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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Rate of hypertensive disorders of pregnancy
Time frame: Delivery/End of pregnancy
Home glucose levels throughout pregnancy
Time frame: Weekly, throughout pregnancy from enrollment to delivery
Birthweight
Time frame: Delivery/End of pregnancy
Neonatal morbidity
Time frame: Delivery/End of pregnancy
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