Remote Patient Monitoring for Preeclampsia

(REACH Trial)

VM
EB
Overseen ByEmily B Rosenfeld, DO
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether monitoring blood pressure from home, rather than only during doctor visits, can better manage high blood pressure during pregnancy. The researchers aim to determine if this approach improves health outcomes for both mother and baby while remaining cost-effective. Participants will either use remote patient monitoring (tracking health data from home) or continue with the usual office visits to manage their condition. Expectant mothers who are less than 23 weeks pregnant and have chronic high blood pressure might be suitable candidates. The trial focuses on making blood pressure management more frequent and convenient. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance prenatal care for future mothers.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, since the study involves adjusting blood pressure medications, you might need to change or adjust your current treatment. It's best to discuss this with the trial staff.

What prior data suggests that remote patient monitoring is safe for managing blood pressure in pregnancy?

Research has shown that pregnant women respond positively to using remote devices for blood pressure monitoring. Studies have found that this method can help control high blood pressure during pregnancy, which is crucial for the health of both mother and baby. For example, one study discovered that women using remote monitoring devices checked their blood pressure more frequently and adhered better to their monitoring routine than those using traditional methods. This suggests that the technology is safe and effective in promoting regular monitoring. No reports of negative effects from using remote monitoring itself have emerged, making it a promising option for managing high blood pressure during pregnancy.12345

Why are researchers excited about this trial?

Researchers are excited about remote patient monitoring for preeclampsia because it offers a new way to manage blood pressure from the comfort of a patient’s home. Unlike the usual care where blood pressure is checked during office visits, this approach uses technology to continuously monitor and adjust treatment based on real-time data. This method could potentially catch blood pressure changes earlier, leading to quicker interventions and better outcomes for both mothers and babies. It's a step toward more personalized and proactive care, which could transform how we handle preeclampsia.

What evidence suggests that remote patient monitoring is effective for preeclampsia?

Research has shown that remote monitoring for pregnant women with high blood pressure can improve their health. In this trial, participants in the Remote Patient Monitoring arm will have their blood pressure managed and medication adjusted based on remote measurements. Studies have found that remote monitoring simplifies access to care and enhances blood pressure management. One study discovered that remote monitoring increased the number of blood pressure checks soon after hospital discharge. Another review found it safe and practical for women at high risk of pregnancy-related high blood pressure problems. Overall, remote monitoring provides quicker and more accurate blood pressure management compared to traditional doctor visits, which is the approach used in the Usual Care arm of this trial.12678

Who Is on the Research Team?

EB

Emily B Rosenfeld, DO

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with chronic hypertension, specifically those who may be at risk of developing preeclampsia. Participants will need to have access to remote monitoring tools and be willing to monitor their blood pressure daily.

Inclusion Criteria

Patients with a viable pregnancy <23 weeks of gestation
Ability to consent
I can follow directions.
See 3 more

Exclusion Criteria

Known fetal demise
Plan to deliver outside of the RWJ Barnabas Health system
Unlikely to follow up, in the opinion of the study staff
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either remote patient monitoring or in-office blood pressure management, with medication titration based on blood pressure readings

Up to 36 weeks
Regular prenatal visits every 1-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including composite perinatal outcomes and cardiac strain assessments

4 weeks post-delivery

What Are the Treatments Tested in This Trial?

Interventions

  • Remote Patient Monitoring
Trial Overview The study tests if managing high blood pressure through daily remote patient monitoring and adjusting medications in real-time can improve pregnancy outcomes compared to standard in-office visits.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Remote Patient monitoringExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Citations

Obstetric Hypertension: The Largest Study in Remote ...Post-hospital discharge remote blood pressure monitoring in pregnancy improved, with a 1.56-fold increase in measurements within the first 20 ...
Remote Blood Pressure Monitoring in Pregnancies at Risk ...This review examines the literature on remote blood pressure monitoring (RBPM) for pregnant women at high risk of hypertensive disorders of pregnancy (HDP).
Cellular-Enabled Remote Patient Monitoring for ...Conclusion. Remote patient monitoring for women whose pregnancies are complicated by hypertension can reduce barriers and improve health outcomes for women ...
Remote Monitoring Compared With In-Office Surveillance ...Remote monitoring can increase postpartum blood pressure ascertainment within 10 days of discharge for women with hypertensive disorders of pregnancy.
Using self-monitoring to detect and manage raised blood ...Self-monitoring of blood pressure during higher-risk or hypertensive pregnancy has been shown to be feasible, acceptable, safe, and no more ...
Hypertension in Pregnancy and PostpartumRecent studies have shown that brief HBPM combined with medication self-management and telehealth support leads to lower BP at 6 and 9 months ...
Maternal mortality solutions: Remote blood pressure ...Maternal mortality solutions: Remote blood pressure monitoring for pregnant and postpartum patients ... Why is maternal mortality so high in the ...
352 Remote blood pressure monitoring during pregnancyPatients with connected devices had more mean entries/day (0.57 vs. 0.35) and higher adherence rates (15% vs. 8%) compared to those with unconnected devices.
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