COVID-19 Impact on Reproduction Open access Peer reviewed

Comparing the Risk of Maternal Complications and Adverse Infant Outcomes Among Pregnancies With and Without COVID ‐19 in the Sentinel System

Mayura U. Shinde, Austin Cosgrove, Maria E. Kempner, Jennifer G. Lyons and 8 more

Pharmacoepidemiology and Drug Safety | Oct 27, 2026

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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, was enabled.

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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.

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Mayura U. Shinde

first | Harvard University | ORCID 0000-0001-7438-0702

Austin Cosgrove

middle | Harvard Pilgrim Health Care

Maria E. Kempner

middle | Harvard Pilgrim Health Care

Jennifer G. Lyons

middle | Harvard University | ORCID 0000-0002-5224-0298

Andrew B. Petrone

middle | Harvard Pilgrim Health Care | ORCID 0000-0001-8413-6236

Elizabeth Messenger‐Jones

middle | Harvard Pilgrim Health Care

Maria Lewis

middle | Harvard Pilgrim Health Care

Yueqin Zhao

middle | United States Food and Drug Administration

Leyla Şahin

middle | United States Food and Drug Administration | ORCID 0000-0002-7685-7524

José J. Hernández‐Muñoz

middle | United States Food and Drug Administration | ORCID 0000-0002-2553-3159

Sengwee Toh

middle | Harvard University | ORCID 0000-0002-5160-0810

Wei Hua

last | United States Food and Drug Administration | ORCID 0000-0002-2258-1892

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BibTeX

@article{Shinde2026Comparing,
  title = {Comparing the Risk of Maternal Complications and Adverse Infant Outcomes Among Pregnancies With and Without COVID ‐19 in the Sentinel System},
  author = {Mayura U. Shinde and Austin Cosgrove and Maria E. Kempner and Jennifer G. Lyons and Andrew B. Petrone and Elizabeth Messenger‐Jones and Maria Lewis and Yueqin Zhao and Leyla Şahin and José J. Hernández‐Muñoz and Sengwee Toh and Wei Hua},
  journal = {Pharmacoepidemiology and Drug Safety},
  year = {2026},
  doi = {10.1002/pds.70511},
  url = {https://doi.org/10.1002/pds.70511}
}

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