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

Carlsson, Ylva ; Bergman, Lina ; Zaigham, Mehreen LU orcid ; Linden, Karolina LU orcid ; Andersson, Ola LU orcid ; Veje, Malin ; Sandström, Anna ; Wikström, Anna-Karin ; Östling, Hanna and Fadl, Helena , et al. (2021) In BMJ Open 11(9).
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... (More)

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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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
BMJ Open
volume
11
issue
9
article number
e049376
publisher
BMJ Publishing Group
external identifiers
  • scopus:85115257400
  • pmid:34521667
ISSN
2044-6055
DOI
10.1136/bmjopen-2021-049376
project
COVID-19 in Pregnancy & Early Childhood
language
English
LU publication?
yes
id
90695631-6b84-40a2-86a5-c57c1c26d772
date added to LUP
2021-09-17 22:47:38
date last changed
2024-04-20 11:25:46
@article{90695631-6b84-40a2-86a5-c57c1c26d772,
  abstract     = {{<p>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.</p><p>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.</p><p>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.</p><p>TRIAL REGISTRATION NUMBER: NCT04433364.</p>}},
  author       = {{Carlsson, Ylva and Bergman, Lina and Zaigham, Mehreen and Linden, Karolina and Andersson, Ola and Veje, Malin and Sandström, Anna and Wikström, Anna-Karin and Östling, Hanna and Fadl, Helena and Domellöf, Magnus and Blomberg, Marie and Brismar Wendel, Sophia and Åden, Ulrika and Sengpiel, Verena}},
  issn         = {{2044-6055}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{COVID-19 in Pregnancy and Early Childhood (COPE) : study protocol for a prospective, multicentre biobank, survey and database cohort study}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2021-049376}},
  doi          = {{10.1136/bmjopen-2021-049376}},
  volume       = {{11}},
  year         = {{2021}},
}