Comparing the Risk of Adverse Infant Outcomes Among Pregnancies with and without COVID-19 in the Sentinel System

Tuesday, August 27, 2024

2:00 PM – 2:15 PM CEST

Location: Room XV

Presenting Author(s)

MS

Mayura Shinde, DrPH

Research Scientist
Harvard Pilgrim Health Care Institute, United States

Slides

Co-Author(s)

AC

Austin Cosgrove

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA, United States
MK

Maria E. Kempner

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA, United States
JL

Jennifer G. Lyons

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA, United States
JM

Jolene Mosley

Department of Population Medicine, Harvard Pilgrim HealthCare Institute, Boston, MA, United States
AP

Andrew Petrone

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachuetts, USA, United States
EM

Elizabeth Messenger-Jones

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA, United States
ML

Maria Lewis

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA, United States
YZ

Yueqin Zhao, PhD

Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States
Leyla Sahin, MD

Deputy Director for Safety
Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA
Silver Spring, United States
José J. Hernández-Muñoz, RPh, MPH, MSc, PhD

Pharmacoepidemiologist
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA
The Woodlands, United States
DT

Darren Toh, ScD

Department of Population Medicine, Harvard Pilgrim Health Care Institute, Boston, Massachusetts, USA, United States
WH

Wei Hua, MSc, MHS, MD, PhD

Deputy Division Director
Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, USA, United States

Background: COVID-19 may increase the risk of developing severe illness among pregnant individuals. Several studies have described clinical characteristics and complications among pregnancies with COVID-19, but data on the impact of maternal COVID-19 on adverse infant outcomes is limited.

Objectives: We implemented the CONSIGN protocol (COVID-19 infection and medicines in pregnancy), as part of an international collaboration across Europe, USA, and Canada, to examine the risk of adverse outcomes in infants delivered by pregnant individuals with COVID-19 compared to pregnant individuals without COVID-19.

Methods: We identified linked mother-infant pairs, in which the pregnancy ended in live-birth delivery and had a COVID-19 diagnosis or positive nucleic acid amplification test (NAAT) for SARS-CoV-2, among four Data Partners with Mother-Infant linkage data in the U.S. FDA’s Sentinel Distributed Database. These were matched on maternal age, pregnancy duration, and select clinical conditions to pregnancies with no evidence of COVID-19 during the six months prior to or during pregnancy. To temporally match pregnancies over time, the estimated pregnancy start dates in the matched pairs were required to be within 14 days of each other. We assessed infant outcomes including low birth weight (LBW) and small for gestation age (SGA) in maternal and infant claims within seven days after delivery, and microcephaly and major congenital malformation (MCM) in infant claims within 90 days after delivery.

Results: From January 2020 to December 2022, we identified 22,865 live-birth pregnancies with COVID-19 and 1:1 propensity-score matched pregnancies without COVID-19. Among pregnancies with COVID-19, 54% were diagnosed in the third trimester (12,274) and < 5% (610) were classified as severe (i.e., hospitalized patients with COVID-19 complications, ICU admission, ventilation, or death). The majority of pregnancies (70%) had term deliveries and 6% were preterm. Overall, we found no increased risk of LBW, SGA, microcephaly, or MCM among pregnancies with COVID-19 compared to those without COVID-19. Pregnancies with severe COVID-19 in the third trimester had a higher proportion of LBW (9% vs. 2%) than pregnancies with non-severe COVID-19 during the same trimester.

Conclusions: We identified nearly 23,000 pregnancies with COVID-19 and found no increased risk of adverse infant outcomes compared to pregnancies without COVID-19. Among < 5% of pregnancies with severe COVID-19 in the third trimester, a higher proportion of LBW was noted. Interpretation of findings may be challenging due to the evolution of the COVID-19 pandemic with changes in treatment, and prevention recommendations that may impact the COVID-19 severity.