NCT05236725

Monitoring and Testing of Blood Pressure in Postpartum Women

Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,607 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high blood pressure, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high blood pressure can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote blood pressure after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor blood pressures without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their blood pressure remotely after delivery found out that this was both possible and acceptable.

Detailed description

This is a randomized control trial. All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, North Carolina that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART-BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit." This nurse home visit occurs via phone call, telehealth visit, or an in person visit approximately 2 weeks after delivery.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Remote Blood Pressure Cuff	specialized, Bluetooth enabled blood pressure monitoring cuff
DEVICE	Blood pressure monitoring smart phone app, BabyScripts™	app that works with the monitoring cuff
BEHAVIORAL	Instructions	Verbal and written instructions to conduct blood pressure checks at home

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-01-07
• Completion: 2025-11-12
• First posted: 2022-02-11
• Last updated: 2026-03-19
• Results posted: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study