Evaluation of COVID-19 as a risk factor for maternal-fetal and neonatal complications: protocol of a systematic review and meta-analysis of cohort and case-control studies

  1. Priscila Bezerra
  2. Fernanda Gabriella de Siqueira Barros Nogueira
  3. Alan Chaves dos Santos
  4. Anna katharina Souza Lima
  5. Davi Emanuel Ribeiro
  6. Elias Almeida Silva Barbosa
  7. Suellen Casado dos Santos
  8. Clístenes Crístian de Carvalho

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Abstract

Background

COVID-19 in pregnant women has been suggested to impair maternal-fetal and neonatal outcomes. We then designed the present systematic review with meta-analysis to evaluate the repercussion of such disease over maternal fetal and neonatal mortality, need for intensive care, way of delivery, premature delivery, birth weight, Apgar score, presence of intrauterine growth restriction (IGR), and presence of amniotic fluid change.

Methods

We will conduct a computerized search through MEDLINE/PubMed, LILACS/BIREME, Web of science, Biorxiv, Medrxiv, and Embase on July 23, 2020. We will include cohort and case-control studies fully reported comparing pregnant women with COVID-19 with those not affected by the disease for maternal fetal and neonatal mortality, need for intensive care, way of delivery, premature delivery occurrence, birth weight, Apgar scores, presence of intrauterine growth restriction, and presence of amniotic fluid change. Three doubles of reviewers will perform in duplicate and independently all steps on screening, risk of bias judgments, and data extraction with ability to discuss disagreements with supervising authors. Pooled effects will be estimated by both fixed and random-effects models and presented according to qualitative and quantitative heterogeneity assessment. Sensitivity analyses will be performed as well as a priori subgroup, meta-regression and multiple meta-regression analyses. We’ll also evaluate the risk of selective publication by assessing funnel plot asymmetry and the quality of the evidence by the application of the GRADE recommendations.

Discussion

This systematic review with meta-analysis aims to assess the repercussion of COVID-19 in pregnant women over maternal-fetal and neonatal outcomes and to help clinicians and health systems improve such population outcomes throughout the current pandemic.

Systematic review registration

This review protocol was also submitted to PROSPERO registration on February 9, 2021.

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  1. ScreenIT

    SciScore for 10.1101/2021.02.23.21252294: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variable4) Comparison between pregnant women with and without COVID-19.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Information sources: We will conduct a computerized search through MEDLINE/PubMed, LILACS/BIREME, Web of science, Biorxiv, Medrxiv, and Embase on July
    Biorxiv
    suggested: (bioRxiv, RRID:SCR_003933)
    Embase
    suggested: (EMBASE, RRID:SCR_001650)
    (fetus[MeSH] OR fetus* OR “fetal structure*” OR fetal OR “fetal tissue” OR “retained fetus” OR pregnancy[MeSH] OR pregnanc* OR gestation OR “pregnant women”[MeSH] OR “prenatal care”[MeSH] OR “antenatal care” OR “infant, newborn”[MeSH] OR newborn* OR neonate* OR “newborn infant*” OR “pregnancy, high-risk”[MeSH] OR “high-risk pregnanc*” OR “high risk pregnanc*” OR “pregnancy complications”[MeSH] OR “complication, pregnancy” OR “complications, pregnancy” OR “pregnancy outcome”[MeSH] OR “pregnancy outcomes” OR “outcome, pregnancy” OR “outcomes, pregnancy” OR “maternal mortality”[MeSH] OR “maternal mortalit*” OR “mortality, maternal” OR “infant, newborn, diseases”[MeSH] OR “neonatal disease*” OR “disease, neonatal” OR “diseases, neonatal” OR “congenital abnormalities”[MeSH] OR “congenital abnormalit*” OR “congenital defects” OR “birth defect*” OR deformit* OR “fetal distress”[MeSH] OR “nonreassuring fetal status” OR “fetal diseases”[MeSH] OR “fetal disease*” OR “embryopath*” OR “perinatal death”[MeSH] OR “perinatal death*” OR “neonatal death*” OR “death, perinatal” OR “deaths, perinatal” OR “death, neonatal” OR “deaths, neonatal”) Study records: Retrieved references will be taken to EPPI Reviewer Web (Beta) for screening steps – “title and abstract” then “full text”.
    MeSH
    suggested: (MeSH, RRID:SCR_004750)
    Analyses will be conducted in Review Manager (RevMan, London, UK, v5.3.5) and R software tools (R Foundation for Statistical Computing, Vienna, Austria), as appropriate.
    RevMan
    suggested: (RevMan, RRID:SCR_003581)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    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.

  2. Version published to 10.1101/2021.02.23.21252294v1 on medRxiv