Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
Recruiting · NCT07209254 · Interventional (participants receive a specific treatment) · Lead sponsor: Jennifer Lewey, MD, MPH
View the official record on ClinicalTrials.gov →Interventions studied
High-touch blood pressure managementLow-touch blood pressure management
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- English or Spanish speaking (able to read/understand consent and instructions)
- Has phone texting capabilities
Exclusion criteria
- 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
Where it is running
3 locations listed across 3 US states.
- NYU Langone Health - New York, New York, United States
- The Ohio State University - Columbus, Ohio, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States