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NCT04615351 Clinical Trial

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

Gestational Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04615351
Other study ID # 1248906-9
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 15, 2020
Est. completion date June 30, 2022

Study information
Verified date October 2020
Source Women and Infants Hospital of Rhode Island
Contact Donna Allard
Phone 4012741122
Email dallard@wihri.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Pilot of Metformin Postpartum

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date June 30, 2022
Est. primary completion date October 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Gestational Diabetes Exclusion Criteria: - Cannot tolerate metformin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin
Medication

Locations
Country Name City State
United States Women & Infants Hospital Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prediabetes or Diabetes glycosylated hemoglobin (HgbA1c) at 1 year postpartum (>/= 5.7% defined as prediabetes, >/=6.5% defined as DM 1 year postpartum
Secondary Prediabetes or diabetes at 15 months postpartum HgbA1c at 15 months postpartum 15 months after delivery and study initiation
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