Gestational Diabetes
Conditions
Brief summary
A Pilot of Metformin Postpartum
Detailed description
The overall goal of this proposal is to assess metformin initiation at the time of hospital discharge for women with a history of gestational diabetes mellitus (GDM) improves maternal health at 1 year post-partum. Our central hypothesis is that diabetes mellitus (DM) prevention with metformin can be initiated days after delivery, rather than months to years after delivery, and result in a pragmatic and efficacious means of preventing DM and improving weight loss over the first year post-partum. To test this hypothesis, we will perform a open-label randomized controlled trial of metformin compared to placebo routine care initiated at the time of hospital discharge in women with a history of GDM.
Interventions
DRUGMetformin
Medication
Sponsors
Women and Infants Hospital of Rhode Island
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Gestational Diabetes
Exclusion criteria
* Cannot tolerate metformin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prediabetes or Diabetes | 1 year postpartum | glycosylated hemoglobin (HgbA1c) at 1 year postpartum (\>/= 5.7% defined as prediabetes, \>/=6.5% defined as DM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediabetes or diabetes at 15 months postpartum | 15 months after delivery and study initiation | HgbA1c at 15 months postpartum |
Countries
United States
Contacts
Primary ContactDonna Allard
Outcome results
None listed