Pregnancy and birth outcomes after SARS-CoV-2 vaccination in pregnancy

  1. Regan N. Theiler
  2. Myra Wick
  3. Ramila Mehta
  4. Amy L. Weaver
  5. Abinash Virk
  6. Melanie Swift

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Abstract

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  1. Version published to 10.1016/j.ajogmf.2021.100467
  2. ScreenIT

    SciScore for 10.1101/2021.05.17.21257337: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: Creation of the registries and subsequent analysis was performed in accordance with human subjects regulations under approval by the Mayo Clinic Institutional Review Board.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisThis study was designed with 80% power, using a two-sided chi-square test with a type I error rate of 0.05, to detect a difference in AOI of 4.9% vs. at least 11.5% between those without versus with a COVID-19 vaccine during pregnancy, based on 1862 and 140 patients in the two groups.
    Cell Line AuthenticationAuthentication: The delivery registry data is derived directly from elements in the electronic medical record and all fields have been validated manually during development.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Data management and statistical analysis was performed using SAS version 9.4 (SAS institute, Cary, NC, USA).
    SAS institute
    suggested: None

    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:
    Limitations of this analysis include the small percentage of non-white subjects in this geographic region, the potential for confounding due to the observational nature of the study, as well as the data currently available being biased toward those vaccinated later in gestation and skewed toward the population in the United States healthcare workforce. Finally, only two COVID-19 infections occurred in the vaccinated group early in pregnancy, so they may be a group who had lower baseline exposure compared to the unvaccinated group. Our findings should give clinicians confidence that COVID-19 vaccination during pregnancy is effective in preventing maternal SARS-CoV-2 infection, and that no pattern of adverse maternal or neonatal outcomes is evident during pregnancy, adding to the growing body of evidence supporting the safety of COVID vaccines in pregnant women. Additional studies will be needed to examine differences in rare adverse birth outcomes, as well as outcomes following vaccination during early pregnancy. Outreach to under-represented populations of pregnant patients should be a focus of future education and vaccination efforts.

    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 rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

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

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.05.17.21257337v1 on medRxiv