Clinical trial NCT02036619: The Belgian Diabetes in Pregnancy Study: BEDIP-N Study
Official title: Prospective and Multi-centric Study on Diabetes During Pregnancy in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Diabetes
Keywords: gestational diabetes
pregestational diabetes
screening
diagnostic criteria
IADPSG
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: The National Lottery
name: FWO clinical doctoral scholarship
name: Novo Nordisk A/S
name: Merck Sharp & Dohme LLC
name: Sanofi
name: AstraZeneca
name: Novartis
First posted: 2014-01-15
Enrollment: 2006
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women without known diabetes attending a first prenatal visit in obsetrical centers, both in university and in non-university hospitals

Brief summary: The General hypothesis is that the IADPSG screening strategy for gestational diabetes (GDM) will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for women diagnosed with the two-step screening strategy.

In this prospective multicentric cohort study, women will be universally screened for pregestational diabetes and GDM at the first prenatal visit during the first trimester by measuring the fasting plasma glucose. In the second trimester, women without diagnosis of diabetes or GDM in the first trimester, will be universally screened for GDM using the 50g glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT) with the IADPSG criteria for GDM. Diagnosis of GDM will be based on the 75g OGTT.

Detailed description: Accurate data on the prevalence of gestational diabetes (GDM) are lacking in Belgium and the current practice for screening for GDM varies across different centers. The discrepancy in recommendations is due to the lack of data based on research in our population concerning the best screening strategy for pregestational diabetes in early pregnancy and the lack of data on the best screening strategy for GDM. A substantial number of centers in Belgium already use the IADPSG screening strategy although not always a an universal screening strategy or not always as an one-step screening strategy.

The General hypothesis is that the IADPSG screening strategy will lead to an important increase in the work load and the prevalence of GDM in Belgium but that this might not be cost effective concerning the prevention of adverse pregnancy outcomes. The risk to develop type 2 diabetes postpartum will probably be lower than for women diagnosed with the two-step screening strategy.

In this prospective cohort study, women will be universally screened for pregestational diabetes and GDM at the first prenatal visit during the first trimester by measuring the fasting plasma glucose. GDM will be defined as a fasting plasma glucose ≥100-125mg/dl. This will allow to identify the most important risk factors for the development of GDM.

In the second trimester, women will be universally screened for GDM using the 50g glucose challenge test (GCT) and the 75g oral glucose tolerance test (OGTT)with the IADPSG criteria for GDM. Compared to the IADPSG screening strategy used in normal routine, the 50g GCT will be an extra test specific for the study. Diagnosis of GDM will be based on the 75g OGTT. Participants and researchers will therefore be blinded for the result of the GCT. The results of the GCT test will be used at the end of the study for research purposes only. The use of a GCT as an universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT with the IADPSG criteria only if the GCT is abnormal, is not yet validated and will be evaluated in the study, since this could be a practical solution. Differences in GDM prevalence and pregnancy outcomes will be analyzed using different diagnostic criteria based on the 75g OGTT: the Carpenter \& Coustan criteria, the IADPSG criteria, and threshold values if diagnostic criteria would be based on an odds ratio of 2.0. The evaluation of different screening strategies and different diagnostic criteria will allow to explore the most cost effective methods for identifying women at risk for adverse pregnancy outcomes and at high risk for the development of type 2 diabetes after pregnancy. By using a multivariable risk estimation model based on the most relevant clinical risk factors and biochemical measures for GDM in our own population, the aim is to develop a simple and cost effective screening algorithm.

This study will also allow to evaluate the best short-term follow up strategy postpartum for women with a previous history of GDM. Different screening tests will be used three months postpartum: a fasting plasma glucose, Hba1c and 75g OGTT.

Eligibility criteria: Inclusion Criteria:

* Women between 18-45 years,
* singleton pregnancy
* between 6-13 weeks of pregnancy
* the delivery has to be planned in the hospital where the study is performed.

Exclusion Criteria:

* \< 18 years or \> 45 year
* multiple pregnancy
* known diabetes or taking metformin
* chronic treatment with corticoids
* signs of a miscarriage
* Chronic medical condition: uncontrolled hypertension, severe heart disease, severe chronic liver disease, severe chronic kidney disease, chronic infection (such as HIV or hepatitis)
* bariatric surgery
* delivery is planned in another center than the screening
* a normal follow up and treatment during pregnancy will not be possible (due to incompliance, psychiatric problems, severe communication problems...)
* participating in another study with any medication or intervention ( including life style intervention) up to 90 days before the start of the study

Primary outcomes:
measure: Difference in GDM prevalence between the 2-step and 1-step IADPSG screening strategy
timeFrame: 2 years
measure: The difference in macrosomia rate between GDM and non-GDM groups according to the IADPSG criteria.
timeFrame: 2.5 years
measure: The number of participants with obesity, a history of GDM, a history of prediabetes or a family history of diabetes in women with and without GDM
timeFrame: 2 years
measure: The glucose tolerance status 3 months postpartum in women with recent GDM.
timeFrame: 3 years
Secondary outcomes:
measure: Differences in rate of large for gestational age baby's, pre-eclampsia and caesarean section between GDM and non-GDM groups according to different diagnostic criteria
timeFrame: 2.5 years
measure: The sensitivity and the specificity of the 50g glucose challenge test as a universal screening tool in a two-step approach with the use of the 75g 2-hour OGTT
timeFrame: 2.5 years
measure: Prevalence of pregestational diabetes in early pregnancy
timeFrame: 2 years
measure: The number of participants with dyslipidaemia and hypertension in women with and without GDM
timeFrame: 2.5 years
measure: Percentage body fat and c-peptide on cord blood in the offspring at birth of mothers with diabetes/GDM and without diabetes/GDM.
timeFrame: 3 years
measure: The prevalence of MODY-2 in women with a fasting plasma glucose ≥92mg/dl in early and late pregnancy
timeFrame: 3 years
measure: The prevalence of women with a fasting plasma glucose ≥ 92-99mg/dl in early pregnancy to have a normal 75g OGTT between 26-28 weeks of pregnancy.
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerpen
country: Belgium
facility: UZA
city: Asse
country: Belgium
facility: OLV Aalst-site Asse
city: Bonheiden
country: Belgium
facility: Imelda Bonheiden
city: Brugge
country: Belgium
facility: AZ St Jan
city: Brussel
country: Belgium
facility: Kliniek St Jan Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Katrien Benhalima, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raets L, Vandewinkel M, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, Roggen N, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Preference of Women for Gestational Diabetes Screening Method According to Tolerance of Tests and Population Characteristics. Front Endocrinol (Lausanne). 2021 Nov 8;12:781384. doi: 10.3389/fendo.2021.781384. eCollection 2021.
citation: Minschart C, De Weerdt K, Elegeert A, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Devlieger R, Mathieu C, Benhalima K. Antenatal Depression and Risk of Gestational Diabetes, Adverse Pregnancy Outcomes, and Postpartum Quality of Life. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3110-e3124. doi: 10.1210/clinem/dgab156.
citation: Benhalima K, Van Crombrugge P, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Devlieger R, Mathieu C. 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. BMC Pregnancy Childbirth. 2014 Jul 11;14:226. doi: 10.1186/1471-2393-14-226.