PROVE—Pre-Eclampsia Obstetric Adverse Events: Establishment of a Biobank and Database for Pre-Eclampsia

Abstract

Pre-eclampsia is a leading cause of maternal and perinatal morbidity and mortality. The burden of disease lies mainly in low-middle income countries. The aim of this project is to establish a pre-eclampsia biobank in South Africa to facilitate research in the field of pre-eclampsia with a focus on phenotyping severe disease.The approach of our biobank is to collect biological specimens, detailed clinical data, tests, and biophysical examinations, including magnetic resonance imaging (MRI) of the brain, MRI of the heart, transcranial Doppler, echocardiography, and cognitive function tests.Women diagnosed with pre-eclampsia and normotensive controls are enrolled in the biobank at admission to Tygerberg University Hospital (Cape Town, South Africa). Biological samples and clinical data are collected at inclusion/delivery and during the hospital stay. Special investigations as per above are performed in a subset of women. After two months, women are followed up by telephonic interviews. This project aims to establish a biobank and database for severe organ complications of pre-eclampsia in a low-middle income country where the incidence of pre-eclampsia with organ complications is high. The study integrates different methods to investigate pre-eclampsia, focusing on improved understanding of pathophysiology, prediction of organ complications, and potentially future drug evaluation and discovery.

Evidence of Neuroinflammation and Blood–Brain Barrier Disruption in Women with Preeclampsia and Eclampsia

“…Women diagnosed with preeclampsia and normotensive controls are enrolled in the biobank at admission to Tygerberg Hospital (Stellenbosch University, Cape Town, South Africa). Biological samples and clinical data are collected at inclusion or delivery, during the hospital stay and postpartum [ 19 ]. Tygerberg Hospital is the largest referral hospital in the Western Cape Provence of South Africa.…”

“…In 2018 there were 32,422 deliveries in the referral area, of which 8067 were considered high risk and delivered at Tygerberg. PROVE biobank includes the majority of women with eclampsia presenting at the hospital, where around 50 women with eclampsia are recruited yearly [ 19 ].…”

“…Ethical approval was obtained (protocol number N18/03/034, Federal Wide assurance number 00001372, Institutional Review Board number IRB0005239) and all included participants signed informed consent before being enrolled in the Preeclampsia Obstetric Adverse Events (PROVE) biobank. The biobank is registered at ISRCTN with registration number ISRCTN10623443 and the protocol has been published previously [ 19 ].…”

“…Data Availability Statement: Anonymized data not published within this article will be made available on request from any qualified investigator after approval, as described in the PROVE protocol [19].…”

“…All included participants signed informed consent before being enrolled in the Preeclampsia Obstetric Adverse Events (PROVE) biobank. The biobank is registered at ISRCTN with registration number ISRCTN10623443 and the protocol has been published previously [ 19 ].…”