The Belgian Diabetes in Pregnancy Study: BEDIP-N Study

NCT02036619 | Completed DMC

• 1 other identifier: BEDIP-N study
• Study Type: observational
• Target: 2,006
• Locations: 1 country
• Sites: 7

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.

Conditions

Gestational Diabetes; Diabetes

Keywords

gestational diabetes; pregestational diabetes; screening; diagnostic criteria; IADPSG

Outcome Measures

Primary Outcomes (4)

• Difference in GDM prevalence between the 2-step and 1-step IADPSG screening strategy

  Evaluation of the difference in GDM prevalence between the 2-step (50 glucose challenge test followed by a 75g OGTT) and 1-step IADPSG (directly 75g OGTT) screening strategy.

  2 years

• The difference in macrosomia rate between GDM and non-GDM groups according to the IADPSG criteria.

  2.5 years

• 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

  risk factors will be analyzed such as ethnicity, maternal age, maternal BMI, family history of diabetes, history of GDM, history of impaired glucose regulation and socio-economic factors

  2 years

• The glucose tolerance status 3 months postpartum in women with recent GDM.

  Evaluation of rate of diabetes and prediabetes 3 months postpartum in women with recent GDM.

  3 years

Secondary Outcomes (7)

• 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

  2.5 years

• 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

  2.5 years

• Prevalence of pregestational diabetes in early pregnancy

  2 years

• The number of participants with dyslipidaemia and hypertension in women with and without GDM

  2.5 years

• Percentage body fat and c-peptide on cord blood in the offspring at birth of mothers with diabetes/GDM and without diabetes/GDM.

  3 years

Study Arms (1)

pregnant women without known diabetes

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• The National Lottery: collaborator
• FWO clinical doctoral scholarship: collaborator
• Novo Nordisk A/S: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Sanofi: collaborator
• AstraZeneca: collaborator
• Novartis: collaborator

Study Sites (7)

OLV Aalst

Aalst, 9300, Belgium

Location

UZA

Antwerp, 2560, Belgium

Location

OLV Aalst-site Asse

Asse, 1730, Belgium

Location

Imelda Bonheiden

Bonheiden, 2820, Belgium

Location

AZ St Jan

Bruges, 8000, Belgium

Location

Kliniek St Jan Brussel

Brussels, 1000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

• Beunen K, Van den Abbeele F, Van Crombrugge P, Verhaeghe J, Vandeginste S, Verlaenen H, 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. Fetal size monitoring in women with gestational diabetes and normal glucose tolerance. Acta Diabetol. 2025 Jan;62(1):35-48. doi: 10.1007/s00592-024-02330-0. Epub 2024 Jul 20.

  PMID: 39031189 DERIVED

• 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.

  PMID: 34858350 DERIVED

• 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.

  PMID: 33693709 DERIVED

• 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.

  PMID: 25015413 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

For women at risk for an heritable form of diabetes, genetic testing for MODY will be performed.

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Katrien Benhalima, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 15, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2017-11

Locations

BE (7)