TY - JOUR
T1 - Study protocol: Establishment of a multicentre pre-eclampsia database and biobank in Sweden
T2 - GO PROVE and up MOST, a prospective cohort study
AU - Thorgeirsdottir, Lilja
AU - Andersson, Malin
AU - Karlsson, Ove
AU - Thörn, Sven Egron
AU - Oras, Jonatan
AU - Sengpiel, Verena
AU - Svanvik, Teresia
AU - Elden, Helen
AU - Linden, Karolina
AU - Junus, Katja
AU - Lager, Susanne
AU - Enskär, Ida
AU - van Veen, Teelkien
AU - Wikström, Johan
AU - Björkman-Burtscher, Isabella
AU - Neely, Anna Stigsdotter
AU - Wikström, Anna Karin
AU - Bergman, Lina
N1 - Funding Information:
Contributors LB and LT wrote the article. LB contributed with information about biosamples in GO PROVE, transcranial Doppler examination, MRI examinations, structure of the online database and inclusion of women in GO PROVE. LT contributed with information about questionnaires, cognitive tests, handling of biosamples and structure of the online database. MA, JO and S-ET provided the methods and contributed to the sections regarding cardiac function and endothelial dysfunction. OK provided the methods and contributed to the sections regarding coagulation. VS contributed to the section about recruitment of the population. TS and SL contributed to the Methods section about placental sampling. HE and KL provided the methods and contributed to the sections regarding women’s experience of childbirth and questionnaires. KJ and TvV contributed to the sections about transcranial Doppler and cerebral autoregulation. IE contributed to the section about recruitment of participants in Uppsala (UPMOST). JW and IB-B provided the methods section and contributed to the sections about MRI. ASN provided the methods section and contributed to the sections about cognitive function tests. A-KW contributed to the section about recruitment in Uppsala and handling of biosamples. All authors revised and approved the final version of the manuscript. Funding This study is supported by the 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 Research Council (2020-01640), Swedish Society for Medical Research and Sahlgrenska University Hospital SU (2018-03591).
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/11/24
Y1 - 2021/11/24
N2 - 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.
AB - 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.
U2 - 10.1136/bmjopen-2021-049559
DO - 10.1136/bmjopen-2021-049559
M3 - Review article
C2 - 34819281
AN - SCOPUS:85120644602
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e049559
ER -