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COVID-19 vaccination in pregnancy: early experience from a single institution [Letter]

Trostle, Megan E; Limaye, Meghana A; Avtushka, Valeryia; Lighter, Jennifer L; Penfield, Christina A; Roman, Ashley S
OBJECTIVE:Vaccination presents an important strategy to mitigate illness in this population. However, there is a paucity of data on vaccination safety and pregnancy outcomes because pregnant women were excluded from the initial phase III clinical trials. Our objective was to describe the maternal, neonatal, and obstetrical outcomes of women who received a messenger RNA (mRNA) COVID-19 vaccination while pregnant during the first 4 months of vaccine availability. STUDY DESIGN/METHODS:This was an institutional review board-approved descriptive study of pregnant women at New York University Langone Health who received at least 1 dose of an mRNA COVID-19 vaccination approved by the US Food and Drug Administration (FDA) (Pfizer-BioNTech or Moderna) from the time of the FDA Emergency Use Authorization to April 22, 2021. Eligible women were identified via search of the electronic medical record (EMR) system. Vaccine administration was ascertained via immunization records from the New York State Department of Health. Women were excluded if they were vaccinated before conception or during the postpartum period. Charts were reviewed for maternal demographics and pregnancy outcomes. Descriptive analyses were performed using the R software version 4.0.2 (The R Foundation, Boston, MA). RESULTS:We identified 424 pregnant women who received an mRNA vaccination. Of those, 348 (82.1%) received both doses and 76 (17.9%) received only 1 dose. The maternal characteristics and vaccination information are shown in Table 1. Of the included women, 4.9% had a history of a confirmed COVID-19 diagnosis before vaccination. After vaccination, no patient in our cohort was diagnosed with COVID-19. In terms of the pregnancy outcomes, 9 women had spontaneous abortions, 3 terminated their pregnancies, and 327 have ongoing pregnancies. Of the women included, 85 delivered liveborn infants. There were no stillbirths in our population. Of the 9 spontaneous abortions, 8 occurred during the first trimester at a range of 6 to 13 weeks' gestation. There was 1 second trimester loss. The rate of spontaneous abortion among women vaccinated in the first trimester was 6.5%. The 327 women with ongoing pregnancies have been followed for a median of 4.6 weeks (range, 0-17 weeks) following their most recent dose. A total of 113 (34.6%) women, initiated vaccination during the first trimester, 178 (54.4%) initiated vaccination during the second trimester, and 36 (11.0%) during the third trimester. Following the vaccination, 2 fetuses (0.6%) developed intrauterine growth restriction, whereas 5 (1.5%) were diagnosed with anomalies. Outcomes for the 85 women who delivered are shown in Table 2. Of the women who delivered, 18.8% were diagnosed with a hypertensive disorder of pregnancy. The rate of preterm birth was 5.9%. One preterm delivery was medically indicated, whereas the remaining 3 were spontaneous. A total of 15.3% of neonates required admission to the neonatal intensive care unit (NICU). Of the NICU admissions, 61.5% were because of hypoglycemia or an evaluation for sepsis. Other reasons for admission included prematurity, hypothermia, and transient tachypnea of the newborn. Of all the neonates, 12.2% were small for gestational age (SGA) per the World Health Organization standards. CONCLUSION/CONCLUSIONS:Our rate of pregnancy-related hypertensive disorders is higher than our baseline institutional rate of 9.5%, however, this may be because of the underlying characteristics of our study population or skewing of our small sample size. Our 12.2% rate of SGA neonates is near the expected value based on the definition that 10% of neonates will be SGA at birth. The NICU admission rate is at par with our institutional rate of 12%. To date, most women in this series have had uncomplicated pregnancies and have delivered at-term. Strengths of this study include using the EMR system to identify subjects and gather data. We did not rely on self-enrollment and self-report, thereby reducing selection and recall bias. By performing manual chart reviews, we obtained detailed and reliable information about individual patients. One limitation of this study is the lack of a matched control group consisting of unvaccinated pregnant women and therefore direct conclusions could not be drawn about the relative risks of complications. In addition, our cohort is small and may not be generalizable. Finally, many women included are healthcare workers who had early access to vaccinations. As more pregnant women become eligible for the COVID-19 vaccinations, there is an urgent need to report on the maternal, neonatal, and obstetrical outcomes of COVID-19 vaccinations during pregnancy. The results of this study can be used to counsel and reassure pregnant patients facing this decision.
PMID: 34411758
ISSN: 2589-9333
CID: 5012972

Pregnant women with severe or critical COVID-19 have increased composite morbidity compared to non-pregnant matched controls

DeBolt, Chelsea A; Bianco, Angela; Limaye, Meghana A; Silverstein, Jenna; Penfield, Christina A; Roman, Ashley S; Rosenberg, Henri M; Ferrara, Lauren; Lambert, Calvin; Khoury, Rasha; Bernstein, Peter S; Burd, Julia; Berghella, Vincenzo; Kaplowitz, Elianna; Overbey, Jessica R; Stone, Joanne
BACKGROUND:In March 2020, as community spread of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) became increasingly prevalent, pregnant women appeared to be equally susceptible to developing Coronavirus Disease 2019 (COVID-19). While the disease course usually appears mild, severe and critical COVID-19 appears to lead to significant morbidity including ICU admission with prolonged hospital stay, intubation, mechanical ventilation and even death. Although there are recent reports regarding the impact of COVID-19 on pregnancy, information regarding the severity of COVID-19 in pregnant versus non-pregnant women remains unknown. OBJECTIVE:We aim to describe the outcomes of severe and critical COVID-19 infection in pregnant versus non-pregnant reproductive aged women. STUDY DESIGN/METHODS:This is a multi-center retrospective case-control study of women with laboratory confirmed SARS-CoV-2 infection hospitalized with severe or critical COVID-19 in four academic medical centers in NYC and one in Philadelphia between March 12 and May 5, 2020. The cases consist of pregnant women admitted specifically for severe or critical COVID-19 and not for obstetric indication. The controls consist of reproductive aged, non-pregnant women admitted for severe or critical COVID-19. The primary outcome is a composite morbidity including: death, need for intubation, extracorporeal membrane oxygenation (ECMO), non-invasive positive pressure ventilation or need for high flow nasal cannula oxygen supplementation. Secondary outcomes include ICU admission, length of stay, need for discharge to long term acute care facility and discharge with home oxygen requirement. RESULTS:Thirty-eight pregnant women with SARS-CoV-2 polymerase chain reaction (PCR) confirmed infection were admitted to five institutions specifically for COVID-19, 29 (76.3%) meeting criteria for severe disease and 9 (23.7%) meeting criteria for critical disease. The mean age and BMI were significantly higher in the non-pregnant control group. The non-pregnant cohort was also noted to have increased frequency of pre-existing medical comorbidities, including diabetes, hypertension and coronary artery disease. Pregnant women were more likely to experience the primary outcome when compared to the non-pregnant control group (34.2% vs. 14.9%, p=0.03, adjusted OR 4.6 [95% CI 1.2-18.2]). Pregnant patients experienced higher rates of ICU admission (39.5% vs. 17.0%, p<0.01, adjusted OR 5.2 [95% CI 1.5-17.5]). Among pregnant women that underwent delivery, 72.7% occurred via cesarean delivery and mean gestational age at delivery was 33.8 ±5.5 weeks in patients with severe disease and 35 ±3.5 weeks in patients with critical COVID-19. CONCLUSIONS:Pregnant women with severe and/or critical COVID-19 are at increased risk for certain morbidities when compared to non-pregnant controls. Despite the higher comorbidities of diabetes and hypertension in the non-pregnant controls, the pregnant cases were at increased risk for composite morbidity, intubation, mechanical ventilation and ICU admission. These findings suggest that pregnancy may be associated with a worse outcome in women with severe and critical COVID-19. Our study suggests that similar to other viral infections such as SARS-CoV and MERS-CoV, pregnant women may be at risk for greater morbidity and disease severity.
PMID: 33221292
ISSN: 1097-6868
CID: 4680062

Differential Uptake of Telehealth for Prenatal Care in a Large New York City Academic Obstetrical Practice during the COVID-19 Pandemic

Limaye, Meghana A; Lantigua-Martinez, Meralis; Trostle, Megan E; Penfield, Christina A; Conroy, Erin M; Roman, Ashley S; Mehta-Lee, Shilpi S
During the coronavirus disease 2019 (COVID-19) pandemic in New York City, telehealth was rapidly implemented for obstetric patients. Though telehealth for prenatal care is safe and effective, significant concerns exist regarding equity in access among low-income populations. We performed a retrospective cohort study evaluating utilization of telehealth for prenatal care in a large academic practice in New York City, comparing women with public and private insurance. We found that patients with public insurance were less likely to have at least one telehealth visit than women with private insurance (60.9 vs. 87.3%, p < 0.001). After stratifying by borough, this difference remained significant in Brooklyn, one of the boroughs hardest hit by the pandemic. As COVID-19 continues to spread around the country, obstetric providers must work to ensure that all patients, particularly those with public insurance, have equal access to telehealth. KEY POINTS: · Telehealth for prenatal care is frequently utilized during the COVID-19 pandemic.. · Significant concerns exist regarding equity in access among lower-income populations.. · Women with public insurance in New York City were less likely to access telehealth for prenatal care..
PMID: 33302308
ISSN: 1098-8785
CID: 4709222

A Modern Measles Outbreak: Understanding maternal immunity and impact on postpartum vaccination uptake

Hirschberg, Carly I; Limaye, Meghana; Roman, Ashley; Friedman, Steven; Lighter, Jennifer L; Deeb, Jessica; Schweizer, William; Wei, Lili; Mehta-Lee, Shilpi S
OBJECTIVE:In October 2018, a measles (rubeola) outbreak was identified in New York City (NYC) & Rockland County (RC) and a public health campaign and hospital policy changes were made to increase awareness of the importance of vaccination and increase vaccination rates. We describe the prevalence of rubeola immunity in pregnant women and the change in uptake of postpartum MMR vaccination before and during the measles outbreak. METHODS:A multi-pronged intervention was developed by the health system with the intent of raising awareness of the outbreak, identifying patients at risk of contracting measles during pregnancy, and limiting exposure of inpatients to the disease. This was a quality improvement study to assess the impact of the intervention and public health policy on the rates of documentation of rubeola immunity and rubeola vaccination rates in non-immune women. Women who delivered at NYU Langone Health prior to the outbreak (7/1/2016 to 7/1/2017) were compared to women who delivered during the outbreak (7/1/18 to 7/1/19). The primary outcome was acceptance of MMR vaccination in non-immune women during the postpartum period. Analysis was conducted using logistic regression and chi-square tests, and alpha was set at 0.05. RESULTS:19585 patients were analyzed. 9,162 women delivered prior to outbreak and 10,423 delivered during the outbreak. Of these, 2589 (13.2%) were documented as living in a high-risk ZIP code, which were areas at the epicenter of the measles outbreak. 14,731 women (75.2%) were tested for rubeola immunity and 3270 (22.2%) of those tested were not immune. In the year of the outbreak, a higher proportion of women had rubeola immunity documented with serum titers than in the year prior to the outbreak (81% vs. 69%, p<0.001). Inpatient compliance with postpartum MMR administration was greater during the outbreak than prior to it (76% vs 59%, p <.001) for patients from both low risk and high-risk ZIP codes. CONCLUSION/CONCLUSIONS:The NYC & RC measles outbreak, together with implementation of a health system wide education program and a change in public health policy led to an increase in the proportion of pregnant women being screened for rubeola immunity. It also led to an increase in uptake of the immediate postpartum MMR vaccine.
PMID: 33453442
ISSN: 2589-9333
CID: 4760102

COVID-19 in pregnancy: creating an outpatient surveillance model in a public hospital system

Trostle, Megan E; Silverstein, Jenna S; Tubridy, Elizabeth; Limaye, Meghana A; Rose, Jessica; Brubaker, Sara G; Chervenak, Judith L; Denny, Colleen C
Objectives We describe a standardized, scalable outpatient surveillance model for pregnant women with COVID-19 with several objectives: (1) to identify and track known, presumed, and suspected COVID-positive pregnant patients both during their acute illness and after recovery, (2) to regularly assess patient symptoms and escalate care for those with worsening disease while reducing unnecessary hospital exposure for others, (3) to educate affected patients on warning symptoms, hygiene, and quarantine recommendations, and (4) to cohort patient care, isolating stable infected patients at home and later within the same physical clinic area upon their return to prenatal care. Methods Pregnant women in an urban public hospital system with presumed or confirmed COVID-19 were added to a list in our electronic medical record as they came to the attention of providers. They received a series of phone calls based on their illness severity and were periodically assessed until deemed stable. Results A total of 83 patients were followed between March 19 and May 31, 2020. Seven (8%) were asymptomatic, 62 (75%) had mild disease, 11 (13%) had severe disease, and three (4%) had critical illness. Conclusions We encourage others to develop and utilize outpatient surveillance systems to facilitate appropriate care and to optimize maternal and fetal well-being.
PMID: 32809968
ISSN: 1619-3997
CID: 4563402

A review of fetal and neonatal consequences of maternal systemic lupus erythematosus

Limaye, Meghana A; Buyon, Jill P; Cuneo, Bettina F; Mehta-Lee, Shilpi S
Systemic lupus erythematosus (SLE) primarily affects women of childbearing age and is commonly seen in pregnancy. The physiologic and immunologic changes of pregnancy may alter the course of SLE and impact maternal, fetal and neonatal health. Multi-disciplinary counseling before and during pregnancy from rheumatology, maternal fetal medicine, obstetrics, and pediatric cardiology is critical. Transplacental passage of autoantibodies, present in about 40% of women with SLE, can result in neonatal lupus (NL). NL can consist of usually permanent cardiac manifestations, including conduction system and myocardial disease, as well as transient cutaneous, hematologic and hepatic manifestations. Additionally, women with SLE are more likely to develop adverse pregnancy outcomes such as preeclampsia, fetal growth restriction, and preterm birth, perhaps due to an underlying effect on placentation. This review describes the impact of SLE on maternal and fetal health by trimester, beginning with pre-pregnancy optimization of maternal health. This is followed by a discussion of neonatal lupus and the current understanding of the epidemiology and pathophysiology of anti-Ro/La mediated cardiac disease, as well as screening, treatment and methods for prevention. Finally discussed is the known increase in preeclampsia and fetal growth issues in women with SLE that can lead to iatrogenic preterm delivery. This article is protected by copyright. All rights reserved.
PMID: 32282083
ISSN: 1097-0223
CID: 4383182

Characteristics and Outcomes of 241 Births to Women With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection at Five New York City Medical Centers

Khoury, Rasha; Bernstein, Peter S; Debolt, Chelsea; Stone, Joanne; Sutton, Desmond M; Simpson, Lynn L; Limaye, Meghana A; Roman, Ashley S; Fazzari, Melissa; Penfield, Christina A; Ferrara, Lauren; Lambert, Calvin; Nathan, Lisa; Wright, Rodney; Bianco, Angela; Wagner, Brian; Goffman, Dena; Gyamfi-Bannerman, Cynthia; Schweizer, William E; Avila, Karina; Khaksari, Bijan; Proehl, Meghan; Heitor, Fabiano; Monro, Johanna; Keefe, David L; DʼAlton, Mary E; Brodman, Michael; Makhija, Sharmila K; Dolan, Siobhan M
OBJECTIVE:To describe the characteristics and birth outcomes of women with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as community spread in New York City was detected in March 2020. METHODS:We performed a prospective cohort study of pregnant women with laboratory-confirmed SARS-CoV-2 infection who gave birth from March 13 to April 12, 2020, identified at five New York City medical centers. Demographic and clinical data from delivery hospitalization records were collected, and follow-up was completed on April 20, 2020. RESULTS:Among this cohort (241 women), using evolving criteria for testing, 61.4% of women were asymptomatic for coronavirus disease 2019 (COVID-19) at the time of admission. Throughout the delivery hospitalization, 26.5% of women met World Health Organization criteria for mild COVID-19, 26.1% for severe, and 5% for critical. Cesarean birth was the mode of delivery for 52.4% of women with severe and 91.7% with critical COVID-19. The singleton preterm birth rate was 14.6%. Admission to the intensive care unit was reported for 17 women (7.1%), and nine (3.7%) were intubated during their delivery hospitalization. There were no maternal deaths. Body mass index (BMI) 30 or higher was associated with COVID-19 severity (P=.001). Nearly all newborns tested negative for SARS-CoV-2 infection immediately after birth (97.5%). CONCLUSION/CONCLUSIONS:During the first month of the SARS-CoV-2 outbreak in New York City and with evolving testing criteria, most women with laboratory-confirmed infection admitted for delivery did not have symptoms of COVID-19. Almost one third of women who were asymptomatic on admission became symptomatic during their delivery hospitalization. Obesity was associated with COVID-19 severity. Disease severity was associated with higher rates of cesarean and preterm birth.
PMID: 32555034
ISSN: 1873-233x
CID: 4485172

Authors' reply re: 'Vaginal seeding' after a caesarean section provides benefits to newborn children: AGAINST: Vaginal microbiome transfer-a medical procedure with clear risks and uncertain benefits [Letter]

Limaye, Meghana A; Ratner, Adam J
PMID: 32150323
ISSN: 1471-0528
CID: 4349622

Detection of SARS-COV-2 in Placental and Fetal Membrane Samples

Penfield, Christina A; Brubaker, Sara G; Limaye, Meghana A; Lighter, Jennifer; Ratner, Adam J; Thomas, Kristen M; Meyer, Jessica; Roman, Ashley S
Introduction/UNASSIGNED:findings that may indicate vertical transmission of the virus in utero. We report our experience with placental/membrane SARS-CoV2 RNA PCR swab results after delivery to a series of symptomatic mothers with confirmed COVID-19 infection in pregnancy. Methods/UNASSIGNED:The time interval from maternal diagnosis of COVID-19 to delivery was calculated in days. Infants were tested with nasopharyngeal swabs for SARS-CoV-2 PCR between days of life 1 and 5 while hospitalized. Hospitalized infants were also assessed for clinical signs and symptoms, including fever, cough, and nasal congestion. Results/UNASSIGNED:Of 32 COVID-19 positive pregnant patients who gave birth in this timeframe, placental or membrane swabs were sent from 11 patients (Table). Three of 11 swabs were positive. None of the infants tested positive for SARS-CoV2 on days of life 1 through 5, and none demonstrated symptoms of COVID-19 infection. Discussion/UNASSIGNED:Although all of our neonates tested negative in the first 5 days of life, many were born via cesarean deliveries with decreased length of exposure to these tissues, which may be associated with a decreased likelihood of vertical transmission. Additionally, nasopharyngeal testing immediately after delivery may not be the ideal approach to evaluate vertical transmission if exposure occurs at the time of delivery, as the virus may require a longer incubation period before these swabs convert to positive. In summary, the presence of viral RNA by RT-PCR in placenta/membranes at the time of delivery suggests the need for further research into the possibility of vertical transmission.
PMID: 32391518
ISSN: 2589-9333
CID: 4430942

Acute Respiratory Decompensation Requiring Intubation in Pregnant Women with SARS-CoV-2 (COVID-19) [Case Report]

Silverstein, Jenna S; Limaye, Meghana A; Brubaker, Sara G; Roman, Ashley S; Bautista, Judita; Chervenak, Judith; Ratner, Adam J; Sommer, Philip M; Roselli, Nicole M; Gibson, Charlisa D; Ellenberg, David; Penfield, Christina A
There is a current paucity of information about the obstetric and perinatal outcomes of pregnant novel coronavirus disease 2019 (COVID-19) patients in North America. Data from China suggest that pregnant women with COVID-19 have favorable maternal and neonatal outcomes, with rare cases of critical illness or respiratory compromise. However, we report two cases of pregnant women diagnosed with COVID-19 in the late preterm period admitted to tertiary care hospitals in New York City for respiratory indications. After presenting with mild symptoms, both quickly developed worsening respiratory distress requiring intubation, and both delivered preterm via caesarean delivery. These cases highlight the potential for rapid respiratory decompensation in pregnant COVID-19 patients and the maternal-fetal considerations in managing these cases.
PMID: 32509416
ISSN: 2157-6998
CID: 4477762