About this trial
A multicenter randomized trial that will compare the effectiveness of two postpartum blood pressure (BP) management strategies in improving blood pressure and cardiac function and increasing patient engagement and feeling of control over one's health
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Delivery within 14 days
Diagnosis of preeclampsia or gestational hypertension with or without severe features during pregnancy or within 14 days postpartum
Initiation of blood pressure medication prior to hospital discharge and up to 14 days postpartum
Disqualifiers
Diagnosis of chronic hypertension prior to delivery (would therefore include super imposed preeclampsia)
Pre-existing cardiovascular disease (including prior myocardial infarction, stroke, heart failure with reduced ejection fraction, ventricular tachycardia, prior cardiac arrest, pacemaker, severe valvular heart disease, or prior cardiac surgery)
Chronic kidney disease (stage 3 or higher)
Using ≥3 BP medications at time of enrollment
Trial design
Parallel
Treatments tested in this trial
High-touch blood pressure management
Other interventionTwelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care
Low-touch blood pressure management
Other intervention10 days of text-based home blood pressure monitoring
Treatment groups
Trial outcomes
Primary outcomes
Mean diastolic blood pressure (DBP)
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
Secondary outcomes
Blood pressure outcome: Mean systolic blood pressure (SBP)
Assessed by 24-hour ambulatory blood pressure monitor (ABPM)
Blood pressure outcome: Mean nocturnal DBP
Assessed by ABPM
Blood pressure outcome: Mean nocturnal SBP
Assessed by ABPM
Blood pressure outcome: Mean DBP
Assessed by home blood pressure monitor and office measurement
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jennifer Lewey, MD, MPH
Lead sponsor
University of Pennsylvania
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator