treatment, and timely escalation of surgical interventions will help you reduce the risk of hysterectomy and severe maternal morbidity.

Postpartum blood loss greater than 1,000 mL occurs in approximately 7% of cesarean delivery (CD) procedures with the administration of oxytocin alone or oxytocin plus misoprostol.¹ Rapid identification and control of hemorrhage is essential to avoid escalating coagulopathy and maternal instability. In cases of excess blood loss, clinicians request assistance from colleagues, endeavor to identify the cause of the bleeding, utilize additional uterotonics (methylergonovine, carboprost, misoprostol), perform uterine massage, warm the uterus, repair lacerations and replace blood products. If blood loss continues after these initial measures, obstetricians may consider uterine artery embolization (UAE) or hysterectomy. While UAE is a highly effective measure to control postpartum hemorrhage, it is not available at all obstetric hospitals. Even when available, there may be a significant time delay from the decision to consult an interventional radiologist to completion of the embolization procedure.

To avoid the permanent sterilization of a hysterectomy, or to obtain time for UAE or correction of coagulopathy, additional uterus-sparing surgical interventions should be considered. These include: 1) progressive uterine devascularization, 2) uterine compression sutures, and 3) intrauterine balloon tamponade. One caveat is that there is very little high-quality evidence from randomized trials to compare the efficacy or outcome of these uterine-sparing surgical interventions. Most of our evidence is based on limited case series and expert recommendations.

Uterine devascularization

Many techniques have been described for performing progressive uterine devascularization. Most experts recommend first performing an O’Leary suture, ligating both ascending uterine arteries and accompanying veins at a point approximately 2 cm closer to the cervix than the uterine incision (FIGURE 1). An absorbable suture is passed through the myometrium, being sure to remain medial to the ascending uterine vessels. Clear visualization of the vessels posteriorly is essential, usually necessitating exteriorization of the uterus. The needle is then driven through an avascular space in the broad ligament close to the uterine vessels, and the suture is tied down. Ureteral injury can be avoided by extending the bladder flap laterally to the level of the round ligament and mobilizing the vesicouterine peritoneum inferiorly, with the suture placed directly on endopelvic fascia. If necessary, the utero-ovarian ligament can be ligated in a second step, just below the uterine-tubal junction. The progressive devascularization intervention can be limited to the first or second steps if bleeding is well controlled.

In our experience, bilateral O’Leary sutures are highly effective at controlling ongoing uterine bleeding, particularly from the lower uterine segment. In the event that they are not successful, placement does not preclude later use of UAE.

Uterine compression sutures

Compression sutures are most often used in the setting of refractory uterine atony. They also may be helpful for controlling focal atony or bleeding from a placental implantation site. More than a dozen different types of uterine compression sutures have been reported in the literature; the B-Lynch, Hyman, and Pereira sutures are most commonly performed.²

Continue to: The B-Lynch suture³ is performed with...

1. Take bites on either side of the right edge of the hysterotomy incision (A and B). Place these bites approximately 3 cm from the edge of the hysterotomy incision.
2. Loop the suture around the fundus and reenter the uterus through the posterior uterine wall at point C, which is directly posterior to point B.
3. Exit the posterior wall of the uterus through point D.
4. Loop the suture over the uterine fundus.
5. Anchor the suture in the lower uterine segment by taking bites on either side of the left edge of the uterine hysterotomy incision (points E and F).
6. Pull the two ends of the suture tight while an assistant squeezes the uterus to aid compression.
7. Place a surgical knot to secure the suture.
8. Close the hysterotomy incision.

The B-Lynch suture was described with an open hysterotomy incision,³ which avoids closing off the lower uterine segment. We have successfully performed a modific tion on a closed uterus, taking care to not drive the lower uterine sutures through both the anterior and posterior walls.

The Hayman suture⁴ was proposed with two important modifications: The suture is placed through-and-through the lower uterine segment with a closed hysterotomy, and the suture can be fixed to the uterine fundus to avoid slippage. This vertical compression suture (FIGURE 3) is performed by placing two to four vertical #2 chromic sutures directly through the anterior to posterior uterine wall, tying the suture on the fundus using a 3-throw technique to minimize slippage of the first knot. In the original description, Hayman also described injecting carboprost into the uterine fundus to stimulate uterine contraction and regularly inspecting the vagina to evaluate the extent of continued bleeding.⁴

Intrauterine balloon tamponade

Many types of balloon tamponade devices have been developed, ranging from the humble condom tied to a Foley urinary catheter to the sophisticated Bakri^6,7 and Belfort-Dildy⁸ balloon tamponade devices. Intrauterine balloon tamponade is highly effective in controlling excess bleeding following vaginal delivery and less effective when used following a CD. In one study of 226 women with postpartum hemorrhage treated with a Bakri balloon the success rate was 89% and 66% following vaginal delivery and CD, respectively.⁹

Continue to: When using balloon tamponade during a CD...

When using balloon tamponade during a CD, some experts recommend partially closing the transverse hysterotomy incision by placing sutures to close edges of the hysterotomy, followed by insertion of the balloon into the uterus and the stem through the cervix into the vagina. Attachment of the stem to a collection bag should help to quickly assess the rate of blood loss. The balloon is inflated after the hysterotomy is closed. Following inflation of an intrauterine balloon, blood loss should decrease almost immediately.¹⁰ If excessive blood loss continues for more than 10 minutes, additional uterus-sparing interventions or hysterectomy may be required. Following successful balloon tamponade, the balloon may be deflated 12 to 24 hours postpartum when maternal stabilization and normal coagulation have been achieved. If bleeding resumes, the balloon may be reinflated and UAE should be considered.

Combined interventions: Uterine devascularization plus uterine compression sutures

There are no high-quality randomized trials comparing the devascularization plus compression sutures versus a single intervention alone, and case series and case reports on this topic are lacking. If uterine devascularization alone does not sufficiently control bleeding, adding a uterine compression stitch might resolve the hemorrhage. Both procedures require only suture material, which is immediately available in all operating rooms. Hence, this combination of interventions can be executed quickly.

Uterine sandwich: Intrauterine balloon tamponade plus uterine compression sutures

CD for placenta previa is associated with an increased risk of postpartum hemorrhage, with bleeding from the lower uterine segment greatly contributing to total blood loss. While O’Leary sutures can stem the flow of bleeding in this area, the use of both an intrauterine balloon tamponade plus uterine compression sutures—a so-called uterine sandwich—may result in maximal reduction in blood loss.^11,12

In one randomized trial, 106 women undergoing CD for a placenta previa were randomly assigned to uterine devascularization alone or double transverse compression suture at the lower uterine segment plus intrauterine Foley catheter balloon. Compared with women receiving devascularization alone, the combination of compression suture plus intrauterine balloon significantly reduced blood loss (1,350 mL vs 750 mL, respectively; P = .0001).¹³

Underutilization of uterine-sparing interventions

In a nationwide study of 50 consecutive Danish peripartum hysterectomy cases, an audit committee concluded that 24% of the hysterectomies could have been avoided, and an additional 30% of hysterectomies might have been avoided, if uterine-sparing surgical interventions had been utilized.¹⁴ In a recent survey of senior ObGyn residents in France, greater than 70% of respondents reported that they had not mastered uterine-sparing techniques of uterine devascularization and compression sutures, nor peripartum hysterectomy.¹⁵ Together, these studies suggest that uterine-sparing interventions are underutilized and that with more training and practice clinicians would become facile with these interventions.

The cornerstones of uterine-sparing surgical interventions are simplicity, safety, and efficacy. If a combination of pharmacologic and multiple uterine-sparing surgical interventions do not control the bleeding, the patient may need an emergency hysterectomy or, if stable, a UAE. While devascularization and compression sutures are described during CD, it is reasonable to use them after vaginal delivery if the next reasonable step would be a laparotomy. When you next face the clinical challenge of a postpartum hemorrhage, rapid recognition of excess blood loss, early identification of the cause, swift pharmacologic treatment, and timely escalation of surgical interventions will help you reduce the risk of hysterectomy and severe maternal morbidity.

Postpartum blood loss greater than 1,000 mL occurs in approximately 7% of cesarean delivery (CD) procedures with the administration of oxytocin alone or oxytocin plus misoprostol.¹ Rapid identification and control of hemorrhage is essential to avoid escalating coagulopathy and maternal instability. In cases of excess blood loss, clinicians request assistance from colleagues, endeavor to identify the cause of the bleeding, utilize additional uterotonics (methylergonovine, carboprost, misoprostol), perform uterine massage, warm the uterus, repair lacerations and replace blood products. If blood loss continues after these initial measures, obstetricians may consider uterine artery embolization (UAE) or hysterectomy. While UAE is a highly effective measure to control postpartum hemorrhage, it is not available at all obstetric hospitals. Even when available, there may be a significant time delay from the decision to consult an interventional radiologist to completion of the embolization procedure.

To avoid the permanent sterilization of a hysterectomy, or to obtain time for UAE or correction of coagulopathy, additional uterus-sparing surgical interventions should be considered. These include: 1) progressive uterine devascularization, 2) uterine compression sutures, and 3) intrauterine balloon tamponade. One caveat is that there is very little high-quality evidence from randomized trials to compare the efficacy or outcome of these uterine-sparing surgical interventions. Most of our evidence is based on limited case series and expert recommendations.

Uterine devascularization

Many techniques have been described for performing progressive uterine devascularization. Most experts recommend first performing an O’Leary suture, ligating both ascending uterine arteries and accompanying veins at a point approximately 2 cm closer to the cervix than the uterine incision (FIGURE 1). An absorbable suture is passed through the myometrium, being sure to remain medial to the ascending uterine vessels. Clear visualization of the vessels posteriorly is essential, usually necessitating exteriorization of the uterus. The needle is then driven through an avascular space in the broad ligament close to the uterine vessels, and the suture is tied down. Ureteral injury can be avoided by extending the bladder flap laterally to the level of the round ligament and mobilizing the vesicouterine peritoneum inferiorly, with the suture placed directly on endopelvic fascia. If necessary, the utero-ovarian ligament can be ligated in a second step, just below the uterine-tubal junction. The progressive devascularization intervention can be limited to the first or second steps if bleeding is well controlled.

In our experience, bilateral O’Leary sutures are highly effective at controlling ongoing uterine bleeding, particularly from the lower uterine segment. In the event that they are not successful, placement does not preclude later use of UAE.

Uterine compression sutures

Compression sutures are most often used in the setting of refractory uterine atony. They also may be helpful for controlling focal atony or bleeding from a placental implantation site. More than a dozen different types of uterine compression sutures have been reported in the literature; the B-Lynch, Hyman, and Pereira sutures are most commonly performed.²

Continue to: The B-Lynch suture³ is performed with...

1. Take bites on either side of the right edge of the hysterotomy incision (A and B). Place these bites approximately 3 cm from the edge of the hysterotomy incision.
2. Loop the suture around the fundus and reenter the uterus through the posterior uterine wall at point C, which is directly posterior to point B.
3. Exit the posterior wall of the uterus through point D.
4. Loop the suture over the uterine fundus.
5. Anchor the suture in the lower uterine segment by taking bites on either side of the left edge of the uterine hysterotomy incision (points E and F).
6. Pull the two ends of the suture tight while an assistant squeezes the uterus to aid compression.
7. Place a surgical knot to secure the suture.
8. Close the hysterotomy incision.

The B-Lynch suture was described with an open hysterotomy incision,³ which avoids closing off the lower uterine segment. We have successfully performed a modific tion on a closed uterus, taking care to not drive the lower uterine sutures through both the anterior and posterior walls.

The Hayman suture⁴ was proposed with two important modifications: The suture is placed through-and-through the lower uterine segment with a closed hysterotomy, and the suture can be fixed to the uterine fundus to avoid slippage. This vertical compression suture (FIGURE 3) is performed by placing two to four vertical #2 chromic sutures directly through the anterior to posterior uterine wall, tying the suture on the fundus using a 3-throw technique to minimize slippage of the first knot. In the original description, Hayman also described injecting carboprost into the uterine fundus to stimulate uterine contraction and regularly inspecting the vagina to evaluate the extent of continued bleeding.⁴

Intrauterine balloon tamponade

Many types of balloon tamponade devices have been developed, ranging from the humble condom tied to a Foley urinary catheter to the sophisticated Bakri^6,7 and Belfort-Dildy⁸ balloon tamponade devices. Intrauterine balloon tamponade is highly effective in controlling excess bleeding following vaginal delivery and less effective when used following a CD. In one study of 226 women with postpartum hemorrhage treated with a Bakri balloon the success rate was 89% and 66% following vaginal delivery and CD, respectively.⁹

Continue to: When using balloon tamponade during a CD...

When using balloon tamponade during a CD, some experts recommend partially closing the transverse hysterotomy incision by placing sutures to close edges of the hysterotomy, followed by insertion of the balloon into the uterus and the stem through the cervix into the vagina. Attachment of the stem to a collection bag should help to quickly assess the rate of blood loss. The balloon is inflated after the hysterotomy is closed. Following inflation of an intrauterine balloon, blood loss should decrease almost immediately.¹⁰ If excessive blood loss continues for more than 10 minutes, additional uterus-sparing interventions or hysterectomy may be required. Following successful balloon tamponade, the balloon may be deflated 12 to 24 hours postpartum when maternal stabilization and normal coagulation have been achieved. If bleeding resumes, the balloon may be reinflated and UAE should be considered.

Combined interventions: Uterine devascularization plus uterine compression sutures

There are no high-quality randomized trials comparing the devascularization plus compression sutures versus a single intervention alone, and case series and case reports on this topic are lacking. If uterine devascularization alone does not sufficiently control bleeding, adding a uterine compression stitch might resolve the hemorrhage. Both procedures require only suture material, which is immediately available in all operating rooms. Hence, this combination of interventions can be executed quickly.

Uterine sandwich: Intrauterine balloon tamponade plus uterine compression sutures

CD for placenta previa is associated with an increased risk of postpartum hemorrhage, with bleeding from the lower uterine segment greatly contributing to total blood loss. While O’Leary sutures can stem the flow of bleeding in this area, the use of both an intrauterine balloon tamponade plus uterine compression sutures—a so-called uterine sandwich—may result in maximal reduction in blood loss.^11,12

In one randomized trial, 106 women undergoing CD for a placenta previa were randomly assigned to uterine devascularization alone or double transverse compression suture at the lower uterine segment plus intrauterine Foley catheter balloon. Compared with women receiving devascularization alone, the combination of compression suture plus intrauterine balloon significantly reduced blood loss (1,350 mL vs 750 mL, respectively; P = .0001).¹³

Underutilization of uterine-sparing interventions

In a nationwide study of 50 consecutive Danish peripartum hysterectomy cases, an audit committee concluded that 24% of the hysterectomies could have been avoided, and an additional 30% of hysterectomies might have been avoided, if uterine-sparing surgical interventions had been utilized.¹⁴ In a recent survey of senior ObGyn residents in France, greater than 70% of respondents reported that they had not mastered uterine-sparing techniques of uterine devascularization and compression sutures, nor peripartum hysterectomy.¹⁵ Together, these studies suggest that uterine-sparing interventions are underutilized and that with more training and practice clinicians would become facile with these interventions.

The cornerstones of uterine-sparing surgical interventions are simplicity, safety, and efficacy. If a combination of pharmacologic and multiple uterine-sparing surgical interventions do not control the bleeding, the patient may need an emergency hysterectomy or, if stable, a UAE. While devascularization and compression sutures are described during CD, it is reasonable to use them after vaginal delivery if the next reasonable step would be a laparotomy. When you next face the clinical challenge of a postpartum hemorrhage, rapid recognition of excess blood loss, early identification of the cause, swift pharmacologic treatment, and timely escalation of surgical interventions will help you reduce the risk of hysterectomy and severe maternal morbidity.