Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

Miranda Hester

Pregnant women were not included in the preauthorization trial for the Pfizer/BioNTech vaccine for COVID-19, which led to conflicting advice on whether they should receive the vaccine. Worries about the effect that the vaccine might have on the child is one of the most common reasons an expectant person might give when declining to get it.

A new investigation offers some need information on whether prenatal exposure to the vaccine was linked to adverse outcomes at birth and during the first months of life.1

The investigators ran a population-based cohort study that included all singleton live birth between March and September 2021 that occurred within a large state-mandated health care organization in Israel that encompasses a quarter of the Israeli population. Primary outcomes at birth for the study were preterm birth and being small for gestational age. Outcomes following birth included inpatient hospitalizations, congenital anomalies, and all-cause death.

There were 24,288 newborns included in the cohort, with 96% born at ≥37 weeks’ gestation. Within this group, 16,69

 were exposed to a maternal COVID-19 vaccine in utero, 2135 in the first trimester and 9364 in the second trimester. The median follow-up period was 126 days for infants exposed to vaccination and 152 days among newborns who were not. The investigators did not note a significant difference in the rate of preterm birth between exposed and unexposed newborns (risk ratio [RR] = 0.95; 95% CI, 0.83-1.10) and no differences were noted for small for gestational age (RR = 0.97; 95% CI, 0.87-1.08). Among the after birth outcomes, no significant difference were noted as well: all-cause neonatal hospitalizations (RR = 0.99; 95% CI, 0.88-1.12), postneonatal hospitalizations after birth (RR = 0.95; 95% CI, 0.84-1.07), congenital anomalies (RR = 0.69; 95% CI, 0.44-1.04), or infant mortality over the study period (RR = 0.84; 95% CI, 0.43-1.72).

The investigators concluded that there was no evident difference between the offspring of women who received the Pfizer/BioNTech vaccine and those of women who did not receive the vaccine. The findings bolster the evidence that supports women receiving the vaccine during pregnancy to protect not only themselves, but their newborns.

This article was originally published on Contemporary Pediatrics®. 

Goldshtein I, Steinberg D, Kuint J, et al. Association of BNT162b2 COVID-19 vaccination during pregnancy with neonatal and early infant outcomes. 

. Epub ahead of print. doi:10.1001/jamapediatrics.2022.0001

Articles

The safety of the Pfizer/BioNTech COVID-19 vaccine in pregnant women, for both mother and baby, has been dependent on observation during the rollout. A large population trial provides further support for the vaccine’s safety.

In Utero COVID-19 vaccine exposure not associated with adverse outcomes

Although mastitis is more often connected to new mothers who are breastfeeding, the condition can occur in infants. A 

 offered information on the clinical presentation, prevalence, and outcomes of a simultaneous serious bacterial infection with mastitis.1

The investigators reviewed the records of infants aged ≤90 days who were treated for mastitis at 28 sites in the United States, Canada, and Spain that were part of the Pediatric Emergency Medicine Collaborative Research Committee. The infants had been seen in the emergency department.

There were 657 infants included in the study and nearly all of them were well-appearing at the time of presentation. There was a history of fever either at home or the emergency department for 138 of the infants and 63 of them had reported poor feeding or fussiness. Blood was collected in 581 infants; Urine was collected in 274 infants; and cerebrospinal fluid cultures were taken for 216 infants. There were pathogens in 0.3%of (95% [CI] 0.04–1.2) of blood, 1.1% (95% CI 0.2–3.2) of urine, and 0.4% (95% CI 0.01–2.5) of cerebrospinal fluid cultures. Site of infection cultures were collected for 335 infants and 77% of those cultures grew a pathogen. The most commonly grown pathogen was methicillin-resistant 

 were the other commonly grown pathogens. Ninety percent of the infants were admitted to inpatient care at the hospital and 22 had to be admitted to the intensive care unit. There were 10 (1.5% [95% CI 0.7–2.8]) cases that had either sepsis or shock and 2 (0.3% [95% CI 0.04–1.1]) had severe cellulitis or necrotizing soft tissue infection. No cases required the use of vasopressors or endotracheal intubation and no infant died.

The investigators concluded that in most cases of neonatal the condition was mild and localized. A serious bacterial infection and adverse outcomes were highly uncommon. When presented with an afebrile, well-appearing infant with mastitis, evaluating for serious bacterial infection is likely not necessary.

1. Kaplan R, Cruz A, Michelson K. Neonatal mastitis and concurrent serious bacterial infection. 

. July 1, 2021. Epub ahead of print. doi:10.1542/peds.2021-051322

A report in Pediatrics offered information on the clinical presentation, prevalence, and outcomes of a simultaneous serious bacterial infection with mastitis.

Neonatal mastitis prevalence and treatment outcomes

Although it’s been around in some capacity for the past 50 years, telehealth and its potential to transform care has become increasingly apparent over the past year, with many patients being satisfied with the care that they’ve received at such visits. A panel discussion at the annual ACOG meeting examined how telehealth had been used over the course of the year. Moderated by Nathaniel G. DeNicola, MD, MSHP, assistant professor of ob/gyn at the George Washington School of Medicine & Health Sciences in Washington, DC, the discussion looked at telehealth in low-risk obstetrics, high-risk obstetrics, and family planning.

For low-risk obstetrics, Kathryn Marko, MD, NCMP, assistant professor of ob/gyn at the George Washington School of Medicine & Health Sciences, said that previous research had shown that although telehealth interventions hadn’t improved vaccination rates and pregnancy wellness, they have shown some effectiveness in smoking cessation programs as well as promoting exclusive breastfeeding and breastfeeding continuation. Marko noted that there had been discussion about changing prenatal care before the pandemic start, but the past year has illustrated that appointments can be spaced out with certain components that require in-person care grouped together and that remote monitoring can ensure proper care along with patient satisfaction. Postpartum care can also be effectively done through telehealth, although evidence still is mixed about phone support. In high-risk pregnancies, telehealth offers a way to monitor diabetes and hypertension and there is moderate evidence that using telehealth can maintain outcomes for mother and child, even with a reduction in outpatient clinic appointments.

Curtis L. Lowery, MD, director of the University of Arkansas for Medical Sciences Institute of Digital Health & Innovation in Little Rock, said that in the postpartum period for high-risk pregnancies telehealth would offer an effective way to track hypertension in the immediate postpartum period.

For family planning, telehealth is more complicated, however. In cases of medical abortions using mifepristone where the patient received the medication after a telehealth visit, a study showed that receiving care via telehealth was not inferior to a traditional clinic visit and a majority of the cases were performed at 13 weeks or less. However, there are 19 states that will not allow for telehealth visits for a medical abortion including much of the southeast United States as well as the Midwest. Additionally, mifepristone’s risk evaluation and mitigation strategy requires it to be dispensed in person at either a clinic, medical office, or hospital. Over the past year, the requirement has been removed temporarily because of the pandemic or reinstated, but the US Food and Drug and Administration issued a letter in April 2021 that lifted the requirement during the pandemic. Contraception also poses a problem with telehealth, said Daniel A. Grossman, MD, professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California, San Francisco, with some states not allowing the use of telehealth for contraception as well as some states putting age restrictions on it. He urged further research into how telehealth could expand contraception access.

 for more coverage from ACOG’s Annual Clinical and Scientific Meeting. For registration information, visit 

A panel discussion at the 2021 American College of Obstetrics and Gynecology’s (ACOG) Annual and Scientific Meeting, being held virtually April 30-May 2, offers insight into how the COVID-19 pandemic has changed telehealth in ob/gyn.

How the pandemic has changed telehealth in ob/gyn

As the United States approaches the 1-year anniversary of the start of shut downs related to the coronavirus 2019 (COVID-19) disease in the United States, there’s a sense of both hope, due to the recent authorization of 3 vaccines, and fatigue because many people feel worn out from dealing with business, educational and recreational closings and limitations.

Accelerated vaccination efforts, rumored easing of 

 recommendations among those who have been fully vaccinated, and the complete lifting of masking restrictions in certain states like Texas, could all lead to even those people who have been most vigilantly staying at home during this pandemic, tempted to relax their protocols. However, officials with Infectious Diseases Society of America hosted a briefing that serves as a reminder that infection prevention measures that have existed from the beginning, testing and wearing masks, will be just as important to ending the pandemic as the vaccines.

In her opening remakes in the briefing, Romney M. Humphries, PhD, D(ABMM), M(ASCP), professor of pathology, microbiology and immunology at Vanderbilt University Medical Center in Nashville, Tennessee, stated that although vaccination may be seen as a priority to many, robust testing for COVID-19 remains essential to infection control. It’s an important tool in not only finding cases, but helping with enrollment for therapeutic clinical trials, determining a community’s quarantine requirements, tracking spikes in cases, and monitoring for variants and further evolution in the virus. Then Mary K. Hayden, MD, FIDSA, professor of internal medicine and pathology at Rush Medical College in Chicago, Illinois, spoke about how one of the difficulties of testing is the vast number of scenarios. She stressed that testing was important not only because of public health implications, but it can also help prevent spread in the home due to family members taking measures, such as wearing masks and having the COVID-19 positive person be physically separated from others.

Humphries discussed whether COVID-19 testing in schools could be a helpful way to control the spread of the disease as well as an avenue for keeping schools open. Testing for COVID-19 in schools would likely follow the patterns of many other things in schools: wealthy districts would have the needed resources and poorer districts might not. She also noted that a lack of infrastructure made it unlikely that schools would be a major area of testing.

She said that other measures, such as having children with symptoms remain at home and monitoring their disease course would be just as helpful in controlling the spread.

The authorization of at-home testing for COVID-19 has made the idea of more robust testing a possibility, but at a literal and figurative price. The $25 or more price point of the tests likely prices it out of the range for some of the most vulnerable population. Additionally, Humphries noted that the test needs to be performed as accurately as possible to get credible results and user error could create problems. Also, home testing may prevent an accurate look at epidemiological data if the results of home tests aren’t provided to health care providers or local public health departments.

Hayden remarked that both testing and the vaccine are just 2 elements of ending the pandemic and that a successful response would include:

, President Joseph Biden stated that as a result of new pharmaceutical collaborations on vaccine production, and new deals struck with currently regulated vaccine developers including Janssen, the US is on pace to provide a vaccine for every adult by the end of May.

As of March 2, the US has reported 3 straight days of fewer than 60,000 new COVID-19 cases. In that same time period, the country surpassed 50 million total administered COVID-19 vaccines—and 25 million persons fully vaccinated with either the two-dose mRNA products from Pfizer or Moderna, or the single-shot adenovirus vaccine from Janssen.

This article was originally posted on Contemporary Pediatrics®.

In a briefing this morning, the Infectious Diseases Society of America (IDSA) stressed the continued importance of coronavirus 2019 disease (COVID-19) control measures that have been there from the start.

IDSA: Testing, masking still key to COVID-19 infection control

	New data on persistence of Zika virus in some infected individuals has led The Centers for Disease Control and Prevention (CDC) to issue an update on testing of asymptomatic pregnant women. The 

 builds on interim guidance for health care providers that was published by CDC in July 2016.

	Emerging epidemiologic and laboratory data, said CDC, indicate that Zika virus IgM can persist beyond 12 weeks in a subset of infected people. As a result, IgM detection may not always indicate a recent infection. A Puerto Rican study of symptomatic patients with nucleic acid test (NAT)-confirmed Zika shows persistence of the virus IgM in 100% of participants at 8 to 15 days after symptom onset and in 87% at more than 60 days after symptom onset. Median time to first negative Zika virus IgM was 4 months (range 8-210 days) according to unpublished data from the ongoing study.

	CDC noted that while IgM persistence could affect test interpretation in all patients infected with Zika, it would have the greatest effect on clinical management of pregnant women with a history of living in or traveling to areas with Zika virus transmission before conception. Pregnant women who test positive for IgM antibody may have been infected with the virus and developed the response before conception.

	CDC’s recommendations for testing symptomatic pregnant women are unchanged. For asymptomatic pregnancy women who live in or frequently travel to areas with Zika virus transmission with CDC Zika Travel Notices, the agency recommends:

	·       Screening for risk of Zika exposure and symptoms, with prompt NAT testing if symptoms develop during pregnancy or a sexual partner tests positive for Zika;

	·       Consideration of NAT testing at least once per trimester, unless a previous test has been positive;

	·       Consideration of NAT testing of amniocentesis specimens if the test is performed for other reasons;

	·       Patient counseling each trimester on limitations of IgM and NAT testing; and

	·       Consideration of IgM testing to determine baseline Zika virus IgM levels as part of preconception counseling.

NEXT: Can corticosteroids be effective hours before delivery?

	Can corticosteroids be effective hours before delivery?

	Administering antenatal corticosteroids only hours prior to delivery may improve survival in very preterm infants, according to results of a Swedish study published in 

	Researchers used data from the Effective Perinatal Intensive Care in Europe study, which gathered information from 19 regions across 11 European countries from 2011 to 2013. The cohort included 4594 singleton infants with a gestational age range of 24 to 31 weeks. The infants did not have severe anomalies and were not otherwise exposed to multiple courses of antenatal corticosteroids. The authors studied 3 outcomes: severe neonatal brain injury, which was defined as an intraventricular hemorrhage grade 3 or greater or cystic periventricular leukomalacia; composite of mortality or severe neonatal morbidity, which was defined as an intraventricular hemorrhage grade of 3 or greater, cystic periventricular leukomalacia, surgical necrotizing enterocolitis, or stage 3 or greater retinopathy of prematurity; and in-hospital mortality.

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	Of the infants in the cohort, 2496 were boys. The average gestational age was 28.5 weeks and the average birth weight was 1213 g. Among the 662 infants unexposed to antenatal corticosteroids, the mortality rate was 20.6% (136 of 661). Administering antenatal corticosteroids was linked with a rapid and immediate decline in mortality, which plateaued with over 50% risk reduction where administration-to-birth interval was 18 to 36 hours. A similar pattern was seen for composite mortality or morbidity outcome. An administration-to-birth interval of more than 48 hours was linked with a significant reduction in the risk of severe neonatal brain injury. The risk reduction association was antenatal corticosteroids was transient and an administration-to-birth interval exceeding 1 week was associated with increasing mortality and risk of severe neonatal brain injury.

	Based on the assumption that a causal relationship existed between mortality and timing of antenatal corticosteroids, the researchers performed a simulation which demonstrated that administering the drugs 3 hours before delivery to infants who had no previous exposure was associated with an estimated decline in mortality of 26%. They concluded that, contrary to previous hypotheses, administration of antenatal corticosteroids in a few hours prior to delivery may prove effective for improving survival and decreasing neonatal morbidity in very preterm infants.

NEXT: Is hepatitis C on the rise in pregnant women?

	Is hepatitis C on the rise in pregnant women?

Centers for Disease Control and Prevention

, the rate of hepatitis C is on the rise in the United States among women giving birth.

	Investigators used US birth certificate data to examine trends and geographic differences in the rates of hepatitis C infection among women who gave birth between 2009 and 2014. They used Tennessee birth certificates to examine individual characteristics and outcomes linked with a hepatitis C infection and a multivariable model to calculated adjusted odds. The data were collected from the National Vital Statistics System and Tennessee Department of Health vital records.

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	During the study period, presence of a hepatitis C infection at time of delivery from states reporting such infections on birth certificates increased by 89%, from 1.8 to 3.4 per 1000 live births. The highest infection rate in 2014 was found in West Virginia, at 22.6 per 1000 live births, while Hawaii had the lowest rate at 0.7 per 1000 live births. In the adjusted analyses of Tennessee births, where the rate is 10.1 per 1000 live births, the odds of having a hepatitis C infection were roughly 3-fold higher among women who lived in rural counties than in those who lived in urban counties. In women who smoked cigarettes while pregnant, the odds of an infection were 4.5-fold higher, and among women who had a concurrent hepatitis B infection, the odds were 17-fold higher.

	The implications for public health practice from these data are that screening for hepatitis C in women who are of childbearing age and providing treatment may help reduce perinatal transmission of the disease. Monitoring infants who are exposed to hepatitis C also could aid in identifying these infections.

The latest on testing guidelines for Zika from the CDC. Plus: Are corticosteroids effective when administered only hours before delivery? Also, a look at the prevalence of hepatitis C among pregnancy women in the United States.

CDC issues advisory on Zika testing

	Postmenopausal women who use ospemifene, a selective estrogen receptor modulator, may experience an increase in vasomotor symptoms during their first 4 weeks on the drug, according to results of a pooled analysis of Phase II and Phase III randomized trials published in 

	The researchers compiled the incidence of vasomotor symptoms treatment-emergent adverse events (TEAEs) from 5 randomized, placebo-controlled clinical studies and baseline parameters associated with vasomotor symptom incidence. Data from a previously unpublished, 6-week placebo-controlled study evaluating ospemifene’s effects on the frequency and severity of vasomotor syndromes were used as well.

	An analysis of pooled vasomotor symptom TEAE data for 2166 women showed an 8.5% incidence of vasomotor symptoms for ospemifene and 3.2% for placebo (

 < 0.0001). The first 4 weeks of ospemifene treatment saw the highest frequency of vasomotor symptoms and the frequency decreased thereafter. An increased incidence of hot flashes was more likely in women who had taken hormone therapy within 6 months before study start (

 = 0.0234), had more vasomotor symptom days per month at baseline (

 = 0.0313), and took the study treatment for a longer period of time (

 = 0.0234), according to results of logistic regression analysis. In the unpublished study of 198 postmenopausal women who experienced moderate to severe vasomotor symptoms, ospemifene 60 mg/d did not worsen the severity and frequency of existing vasomotor symptoms.

	The researchers concluded that vasomotor symptom TEAEs were more frequent with ospemifene 60 mg/d than with placebo, especially in women who had previously used hormone therapy. The vasomotor symptoms lessened at 4 weeks and ospemifene did not worsen existing vasomotor symptoms in women who were experiencing moderate to severe hot flashes.

NEXT: Cerclage suture linked with preterm birth

Cerclage suture linked with preterm birth

	A study by British researchers suggests that cerclages done with braided sutures are more likely to end in preterm birth (PTB) or a nonviable pregnancy than are those done with monofilament sutures. The braided material, say the authors, appears to promote vaginal bacterial dysbiosis, which in turn results in local tissue inflammation and premature cervical remodeling.

, the findings are from a retrospective analysis and the researchers see an urgent need for clinical trials, powered for the outcomes of PTB, neonatal morbidity, and mortality, to assess the impact of cerclage suture material.

	The authors assessed birth outcomes in a cohort of 678 women who received cervical cerclages at five UK university hospitals over a 10-year period. Half of the procedures were done with braided suture material and half with monofilament suture. The women in whom the braided suture was used had higher rates of nonviable births (delivery <24 weeks or intrauterine death) compared to those in whom the monofilament suture was used (15% versus 5%; 

<0.0001). The braided suture also was associated with an increased rate of PTB at 24 to 37 weeks’ gestation: 28% versus 17% for monofilament; 

	Although a history of PTB contributed significantly to the nonviable births, the researchers said the braided suture was the “primary driver” of that observed outcome irrespective of potential confounders including maternal age, ethnicity, and parity. It was also the major variable influencing risk of PTB, independent of maternal age, ethnicity, parity, and history of previous PTB. Distribution of cervical length was similar between the braided and monofilament suture groups.

	The braided material, the authors found, caused a “marked shift toward dysbiosis” 4 weeks after cerclage and that change persisted until 16 weeks after the procedure. The material was also associated with an increasing proportion of women with reduced levels of 

 spp and increased diversity of anaerobic bacteria. In contrast, the women who had cerclages with monofilament suture maintained high levels of 

 spp, which remained stable. The researchers also noted that the braided material was associated with increased release of inflammatory cytokines-including interleukin (IL)-1β, IL-6, IL-8, and tumor necrosis factor-α-into cervicovaginal fluid.

	“We estimate that a global shift to monofilament suture use for cervical cerclage would prevent 170,000 PTBs [number needed to treat (NNT), 9.4; 95% confidence interval (CI), 5.9 to 22.6] and 172,000 fetal losses [NNT, 9.3; 95% CI, 6.6 t 16.0) per annum worldwide,” said the authors. 

NEXT: How delaying pregnancy can decrease risk of microcephaly from Zika virus

	How delaying pregnancy can decrease risk of microcephaly from Zika virus

	Strategic delays when planning pregnancy may help mitigate birth defects caused by the Zika virus, according to results of an epidemiologic study published in 

	Researchers used a vector-borne Zika virus transmission model fitted to the epidemiologic data derived from 2015 to 2016 in Colombia. The intervention was recommendations to delay pregnancy by 3, 6, 9, 12, or 24 months, at different levels of adherence. Weekly and cumulative incidence of prenatal infections and microcephaly cases were measured.

	The authors found that with 50% adherence to the recommendations to delay pregnancy by 9 to 24 months, the cumulative incidence of prenatal Zika virus infection was likely to decrease by 17% to 44%, whereas recommendations to delay pregnancy by 6 months or less were likely to increase prenatal infections by 2% to 7%. Researchers noted that delaying pregnancy could lead to women becoming pregnant during the peak of a Zika virus outbreak.

	It was noted that sexual transmission of Zika virus was not explicitly accounted for in the model due to limited data, but it would be implicit in the overall transmission rate.

	The investigators concluded that delaying pregnancy can have a substantial effect on reducing cases of microencephaly but it can exacerbate Zika outbreaks if the duration of the delay is insufficient. Several factors need to be carefully considered when promoting strategic delays, including the timing of initiation of the intervention, duration of the delay, and population adherence. “In the absence of a vaccine or therapeutic drugs for Zika virus infection,” the authors said, “a combination of mass and individual pregnancy-delay strategies with effective vector-control measures is needed to curtail the spread and burden of the ongoing outbreak in the Americas.”

A study examines if ospemifene is linked to increased hot flashes. Plus: Do certain cerclage sutures increase the risk of preterm birth? Also, do pregnancy delays actually decrease the risk of microcephaly as a result of congenital Zika infection?