CompletedPhase 4

Metformin Postpartum for GDM RCT for Reduced Weight Retention

United States114 participantsStarted 2011-01

Plain-language summary

The purpose of this study is to determine whether the study drug metformin is helpful in reducing weight after pregnancy in women with gestational diabetes. This pilot study will provide information on how well women are able to take metformin postpartum, whether metformin increases weight loss, and whether there are any increased risks of side effects to you as a new mother.

Who can participate

Age range18 Years – 49 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Postpartum women with a delivery greater than 34 weeks of pregnancy * Between the ages of 18 to 49 years * Women with a diagnosis of gestational diabetes mellitus (either treated with insulin, oral hypoglycemic agent or diet-controlled) after 24 weeks in most recent pregnancy based on a confirmatory 3 hour glucola test (based on either the Carpenter and Coustan's of the Diabetes Task Force criteria) Exclusion Criteria: * women with pre-gestational diabetes mellitus (either Type I or Type II DM) * women unable to tolerate metformin based on patient history * women who will be discharged hom eon insulin or oral hypoglycemic agent in the immediate postpartum period * women with a BMI \<25 kg/m²

What they're measuring

Weight Change

Timeframe: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)

Trial details

NCT IDNCT01280409

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

Results submitted2016-02-29

View on ClinicalTrials.gov More Diabetes, Gestational trials