The November issue of Contemporary OB/GYN is one you do not want to miss.

Volume 65 No 11: The Technology Issue, November 2020

 know what you thought of this month’s cover story, '

on Facebook and Twitter, or by email at COGeditorial@mmhgroup.com.

 laparoscopic abdominal entry is the most dangerous part of any laparoscopic procedure?

Have you practiced shared decision-making with your patients? 

Why shared decision-making matters more than ever,

to our editorial staff at COGEditorial@mmhgroup.com. 

Articles

What did you think of the November cover story?

Moderna also reported that the primary efficacy analysis of its phase 3 COVE study of mRNA-1273 demonstrated a high efficacy rate of 94.1%, with a 100% efficacy rate against severe COVID-19. A total of 196 cases of COVID-19, including 30 severe cases, among 30,000 participants were included in the analysis.

Vaccine efficacy was initially reported at the first interim analysis with a total of 95 cases based on pre-specified success criteria on efficacy. Today’s primary analysis was based on the 195 cases, of which 185 cases were observed in the placebo group versus 11 cases in the mRNA-1273 group. The primary end point is based on the analysis of COVID-19 cases confirmed and adjudicated starting 2 weeks following the second dose of the vaccine.

Continue reading this article on Drug Topics.

Moderna announced yesterday its plan to apply for emergency FDA authorization for its COVID-19 vaccine candidate. 

Moderna requests emergency FDA authorization for COVID-19 vaccine

Results of an observational cohort study from UT Southwestern in Dallas found that 95% of women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during pregnancy did not have a higher risk of experiencing adverse pregnancy outcomes. These findings, published in 

, offer new insight into existing research and contribute to further understanding of SARS-CoV-2 infection in pregnancy.

"We found that 5% of all delivered women with SARS-CoV-2 infection develop severe or critical illness, which is lower than previous reports," said the study's co-author and 

The study included data of 3,374 pregnant women (mean [SD] age, 27.6 [6] years) who were tested for SARS-CoV-2 infection and delivered between March 18 to August 22 at Parkland Health and Hospital System, a high-volume urban maternity care center with widespread access to SARS-CoV-2 testing in outpatient, emergency department, and inpatient settings. This included 252 women who were SARS-CoV-2 positive and 3,122 who were SARS-CoV-2 negative.

Testing was performed for outpatient areas, and before May 14, 2020, for inpatient areas on the basis of symptoms (fever, cough, dyspnea, myalgia, loss of smell or taste, vomiting, diarrhea, or sore throat) or specific risk criteria. On May 14, the hospital system implemented a universal testing protocol in its labor and delivery unit. Women presenting for care with external positive testing results were included without repeat testing.

"The rate of hospitalization for the indication of COVID-19 is similar to that of non-pregnant women, at 6% (14/252) – markedly different than prior reports – in June 2020 the CDC reported 31.5% of pregnant women were hospitalized vs 5.8% of non-pregnant women," said Spong.

Neonatal testing protocols included SARS-CoV-2 testing at 24 and 48 hours among infants born within 4 weeks of maternal SARS-CoV-2 diagnosis, or when clinically indicated; admission to a neonatal intensive care unit isolation ward was routine for infants born to symptomatic mothers until maternal transmission-based precautions could be discontinued or until discharge.

Early neonatal SARS-CoV-2 infection occurred in 3% of tested infants, primarily among those born to asymptomatic or mildly symptomatic women.

Researchers found no difference in outcomes of preterm birth, preeclampsia with severe features, or cesarean delivery for fetal indication among women with and without SARS-CoV-2 infection diagnosed during pregnancy (52 women [21%] vs 684 women [23%]; relative risk, 0.94; 95%CI, 0.73-1.21; P = .64).

According to study findings, maternal illness severity had no association with placental abnormalities. Findings did suggest, however, that that the risk of delivery at less than 37, 34, and 28 weeks increased with worsening maternal COVID-19 illness severity.

According to the results, 5% of all delivered women with SARS-CoV-2 infection present with or developed severe or critical illness. These findings, note the authors, are novel and lower than rates in previous reports.

The authors call for further research to understand whether maternal infection with SARS-CoV-2 is associated with long-term maternal or infant health.

Adhikari EH, Moreno W, Zofkie AC, et al. Pregnancy Outcomes Among Women With and Without Severe Acute Respiratory Syndrome Coronavirus 2 Infection. 

 2020;3(11):e2029256. doi:10.1001/jamanetworkopen.2020.29256

The findings provide novel information on the outcome in pregnancy that are counter to smaller reports.

COVID-19 during pregnancy may not cause adverse outcomes

The data below is a reflection of data collected weekly by the 

Centers for Disease Control and Prevention

 (CDC). The cases reported are only confirmed cases with laboratory evidence of SARS-CoV-2 infection.

Here’s the latest data, updated on November 27:

Pregnant women with COVID-19, United States:

Data is updated weekly based on data collected by the Centers for Disease Control and Prevention (CDC). The cases reported are only confirmed cases with laboratory evidence of SARS-CoV-2 infection. CDC’s case numbers are validated through a confirmation process with each jurisdiction.

Currently, there are 56 U.S.-affiliated jurisdictions reporting cases of COVID-19, including 50 states, District of Columbia, Guam, New York City, the Northern Marina Islands, Puerto Rico, and the U.S. Virgin Islands.

Find previous data and the latest COVID-19 updates 

Data on COVID-19 during pregnancy, as reported by the CDC, in collaboration with state, local, and territorial health departments and external partners.

COVID-19 Pregnancy Data in the United States: November 27 update

You can expect a variety of topics to be covered this week on 

S2E8: Skeletal dysplasia with David Abel, MD

This episode of Pap Talk by Contemporary OB/GYN features David Abel, MD, as he discusses various elements of skeletal dysplasia and how practitioners can help their patients.

Poll: Do you treat patients affected by skeletal dysplasia?

This week's poll focuses on skeletal dysplasia. 

What to look for this week on Contemporary OB/GYN

This week on Contemporary OB/GYN: November 30 to December 4

Women with interstitial lung disease can have safe pregnancies

Pregnant women with autoimmune-related interstitial lung disease (ILD) can have safe pregnancy outcomes if closely monitored by a multidisciplinary team of physicians.

First enhanced recovery after surgery guideline for minimally invasive gynecologic surgery

The first Enhanced Recovery After Surgery (ERAS) guideline for standardizing and optimizing perioperative care for women undergoing minimally invasive gynecologic surgery (MIGS) has been published in The Journal of Minimally Invasive Gynecology.

L&D discharge profiles in the wake of COVID-19

The results of this retrospective study reflect experience with both vaginal and cesarean deliveries early in the pandemic, in comparison with similar periods in 2018 and 2019.

Oral and IUD emergency contraception provision

Less than half of ob/gyns offer their patients the two most effective forms of emergency contraception -- ulipristal acetate and the copper intrauterine device (IUD) -- according to a national survey.

It was a very busy week for the Contemporary OB/GYN team. 

In case you missed it: Nov. 23 to Nov. 27

Operation Warp Speed (OWS) officials announced that about 40 million doses of 2 safe and highly effective vaccines for coronavirus disease 2019 (COVID-19) – made by Moderna and Pfizer – could be available for distribution by the end of December, pending FDA approval.

The distribution is enough to vaccinate about 20 million Americans at high risk for COVID-19, Department of Health and Human Services (HHS) Secretary Alex Azar, MD, said in a news briefing on Wednesday.

Both Pfizer and Modera have created messenger RNA (mRNA) vaccine candidates; Pfizers’ showed a 95% efficacy rate in a recent update, whereas Moderna reported meeting its primary end point of efficacy, with 94.5% .

The CDC has moved to facilitate rapid distribution of vaccine to each state, Gen. Gustave Perna, OWS chief operating officer, said in the briefing.

The CDC has collaborated with commercial industry to produce, store, distribute, and administer the vaccine. Perna mentioned McKesson, in addition to Pfizer and Moderna, as partners in distributing the vaccine.

Officials with Operation Warp Speed said that COVID-19 vaccine distribution will begin 24 hours after the Food and Drug Administration's (FDA) approval.

Officials expect to see 40 million COVID-19 vaccine doses distributed in December

 revealed that 84% of respondents made available at least one form of emergency contraception, only 18% offer oral ulipristal acetate 30 mg and 29% a copper IUD.

“This study gives us a good picture of ob/gyn practices regarding emergency contraception, in particular about the use of the copper IUD, and highlights areas for improvement,” said principal investigator Daniel Grossman, MD, a professor of ob/gyn and reproductive sciences at the University of California, San Francisco.

The survey targeted fellows and junior fellows of the American College of Obstetricians and Gynecologists (ACOG) between August 2016 and March 2017. The final sample was 1,280 respondents, for a 52.2% response rate.

In total, 80.4% of respondents reported offering patients levonorgestrel 1.5 mg, while 30.5% reported offering combined hormonal contraceptive pills specifically for emergency contraception.

Only 5.4% reported not offering any form of emergency contraception and 11.3% reported not seeing patients for emergency contraception or referring them elsewhere.

The three major reasons for not recommending a copper IUD for emergency contraception were that it was rare for a patient to come to the office seeking emergency contraception (52.4%), lack of patient interest and/or request (33.7%), and that the practice did not stock copper IUDs on site (27.8%).

Expense, inadequate insurance reimbursement, and concern that the IUD acts as an abortifacient were also cited as reasons not to recommend a copper IUD.

Among respondents who reported offering copper IUDs for emergency contraception, only 56.8% reported recommending it for emergency contraception in the past 12 months; 52.3% reported recommending it 10 times or less in the past year and 4.6% reported recommending it 11 times or more in the past year.

Moreover, only 30.3% of practitioners who offered copper IUDs for emergency contraception reported placing one in the prior 12 months, 22.7% reported placing a copper IUD once or twice in the past year, and 7.6% reported placing one three or more times in the past year.

“I was surprised that practices are still lagging behind the evidence that ulipristal acetate and the copper IUD are the two most effective forms of emergency contraception,” Grossman told 

. “I was also surprised that almost a third of ob/gyns still offer combined oral contraceptives for emergency contraception, which are no longer recommended by ACOG.”

The barriers to offering the copper IUD for emergency contraception include the patient lacking information about the option and the physician not stocking the IUD on site. “The former could be addressed by patient education, while the latter could be addressed by training,” Grossman said.

Long-Acting Reversible Contraception (LARC) Program Help Desk

 to assist with both clinical and billing/reimbursement questions.

Grossman said ob/gyns should educate their patients about all of the options for emergency contraception and address the barriers in their practices and communities to offering ulipristal acetate and the copper IUD. “For example, if few pharmacies stock ulipristal acetate, clinicians should consider prescribing the medication in advance because patients may face delays in filling the prescription,” he said. “That way, they will have the medication on hand, if and when they need it.”

Even though levonorgestrel emergency contraception is available over the counter, “ob/gyns and other women’s health clinicians play an important role in ensuring access to the most effective emergency contraception methods, as well as providing ongoing contraception to those who want it,” Grossman said.

Dr. Grossman reports no relevant financial disclosures.

Castleberry NM, Stark L, Schulkin J, et al. Oral and IUD emergency contraception provision among a national sample of obstetrician-gynecologists. Contraception. Published online September 6, 2020. doi:10.1016/j.contraception.2020.08.013

Journal of Comparative Effectiveness Research

 also found that the risk of prolonged opioid use was significantly greater if comorbidities existed before diagnosis.

Senior author Georgine Lamvu, MN, MPH, a professor of ob/gyn at the University of Central Florida College of Medicine in Orlando, was prompted to undertake the analysis after a colleague remarked to her that he did not believe that women with endometriosis used opioids.

“In my practice, I had seen many women with endometriosis who reported using opioids, so I was curious to find out the actual numbers,” Lamvu told 

Medical and pharmacy claims information on 79,947 women with endometriosis from July 2015 to June 2018 were analyzed from the Symphony Health database.

The date of the first endometriosis diagnosis was deemed the index date and the 1-year period preceding the index data was considered the baseline period.

Women were aged 18 to 49 at the index date and had continuous pharmacy and medical enrollment for at least 1 year before and after their endometriosis diagnosis; in other words, at least one pharmacy claim every 3 months during the study period.

Women with endometriosis who used opioids at baseline were 61% more likely to receive opioids post-diagnosis.

The risk of prolonged opioid supply post-diagnosis was highest among women with a prolonged supply at baseline: relative risk (RR) 21.14, which significantly decreased to 1.32 for patients without a prolonged supply but with at least one comorbidity, 1.37 for pain comorbidities and 1.07 for psychiatric co-morbidities.

“I was surprised to find out how many women with endometriosis actually used opioids beyond 90 days,” Lamvu said. “All the other findings were expected.”

There is limited evidence to indicate that long-term opioid therapy is effective in treating other chronic pain conditions and no research to validate that opioids are efficacious for endometriosis-related pain.

“Nonetheless, the risk of opioid-related adverse events correlates with the dose and duration of opioid use,” Lamvu said. “This can lead to opioid-induced hyperalgesia, which counterproductively amplifies pain.”

In addition, high daily doses and prolonged use of opioids for chronic non-cancer pain can increase the risk of opioid abuse. More definitive is that comorbid psychiatric disorders in patients with chronic pain conditions like low back pain are linked to opioid misuse.

“The high prevalence of psychiatric comorbidities in patients with endometriosis suggests that this population may be vulnerable to opioid misuse,” Lamvu said.

Optimal endometriosis treatment should encompass a patient-centric strategy, according to Lamvu, integrating pharmacologic and surgical options to manage symptoms, in conjunction with therapies to improve health-related quality of life.

“Multi-disciplinary care with adequate management of comorbidities could optimize endometriosis treatment and reduce inappropriate or excessive treatment with opioids,” Lamvu said.

The analysis identifies a group of women who need specific counseling on the risks of long-term opioid use. “However, because we have no research that shows that opioids are effective for endometriosis-related pain, we need more research on this topic,” Lamvu said. “Also, because many women with endometriosis have surgery, post-op opioid use needs to be discussed with caution.”

Lamvu has served as a research consultant for AbbVie.

Lamvu G, Soliman A, Johns B, et al. Impact of pain and nonpain co-morbidities on opioid use in women with endometriosis. J Comp Eff Res. Published online November 3, 2020. doi:10.2217/cer-2020-0181

The risk of opioid use after endometriosis diagnosis is significantly greater in patients who used opioids before diagnosis, according to a retrospective analysis of data from a large health database.

Impact of opioids in women with endometriosis

a BELS-certified medical writer and editor, and an editorial consultant for 

A retrospective study by researchers from Cedars-Sinai Medical Center in Los Angeles of the impact of COVID-19-driven changes in Labor and Delivery (L&D) protocols shows that shortening lengths of stay (LOS) was safe for both mothers and their babies. The results reflect experience with both vaginal and cesarean deliveries early in the pandemic, in comparison with similar periods in 2018 and 2019.

Beginning in March 2020, in response to COVID-19, Cedars-Sinai modified its L&D practices to reduce risk of infection to patients and staff. Among the measures instituted were:

Permitting no visitors during the hospital stay for mothers admitted with or suspected to have COVID-19;

Allowing COVID-19-negative mothers to have only one support person during delivery and no visitors postpartum (after April 20, 2020, a single support person was allowed postpartum for COVID-19-negative mothers);

Advising COVID-19-positive mothers or those undergoing testing for it to be temporarily separated from their newborns after delivery; and

Recommending protective measures, such as isolette care in the room and gloving and masking during handling of the newborn, to COVID-19-positive mothers or those undergoing testing who did not want to be temporarily separated from their newborns after delivery.

During the period of study—January 1, 2020 to April 30, 2020—1,936 deliveries occurred: 1,016 before the changes were made and 920 after. Only two COVID-19 laboratory test-positive cases occurred during the study period, both of which were removed from the LOS analysis.

Postpartum LOS was significantly shorter after implementation of the COVID-19-driven measures. Of the patients treated post-implementation, 48.5% had a one-night stay after vaginal delivery, versus 24.9% in the preimplementation group (

 < .0001). Among those who delivered by cesarean, 40.9% had an LOS of two nights or less postimplementation, versus 11.8% preimplementation (

Reviewing newborn care, the authors found that 49.0% delivered vaginally were discharged home after one night in the post-implementation group versus 24.9% in the preimplementation group (

 < .0001). A similar trend was seen in association with cesarean delivery: 42.5% discharge rate after two nights or less in the post-implementation group vs 12.5% in the preimplementation group (

There were no differences in cesarean delivery rate, induction of labor, or adverse maternal or neonatal outcomes between the two groups. Adjustment for month-to-month variation in length of postpartum hospitalization for mothers and newborns showed no significant differences in neonatal or maternal LOS between January to February and March to April in 2018 and 2019, regardless of mode of delivery.

The American Journal of Obstetrics & Gynecology Maternal-Fetal Medicine

, the authors said that “the reasons for this reduction in postpartum length of stay are likely multifactorial but may be attributed partially to changes to our visitor policy…It is likely that the initial restrictions may have motivated patients and providers toward an earlier discharge.”

The researchers said their study “suggests that it is reassuring that these early discharges were not associated with an increased rate of readmissions or postpartum medical complications,” noting that “future studies are needed to determine what long-term effects the shorter stay might have on other outcomes such as maternal health, bonding, and ongoing breastfeeding.”

Greene NH, Kilpatrick SJ, Wong MS, et al. Impact of labor and delivery unit policy modifications on maternal and neonatal outcomes during the coronavirus disease 2019 pandemic.