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COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and
Ylva Carlsson1,2, Lina Bergman1,2, Mehreen Zaigham3,4
1Department of Obstetrics and Gynaecologyhe, Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Insights
This study examines the impact of SARS-CoV-2 (COVID-19) on pregnancy outcomes and long-term maternal and child health. It establishes a biobank and database to track health and parental experiences during the pandemic.
Area of Science:
- Obstetrics and Gynecology
- Infectious Diseases
- Public Health
- Epidemiology
Background:
- Limited knowledge exists on SARS-CoV-2 effects on pregnancy outcomes.
- Studies on COVID-19's impact in early pregnancy and long-term follow-up are scarce.
- Understanding pandemic effects on maternal and child health is crucial.
Purpose of the Study:
- To investigate the impact of COVID-19 on pregnancy outcomes.
- To assess long-term maternal and child health following SARS-CoV-2 infection during pregnancy.
- To examine parental experiences of pregnancy, childbirth, and early parenthood during the COVID-19 pandemic.
Main Methods:
- Prospective, multicentre cohort study in Sweden involving over 86,000 deliveries annually.
- Inclusion of pregnant women who test positive for SARS-CoV-2 (COVID-19 group) or are non-infected (screening group).
- Collection of biological samples, health data from registers, and parental experiences via questionnaires and interviews.
Main Results:
- Data collection ongoing; results to be published in peer-reviewed journals.
- Establishment of a comprehensive database and biobank for pregnant women and infants.
- Analysis of short- and long-term health outcomes and parental experiences.
Conclusions:
- The study will provide crucial insights into the effects of COVID-19 on pregnancy and long-term health.
- Findings will inform clinical practice and public health strategies related to infectious diseases in pregnancy.
- The research addresses a significant gap in understanding the pandemic's impact on families.
Introduction:
There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic.
Methods And Analysis:
This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews.
Ethics And Dissemination:
Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals.
Trial Registration Number:
NCT04433364.
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