About this trial
The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hypertensive disorders of pregnancy (HDP) diagnosis, specifically gestational hypertension, preeclampsia, eclampsia, or HELLP syndrome, according to ACOG guidelines
Postpartum day 0-4
Age ≥ 18 years
Able to communicate in English or in Spanish
Disqualifiers
Pre-gestational hypertension
Type 1 or type 2 diabetes mellitus
Admitted to intensive care unit at the time of screening
Diagnosed with HDP during postpartum readmission after discharge from delivery hospitalization
Trial design
Parallel
Treatments tested in this trial
Nifedipine ER
DrugInitiation of nifedipine ER postpartum at randomly assigned threshold during the first 6 weeks postpartum.
Treatment groups
Trial outcomes
Primary outcomes
Chronic hypertension
Diagnosis of chronic hypertension, defined as stage I hypertension with BP \>130/80 mmHg
Secondary outcomes
Endothelial dysfunction
Brachial artery flow-mediated dilation will assess endothelial dysfunction.
Arterial stiffness
Carotid-femoral pulse wave velocity will assess arterial stiffness.
Cardiac structure and function
Transthoracic echocardiogram will assess cardiac structure and function.
Unplanned healthcare utilization
Unplanned hospital readmissions, emergency department visits, and clinic visits.
Other outcomes
Serum biomarkers of cardiovascular risk
Soluble fms-like tyrosine kinase (sFlt-1), Lipoprotein (a), TNF-alpha, IL-6, NT-proBNP, CRP, high-sensitivity troponin
Breastfeeding initiation and duration
Assessed with Infant Feeding Practices Postnatal Questionnaires
Sponsors and contacts
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Medical College of Wisconsin
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator