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Monitoring and Testing of Blood Pressure in Postpartum Women

NCT ID: NCT05236725

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1602 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2025-11-12

Brief Summary

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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 BP, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high BP can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote BP after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor BPs without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their BP remotely after delivery found out that this was both possible and acceptable.

Detailed Description

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This is a randomized control trial (RCT). 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, NC 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 \~2 weeks after delivery.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care (SOC)

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Remote Blood Pressure Monitoring (rBPM)

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 Type EXPERIMENTAL

Remote Blood Pressure Cuff

Intervention Type DEVICE

specialized, Bluetooth enabled BP monitoring cuff

Blood Pressure (BP) monitoring smart phone app, BabyScripts™

Intervention Type DEVICE

app that works with the monitoring cuff

Instructions

Intervention Type BEHAVIORAL

Verbal and written instructions to conduct BP checks at home

Interventions

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Remote Blood Pressure Cuff

specialized, Bluetooth enabled BP monitoring cuff

Intervention Type DEVICE

Blood Pressure (BP) monitoring smart phone app, BabyScripts™

app that works with the monitoring cuff

Intervention Type DEVICE

Instructions

Verbal and written instructions to conduct BP checks at home

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Women that received prenatal care at one of the Atrium Health Wake Forest Baptist OB/MFM outpatient clinic locations in Forsyth County, NC
* Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
* Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
* Currently resides in Forsyth County, NC
* 18 years of age or older
* Able to read and understand either English or Spanish
* 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

* Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
* Resides outside of Forsyth County, NC
* Under 18 years of age
* Unable to read or understand either English or Spanish
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth T Jensen, MPH PhD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Locations

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Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00077904

Identifier Type: -

Identifier Source: org_study_id