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NCT03570632 · ClinicalTrials.gov registry record · Phase 4
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
A Phase 4 study of Diabetes Mellitus, Type 1 and Pregnancy in Diabetes, sponsored by Maisa N. Feghali, MD.
- Active
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT03570632: Active Phase 4 study of Diabetes Mellitus, Type 1 and Pregnancy in Diabetes, sponsored by Maisa N. Feghali, MD.
NCT03570632 is a Phase 4 study of Diabetes Mellitus, Type 1 and Pregnancy in Diabetes that is active but no longer recruiting, run by Maisa N. Feghali, MD. The registered enrollment target is 60 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03570632, a Phase 4 study of Diabetes Mellitus, Type 1 and Pregnancy in Diabetes, is active but no longer recruiting, sponsored by Maisa N. Feghali, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.
Conditions Studied
Interventions
- DRUG Metformin
Study Locations (1)
Pennsylvania
- Magee Womens Hospital of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 4 |
What the registry record for NCT03570632 still lists
NCT03570632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Metformin is the first listed.
NCT03570632 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03570632 about?
NCT03570632 is a clinical study titled "Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus". Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At pres...
What is the current status of trial NCT03570632?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2019-07-08. Estimated completion is 2026-05-31.
What conditions does trial NCT03570632 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Pregnancy in Diabetes.
What interventions are being tested in trial NCT03570632?
The interventions under investigation include: Metformin (DRUG).
Who is sponsoring clinical trial NCT03570632?
This trial is sponsored by Maisa N. Feghali, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03570632 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03570632's enrollment target sits among peer trials
60 64th of 118 higher than 53 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 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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