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

NCT ID: NCT07209254

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

770 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2029-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Hypertension, Pregnancy Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High-touch blood pressure management

Group Type EXPERIMENTAL

High-touch blood pressure management

Intervention Type OTHER

Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care

Low-touch blood pressure management

Group Type EXPERIMENTAL

Low-touch blood pressure management

Intervention Type OTHER

10 days of text-based home blood pressure monitoring

Interventions

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High-touch blood pressure management

Twelve weeks of text-based home blood pressure monitoring with BP self-management and team-based care

Intervention Type OTHER

Low-touch blood pressure management

10 days of text-based home blood pressure monitoring

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Jennifer Lewey, MD, MPH

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Lewey, MD, MPH

Assistant Professor of Medicine (Cardiovascular Medicine)

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jennifer Lewey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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New York University

New York, New York, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Central Contacts

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Jennifer Lewey, MD, MPH

Role: CONTACT

215-662-7700

Alexis Giron, M.S

Role: CONTACT

Facility Contacts

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Christina Penfield, MD, MPH

Role: primary

(646)-754-2700

Michelle Rojas

Role: backup

(646)-293-1160

Anna Bartholomew, MPH, BSN, RN

Role: primary

614-685-3229

Alexis Giron, M.S

Role: primary

215-275-2507

Meaghan McCabe, MPH

Role: backup

Other Identifiers

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858860

Identifier Type: -

Identifier Source: org_study_id

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