Monitoring and Testing of Blood Pressure in Postpartum Women (SMART-BP)

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Hypertension

Treatments: Behavioral: Instructions; Device: Blood Pressure (BP) monitoring smart phone app, BabyScripts™; Device: Remote Blood Pressure Cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT05236725

IRB00077904

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,602 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,602 participants in 2 patient groups

Standard of Care (SOC)

No Intervention group

Description:

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)

Remote Blood Pressure Monitoring (rBPM)

Experimental group

Description:

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

Treatment:

Device: Remote Blood Pressure Cuff

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

Behavioral: Instructions