Remote Monitoring for Postpartum High Blood Pressure

Overseen By Erin Linden

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Antihypertensives

Disqualifiers: Medical comorbidity, Opted out, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal duration for new mothers to use at-home blood pressure monitoring after experiencing high blood pressure during pregnancy. The researchers aim to determine whether monitoring for 2 weeks or 6 weeks affects health outcomes. Participants will be divided into two groups: one will monitor their blood pressure for 2 weeks, and the other for 6 weeks. This trial suits those who gave birth at the University of Minnesota Medical Center and are part of the HOPE-BP Program. As an unphased trial, it offers participants the opportunity to contribute to important research that could enhance postpartum care for new mothers.

Will I have to stop taking my current medications?

If you are still taking blood pressure medication two weeks after delivery, you cannot join the trial. So, you would need to stop those medications by then to participate.

What prior data suggests that this remote monitoring program is safe for postpartum patients with high blood pressure?

A previous study showed that checking blood pressure at home after giving birth is safe, easy, and cost-effective, whether done for 2 weeks or 6 weeks. Research indicates that this method not only helps monitor blood pressure but also may improve health in both the short and long term.

Data from the United States show that home blood pressure monitoring after childbirth leads to better outcomes compared to usual care. Specifically, the 6-week program has been linked to improved blood pressure readings and fewer hospital visits postpartum. No major negative effects have been reported from these programs, making them a well-tolerated option for new mothers managing high blood pressure after pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of remote home monitoring on postpartum high blood pressure management. Unlike standard care, which typically involves regular in-person visits with a healthcare provider, this approach allows new mothers to monitor their blood pressure from home. This can offer greater convenience and flexibility, potentially leading to better adherence and more timely interventions. The trial compares two durations of monitoring—2 weeks and 6 weeks—to determine which is most effective, aiming to enhance postpartum care and outcomes for mothers dealing with high blood pressure.

What evidence suggests that this trial's treatments could be effective for postpartum high blood pressure?

Research has shown that checking blood pressure at home after childbirth can reduce hospital visits and improve adherence to medical advice. In this trial, participants will be randomized into either a two-week or a six-week home monitoring program. Studies have found that the two-week home monitoring program saves money and improves health compared to regular care. Meanwhile, monitoring for six weeks at home can help control blood pressure, with some studies noting a drop in the lower blood pressure number by up to 4.5mmHg. Whether short or long, home monitoring programs help track and manage blood pressure after pregnancy. Evidence supports that checking blood pressure at home effectively manages it after childbirth. ^{2 4 6 7 8}

Who Is on the Research Team?

Bethany Sabol, MD MAS

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals who have had high blood pressure or pre-eclampsia during pregnancy and are in the postpartum period. The study aims to find out if monitoring their blood pressure at home for a shorter (2 weeks) or longer (6 weeks) time helps better manage their condition.

Inclusion Criteria

Discharged after delivery at University of Minnesota Medical Center

Enrolled into the HOPE-BP Program

I am 18 years old or older.

Exclusion Criteria

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

I have been on blood pressure medication for at least 2 weeks.

I have chosen not to participate in clinical research.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in a postpartum remote blood pressure monitoring program for either 2 or 6 weeks

2-6 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 6-week postpartum visit

6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 2-Week Home Monitoring
• 6-Week Home Monitoring

Trial Overview The HOPE-BP 2.0 trial is testing whether a 2-week or a 6-week duration of remote blood pressure monitoring at home after giving birth provides better clinical outcomes for those with hypertensive disorders of pregnancy.

How Is the Trial Designed?

Group I: 6-Week Arm Active Control 1 Intervention

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

Group II: 2-Week Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11326966/

Clinical Outcomes Associated With a Remote Postpartum ... Remote monitoring of postpartum hypertension was associated with fewer readmissions, increased adherence to national clinical guidelines, and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25001565

Feasibility of Postpartum Blood Pressure Monitoring for ... Among those with normal BP at enrollment, 87% had elevated BP on at least 1 day during the 12-week monitoring period. These findings highlight the need for ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073302

Hypertension in Pregnancy and Postpartum Data from the United States highlight favorable outcomes for postpartum HBPM compared with usual care.

4. ajog.org ajog.org/article/S0002-9378(23)01914-2/fulltext

1085 Remote Blood Pressure Monitoring for Postpartum ... Conclusion. Remote blood pressure management of postpartum hypertension is cost saving with better outcomes compared to usual care. These data support broad ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03185455

Remote Surveillance of Postpartum Hypertension Patient will be randomized to usual one time office visit based blood pressure check or to text-message based remote surveillance for two weeks.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12235407/

Feasibility of Postpartum Blood Pressure Monitoring for ... Other predefined exploratory and safety outcomes were the detection of elevated BP >140/90 mm Hg and incidence of adverse CV events, including ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666577823000928

Postpartum remote home blood pressure monitoring Postpartum home blood pressure monitoring is safe, feasible, acceptable, and cost-saving. It holds particular promise in improving both short- and long-term ...

8. journals.lww.com journals.lww.com/greenjournal/fulltext/2023/08000/postpartum_home_blood_pressure_monitoring__a.9.aspx

Postpartum Home Blood Pressure Monitoring: A Systematic... Notably, one trial found that home BP monitoring resulted in small, sustained reductions of diastolic BP up to 3–4 years postpartum. If confirmed, 50 these ...