Metformin for Preeclampsia Prevention in Pregnant Women With Type 1 Diabetes Mellitus
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.