Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

At 24-48 hours after delivery, women who are eligible for participation will be approached and consented to the study. Maternal weight will be measured and 20ml of maternal blood will be obtained to assess glucose control and lipid profile. Women will be counseled regarding diet, exercise and glucose control. Data including maternal demographics, clinical characteristics and neonatal outcomes will be collected. At 3 weeks postpartum, a research nurse will contact the subject via telephone call to inquire about adverse or side effects, ability to take the prescribed medication (metformin or placebo), and to answer questions about the study. At 6 weeks postpartum, maternal weight will be measured , blood will be obtained and side effects will be evaluated again. Finally, a satisfaction survey will be completed.


Criteria:

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


NCT ID:

NCT01280409


Primary Contact:

Principal Investigator
Jerrie S Refuerzo, MD
The University of Texas Health Science Center, Houston


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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