Study protocol: establishment of a multicentre pre-eclampsia database and biobank in Sweden: GO PROVE and UP MOST, a prospective cohort study
Susanne Lager,
Verena Sengpiel,
Anna-Karin Wikström,
Helen Elden,
Lina Bergman,
Isabella Björkman-Burtscher,
Teresia Svanvik,
Karolina Linden,
Ove Karlsson,
Lilja Thorgeirsdottir,
Malin Andersson,
Sven-Egron Thörn,
Jonatan Oras,
Katja Junus,
Ida Enskär,
Teelkien van Veen,
Johan Wikström,
Anna Stigsdotter Neely
Affiliations
Susanne Lager
Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden
Verena Sengpiel
Department of Obstetrics and Gynecology, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden
Anna-Karin Wikström
Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden
Helen Elden
6 Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Lina Bergman
Department of Obstetrics and Gynecology, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden
Isabella Björkman-Burtscher
Department of Radiology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden
Teresia Svanvik
Department of Obstetrics and Gynecology, Region Västra Götaland, Sahlgrenska University Hospital, Goteborg, Sweden
Karolina Linden
6 Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Ove Karlsson
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Lilja Thorgeirsdottir
Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Goteborg, Sweden
Malin Andersson
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Sven-Egron Thörn
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Jonatan Oras
Department of Anaesthesiology and Intensive Care, Institute of clinical sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
Katja Junus
Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden
Ida Enskär
Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden
Teelkien van Veen
Department of Obstetrics and Gynecology, University Medical Center Groningen, Groningen, The Netherlands
Johan Wikström
Department of Surgical Sciences, Neuroradiology, Uppsala University, Uppsala, Sweden
Anna Stigsdotter Neely
Department of Social and Psychological Studies, Karlstad University, Karlstad, Sweden
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).Results from the study will be published in international peer-reviewed journals.Trial registration number ISRCTN13060768
