Metformin in obese non-diabetic pregnant women (MOP Trial).
Phase 1
- Conditions
- Obesity in pregnancy. Obesity in pregnancy has been identified by Confidential Enquiry into Maternal And Child Health (CEMACH) (2008-2011) as a major health risk to mother and baby.Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2008-005892-83-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 450
Inclusion Criteria
1. Obese pregnant women with bmi >35
2. Informed written consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1. Gestational diabetes at booking, Type I and Type II diabetes.
2. Presence of contra indications to metformin (renal, liver and heart failure).
3. Moving out of study area for pregnancy management.
4. Participants who suffer with hyperemesis.
5. Participants who are 18 years and below.
6. Participants with high alcohol intake.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method