SARS‐CoV‐2 during pregnancy and associated outcomes: Results from an ongoing prospective cohort

  1. Nina M. Molenaar
  2. Anna‐Sophie Rommel
  3. Lotje de Witte
  4. Siobhan M. Dolan
  5. Whitney Lieb
  6. Erona Ibroci
  7. Sophie Ohrn
  8. Jezelle Lynch
  9. Christina Capuano
  10. Daniel Stadlbauer
  11. Florian Krammer
  12. Lauren B. Zapata
  13. Rachel I. Brody
  14. Victor J. Pop
  15. Rebecca H. Jessel
  16. Rhoda S. Sperling
  17. Omara Afzal
  18. Frederieke Gigase
  19. Roy Missall
  20. Teresa Janevic
  21. Joanne Stone
  22. Elizabeth A. Howell
  23. Veerle Bergink

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Abstract

Background

The COVID‐19 pandemic is an ongoing global health threat, caused by the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). Questions remain about how SARS‐CoV‐2 impacts pregnant individuals and their children.

Objective

To expand our understanding of the effects of SARS‐CoV‐2 infection during pregnancy on pregnancy outcomes, regardless of symptomatology, by using serological tests to measure IgG antibody levels.

Methods

The Generation C Study is an ongoing prospective cohort study conducted at the Mount Sinai Health System. All pregnant individuals receiving obstetrical care at the Mount Sinai Healthcare System from 20 April 2020 onwards are eligible for participation. For the current analysis, we included participants who had given birth to a liveborn singleton infant on or before 22 September 2020. For each woman, we tested the latest prenatal blood sample available to establish seropositivity using a SARS‐CoV‐2 serologic enzyme‐linked immunosorbent assay. Additionally, RT‐PCR testing was performed on a nasopharyngeal swab taken during labour. Pregnancy outcomes of interest (i.e., gestational age at delivery, preterm birth, small for gestational age, Apgar scores, maternal and neonatal intensive care unit admission, and length of neonatal hospital stay) and covariates were extracted from medical records. Excluding individuals who tested RT‐PCR positive at delivery, we conducted crude and adjusted regression models to compare antibody positive with antibody negative individuals at delivery. We stratified analyses by race/ethnicity to examine potential effect modification.

Results

The SARS‐CoV‐2 seroprevalence based on IgG measurement was 16.4% (95% confidence interval 13.7, 19.3; n=116). Twelve individuals (1.7%) were SARS‐CoV‐2 RT‐PCR positive at delivery. Seropositive individuals were generally younger, more often Black or Hispanic, and more often had public insurance and higher pre‐pregnancy BMI compared with seronegative individuals. None of the examined pregnancy outcomes differed by seropositivity, overall or stratified by race/ethnicity.

Conclusion

Seropositivity for SARS‐CoV‐2 without RT‐PCR positivity at delivery (suggesting that infection occurred earlier during pregnancy) was not associated with selected adverse maternal or neonatal outcomes among live births in a cohort sample from New York City.

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  1. Version published to 10.1111/ppe.12812
  2. ScreenIT

    SciScore for 10.1101/2021.02.01.21250943: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: All participants provided informed consent per the institutional review board (IRB)-approved study protocol (IRB at the Icahn School of Medicine at Mount Sinai, protocol IRB-20-03352, April 15, 2020).
    IRB: All participants provided informed consent per the institutional review board (IRB)-approved study protocol (IRB at the Icahn School of Medicine at Mount Sinai, protocol IRB-20-03352, April 15, 2020).
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisFor the current interim analysis, we focused on participants who gave birth to a liveborn singleton infant on or before August 15, 2020; we excluded (from this interim analysis) participants with other outcomes (e.g., miscarriage, abortion, stillbirth) due to limited statistical power (n=3).
    Sex as a biological variableStudy design and participants: The Generation C Study is a prospective cohort study designed to examine the impact of SARS-CoV-2 infection and immune response in pregnant women (symptomatic and asymptomatic) on maternal, fetal, and neonatal outcomes.

    Table 2: Resources

    Antibodies
    SentencesResources
    The Generation C Study utilizes existing infrastructure to collect blood samples from pregnant women throughout pregnancy to test for IgG antibodies to SARS-CoV-2.
    IgG
    suggested: None
    SARS-CoV-2
    suggested: None
    Statistical analysis: First, we calculated the SARS-CoV-2 seroprevalence in our sample as the number of women with SARS-CoV-2 spike IgG antibodies divided by the total number of women in the sample and constructed a 95% confidence interval around the estimate.
    SARS-CoV-2 spike IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    SPSS software version 26.0 was used for data analysis.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Strengths and limitations: We measured antibodies with a very sensitive test right after the start of the pandemic in an ethnically and socially diverse sample of pregnant women. The findings of this analysis are subject to limitations. First, we measured SARS-CoV-2 seropositivity in the second and third trimester during antenatal care or at labor and delivery. Consequently, we cannot be certain when these women were infected with SARS-CoV-2. However, since widespread community transmission of SARS-CoV-2 began in March 2020, we can be sure that the infection occurred during pregnancy since all women included in this study delivered by mid-August 2020. Second, due to the putative decay of SARS-CoV-2 antibodies in milder COVID-19 cases over time 16, we cannot preclude potential misclassification of women as seronegative who were infected earlier in pregnancy and no longer produced antibodies at the time of blood sampling. Although our study was designed to collect multiple blood samples from participants during each trimester of pregnancy, very few participants in the current analysis had repeat blood samples; this precluded us from examining potential seroconversion throughout pregnancy. However, recent findings about the serologic assay used in our study indicate that robust antibodies to SARS-CoV-2 infection persist for at least five months in the majority of the people 17. Third, we were unable to obtain information on presence of symptoms which may impact maternal and infa...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from scite Reference Check: We found no unreliable references.

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  3. Version published to 10.1101/2021.02.01.21250943v1 on medRxiv