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Metformin Postpartum for GDM

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by The University of Texas Health Science Center, Houston.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01280409
First received: January 19, 2011
Last updated: May 18, 2011
Last verified: May 2011
History of Changes

January 19, 2011
May 18, 2011
January 2011
February 2013   (final data collection date for primary outcome measure)
Weight Change [ Time Frame: At 6 weeks postpartum visit (2nd research visit) ] [ Designated as safety issue: No ]

The weight change in kilograms defined as:

weight change = Weight(pp) - Weight(6wk)
Same as current
Complete list of historical versions of study NCT01280409 on ClinicalTrials.gov Archive Site
  • Achievement of pre-pregnancy weight [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the percentage of women that achieve their self-reported pre-pregnancy weight.
  • Ideal Body weight [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the percentage of women that achieve their ideal body weight.
  • Hemoglobin a1c [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the change in hemoglobin a1c.
  • HDL, LDL, triglyceride [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    We will calculate the change in LDL, HDL, and triglyceride levels.
  • Satisfaction Survey [ Time Frame: At 6 weeks postpartum ] [ Designated as safety issue: No ]
    Results of the satisfaction survey will be analyzed.
Same as current
Not Provided
Not Provided
 
Metformin Postpartum for GDM
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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes, Gestational
  • Drug: Metformin
    Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
  • Drug: Placebo
    Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Metformin
    Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
April 2013
February 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 49 Years
No
Contact: Jerrie S Refuerzo, MD 713.500.6416 Jerrie.S.Refuerzo@uth.tmc.edu
Contact: Maria S Hutchinson, MS 713.500.5850 Maria.S.Keefer@uth.tmc.edu
United States
 
NCT01280409
HSC-MS-10-0426
No
Jerrie Refuerzo, MD, University of Texas Health Science Center at Houston
The University of Texas Health Science Center, Houston
Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research
Principal Investigator: Jerrie S Refuerzo, MD The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP