Remote Blood Pressure Monitoring for Postpartum Women

(SMART-BP Trial)

Overseen By Elizabeth T Jensen, MPH PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Outside Forsyth County, Under 18, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether checking blood pressure at home benefits women who have recently given birth. Some women develop high blood pressure after delivery, which can be dangerous if not monitored. The trial tests a smartphone app (Blood Pressure monitoring app, BabyScripts™) and a special blood pressure cuff, allowing women to check their blood pressure from home instead of staying longer in the hospital. Women who gave birth at Atrium Health Wake Forest Baptist and have a smartphone might be suitable candidates. The study aims to determine if remote monitoring is a safer and more convenient option. As an unphased trial, it offers participants the chance to contribute to research that could make postpartum care more accessible and convenient.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that remote blood pressure monitoring is safe for postpartum women?

Research shows that monitoring blood pressure from home for new mothers is safe and easy. Studies have found that the BabyScripts app, used with a Bluetooth blood pressure cuff, helps women track their blood pressure at home. Most women using the app actively recorded their blood pressure, which helped identify those with high blood pressure.

Previous research also shows that this type of home monitoring is not only safe but also practical and well-received by new mothers. It helps detect high blood pressure in various groups of women, leading to better health outcomes and lower costs compared to traditional doctor visits. Overall, past studies have proven the reliability of the tools used in this trial, such as the app and the cuff. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about remote blood pressure monitoring for postpartum women because it offers a new way to manage blood pressure from the comfort of home. Unlike traditional methods that require frequent in-person visits, this approach uses a smartphone app and a Bluetooth-enabled blood pressure cuff to allow continuous monitoring. This means women can track their blood pressure more conveniently and consistently, which could lead to earlier detection of issues and better overall health outcomes. The integration of technology into postpartum care is a step forward, potentially making it easier for new moms to prioritize their health during a busy and demanding time.

What evidence suggests that remote blood pressure monitoring is effective for postpartum women?

Studies have shown that checking blood pressure from home after childbirth is effective and reliable. In this trial, participants in the Remote Blood Pressure Monitoring (rBPM) arm will use a remote blood pressure cuff and an app like BabyScripts to help new mothers check their blood pressure more often, which is important for spotting high blood pressure early. One study reported that mothers using remote monitoring had better health outcomes, with improved blood pressure readings. Research also shows that this method is cost-effective and can help make healthcare more accessible for everyone. Overall, remote blood pressure monitoring is a promising way to keep new mothers healthy without needing extra hospital visits. ^{6 7 8 9 10}

Who Is on the Research Team?

Elizabeth T Jensen, MPH PhD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

This trial is for women over 18 in Forsyth County, NC who've recently given birth and received postpartum care at The Birth Center at Atrium Health Wake Forest Baptist. Participants need daily access to a smartphone with Wi-Fi or data and must be able to read English or Spanish.

Inclusion Criteria

Women who have given birth at The Birth Center at Atrium Health Wake Forest Baptist.

Women who received pregnancy care at certain Atrium Health Wake Forest Baptist clinics in Forsyth County, NC.

Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Exclusion Criteria

Unable to read or understand either English or Spanish

Resides outside of Forsyth County, NC

Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Prior to discharge

1 visit (in-person)

Treatment

Participants receive remote blood pressure monitoring for 3 weeks postpartum using a Bluetooth enabled BP cuff and smartphone app

3 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including encounters for urgent or emergent care

8 weeks

Includes potential visits to Emergency Department, OB Triage, and Urgent Care

What Are the Treatments Tested in This Trial?

Interventions

• Blood Pressure (BP) monitoring smart phone app, BabyScripts™
• Instructions
• Remote Blood Pressure Cuff

Trial Overview

The study tests if monitoring blood pressure using a smart phone app, BabyScripts™, along with remote BP cuff instructions can effectively track BP levels in new mothers for three weeks after leaving the hospital.

How Is the Trial Designed?

Group I: Remote Blood Pressure Monitoring (rBPM) Experimental Treatment 3 Interventions

Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring: * a specialized, Bluetooth enabled BP monitoring cuff (Clinically Validated, A\&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2) * BP monitoring smart phone app, BabyScripts™ * Verbal and written instructions, to conduct BP checks at home

Group II: Standard of Care (SOC) Active Control 1 Intervention

Subjects randomized to SOC arm are provided with the appropriate standard of care depending upon their risk level (as determined by their individual provider or WFBMC Maternal-Fetal Medicine provider)

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

This randomized controlled trial involving 186 women with postpartum hypertension demonstrated that self-management, which included daily blood pressure monitoring and telemonitoring for medication adjustments, was feasible and led to better blood pressure control compared to usual care.

The intervention group showed significantly lower blood pressure, particularly diastolic pressure, at 6 weeks and maintained better control up to 6 months, suggesting that self-management could be an effective strategy for managing postpartum hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Management of Postnatal Hypertension: The SNAP-HT Trial. Cairns, AE., Tucker, KL., Leeson, P., et al.[2021]

The MyWellSpan mobile application was found to be a feasible method for postpartum women who experienced preeclampsia to self-monitor their blood pressure, with 69% of participants submitting at least one measurement.

Participants reported high satisfaction with the ease of use of the blood pressure cuff and the monitoring process, indicating that mobile health applications could effectively engage this population in their postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Using Blood Pressure Self-Monitoring and the Epic MyChart Blood Pressure Flowsheet to Monitor Blood Pressure After Preeclampsia. Burgess, A., Gartrell, K., Anderson, T.[2023]

Telehealth has emerged as a valuable tool for postpartum care, particularly for managing hypertension, with evidence suggesting it improves compliance and reduces disparities in follow-up care.

Remote blood pressure monitoring is feasible and acceptable for postpartum women, making it a promising strategy for enhancing maternal health outcomes during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing Better Evidence on Remote Monitoring for Postpartum Hypertension: A Silver Lining of the Coronavirus Pandemic. Sawyer, MR., Jaffe, EF., Naqvi, M., et al.[2020]

Hypertensive disorders of pregnancy are a major cause of maternal morbidity and mortality, particularly in the postpartum period, highlighting the need for effective monitoring and care during this time.

Implementing remote blood pressure monitoring programs can improve care for postpartum patients, enhance blood pressure control, and reduce racial disparities in healthcare access, while being well-received by both patients and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum remote home blood pressure monitoring: the new frontier. Corlin, T., Raghuraman, N., Rampersad, RM., et al.[2023]

Postpartum home blood pressure monitoring significantly increases the likelihood of obtaining BP measurements in the first 10 days after delivery compared to clinic-based follow-up, with a relative risk of 2.11, indicating it may enhance early detection of hypertension.

Home BP monitoring is associated with reduced unplanned hypertension-related hospital admissions (adjusted relative risk 0.12), and it helps to reduce racial disparities in BP ascertainment by about 50%, although it does not appear to affect treatment initiation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum Home Blood Pressure Monitoring: A Systematic Review. Steele, DW., Adam, GP., Saldanha, IJ., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05595629

App-based Remote Blood Pressure Monitoring

Remote postpartum blood pressure monitoring program with text messages has been shown to increase adherence to recommended postpartum blood pressure checks.

2.

babyscripts.com

babyscripts.com/blog/blood-pressure-monitoring-should-the-standard-for-maternal-healthcare

Blood pressure monitoring should be the standard for ...

Remote BP monitoring has an immediate positive impact on maternal health outcomes, and pregnant and postpartum moms of all risk profiles should be on it.

3.

ajogmfm.org

ajogmfm.org/article/S2589-9333(24)00168-X/fulltext

Remote blood pressure management for postpartum ...

This study aimed to evaluate the cost-effectiveness of remote blood pressure management to determine the scalability of these programmatic interventions.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10407242/

Postpartum remote home blood pressure monitoring

Remote monitoring of postpartum hypertensive disorders of pregnancy is a reliable and effective alternative to current follow-up care models.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S155541552500159X

Nurse Practitioners Driving Virtual Postpartum Care

A standardized approach to hypertensive disorders of pregnancy using remote patient monitoring may improve outcomes through optimized PP blood ...

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babyscripts.com

babyscripts.com/mybloodpressure-remote-patient-monitoring

Babyscripts myBloodPressure | Remote Patient Monitoring

Remote patient monitoring solution with everything you need to manage blood pressure for maternity patients, configurable based on risk level.

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.

babyscripts.com

babyscripts.com/blog/rpm-data-shows-significant-impact-on-blood-pressure-risk-identification-for-maternity-patients

RPM Data Shows Significant Impact on Blood Pressure ...

According to another study, one in 10 women who develop hypertension as a result of pregnancy might not experience it until more than six weeks after childbirth ...

9.

journals.lww.com

journals.lww.com/greenjournal/abstract/2023/05001/remote_patient_monitoring_for_postpartum.234.aspx

Remote Patient Monitoring for Postpartum Hypertensive...

Hypertensive disorders of pregnancy (HDP) account for 2.5–4.6% of readmissions within 6 weeks postpartum (PP); 60% occur in the first 7 days.

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38512155/

Postpartum Remote Blood Pressure Monitoring Using a ...

Conclusion: Most women enrolled in the app were highly engaged and entered seven or more readings. Patients with critical blood pressures were identified; thus, ...