Remote Patient Monitoring for Chronic Hypertension During Pregnancy (REACH)

NCT07115199 | Not Yet Recruiting DMC

• 2 other identifiers: Pro2025001233K12TR004788
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We hypothesize that frequent remote monitoring of blood pressure and real-time antihypertensive medication titration will optimize pregnancy outcomes in a clinically meaningful and cost-effective manner compared to the current standard of care. Therefore, this pilot study, as part of the K12 training support, will evaluate the feasibility of a randomized clinical trial to treat mild chronic hypertension with medication therapy to a blood pressure goal of less than 140/90 mmHg based on remote daily patient monitoring compared to in-office blood pressure readings.

Conditions

Chronic Hypertension in Pregnancy

Keywords

Chronic hypertension in pregnancy; Remote Patient Monitoring

Outcome Measures

Primary Outcomes (1)

• Composite perinatal outcomes

  This study will examine a primary composite of perinatal outcomes (Perinatal death, placental abruption, superimposed preeclampsia with severe features, or indicated preterm birth \<35 weeks)

  Delivery until 28 days after birth

Secondary Outcomes (2)

• Cardiac strain

  36 weeks gestation

• POCUS

  36 weeks gestation

Other Outcomes (2)

• Accuracy of BP reading

  From randomization to delivery (up to 36 weeks)

• Feasibility of study procedures

  From randomization to delivery (up to 36 weeks)

Study Arms (2)

Remote Patient monitoring

EXPERIMENTAL

The patients randomized to this intervention will get set up with remote patient monitoring. For these patients, blood pressure management and medication adjustment will be based on remote blood pressure measurements.

Procedure: Remote Patient Monitoring

Usual Care

NO INTERVENTION

For these patients, blood pressure medication will be managed based on in office blood pressure readings.

Interventions

Remote Patient Monitoring PROCEDURE

The patients randomized to this intervention will get set up with remote patient monitoring. For these patients, blood pressure management and medication adjustment will be based on remote blood pressure measurements.

Remote Patient monitoring

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 or older
• Patients with a viable pregnancy \<23 weeks of gestation
• Chronic hypertension is defined as: 1) Currently receiving treatment for hypertensive disorders OR 2) Newly diagnosed or untreated chronic hypertension is defined as systolic blood pressure \>=140 mm Hg or diastolic blood pressure \>=90 mm Hg prior to 20 weeks of gestation
• Viable pregnancy \<23 weeks of gestation
• Ability to follow directions
• Ability to consent
• Speak English or Spanish

You may not qualify if:

• Known secondary cause of hypertension
• Known major fetal anomaly
• Known fetal demise
• Suspected fetal growth restriction
• Membrane rupture
• Planned termination
• Plan to deliver outside of the RWJ Barnabas Health system
• Known sensitivity to labetalol or nifedipine
• Unlikely to follow up, in the opinion of the study staff.
• Any medical condition that the providers feel is a contraindication to the REACH algorithm.
• Unwillingness to take blood pressure at home

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (25)

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MeSH Terms

Interventions

Remote Patient Monitoring

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Emily B Rosenfeld, DO

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily B Rosenfeld, DO

CONTACT

732-402-4960; er720@rwjms.rutgers.edu

Vanessa Martinez, MPH

CONTACT

908-335-9249; vm310@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal-Fetal Medicine Faculty

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 11, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)