BMJ Open (Sep 2021)

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

  • Anders Elfvin,
  • Åsa Leijonhufvud,
  • Sophia Brismar Wendel,
  • Magnus Domellöf,
  • Thomas Abrahamsson,
  • Anna Wessberg,
  • Helena Fadl,
  • Maria Jonsson,
  • Verena Sengpiel,
  • Anna-Karin Wikström,
  • Ulrika Aden,
  • Ola Andersson,
  • Lina Bergman,
  • Marie Blomberg,
  • Fredrik Ahlsson,
  • Anna Sandström,
  • Ylva Carlsson,
  • Johanna Berg,
  • Jan-Åke Liljeqvist,
  • Mehreen Zaigham,
  • Karolina Linden,
  • Malin Veje,
  • Hanna Östling,
  • Anna Hagman,
  • Anna Sand,
  • Anna-Carin Wihlbäck,
  • Elin Naurin,
  • Emma Von Wowern,
  • Gilda Dumitrescu,
  • Gustaf Biasoletto,
  • Johan Berg,
  • Kathrin Rothbarth,
  • Kristina Pettersson,
  • Linda Hjertberg,
  • Linda Iorizzo,
  • Magnus Lindh,
  • Maria Lindqvist,
  • Maria Revelj,
  • Maria Svenvik,
  • Marie Vikström Bolin,
  • Marie-Charlotte Nilsson,
  • Matilda Friman Mathiasson,
  • Merit Kullinger,
  • Mirjana Janes-Nakic,
  • Ove Karlsson,
  • Pihla Kuusela,
  • Sandra Holmström,
  • Sofie Graner,
  • Susanne Woxenius,
  • Åsa Pontén

DOI
https://doi.org/10.1136/bmjopen-2021-049376
Journal volume & issue
Vol. 11, no. 9

Abstract

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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.