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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
114
Memorial Hermann Hospital, Texas Medical Center
Houston, Texas, United States
University of Texas Health Science Center at Houston, Professional Building
Houston, Texas, United States
Weight Change
The weight change in kilograms defined as: weight change = Weight(pp) - Weight(6wk)
Time frame: within 24 hours after delivery; at 6 weeks postpartum visit (2nd research visit)
Number of Participants Who Achieved Pre-pregnancy Weight
Time frame: At 6 weeks postpartum
Number of Participants Who Achieved Their Ideal Body Weight
Time frame: At 6 weeks postpartum
Hemoglobin a1c
We will calculate the change in hemoglobin a1c.
Time frame: At 6 weeks postpartum
HDL, LDL, Triglyceride
We will calculate the change in LDL, HDL, and triglyceride levels.
Time frame: At 6 weeks postpartum
Self-reported Compliance With Medications
Time frame: 3 weeks postpartum
Self-reported Compliance With Medications
Time frame: 6 weeks postpartum
Difficulty With Diet as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Difficulty With Exercise as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Difficulty With Medication as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
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Satisfaction With Diet as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Satisfaction With Exercise as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum
Satisfaction With Medication as Assessed by a 5-point Likert Scale
Time frame: At 6 weeks postpartum