Status:
UNKNOWN
Early Gestational Diabetes Mellitus
Lead Sponsor:
University Hospital, Lille
Conditions:
Gestational Diabetes
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
In 2010, the International Association of the Diabetes and Pregnancy Study Groups (IADPSG) panel published consensus-based recommendations on the diagnosis and classification of hyperglycemia in pregn...
Eligibility Criteria
Inclusion
- Pregnant woman
- Singleton pregnancy
- Early GDM defined by a fasting plasma glucose between 5.1 mmol/l and 6.1 mmol/ with at least one risk factor (age ≥35 years and/or BMI ≥ 25 kg/m2 and/or familial history of diabetes and/or personal history of GDM and/or personal history of macrosomia).
- First prenatal visit prior 20 weeks of gestation at the time of randomization.
- Signed informed consent
Exclusion
- Diabetic follow-up started at time of inclusion
- Pre-existing diabetes in pregnancy
- Renal impairment
- Hepatic insufficiency
- History of bariatric surgery
- Long time corticosteroids treatment
- Insufficient understanding
- Language difficulties
- Lack of social Insurance
- Person in emergency situation
- Person under the protection of justice (tutelage/ curatorship)
- Persons deprived of their liberty
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
2010 Patients enrolled
Trial Details
Trial ID
NCT04451915
Start Date
November 30 2020
End Date
December 1 2023
Last Update
January 27 2023
Active Locations (10)
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1
CH ARRAS
Arras, France
2
Hopital Estaing - Chu63 - Clermont Ferrand
Clermont-Ferrand, France
3
Hop Claude Huriez Chu Lille
Lille, France, 59037
4
Hopital Saint Vincent - Saint Antoine - Lille
Lille, France, 59037