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Could a common diabetes pill prevent dangerous pregnancy complications?

NCT ID NCT03570632

Prevention Sponsor: Maisa N. Feghali, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times

Summary

This phase 4 trial tests whether taking metformin daily before 20 weeks of pregnancy can reduce the risk of high blood pressure disorders, like preeclampsia, in pregnant women with type 1 diabetes. About 60 women will receive either metformin plus standard care or standard care alone. The study aims to find a safe, effective prevention strategy for a serious complication that currently lacks proven preventive options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin
What this could lead to
If it works, this could offer a safe, daily pill to prevent dangerous pregnancy complications in women with type 1 diabetes.
What could go wrong
This is a small, early-phase trial with only 60 participants, so results may not apply to everyone. Metformin can cause stomach upset, and its effectiveness is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

24 people

The number who actually took part.

Started

Jul 2019

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women 18-50 years * 12 0/7 and 19 6/7 weeks of gestation * Diagnosed with type 1 DM prior to pregnancy. Exclusion Criteria: * Known allergy or adverse reaction to metformin * Multiple gestation * Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy * Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine \> 1.1 mg/dL), proteinuria (P:C \>0.3 or 24-hour urine protein \> 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).

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Conditions

The condition(s) this trial relates to.

gestational diabetes Pregnancy in Diabetics type 1 diabetes mellitus type 1 diabetes mellitus 1 hypertension, pregnancy-induced prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus, type 1 Pregnancy in diabetes

Contacts and locations

Locations

  • Magee Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213, United States

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