Metformin Postpartum for GDM RCT for Reduced Weight Retention
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 11/30/2018 |
| Start Date: | January 2011 |
| End Date: | August 2014 |
The Effects of Metformin on Retained Postpartum Weight in Women With Gestational Diabetes: A Randomized, Placebo-Controlled Trial
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.
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.
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.
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.
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
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