NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

The Belgian Diabetes in Pregnancy Study: BEDIP-N Study
The Belgian Diabetes in Pregnancy Study: BEDIP-N Study

NCT02036619

CompletedN/A

Sponsor: Universitaire Ziekenhuizen KU Leuven

Conditions: Gestational Diabetes, Diabetes

Countries: Belgium

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (7)
  • Aalst, Belgium
  • Antwerp, Belgium
  • Asse, Belgium
  • Bonheiden, Belgium
  • Bruges, Belgium
  • Brussels, Belgium
  • Leuven, Belgium