NCT04615351

A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	Metformin	Medication

Timeline

• Start date: 2020-11-15
• Primary completion: 2021-10-31
• Completion: 2022-06-30
• First posted: 2020-11-04
• Last updated: 2020-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study