The Belgian Diabetes in Pregnancy Study: BEDIP-N Study (NCT02036619) | Clinical Trial Compass
CompletedNot Applicable
The Belgian Diabetes in Pregnancy Study: BEDIP-N Study
Belgium2,006 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in GDM prevalence between the 2-step and 1-step IADPSG screening strategy
Timeframe: 2 years
2
The difference in macrosomia rate between GDM and non-GDM groups according to the IADPSG criteria.
Timeframe: 2.5 years
3
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
4
The glucose tolerance status 3 months postpartum in women with recent GDM.