Cohort profile: COVID-19 in a cohort of pregnant women and their descendants, the MOACC-19 study

  1. Javier Llorca
  2. Carolina Lechosa-Muñiz
  3. Pilar Gortázar
  4. María Fernández-Ortiz
  5. Yolanda Jubete
  6. María J. Cabero
  7. the MOACC-19 group
  8. Jéssica Alonso-Molero
  9. Bárbara Arozamena
  10. Laura Conde-Gil
  11. Elsa Cornejo del Río
  12. Rocío Cuesta-González
  13. Trinidad Dierssen-Sotos
  14. Pelayo Frank de Zulueta
  15. Inés Gómez-Acebo
  16. Coral Llano-Ruiz
  17. Lorena Lasarte-Oria
  18. Sonia López-Gómez
  19. Sonia Mateo-Sota
  20. Victoria Orallo
  21. Rosa Pardo
  22. Daniel Pérez González
  23. María Sáez de Adana Herrero

Reviewed by

Read the full article See related articles

Listed in

Log in to save this article

Abstract

Purpose

The Mother and Child Covid-19 study is a cohort recruiting pregnant women and their children in Cantabria, North of Spain, during COVID-19 pandemic in order to ascertain Consequences of SARS-CoV-2 infection on pregnant women and their descendants. This article reports the cohort profile and preliminary results as recruitment is still open.

Participants

Three sub-cohorts can be identified at recruitment. Sub-cohort 1 includes women giving birth between 23 rd March and 25 th May 2020; they have been retrospectively recruited and could have been exposed to COVID-19 only in their third trimester of pregnancy. Sub-cohort 2 includes women giving birth from 26 th May 2020 on; they are being prospectively recruited and could have been exposed to COVID-19 in both their second and third trimesters of pregnancy. Sub-cohort 3 includes women in their 12 th week of pregnancy prospectively recruited from 26 th May 2020 on; they could have been exposed to COVID-19 anytime in their pregnancy. All women are being tested for SARS-CoV-2 infection using both RT-PCR for RNA detection and ELISA for anti-SARS-CoV-2 antibodies. All neonates are being tested for antibodies using immunochemoluminiscency tests; if the mother is tested positive for SARS-CoV-2 RNA, a naso-pharyngeal swab is also obtained from the child for RT-PCR analysis.

Findings to date

As of 22 nd October, 1167 women have been recruited (266, 354 and 547 for sub-cohorts 1, 2 and 3, respectively). Fourteen women tested positive to SARS-CoV-2 RNA by the day of delivery. All fourteen children born from these women tested negative for SARS-CoV-2 RNA.

Future plans

Children from women included in sub-cohort 3 are expected to be recruited by the end of 2020. Children will be followed-up for one year in order to ascertain the effect that COVID-19 on their development.

ARTICLE SUMMARY

Strengths and limitations

Strengths

  • This cohort would ascertain the effect of COVID-19 in both mother and children whatever the trimester of the infection.

  • It would also compare health care provided to pregnant women during the COVID-19 pandemic with that provided in the same hospital before the emergence of COVID-19.

  • The cohort is recruited in Spain, one of the developed countries earlier and more affected by COVID-19.

Limitations

  • The study could be underpowered according to the prevalence reported in a Spanish national study.

  • Information regarding exposure to people infected by SARS-CoV-2 or risk activities is self-reported.

Article activity feed

  1. ScreenIT

    SciScore for 10.1101/2020.08.20.20178657: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical considerations: The study was approved by the Clinical Research Ethics Committee of Cantabria (reference: 2020.174).
    Consent: Two different written informed consents -one for the mother and one for the child-have to be signed by the mother before being admitted in the study.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variableFrom 23th March 2020 on, all pregnant women admitted for delivery were tested to SARS-CoV-2 active infection using RT-PCR. Recruitment: MOACC-19 is intended to recruit at least 1000 pregnant women and their neonates.

    Table 2: Resources

    Antibodies
    SentencesResources
    In the follow up, new blood samples by venopuncture (mother) or finger prick (child) will be obtained at 6 and 12 months in order to study anti-SARS-CoV-2 antibodies.
    anti-SARS-CoV-2
    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:
    Strengths and limitations: In this article we are reporting the inception and first results of a cohort of women who have been pregnant in the COVID-19 pandemic in Spain and their children. The study has some limitations. Firstly, it has been designed for recruiting 1000 women and children under the assumption that prevalence of COVID-19 infection in Spain by 31st March would be about 15%, as suggested by the first version of a report from the Imperial College (36). The fact that a Spanish national study later reported the prevalence to be 5% (37) could make our study underpowered. If it happens, we would deal it by enlarging our cohort. Secondly, information regarding exposure to people infected by SARS-CoV-2 or risk activities is self-reported, which makes it less reliable than recorded variables such as those regarding pregnancy control or delivery results; therefore, some information bias could be expected, although it could possibly be a non-differential one. Thirdly, women participating in the study could be more motivated than women rejecting it. In this regard, recruitment of women in sub-cohort 1 was delayed for some weeks, as many women were reluctant to come back to the hospital in the middle of the pandemic, where news about hospital activity and number of admitted or dead patients by COVID-19 were alarming. As the first wave went on, they became much more cooperative and widely agreed in participating in the study. This did not happen in sub-cohorts 2 and 3 as th...

    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 10.1101/2020.08.20.20178657v2 on medRxiv
  3. Version published to 10.1101/2020.08.20.20178657v1 on medRxiv