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Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension

NCT07209254 · University of Pennsylvania
In plain English

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About this study
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
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
Study design
Enrollment target: 770 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2026-03-02
Estimated completion: 2029-11
Last updated: 2026-03-18
Interventions
Other: High-touch blood pressure managementOther: Low-touch blood pressure management
Primary outcomes
  • Mean diastolic blood pressure (DBP) (12 months postpartum)
Sponsor
Jennifer Lewey, MD, MPH · other
With: Patient-Centered Outcomes Research Institute
Contacts & investigators
ContactJennifer Lewey, MD, MPH · contact · Jennifer.Lewey@pennmedicine.upenn.edu · 215-662-7700
ContactAlexis Giron, M.S · contact · Alexis.Giron@Pennmedicine.upenn.edu
InvestigatorJennifer Lewey, MD, MPH · principal_investigator, University of Pennsylvania
All locations (3)
New York UniversityNot Yet Recruiting
New York, New York, United States
The Ohio State UniversityNot Yet Recruiting
Columbus, Ohio, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States