Health TrialsbyHealthPanel

HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring

ConditionsPostpartumHypertensionHypertensive Disorder of Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Minnesota

About this trial

Postpartum remote blood pressure monitoring programs for patients with hypertensive disorders of pregnancy (HDP) are becoming part of standard postpartum management. Existing programs range in duration from 2 to 6 weeks but there has not been any evaluation as to what program duration is optimal. The primary objective of this study is to evaluate the impact of program duration on clinical outcomes for patients participating in a single institution's postpartum remote blood pressure monitoring program for patients with HDP.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older

Discharged after delivery at University of Minnesota Medical Center

Enrolled into the HOPE-BP Program

Disqualifiers

Ongoing antihypertensive medication use at 2 weeks (time of randomization)

Have a medical comorbidity that would not be clinically appropriate to randomize

Patients opted out of clinical research

Trial design

Design model

Parallel

Treatments tested in this trial

  • 2-Week Home Monitoring

    Diagnostic test

    Those who are randomized into the 2-week intervention arm will be unenrolled from the postpartum remote blood pressure monitoring program and therefore will no longer be transmitting twice daily blood pressures for review.

  • 6-Week Home Monitoring

    Diagnostic test

    HOPE-BP provides remote monitoring for the 35% of approximately 2,800 annual births at our institution complicated by HDP. Eligible patients enroll at hospital discharge into a 6-week program, submitting blood pressure readings twice daily via Epic's MyChart Care Companion. Participants receive immediate automated feedback, and a dedicated Maternal Fetal Medicine nursing team reviews data daily (Monday-Friday, 8 AM-4 PM), initiating or adjusting antihypertensive therapy as needed.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: 2-Week ArmActive comparator 1 intervention
Group B: 6-Week ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Diastolic Blood Pressure

The primary outcome will be the patient's diastolic blood pressure (DBP) at their 6-week postpartum visit.

Time frame
Week 6

Secondary outcomes

1

Systolic Blood Pressure at 6 weeks post-partum

Patient's systolic blood pressure at their 6-week postpartum visit

Time frame
Week 6
2

6-Week Post-partum Follow-up Rates

Participants who complete a 6-week post-partum visit / Total participants eligible for a 6-week post-partum visit

Time frame
Week 6
3

Unscheduled OB visit, triage visit, ED visit, or readmission rates

Time frame
Week 6
4

Patient Satisfaction Survey responses at 6 weeks

PSS Score, where higher score indicates greater satisfaction

Time frame
Week 6

Other outcomes

Sponsors and contacts

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

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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