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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 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.

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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

Diabetes Mellitus, Type 1 Pregnancy in Diabetes

Interventions

  • DRUG Metformin

Study Locations (1)

Pennsylvania

  • Magee Womens Hospital of UPMC - Pittsburgh

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2019-07-08
Est. Completion 2026-05-31
Phase Phase 4

Sponsor

Maisa N. Feghali, MD

3 total trials

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What the Registry Record Tells You About NCT03570632

The ClinicalTrials.gov registry entry for NCT03570632 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (95% lower). The listed sponsor is Maisa N. Feghali, MD, which has 3 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.