A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
American Association of Obstetricians and Gynecologists Foundation
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
Diagnosed with a hypertensive pregnancy by either of the following criteria:
* Taking an antihypertensive medication for the diagnosis of chronic or essential hypertension at the time of admission
* Hypertension, chronic hypertension, or essential hypertension must be present in the prospective participant's medical record
* Antihypertensive" can be any medication taken for the purpose of blood pressure control per the medical record
* A documented hypertensive disorder of pregnancy (gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, superimposed preeclampsia, or eclampsia) prior to delivery
Eligible participants must report a planned contraceptive method as part of the consent process, to be noted on their consent document.
Has two or more blood pressures ≥160/110 Millimeters of mercury (mmHg) at least 60 minutes apart
* If an admitted patient does not meet this blood pressure criterion but is otherwise eligible, participants can consent to have a BNP drawn within 12 hours of delivery as an alternative measure of cardiovascular risk (if the brain natriuretic peptide (BNP) is ≥100 Picograms per milliliter (pg/ml), participants are eligible to participate)
You may not be if
Non-English speaking
Ongoing pregnancy
Stated desire to become pregnant within 8 months post-delivery
Intention to breastfeed after enrollment
BNP ≥1000 pg/ml within 12 hours of delivery, clinical team to be notified of result
Comorbidities that may affect cardiovascular risk assessment (per protocol)
Contraindication to dapagliflozin (per protocol)
Clareo Health | A Randomized, Placebo-controlled Trial of DAPAgliflozin (DAPA) for Cardiovascular Risk Reduction in the Postpartum Period of Hypertensive Pregnancies (HP)
