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The Belgian Diabetes in Pregnancy Study: BEDIP-N Study

NCT02036619 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2006

Last updated 2018-05-11

No results posted yet for this study

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

Sponsors & Collaborators

  • The National Lottery

    collaborator UNKNOWN

  • FWO clinical doctoral scholarship

    collaborator UNKNOWN

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Katrien Benhalima, MD · Universitaire Ziekenhuizen KU Leuven

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2017-03-31
Completion
2018-01-31

Countries

  • Belgium

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02036619 on ClinicalTrials.gov