HOPE-BP 2.0: Evaluating the Optimal Duration of Postpartum Remote Blood Pressure Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Diastolic Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Discharged after delivery at University of Minnesota Medical Center
- •Enrolled into the HOPE-BP Program
Exclusion Criteria
- •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
Arms & Interventions
2-Week Arm
Participants randomized into the 2 week arm will be immediately unenrolled from the postpartum remote blood pressure monitoring program and resume standard postpartum care
Intervention: 2-Week Home Monitoring (Diagnostic Test)
6-Week Arm
Patients randomized into the 6 week arm will continue and complete the program in its entirety per current SOC (4 additional weeks)
Intervention: 6-Week Home Monitoring (Diagnostic Test)
Outcomes
Primary Outcomes
Diastolic Blood Pressure
Time Frame: Week 6
The primary outcome will be the patient's diastolic blood pressure (DBP) at their 6-week postpartum visit.
Secondary Outcomes
- 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)
- Rate of new hypertension diagnosis at 6 weeks postpartum(Week 6)