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NCT02932475 · ClinicalTrials.gov registry record · Phase 3
Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
A Phase 3 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 3
- Development phase
- 831
- Enrollment target
NCT02932475: Clinical Trial Phase 3 study, sponsored by University of North Carolina, Chapel Hill.
NCT02932475 is a Phase 3 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 831 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02932475, a Phase 3 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 831 participants
- Enrollment target
Study Summary
Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a singleton fetus will be randomized to double-blinded insulin/placebo versus insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
Primary Outcome
Participants with one or more of the following: * capillary blood glucose level of \< 30 mg/dL or capillary blood glucose requiring medical treatment, or * Birth trauma (umbilical cord artery pH \< 7.0 or shoulder dystocia with brachial plexus injury), or * Hyperbilirubinemia requiring phototherapy, or * Deliver \< 37 weeks' gestation, or * Miscarry, are stillborn, experience a neonatal demise, or * Large for gestational age infant (birth weight \> 90th percentile for gestational age), or * Sma
Interventions
- DRUG Placebo
- DRUG Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 831 participants |
| Start Date | 2017-05-25 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 3 |
Why NCT02932475 stopped before completion
NCT02932475 is an interventional study that assigns participants to a tested intervention. The registered 831 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02932475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02932475 about?
NCT02932475 is a clinical study titled "Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)". Purpose: The objective of this proposal is to study the safety and efficacy of metformin added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women. Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S. clinical centers Procedures (me...
What is the current status of trial NCT02932475?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 831 participants. The study started on 2017-05-25. Estimated completion is 2022-06-15.
What interventions are being tested in trial NCT02932475?
The interventions under investigation include: Placebo (DRUG), Metformin (DRUG).
Who is sponsoring clinical trial NCT02932475?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02932475's enrollment target sits among peer trials
831 397th of 2000 higher than 1,603 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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