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Remote Blood Pressure Monitoring for Postpartum Women (SMART-BP Trial)

N/A

Recruiting

Led By Elizabeth T Jensen, MPH PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Must not have

Under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 10 postpartum

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether or not checking a woman's blood pressure remotely for 3 weeks after childbirth is an effective way to monitor BP without having to extend their hospital stay.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There are no direct side effects from participating as it involves non-invasive blood pressure monitoring. However, there may be indirect consequences such as anxiety from self-monitoring or data privacy concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am younger than 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 10 postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 10 postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 10 postpartum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Median number of rBPM measures obtained

Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines

Secondary study objectives

Acceptability of rBPM in postpartum period

Median number of encounters for urgent or emergent care

Other study objectives

Validate and calibrate previously developed predictive algorithm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Remote Blood Pressure Monitoring (rBPM)Experimental Treatment3 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 Control1 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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Instructions

2021

N/A

~110

0 / 2Eligibility criteria met