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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorJennifer Lewey, MD, MPH

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • High-touch blood pressure management

    Other intervention

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

  • Low-touch blood pressure management

    Other intervention

    10 days of text-based home blood pressure monitoring

Treatment groups

770 Participants
are divided into 2 treatment groups
Group A: High-touch blood pressure managementExperimental treatment 1 intervention
Group B: Low-touch blood pressure managementExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean diastolic blood pressure (DBP)

Assessed by 24-hour ambulatory blood pressure monitor (ABPM)

Time frame
12 months postpartum

Secondary outcomes

1

Blood pressure outcome: Mean systolic blood pressure (SBP)

Assessed by 24-hour ambulatory blood pressure monitor (ABPM)

Time frame
12 months postpartum
2

Blood pressure outcome: Mean nocturnal DBP

Assessed by ABPM

Time frame
12 months postpartum
3

Blood pressure outcome: Mean nocturnal SBP

Assessed by ABPM

Time frame
12 months postpartum
4

Blood pressure outcome: Mean DBP

Assessed by home blood pressure monitor and office measurement

Time frame
12 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Lewey, MD, MPH

Lead sponsor

University of Pennsylvania

Sponsor institution

Patient-Centered Outcomes Research Institute

Collaborator