As experts evaluate emerging evidence and the pattern of information that comes about, there is a consistent theme that pregnant women are more severely affected by COVID-19, says infectious disease expert Denise Jamieson, MD, MPH, who is the James Robert McCord Professor and Chair of the Department of Gynecology and Obstetrics at Emory University School of Medicine in Atlanta.

Jamieson delivered the Howard Taylor International Lecture: Global Health Threats – Novel Coronavirus & Beyond, during the American College of Obstetricians and Gynecologists’ (ACOG) 2020 Virtual Annual Meeting. Her career has focused on emerging infectious diseases in pregnancy like influenza, ebola, Zika virus, and maternal immunizations. From 1997 to 2017, she was at the Centers for Disease Control and Prevention, where she held a variety of different leadership positions.

Jamieson acknowledged Sonja A. Rasmussen, MD, MS, who serves in the Department of Pediatrics, College of Medicine, Department of Epidemiology, College of Public Health and Health Professions, University of Florida, Gainesville.

“Much of what I am going to present represents the evolution of our joint thinking and ideas over many years,” Jamieson said.

She summarized lessons learned from other outbreaks – monkeypox in 2003; SARS in 2003; influenza (Swine flu) in 2009-10; and Zika in 2015-16 – to see what can be applied to the current pandemic.

Monkeypox was a relatively obscure outbreak, but it taught scientists lessons that are relevant now, she said. It began innocuously when a family from Wisconsin adopted a prairie dog from an exotic animal swap meet. But the prairie dog became ill and bit a 3-year-old child in the home. The child became ill with fever and lesions at the site of the bite. The animal dealer then became ill, as did the mother of the child. As it ends up, Gambian pouched rats that had been shipped from Ghana to Texas were the source of the virus. Although the rats had a level of immunity, American prairie dogs did not.

Some of the infected prairie dogs ended up in homes with pregnant mothers. Therefore, there was concern about how to advise pregnant women. “Although there had been at least one reported case of congenital monkeypox, not much was known specifically about monkeypox in pregnancy. However, extrapolating from another pox virus, we knew there was increased morbidity and mortality among pregnant women with smallpox. We also knew that there had been rare cases of fetal vaccinia, vertical transfer of vaccinia virus, the live virus in the smallpox vaccine. Despite these risks, it was recommended that all close contacts with monkeypox be offered vaccination with the smallpox vaccine, regardless of pregnancy status. In other words, pregnant women were not excluded from emergency use of smallpox vaccine.”

Global threats to health may include zoonotic vectors, and that it’s important to rapidly address pregnancy issues during outbreak including use of mitigation measures.

That outbreak has relevance to the ongoing discussions about potential use of COVID-19 vaccine among pregnant patients, she said. SARS in 2003 highlights the case of a super spreader event. After one person in China became ill with it and stayed at a hotel, the virus spread and became the first pandemic of the 21st century. Due to unprecedented scientific, medical and public health collaboration, the global response to SARS was extraordinarily rapid and effective. By July of 2003, SARS had been contained. 

“The world was lucky with this first coronavirus pandemic,” Jamieson said. “There were characteristics of the virus that made it easier to control but there also was a coordinated, strong and swift public health response, that included measures such as mandatory quarantine, contact tracing, symptom and fever screening, travel bans, strict infection control procedures at hospitals and universal masking in affected countries.”

The lessons learned from SARS included that global travel represents a major risk for disease transmission. “We also learned that a coordinated public health response can be effective at controlling a pandemic,” she said.

During the influenza and H1N1 pandemic in 2009-2010, the second documented death was an otherwise healthy woman who was pregnant, portending the role that pregnant women would play in that pandemic. “Fairly early on it was clear that pregnant women with influenza were at risk for severe disease,” Jamieson said. An early 

 paper summarized the cases reported to the Centers for Disease Control and Prevention (CDC).

“We found that pregnant women were more likely to be hospitalized with influenza compared to the general population,” she said. A later report found that 5% of all H1N1 deaths were among pregnant women,3 which was a disproportionate number of deaths.

“We also confirmed that early antiviral therapy helped prevent severe disease and death,” Jamieson said. “Only one death occurred in a pregnant woman who received treatment within two days of symptom onset.”

The lessons learned with this pandemic included being reminded that pregnant women may be more vulnerable to severe disease from some emerging pathogens, and, specifically from respiratory pathogens.

Jamieson also covered the Zika virus, which first was identified in 1947 in a monkey in the Zika Forest in Uganda. It would not be until 2015 that Zika was first identified in the Americas. An outbreak occurred in Brazil, then 8 to 9 months later there was an increased incidence of microcephaly in infants born there. By April of 2016 enough evidence had accumulated to conclude that Zika virus in pregnancy could cause a congenital syndrome, which included microcephaly.

Lessons learned from Zika included the role of global travel in importing cases to the United States; it underlined the importance of specifically evaluating pregnancy outcomes as part of infectious disease investigation; it also highlighted the need for having surveillance systems specifically tailored for pregnant women.

“Because the national surveillance systems were set up prior to the realization that Zika caused birth defects, the CDC system did not routinely collect pregnancy status or outcomes. Therefore, we set up several different systems in the US and elsewhere to collect this critically important information. 

She ended with a short review of COVID-19 and some of what has been learned so far.

There are key questions, she said, with COVID-19 and pregnancy. Are pregnant women more susceptible to becoming infected with SARS-CoV-2 or at an increased risk for severe disease? Second, is there perinatal transmission? And third, what are the effects of the virus on the pregnancy, including the fetus/neonate?

On susceptibility, “we have no data,” she said. “Once asymptomatic infection was recognized, many labor and delivery units started universal testing of all women admitted for delivery.” 

(See related Figure “Universal screening of pregnant women presenting to labor and delivery in the U.S.)

 “You can see here a wide range of overall prevalence of positive test results, depending on time and place of testing, as well as whether women were symptomatic or asymptomatic. However, since we don’t have reliable estimates of overall prevalence in non-pregnant populations, we cannot conclude anything about susceptibility.”

As regards severity in pregnancy, the best data are from the CDC. Its Morbidity and Mortality Weekly Report (MMWR) summarizes data from the CDC surveillance system, which includes case reports submitted by the 50 states, the District of Columbia, and New York City. 

(See related Figure “Women of reproductive age (WRA) with SARS-CoV-2 infection by pregnancy status – Jan 22-June 7”)

“Although there is a large amount of missing data, I think this report is the best information we’ve had to date about severity of COVID in pregnancy. When adjusted for age and comorbidities, pregnant women were more likely to be hospitalized, admitted to the ICU, and require mechanical ventilation compared to non-pregnant women. There was not an increased risk of death.” 

(See related figure “Hospitalization, ICU admission, mechanical ventilation, and death among pregnant women and nonpregnant WRA with SARS-CoV-2 infection”).

“It will be important to look at updated data from the CDC surveillance system, which should include case reports beyond June 7 and hopefully with more complete information about pregnancy status,” Jamieson said.

In terms of transmission risk of the virus to the fetus (known as vertical transmission), the story of this possibility has been unfolding over time, she said. “There were some initial reports of possible perinatal transmission. There were early reports of infants with elevated IgM at birth. Since IgM does not readily cross the placenta, this suggested possible perinatal transmission. However, there are multiple problems with using IgM assays to diagnose congenital infections, including possible fetal-maternal leakage of IgM and inaccurate test results. There were also some reports of several infants testing positive several days after birth. In these cases, it was hard to sort out intrauterine or intrapartum transmission from postnatal transmission. Therefore, it is important to use carefully defined criteria to address perinatal transmission.”

She cited criteria used by Dean A. Blumberg, MD, and colleagues, from their editorial “Vertical Transmission of SARS-CoV-2: What is the optimal definition?”

“They suggested that you need three things: the mother needs to be positive around the time of birth; you need evidence of early exposure, as well as persistence,” she said. Evidence of early exposure means that virus is detected in any of the following: swab of neonatal respiratory tract in the first 24 hours of life; amniotic fluid; umbilical cord blood; neonatal blood sample in the first 24 hours of life. With persistence, you can have either of the following: swab of the respiratory is positive more than 24 hours after the start of life; or the neonate has a positive SARS-CoV-2 IgM assay in the first 7 days of life.

“I think there are now a handful of cases that meet these criteria, and are likely intrauterine transmission,” she said.

As more data becomes available, the impact to pregnant women will become more and more clear, she said. As she noted, there is a consistent pattern that pregnant women are more severely affected by COVID, although she does not think it is as severe as the other diseases she covered.

One audience member asked if Jamieson thought pregnant women should be offered the COVID vaccine, even if there is no safety data.

Should pregnant women be prioritized? Because they’re at an increased risk for severe disease, and that is that prioritization scheme that is being worked on, whether they should be prioritized. I don’t think we have enough data to really address that piece,” she said. “But the way I would look at it is, ‘Should pregnant women be excluded from the opportunity to be vaccinated based on their pregnancy status? So if you are a pregnant healthcare worker and you’re in the top priority to be vaccinated, should you be categorically excluded from the opportunity to be vaccinated just because you happen to be pregnant? My answer would be, emphatically, no. I think with careful counseling about what we know and what we don’t know about the vaccine and depending on what vaccine is available, pregnant women should be given the opportunity to be vaccinated, with careful counseling about what we know and what we don’t know. And just of note there are some of the vaccine platforms that are in Phase III trials that we know quite a bit about, some we know much less about. But I think whatever the safety and efficacy data is we owe it to our patients to talk to them about the vaccine and to be able to offer the vaccine.”

Editor’s Note: Contemporary OB/GYN will soon publish a fuller article from Jamieson’s presentation, including more related studies.

Jamieson DJ, Honein MA, Rasmussen SA, et al. H1N1 2009 influenza virus infection during pregnancy in the USA. 

2009; 374(9688): 451-458. doi.org/10.1016/S0140-6736(09)61304-0

Blumberg DA, Underwood MA, Hedriana HL, Lakshminrusimha S. Vertical Transmission of SARS-CoV-2: What is the Optimal Definition? 

. 2020 Jun;37(8):769-772. doi: 10.1055/s-0040-1712457. Epub 2020 Jun 5. PMID: 32503058; PMCID: PMC7356079.

Articles

ACOG

As experts evaluate emerging evidence and the pattern of information that comes about, there is a consistent theme that pregnant women are more severely affected by COVID-19.

COVID does affect pregnant women more severely

, AbbVie) with add-back therapy was effective in reducing heavy menstrual bleeding associated with uterine fibroids, regardless of numerous patient variables, according to an analysis presented at the American College of Obstetricians and Gynecologists’ (ACOG) 2020 Virtual Conference.

The analysis used pooled data from two Phase 3 elagolix studies (Elaris UF-1 and UF-2) to gauge the effect of age; body mass index (BMI); ethnicity; race; fibroid location based on the International Federation of Gynecology and Obstetrics (FIGO) classification; uterine and primary fibroid volume; and pregnancy history.

The oral drug received FDA approval in May 2020.

“There is a large unmet need in the uterine fibroid space for noninvasive treatment options,” said Ayman Al-Hendy, MD, Ph.D., lead author of the analysis and a professor of ob/gyn at The University of Chicago. “The main form of treatment has been and continues to be surgery, typically in the form of hysterectomies, which are major surgical procedures with potential for complications and risks, both short term and long term.”

Dr. Al-Hendy believes too many hysterectomies are performed in the U.S., with roughly 600,000 per year, primarily due to uterine fibroids.

“The unmet need for an alternative that is noninvasive, safe, effective and durable was the major motivation for this research,” Dr. Al-Hendy told 

The two studies, comprising a total of 791 women, evaluated the efficacy of elagolix (300 mg BID) with add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate [E2/NETA]).

The primary dual endpoint was the proportion of women with <80 mL menstrual blood loss (MBL) during the final month of treatment and ≥50% MBL reduction from blood loss to the final month of treatment. The average treatment duration was 6 months.

In all subgroups of women who received elagolix+E2/NETA, the percentage of responders to the primary dual endpoint was statistically significant compared to placebo: 72.2% vs. 9.3% (

There was also a statistically significant difference in amenorrhea: 50.4% for the combination therapy vs 4.5% for placebo (

Adverse events for each subgroup were consistent with the overall study population.

“I was pleasantly surprised by the high response rate and the number of patients who responded positively to elagolix,” Dr. Al-Hendy said. “Seven out of 10 women no longer experienced heavy menstrual bleeding (HMB) compared to 1 out of 10 women on placebo.”

Dr. Al-Hendy said it is encouraging that there is now an effective and safe oral treatment to help patients with HMB due to uterine fibroids.

“Additionally, fibroid treatment recommendations have historically been based on the size and location of the fibroid(s), with submucosal fibroids growing in the uterine cavity being surgically removed,” he said. “These new data demonstrate that women treated with elagolix were able to experience the same efficacy and safety results for their symptoms, regardless of factors such as primary fibroid volume, fibroid location, and/or total uterine volume.”

FDA approval of Oriahnn is a paradigm shift in treating women with HMB due to uterine fibroids, according to Dr. Al-Hendy. “The analysis reassures us that medical management is a safe and effective treatment,” he said.

As a gynecologist, Dr. Al-Hendy hopes that uterine fibroids can soon be managed medically, with surgery as a last resort. “It is important that healthcare providers discuss all treatment options with their patients and ensure a patient-centric approach to meet their individual treatment goals,” he said.

Dr. Al-Hendy also advocates additional research in developing “fertility-friendly” options for women who seek to treat their fibroids while achieving their fertility goals.

Dr. Al-Hendy has provided paid consulting services to AbbVie, Bayer, Myovant, Novartis and ObsEva.

“There is a large unmet need in the uterine fibroid space for noninvasive treatment options,” said Ayman Al-Hendy, MD, Ph.D., lead author of the analysis and a professor of ob/gyn at The University of Chicago. 

Elagolix effective for heavy menstrual bleeding due to uterine fibroids in wide range of women

Chaniece B. Wallace, MD, expectant mother and Pediatric Chief Resident at Indiana University School of Medicine, passed away on October 24 after giving birth to baby Charlotte via emergency cesarean section.

the American College of Obstetricians and Gynecologists 

honored Dr. Wallace with a moment of silence on Oct. 30. The moment of silence was taken at the end of the presentation, “

Disparities in Maternal Mortality/Morbidity,

” delivered by Elizabeth A. Howell, MD, MPP.

Wallace’s pregnancy was going smoothly until a routine doctor’s appointment in her third trimester, during which she was diagnosed with preeclampsia.

 She also shared concerns about developing pains in her abdominal area.

Overcoming racism and unconscious bias in ob/gyn

“My wife kept letting them know 'I am having severe pains in my abdomen' and she was pointing to the area where her liver is located,” said husband Anthony Wallace.

 The doctors rushed her in for an emergency cesarean, but further complications arose after baby Charlotte arrived prematurely.

From October 20 to October 22, Wallace underwent multiple operations to address developing conditions; her kidneys were low-functioning and her liver had ruptured.

The loss highlights the glaring racial disparities in maternal mortality and morbidity for Black women in the U.S. The pregnancy-related mortality rate for Black women is 5.2 times higher than for white women, and the rates of maternal mortality and severe maternal morbidity are 3 to 4 times higher in Black women than in white women.

 has been created to help support the Wallace family during this difficult time.

Frellick M. Black Chief Resident Dies After Childbirth, Highlights Tragic Trend. Medscape. October 28, 2020. Accessed October 30, 2020. 

Washington T. Death of young mother brings attention to racial differences in maternal mortality. WRTV Indianapolis. October 28, 2020. Accessed October 30, 2020. 

www.wrtv.com/news/working-for-you/death-of-young-mother-brings-attention-to-racial-differences-in-maternal-mortality

Charlotte Wallace. GoFundMe. October 26, 2020.Accessed October 30, 2020. 

Racial and Ethnic Disparities Continue in Pregnancy-Related Deaths. Press release. The Centers for Disease Control and Prevention. September 5, 2019. Accessed October 30, 2020. 

www.cdc.gov/media/releases/2019/p0905-racial-ethnic-disparities-pregnancy-deaths.html

The devastating loss of 30-year-old Chaniece B. Wallace, MD, highlights the glaring racial disparities in maternal mortality and morbidity in the U.S. 

Dr. Chaniece Wallace (1990-2020)

The American College of Obstetricians and Gynecologists’ (ACOG) 2020 Virtual Conference starts this Friday, Oct. 30, with presentations by preeminent experts in ob/gyn. Presentations will be given through Saturday, Oct. 31. Check out the full schedule 

 and register to attend. It will stream live and on-demand.

 embrace telehealth when prescribing contraceptives, incorporate reproductive justice into their practice, and include the United States Medical Eligibility Criteria for Contraceptive Use (US MEC) as a contraceptive resource, according to Eve Espey, MD, MPH, Chair of ob/gyn at the University of New Mexico in Albuquerque.

In her presentation at the American College of Obstetricians and Gynecologists (ACOG) 2020 Virtual Conference, Dr. Espey notes that especially in the era of the COVID epidemic, telehealth sessions are a viable alternative to in-person clinical visits for contraception in patients seeking short-acting methods like oral contraceptive pills, the contraceptive patch, and the contraceptive ring.

“Telehealth visits serve to ensure patient-centered, shared decision-making counseling, as well as allowing the provider to confirm that the patients are good candidates with no contraindications for their method of choice,” Dr. Espey told 

In the case of estrogen-containing contraceptives, a history ruling out contraindications and a prior normal blood pressure (BP) reading in the chart or a self-reported normal BP is sufficient for prescribing the method.

“Similarly, a 12-month prescription of a contraception to be filled at a single pharmacy visit in states that permit this, and considering refills beyond a year, can improve care for patients during COVID,” Dr. Espey said.

SisterSong, a Women of Color Reproductive Justice Collective, defines reproductive justice as the human right to maintain personal bodily autonomy, have children or not have children, and parent children in safe and sustainable communities. “For clinicians, that means actively opposing reproductive oppression and adopting an entirely patient-centered framework, where we work to leave our biases at the door, respect the values and preferences of our patients, value the reproductive desires of all our diverse patients equally, and ensure affordable access to all contraceptives,” Dr. Espey said.

Reproductive justice also entails not pushing one’s own beliefs about who needs contraception and/or what kinds of contraceptives are most appropriate for any given patient. “Allow patients to drive conversations and decision-making about contraception, including honoring their decisions about whether and when to start and stop contraceptive methods,” Dr. Espey said.

The US Medical Eligibility Criteria (US MEC) provides user-friendly, data-driven guidance on appropriate candidates for contraception.

“The resource uses data from ongoing systematic literature reviews and integrates the best up-to-date evidence on safety of contraceptives for patients, with a number of different characteristics and conditions,” Dr. Espey said.

One of the new developments in contraception is the extended use of long-acting reversible contraception (LARC), particularly during the pandemic, “to ensure excellent contraception and minimize unnecessary patient-provider contact,” Dr. Espey said.

Passage of proactive policy measures to improve contraception adherence is also needed in many states; examples include passing legislation to require insurance coverage for 12 months of contraceptives dispensed at a time or passing contraceptive equity laws to ensure that contraceptives are covered to the same degree as other pharmaceuticals.

Two new contraceptives on the market are a 1-year combined estrogen-progestin vaginal ring and a new lower-dose contraceptive patch.

“Continuing contraceptive technology development ensures a wide array of methods to fulfill patients’ needs over their reproductive lifespans,” Dr. Espey said.

In addition, oral emergency contraception, including levonorgestrel (Plan B, Next Step) and ulipristal acetate (Ella) are not abortifacients, according to Dr. Espey. “The public and some providers remain confused about oral emergency contraception, which acts by delaying ovulation in contrast to mifepristone, which is one of two medications used for early medication abortion and for early pregnancy loss management,” she said.

Likewise, intrauterine devices (IUDs) do not cause pelvic inflammatory disease or tubal infertility. “These two conditions are caused by sexually transmitted infections and not independently by IUDs,” Dr. Espey said.

The ACOG 2020 Virtual Conference will be held on October 30 and 31 from noon to 4 pm ET. 

Dr. Espey reports no relevant financial disclosures.

“Telehealth visits serve to ensure patient-centered, shared decision-making counseling, as well as allowing the provider to confirm that the patients are good candidates with no contraindications for their method of choice,” Eve Espey, MD, MPH, said.

Contraception lessons for 2020

Implementation of vaginal cleansing for cesarean delivery decreased the surgical site infection (SSI) rate by 33% over a 4-year period at one Pennsylvania hospital, according to a quality improvement study presented at the American College of Obstetricians and Gynecologists (ACOG) 2020 Virtual Conference.

However, the addition of intravenous azithromycin did not result in any additional change in SSI rate.

“Nonetheless, we continue to support the use of azithromycin at our hospital, given the strong evidence from the previous randomized controlled trials,” said principal investigator Johanna Quist-Nelson, MD, who at the time of the study was a maternal-fetal medicine fellow at Thomas Jefferson University Hospital in Philadelphia.

Dr. Quist-Nelson was inspired to complete the study during her training after observing how difficult it was for patients who experienced wound infections after cesarean. “Often these patients are in pain, have trouble breastfeeding and sometimes need to be re-admitted,” she said. “This can lead to poor bonding of the maternal-infant dyad and increase the risk for postpartum depression.”

After Dr. Quist-Nelson and her team noted a high rate of SSI, they reviewed evidence of low-risk interventions that could decrease that risk of wound infections, they sought to implement them.

“We aimed to reduce our SSI rate by 30% in a high-risk population by sequential implementation of vaginal cleansing and azithromycin for women who underwent a cesarean delivery after having labored or experienced prelabor rupture of membranes (PROM),” Dr. Quist-Nelson told 

The study consisted of 1,033 patients who delivered via cesarean during labor or after PROM at Thomas Jefferson Hospital from 2016 to 2019.

“The hospital serves an urban population, in which the majority of patients come from racial backgrounds that experience systemic racism,” Dr. Quist-Nelson said.

At the start of the study, the investigators initiated vaginal cleansing routinely for women in labor or with PROM prior to cesarean, and15 months before the addition of azithromycin to the same population.

All providers were trained in vaginal cleansing, which comprised 30 seconds of cleaning the perineum from the anterior to posterior direction using a sponge stick with 10% povidone-iodine or the sponge portion of a 4% chlorhexidine scrub brush.

Cleansing was performed at the time of urinary catheter placement in the operating room using povidone-iodine supplies that were also available prior to vaginal delivery.

Azithromycin 500 mg IV was ordered if cesarean delivery was planned within 1 hour. “Routine pre-operative antibiotics -- generally weight-based dosing of cefazolin -- were given preferentially prior to administration of azithromycin,” Dr. Quist-Nelson said. “The ideal timing of azithromycin was within 1 hour prior to incision, although the timing was dependent on the urgency of the cesarean delivery.”

Vaginal cleansing alone decreased the SSI rate by 33%, from 22.8% to 15.2%, over the study period.

“It was surprising to our team that azithromycin did not further lower our post-cesarean SSI rate,” Dr. Quist-Nelson said. “We had hoped to see a further decrease in our population.”

That implementation of vaginal cleansing and azithromycin are feasible and effective, according to Dr. Quist-Nelson, who is now an assistant professor of maternal-fetal medicine at the University of North Carolina in Chapel Hill.

To further decrease SSI with vaginal cleansing, she recommends that healthcare facilities take advantage of supplies already existing on their labor floor.

“Before we began the study, our hospital already had iodine-soaked sponges that came in packets,” Dr. Quist-Nelson said. “We simply ordered more of these packets and placed them prominently in the operating room.”

However, merely putting supplies in place is not enough. Providers still needed reminders after implementation in order to increase compliance. “Using a reminder system in the electronic medical record (EMR) was very helpful for our providers to remember to order azithromycin for the appropriate patients,” Dr. Quist-Nelson said.

Dr. Quist-Nelson reports no relevant financial disclosures.

Principal investigator Johanna Quist-Nelson, MD, was inspired to complete the study during her training after observing how difficult it was for patients who experienced wound infections after cesarean. 

Impact of vaginal cleansing and azithromycin on cesarean surgical site infections

“Why not?” said Aaron Caughey, a professor and chair of the Department of Obstetrics and Gynecology at Oregon Health & Science University in Portland, who is presenting on timing of induction of labor Oct. 30 at the American College of Obstetricians and Gynecologists (ACOG) 

“We know that the optimal gestational age to deliver is full-term: between 39 and 40 weeks,” Dr. Caughey told 

. “However, some pregnancies extend beyond this point.”

Dr. Caughey said that although all women could be induced in the 39- to 40-week range, “there has been a concern that intervening will lead to more cesareans and be too costly.”

In 2006, Dr. Caughey and his associates started showing that despite most clinicians’ beliefs, perhaps early induction does not cause more cesareans. Other investigators have found similar findings, and the recent large, randomized trial, ARRIVE, demonstrated that induction of labor at 39 weeks in nulliparous women as compared to expectant management leads to a lower rate of cesareans.

“The evidence suggests outcomes are as good or better for delivery at 39 to 40 weeks gestation as opposed to waiting until 41 weeks,” Dr. Caughey said.

Dr. Caughey believes the revelation that induction of labor might actually reduce the risk of cesarean delivery will be a surprise to many clinicians. And while he has conducted some of this research, he believes that “healthy suspicion of the findings is well-founded as studies should be replicated and studied in a range of clinical environments.

For many clinicians, “when one spends time on the labor floor, women being induced have a higher risk of cesarean. Thus, when one compares women with induction to women with spontaneous labor, induction of labor does have a higher risk of cesarean,” Dr. Caughey said. 

“But when one compares induction of labor to expectant management of the pregnancy in the full term (39 to 40 weeks gestation) and post-term (41 weeks gestation) periods, it appears that there are enough developments with expectant management that induction of labor does not increase the risk of cesarean.”

A 2018 cost-effectiveness analysis of induction of labor at 39 weeks of gestation versus expectant management among a theoretical cohort of 1.6 million low-risk nulliparous women found that induction of labor resulted in 54,498 fewer cesarean deliveries and 79,152 fewer cases of hypertensive disorders of pregnancy, again consistent with the ARRIVE trial. The analysis also concluded that induction of labor resulted in 795 fewer cases of stillbirth.

“Despite induction of labor being associated with increased costs, there was an increase in quality-adjusted life-years (QALYs), with an incremental cost-effectiveness ratio of $87,691.91 per QALY,” said Dr. Caughey, who spearheaded the analysis.

However, if the cost of induction of labor was increased by $180, elective induction would no longer be cost-effective.

Hence, while induction of labor in the full-term period is not a violation of the standard of care, the evidence is still evolving and local practice patterns can impact these outcomes.

“Whether individual clinicians and healthcare systems offer routine induction of labor at 39 weeks is dependent on local capacity and careful evaluation and allocation of healthcare resources, along with patient preferences,” Dr. Caughey said. “Going forward, we will have to see how early induction of labor plays out in a variety of settings.”

Dr. Caughey reports no relevant financial disclosures.

Is 39 the new 41 when it comes to weeks of gestation for induction of labor?

Timing of induction of labor

Presentations will be given through Saturday, Oct. 31. Check out the full schedule 

The guidelines, developed by a consensus of 19 national organizations convened by ASCCP, are an update to 2012 consensus guidelines. New guidelines emphasize reducing invasive procedures while maintaining high standards of cancer prevention.

New guidance for managing further testing in patients with minimal abnormalities detected during cervical cancer screenings will be shared at the American College of Obstetricians and Gynecologists (ACOG) 2020 Virtual Conference.

“Although the older guidelines represented a conceptual breakthrough in risk-based management, those recommendations retained a continued reliance on complicated algorithms and insufficiently incorporated past screening history,” said Rebecca Perkins, MD, first co-author of the new guidelines. “Since their issuance, we have developed a more nuanced understanding of how prior results affect risk, and more variables to consider, such as the natural progression of human papillomavirus (HPV) and cervical carcinogenesis.”

Screening outcomes among 1.5 million people revealed that 90% of test results were normal and only 0.75% were severely abnormal.

“Colposcopy is still recommended if the estimated risk of currently having a precancer or cancer is from 4% to 24% or if testing results are positive for the HPV types 16 or 18, which are most highly associated with cervical cancer,” said Dr. Perkins, an associate professor of ob/gyn at Boston University School of Medicine and Boston Medical Center.

If the risk of currently having a precancer is from 25% to 59%, the patient may choose either a colposcopy with biopsy or proceed directly to treatment. But if the risk is 60% or higher, it is preferred that patients undergo treatment without requiring a biopsy first, according to Dr. Perkins. 

“This was an option in the prior guidelines, but has been more clearly defined in the new guidelines,” she said.

In addition, patients with minor abnormalities, such as Pap test results that indicate low-grade or atypical squamous cells of undetermined significance (ACS-US) or HPV infections, “can defer colposcopy, if these results were preceded by negative screening with either HPV testing or co-testing within the past 5 years or if preceded by a colposcopy at which precancer was not found in the past year,” Dr. Perkins told 

. “Previously, colposcopy was always recommended for these outcomes, but new data indicate that follow-up in 1 year is safe for many patients.”

Adhering to the new guidelines will result in fewer patients being referred to colposcopy, “and those who are referred are at higher risk for precancer,” Dr. Perkins said. “The new guidelines are also designed to minimize unnecessary biopsies where precancer is not found, reduce patient harm and allow resources to be concentrated on high-risk patients.”

Hence, colposcopists should have a high level of suspicion and biopsy all abnormal-appearing areas, typically two to four biopsies per colposcopy. 

“They should also expect that a higher proportion of their colposcopy patients will have precancer requiring treatment,” Dr. Perkins said.

The guidelines’ framework is based on a patient's risk of precancer rather than a specific combination of test results. 

“This will allow more personalized recommendations for patients, and more streamlined incorporation of new screening and diagnostic technologies into clinical practice,” Dr. Perkins said. “Management of abnormal test results will shift from paper algorithms to electronic decision aids, which will further facilitate patient care predicated on the best available data.”

Dr. Perkins reports no relevant financial disclosures.

The American College of Obstetricians and Gynecologists’ (ACOG) 2020 Virtual Conference starts this Friday, Oct. 30, with presentations by preeminent experts in ob/gyn. 

New ASCCP consensus guidelines for managing abnormal cervical cancer screening test results

However, the analysis, which was presented at the 2020 virtual annual meeting of the North American Menopause Society (NAMS), found that two or more moderate or severe menopausal symptoms are associated with an increased risk for cardiovascular disease and stroke.

Matthew Nudy, MD, a cardiology fellow at Penn State Hershey Medical Center, is the principal investigator on the analysis and he had completed prior research on cardiovascular disease in postmenopausal women for the WHI-CaD study. “We were interested in better understanding what is associated with cardiovascular disease in postmenopausal women and if calcium and vitamin D supplementation could alter those associations,” he said.

The multicenter WHI-CaD study across the United States was conducted from the early 1990s to 2005, and funded by the National Heart, Lung, and Blood Institute (NHLBI).

The double-blind, randomized, placebo-controlled study was designed to test the effects of 400 IU of 25-hydroxyvitamin-D and 1000 mg of elemental calcium per day on incident hip fracture and other health outcomes in women between the ages of 50 and 79. A total of 20,050 women were followed for a median of 7 years.

The outcomes assessed for the analysis were hip fracture, colorectal cancer, invasive breast cancer, all-cause mortality, CaD global index (composite endpoint of the aforementioned events), coronary heart disease, stroke, cardiovascular death, and total cardiovascular disease.

Menopausal symptoms included hot flashes, night sweats, dizziness, heart racing or skipping beats, tremors, feeling restless or fidgety, feeling tired, difficulty concentrating, forgetfulness, mood swings, vaginal dryness, breast tenderness, headache or migraine, and waking up multiple times at night.

The severity of menopausal symptoms (none; mild; moderate or severe) was measured via a baseline questionnaire.

The investigators found no association between the severity of vasomotor symptoms of hot flashes and night sweats; and any health outcome.

In contrast, the number of menopausal symptoms was significantly associated with risk for stroke: hazard ratio (HR) 1.41 for at least two menopausal symptoms; 95% confidence interval (CI): 1.04 to 1.91, compared to no menopausal symptoms.

For one menopausal symptom, the HR for stroke was 1.19; 95% CI: 0.88 to 1.61, compared to no menopausal symptoms.

The number of menopausal symptoms was also significantly connected to total cardiovascular disease: HR 1.37; 95% CI: 1.20 to 1.56, for at least two menopausal symptoms vs. none.

For one menopausal symptom, the HR for total cardiovascular disease was 1.00; 95% CI: 0.87 to 1.15, compared to no menopausal symptoms.

When stratified by randomization status, CaD did not influence any association evaluated. But the severities of most individual menopausal symptoms, including headaches or migraines, or difficulty concentrating, were linked to a higher total cardiovascular disease risk.

“I was surprised that the severity of vasomotor symptoms was not associated with any health outcome in our analysis,” Dr. Nudy told 

. “In addition, calcium and vitamin D supplementation did not alter any association.”

Because patients with more moderate and severe menopausal symptoms may be likely to see a physician for treatment, “this may be an ideal time to assess their risk of cardiovascular disease,” Dr. Nudy said. “The number or type of moderate or severe menopausal symptoms, but not vasomotor symptoms alone, could be a marker of higher risk for cardiovascular disease.”

Dr. Nudy reports no relevant financial disclosures.

NAMS

A secondary analysis of the Women’s Health Initiative (WHI)-Calcium and Vitamin D (CaD) clinical trial has concluded that vasomotor symptom severity is not linked to any clinical event. 

Vasomotor symptom severity not linked to any clinical event in menopause

Dr. Santoro highlights just some of the content from the scientific program, including cardiovascular disease, the effect of menopause on vasomotor symptoms; genitourinary syndrome of menopause; and hormones of menopause, including a look into FSH as an active driver of menopause.

All presentations have been pre-recorded and now are available for on-demand viewing beginning Sept. 28 through Sept. 21, 2021. Live Q&A sessions will be held from Oct. 5 to Oct. 9. The full program can be found 

Videos

In this video, Senior Editor Angie DeRosa interviews Nanette Santoro, MD, Chair of the 2020 Scientific Program Committee for the Virtual Annual Meeting of the North American Menopause Society (NAMS). 

Highlights from NAMS 2020 Virtual Annual Meeting

This article is based on information presented at the 2020 Virtual Annual Meeting of the North American Menopause Society (NAMS). According to NAMS, all presentations have been pre-recorded and now are available for on-demand viewing beginning Sept. 28 through Sept. 21, 2021. For more information, click 

The findings are independent of sleep risk factors and depressive symptoms.

“I have a longstanding interest in understanding how trauma is related to poor sleep and health,” said first author Karen Jakubowski, PhD, a postdoctoral scholar in psychiatry at the University of Pittsburgh in Pennsylvania. 

“Although some past studies have found that trauma is connected to poor sleep, these studies measured sleep at only one time point. We realized there was a gap in our knowledge of whether trauma is related to poor sleep measured at multiple points over time, particularly in midlife women.”

The investigators used both objective and self-report measures of sleep, “which makes this research even more novel and exciting,” Dr. Jakubowski told 

The ongoing study, which is being conducted at the University of Pittsburgh, consists of a cohort of midlife women, aged 40 to 60 at baseline, who had participated in a previous study on menopausal hot flashes and cardiovascular health from 2012 to 2015.

The women were invited to return to the laboratory 5 years later for a follow-up visit between 2017 and 2020.

Of the 296 women assessed at baseline, 72% were White and 28% Black, with an average age of 54. For the follow-up visit, 166 women were evaluated.

At both baseline and follow-up, women reported adult trauma (Brief Trauma Questionnaire), demographics, depressive symptoms, sleep quality (Pittsburgh Sleep Quality Index [PSQI]) and apnea.

They also provided physical measures of height/weight, as well as a 3-day objective sleep assessment via actigraphy: duration and wake after sleep onset (WASO).

At baseline only, women reported childhood trauma (Child Trauma Questionnaire).

Linking childhood trauma (any/none) and adult trauma (any/none) at baseline with poor sleep (duration <7 hours, WASO ≥31 minutes, PSQI >5) across both baseline and follow-up visits were then assessed.

At baseline, 44% of women reported childhood trauma, compared to 60% who reported adult trauma.

Persistently poor sleep duration, WASO and sleep quality was observed in 61%, 60%, and 33% of women, respectively, at both baseline and follow-up visits.

Childhood trauma was related to persistently poor WASO: odds ratio (OR) 2.32; 95% confidence interval (CI): 1.11 to 4.84 (

Poor sleep occurs frequently among midlife women, which is significantly linked to childhood and adult trauma, according to a prospective study presented at the 2020 Virtual Annual Meeting of the North American Menopause Society (NAMS).

Latest Conference Articles