NCT03570632CompletedPhase 4
Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 15 Jun 2018
- Start date
- 8 Jul 2019
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Maisa N. Feghali, MD
- Diseases
- Type 1 diabetes
- NCT number
- NCT03570632
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 24
- From 8 Jul 2019 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known allergy or adverse reaction to metformin
Lab values
- 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).
Other
- Multiple gestation
- Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy
Who the study is looking for
- Pregnant women 18-50 years
- 12 0/7 and 19 6/7 weeks of gestation
- Diagnosed with type 1 DM prior to pregnancy.
Age in the registry: 18 years to 50 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Magee-Womens Hospital of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.