NCT07204756

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jan 2028

First Submitted

Initial submission to the registry

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 7, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

September 24, 2025

Last Update Submit

January 12, 2026

Conditions

HypertensionPostpartumHypertensive Disorder of Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Diastolic Blood Pressure

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

    Week 6

Secondary Outcomes (6)

  • Systolic Blood Pressure at 6 weeks post-partum

    Week 6

  • 6-Week Post-partum Follow-up Rates

    Week 6

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

    Week 6

  • Patient Satisfaction Survey responses at 6 weeks

    Week 6

  • Rate of severe hypertension

    Week 6

  • +1 more secondary outcomes

Study Arms (2)

2-Week Arm

ACTIVE COMPARATOR

Participants randomized into the 2 week arm will be immediately unenrolled from the postpartum remote blood pressure monitoring program and resume standard postpartum care

Diagnostic Test: 2-Week Home Monitoring

6-Week Arm

ACTIVE COMPARATOR

Patients randomized into the 6 week arm will continue and complete the program in its entirety per current SOC (4 additional weeks)

Diagnostic Test: 6-Week Home Monitoring

Interventions

2-Week Home MonitoringDIAGNOSTIC_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.

2-Week Arm
6-Week Home MonitoringDIAGNOSTIC_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.

6-Week Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Discharged after delivery at University of Minnesota Medical Center
  • Enrolled into the HOPE-BP Program

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

HypertensionToxemia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInfections

Study Officials

  • Bethany Sabol, MD MAS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Linden

CONTACT

612-625-2273linde491@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

January 7, 2026

Primary Completion (Estimated)

January 31, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)