This trial is a pilot-scale, single institution randomized, placebo-controlled trial to assess the feasibility, acceptability, and efficacy of administering dapagliflozin for cardiovascular risk reduction in the postpartum period. The target population is patients at high risk of adverse cardiovascular outcomes within five years post-delivery.
Eligible participants will be randomized to receive either: 1) dapagliflozin (10mg daily) for six months (DAPA group) or 2) an orally administered, daily placebo (Control group).
The study hypothesizes:
The dapagliflozin group will have higher cardiovascular risk reduction scores than the Control Group.
Admitted for delivery at the University of Michigan (UM) Labor and Delivery (L&D) unit or enrolled in the UM postpartum blood pressure monitoring program following a delivery at the UM L&D unit
Determined to be at least 23 and 0/7 weeks of gestation based on a clinically acceptable dating method (can be a single or multifetal gestation with or without the presence of fetal anomalies) at the time of delivery
Consents to participation and must understand/read/speak English with the ability to understand and willingness to sign a written informed consent in English
Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission
Non-English speaking
Ongoing pregnancy
Stated desire to become pregnant within 8 months post-delivery
Intention to breastfeed after enrollment
University of Michigan
Lead sponsor
Society for Maternal-Fetal Medicine Foundation
Collaborator
American Association of Obstetricians and Gynecologists Foundation
Collaborator