Comparing the Risk of Maternal Complications and Adverse Infant Outcomes Among Pregnancies With and Without COVID ‐19 in the Sentinel System
BACKGROUND: SARS-CoV-2 infection during pregnancy may increase the risk of adverse pregnancy outcomes, but knowledge about the timing of COVID-19 infection during pregnancy on these outcomes is limited. OBJECTIVES: We implemented the CONSIGN protocol to examine the impact of COVID-19 on pregnancy-related complications and adverse infant outcomes. STUDY DESIGN: We identified eligible females with live-birth deliveries who had a COVID-19 diagnosis or a positive-confirmed test for SARS-CoV-2. Pregnancies with COVID-19 were propensity score (PS) matched 1:1 to pregnancies without COVID-19 during the 6 months prior to or during pregnancy. RESULTS: From 2020 to 2023, we identified 69 901 pregnancies with COVID-19 and 1:1 matched pregnancies without COVID-19. Most pregnancies with COVID-19 were diagnosed in the third trimester (49%, 33 979/69 901) and < 5% (1860/69 901) were classified as severe. Pregnancies with severe COVID-19 in the first trimester had a higher rate of preterm delivery, and pregnancies with severe COVID-19 in the second trimester had a higher rate of cesarean section compared to those without COVID-19. No increased risk of adverse infant outcomes was observed among 22 865 linked mother-infant pairs with COVID-19 although a slightly increased risk of low birth weight was noted among pregnancies exposed to severe COVID-19 in the third trimester. CONCLUSION: Among nearly 70 000 live-birth pregnancies with COVID-19, severe COVID-19 was associated with cesarean section and preterm delivery. No association with adverse infant outcomes was noted. Our study enabled assessment of the timing and severity of COVID-19 on adverse pregnancy outcomes, although changing treatment and prevention recommendations might impact trends of these outcomes.
Authors
- Andrew B. Petrone (ORCID: https://orcid.org/0000-0001-8413-6236)
- Wei Hua (ORCID: https://orcid.org/0000-0002-2258-1892)
- Yueqin Zhao
- Elizabeth Messenger‐Jones
- Maria E. Kempner
- Jennifer G. Lyons (ORCID: https://orcid.org/0000-0002-5224-0298)
- Sengwee Toh (ORCID: https://orcid.org/0000-0002-5160-0810)
- José J. Hernández‐Muñoz (ORCID: https://orcid.org/0000-0002-2553-3159)
- Austin Cosgrove
- Leyla Şahin (ORCID: https://orcid.org/0000-0002-7685-7524)
- Mayura U. Shinde (ORCID: https://orcid.org/0000-0001-7438-0702)
- Maria Lewis
Institutions
- United States Food and Drug Administration (US)
- Center for Drug Evaluation and Research (US)
- Harvard University (US)
- Harvard Pilgrim Health Care (US)
Publication Details
- Journal
- Pharmacoepidemiology and Drug Safety
- Published
- 2026-10-27
- DOI
- https://doi.org/10.1002/pds.70511
- Primary Topic
- COVID-19 Impact on Reproduction
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Kaiser Permanente
- U.S. Food and Drug Administration