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Study protocol: establishment of a multicentre pre-eclampsia database and biobank in Sweden: GO PROVE and UP MOST, a prospective cohort study
Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Göteborg, Sweden.
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID iD: 0000-0003-2020-4695
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
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2021 (English)In: BMJ Open, E-ISSN 2044-6055, Vol. 11, no 11, article id e049559Article in journal (Other academic) Published
Abstract [en]

Introduction Pre-eclampsia, a multisystem disorder in pregnancy, is one of the most common causes of maternal morbidity and mortality worldwide. However, we lack methods for objective assessment of organ function in pre-eclampsia and predictors of organ impairment during and after pre-eclampsia. The women’s and their partners’ experiences of pre-eclampsia have not been studied in detail. To phenotype different subtypes of the disorder is of importance for prediction, prevention, surveillance, treatment and follow-up of pre-eclampsia.

The aim of this study is to set up a multicentre database and biobank for pre-eclampsia in order to contribute to a safer and more individualised treatment and care.

Methods and analysis This is a multicentre cohort study. Prospectively recruited pregnant women ≥18 years, diagnosed with pre-eclampsia presenting at Sahlgrenska University Hospital, Uppsala University Hospital and at Södra Älvsborgs Hospital, Sweden, as well as normotensive controls are eligible for participation. At inclusion and at 1-year follow-up, the participants donate biosamples that are stored in a biobank and they are also asked to participate in various organ-specific evaluations. In addition, questionnaires and interviews regarding the women’s and partner’s experiences are distributed at follow-up.

Ethics and dissemination By creating a database and biobank, we will provide the means to explore the disorder in a broader sense and allow clinical and laboratory discoveries that can be translated to clinical trials aiming at improved care of women with pre-eclampsia. Further, to evaluate experiences and the psychological impact of being affected by pre-eclampsia can improve the care of pregnant women and their partners. In case of incidental pathological findings during examinations performed, they will be handled in accordance with clinical routine. Data are stored in a secure online database. Biobank samples are identified through the women’s personal identification number and pseudonymised after identification in the biobank before analysis.

This study was approved by the regional ethical review board in Gothenburg on 28 December 2018 (approval number 955-18) and by the Swedish Ethical Review Authority on 27 February 2019 (approval number 2019-00309).

Place, publisher, year, edition, pages
BMJ Publishing Group Ltd, 2021. Vol. 11, no 11, article id e049559
Keywords [en]
maternal medicine, neurology, qualitative research, radiology & imaging, ultrasonography
National Category
Obstetrics, Gynecology and Reproductive Medicine
Research subject
Engineering Psychology
Identifiers
URN: urn:nbn:se:ltu:diva-88158DOI: 10.1136/bmjopen-2021-049559ISI: 000722687700018PubMedID: 34819281Scopus ID: 2-s2.0-85120644602OAI: oai:DiVA.org:ltu-88158DiVA, id: diva2:1616202
Funder
Swedish Research Council, 2020-01640
Note

Funder:Swedish Brain Fund, Märta Lundqvist’s foundation, Jane and Dan Olsson’s foundation, the Foundation of the Health and Medical care committee of the Region of Västra Götaland, Sweden (VGFOUREG851391), (VGFOUREG930918), Gothenburg Society of Medicine (GLS934555 and GLS878481), Sahlgrenska University Hospital, ALF Västra Götalands Region (ALFGBG-925851),  Swedish Society for Medical Research and Sahlgrenska University Hospital SU (2018-03591)

Available from: 2021-12-02 Created: 2021-12-02 Last updated: 2023-08-28Bibliographically approved

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Stigsdotter Neely, Anna

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