Two phone-based approaches to manage high blood pressure after delivery
Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
NA · University of Pennsylvania · NCT07209254
This trial tests whether two different mobile phone programs help people with pregnancy-related high blood pressure after delivery control their blood pressure, protect heart function, and feel more involved in their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 770 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pennsylvania (other) |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT07209254 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized trial compares a high-touch versus a low-touch mobile health strategy for managing postpartum blood pressure among people diagnosed with preeclampsia or gestational hypertension. Eligible participants are enrolled within 14 days of delivery and must have started blood pressure medication before hospital discharge or within 14 days postpartum; they also need to read English or Spanish and have texting capability. Participants are randomized to more intensive remote monitoring and clinician contact or a lower-intensity texting/monitoring program, with outcomes including blood pressure control, measures of cardiac function, and patient-reported engagement and sense of control. The trial is conducted at NYU Langone, The Ohio State University, and the University of Pennsylvania.
Who should consider this trial
Good fit: Adults aged 18 or older who delivered within the past 14 days, were diagnosed with preeclampsia or gestational hypertension (with or without severe features), started blood pressure medication before discharge or within 14 days postpartum, and can read English or Spanish and receive text messages.
Not a fit: People with chronic hypertension before pregnancy, pre-existing cardiovascular disease, stage 3 or higher chronic kidney disease, or those already taking three or more blood pressure medications are excluded and unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the approach could improve postpartum blood pressure control and reduce short-term cardiac problems while making it easier for new parents to manage their health at home.
How similar studies have performed: Previous smaller studies and pilot programs of remote postpartum blood pressure monitoring and mobile health interventions have improved monitoring and follow-up and patient engagement, but evidence on long-term blood pressure and cardiac outcomes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York and 2 other locations
- NYU Langone Health — New York, New York, United States (NOT_YET_RECRUITING)
- The Ohio State University — Columbus, Ohio, United States (NOT_YET_RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Jennifer Lewey, MD, MPH — University of Pennsylvania
- Study coordinator: Jennifer Lewey, MD, MPH
- Email: Jennifer.Lewey@pennmedicine.upenn.edu
- Phone: 215-662-7700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension, Pregnancy Induced, Postpartum Hypertension, Blood pressure management, Preeclampsia, Hypertension, pregnancy induced