COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study

Abstract

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.

Keywords: COVID-19; epidemiology; neonatology; obstetrics.

Figure 1

(A) COVID-19 group: data and biospecimen collection overview. (B) Screening group: data and biospecimen collection overview. BSES, Breastfeeding Self-Efficacy Scale short form; CEQ, Childbirth Experience Questionnaire; COPE, COVID-19 in Pregnancy and Early Childhood; EPDS, Edinburgh Postnatal Depression Scale; EQ5D, EuroQol 5D; FTFQ, First Time Fathers Questionnaire; GSE, General Self-Efficacy scale; HADS, Hospital Anxiety and Depression Scale; SOC, Sense of Coherence Scale; SQ-PTSD, Screen Questionnaire-Post-Traumatic Stress Disorder; VAS, Visual Analogue Scale.