Efficacy of metformin in pregnant obese women: a randomised controlled trial

Phase 3

Completed

• Conditions: Obesity, pregnancy; Nutritional, Metabolic, Endocrine; Obesity

• Registration Number: ISRCTN51279843
• Lead Sponsor: niversity of Edinburgh and NHS Lothian (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-14
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1. Caucasian obese (body mass index [BMI] greater than or equal to 30 kg/m^2) pregnant women between 12-0 and 16+0 weeks gestation
2. Women aged greater than 16 years
3. Signed informed consent form

Exclusion Criteria

1. Non Caucasian women
2. Women with a BMI less than or equal to 29 kg/m^2
3. Gestation greater than than 16 weeks
4. Women with pre-existing diabetes
5. Women with gestational diabetes in a previous pregnancy
6. Women with systemic disease requiring regular medication
7. Gestational diabetes in index pregnancy (diagnosed with 75 g oral glucose tolerance test [OGTT] prior to randomisation)
8. Previous delivery of a baby less than 3rd centile or previous pregnancy with pre-eclampsia prompting delivery before 32 weeks gestation
9. A known hypersensitivity to metformin hydrochloride or to any of the excipients
10. Known abnormalities of the liver (tested prior to randomisation)
11. Renal failure or renal dysfunction
12. Acute conditions with the potential to alter renal function such as:
12.1. Dehydration sufficient to require intravenous infusion
12.2. Severe infection
12.3. Shock
12.4. Intravascular administration of iodinated contrast agents
12.5. Acute or chronic diseases which may cause tissue hypoxia such as cardiac or respiratory failure, recent myocardial infarction, shock or hepatic insufficiency, acute alcohol intoxication or alcoholism
13. Lactation
14. Multiple pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified