Recruiting NCT07209254
Randomized Controlled Trial of Two Mobile Health Strategies to Manage Postpartum Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-touch blood pressure management, Low-touch blood pressure management.
- Who it may be relevant to
- Registry conditions: Hypertension, Pregnancy Induced. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Other High-touch blood pressure management
Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care - Other Low-touch blood pressure management
10 days of text-based home blood pressure monitoring
Primary outcome measures
- Mean diastolic blood pressure (DBP) [Time frame: 12 months postpartum]
Secondary outcome measures (10)
- Blood pressure outcome: Mean systolic blood pressure (SBP) [Time frame: 12 months postpartum]
- Blood pressure outcome: Mean nocturnal DBP [Time frame: 12 months postpartum]
- Blood pressure outcome: Mean nocturnal SBP [Time frame: 12 months postpartum]
- Blood pressure outcome: Mean DBP [Time frame: 12 months postpartum]
- Chronic Hypertension [Time frame: 12 months postpartum]
- Echocardiogram Outcomes [Time frame: 12 months postpartum]
- Patient Reported Outcome - Patient Activation Measure [Time frame: Post-randomization to 1 year postpartum]
- Patient Reported Outcome - Perceived Stress [Time frame: Post-randomization to 1 year postpartum]
- Patient Reported Outcome - Self-Efficacy [Time frame: Post randomization to 1 year postpartum]
- Implementation Outcome: Acceptability of Intervention [Time frame: From 6 weeks postpartum through 1 year postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- NYU Langone Health — New York
- The Ohio State University — Columbus
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07209254 · 858860