Open Access Study protocol

The Belgian Diabetes in Pregnancy Study (BEDIP-N), a multi-centric prospective cohort study on screening for diabetes in pregnancy and gestational diabetes: methodology and design

Katrien Benhalima1*, Paul Van Crombrugge23, Johan Verhaeghe1, Sofie Vandeginste2, Hilde Verlaenen3, Chris Vercammen4, Els Dufraimont4, Christophe De Block5, Yves Jacquemyn5, Farah Mekahli6, Katrien De Clippel6, Roland Devlieger1 and Chantal Mathieu1

Author Affiliations

1 Department of Endocrinology and Department of Obstetrics & Gynecology, UZ Gasthuisberg, KU Leuven, Herestraat 49, 3000 Leuven, Belgium

2 Department of Endocrinology and Department of Obstetrics & Gynecology, OLV ziekenhuis Aalst-Asse-Ninove, Moorselbaan 164, 9300 Aalst, Belgium

3 Department of Endocrinology and Department of Obstetrics & Gynecology, OLV ziekenhuis Aalst-Asse-Ninove, Bloklaan 5, 1730 Asse, Belgium

4 Department of Endocrinology and Department of Obstetrics & Gynecology, Imelda ziekenhuis, Imeldalaan 9, 2820 Bonheiden, Belgium

5 Department of Endocrinology and Department of Obstetrics & Gynecology, UZA, Wilrijkstraat 10, 2560 Edegem, Belgium

6 Department of Endocrinology and Department of Obstetrics & Gynecology, Kliniek St-Jan Brussel, Kruidtuinlaan 32, 1000 Brussel, Belgium

For all author emails, please log on.

BMC Pregnancy and Childbirth 2014, 14:226  doi:10.1186/1471-2393-14-226

Published: 11 July 2014

Abstract

Background

The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recommends universal screening with a 75 g oral glucose tolerance test (OGTT) using stricter criteria for gestational diabetes (GDM). This may lead to important increases in the prevalence of GDM and associated costs, whereas the gain in health is unclear. The goal of ‘The Belgian Diabetes in Pregnancy Study’ (BEDIP-N) is to evaluate the best screening strategy for pregestational diabetes in early pregnancy and GDM in an ethnically diverse western European population. The IADPSG screening strategy will be followed, but in addition risk questionnaires and a 50 g glucose challenge test (GCT) will be performed, in order to define the most practical and most cost effective screening strategy in this population.

Methods

BEDIP-N is a prospective observational cohort study in 6 centers in Belgium. The aim is to enroll 2563 pregnant women in the first trimester with a singleton pregnancy, aged 18–45 years, without known diabetes and without history of bariatric surgery. Women are universally screened for overt diabetes and GDM in the first trimester with a fasting plasma glucose and for GDM between 24–28 weeks using the 50 g GCT and independently of the result of the GCT, all women will receive a 75 g OGTT using the IADPSG criteria. Diabetes and GDM will be treated according to a standardized routine care protocol. Women with GDM, will be reevaluated three months postpartum with a 75 g OGTT. At each visit blood samples are collected, anthropometric measurements are obtained and self-administered questionnaires are completed. Recruitment began in April 2014.

Discussion

This is the first large, prospective cohort study rigorously assessing the prevalence of diabetes in early pregnancy and comparing the impact of different screening strategies with the IADPSG criteria on the detection of GDM later in pregnancy.

Trial registration

ClinicalTrials.gov: NCT02036619. Registered 14-1-2014.

Keywords:
Overt diabetes in pregnancy; Gestational diabetes; Screening; Diagnostic criteria