Medical Optimization of Management of Type 2 Diabetes Complicating Pregnancy (MOMPOD)
Status:
Recruiting
Trial end date:
2021-12-30
Target enrollment:
Participant gender:
Summary
Purpose: The objective of this proposal is to study the safety and efficacy of metformin
added to insulin for treatment of type 2 diabetes mellitus (T2DM) among pregnant women.
Participants: 950 pregnant women with type 2 diabetes complicating pregnancy from 10 U.S.
clinical centers
Procedures (methods): Pregnant women with T2DM between 10 weeks and 22 weeks 6 days and a
singleton fetus will be randomized to double-blinded insulin/placebo versus
insulin/metformin. Primary outcome is composite adverse neonatal outcome (clinically relevant
hypoglycemia, birth trauma, hyperbilirubinemia, stillbirth/neonatal death). Study visits
monthly at clinical visits; blood draw at 24-30 weeks, newborn anthropometric measurements at
less than 72 hours of life. Maternal and infant outcomes will be chart abstracted.
Phase:
Phase 3
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)