A Pragmatic Approach to Lowering the Risk of Diabetes Mellitus After A Diagnosis of Gestational Diabetes Mellitus
1 other identifier
interventional
200
1 country
1
Brief Summary
A Pilot of Metformin Postpartum
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedFirst Posted
Study publicly available on registry
November 4, 2020
CompletedStudy Start
First participant enrolled
November 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 4, 2020
October 1, 2020
12 months
October 26, 2020
October 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Prediabetes or Diabetes
glycosylated hemoglobin (HgbA1c) at 1 year postpartum (\>/= 5.7% defined as prediabetes, \>/=6.5% defined as DM
1 year postpartum
Secondary Outcomes (1)
Prediabetes or diabetes at 15 months postpartum
15 months after delivery and study initiation
Study Arms (2)
Metformin
ACTIVE COMPARATORMetformin 500 mg to be taken twice per day for two weeks and then metformin 1000 mg PO twice daily after tolerating the lower dose
Routine Care
NO INTERVENTIONDischarge information about maintaining a healthy diet
Interventions
Eligibility Criteria
You may qualify if:
- Gestational Diabetes
You may not qualify if:
- Cannot tolerate metformin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 4, 2020
Study Start
November 15, 2020
Primary Completion
October 31, 2021
Study Completion
June 30, 2022
Last Updated
November 4, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share