Monitoring and Testing of Blood Pressure in Postpartum Women

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05236725
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Sep 2025
Primary completion
Jan 7, 2025
Completion
Nov 12, 2025

Study Design

Enrollment
1,607 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: 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 Atrium Health Wake Forest Baptist Maternal-Fetal Medicine provider)
  • Experimental: 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 blood pressure monitoring app (BabyScripts) and Bluetooth enabled blood pressure cuff/monitor, and will receive the following equipment and monitoring: * a specialized, Bluetooth enabled blood pressure monitoring cuff (Clinically Validated, A\&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2) * Blood pressure monitoring smart phone app, BabyScripts™ * Verbal and written instructions, to conduct blood pressure checks at home

Primary Outcome Measure

Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant [ Time Frame: Discharge through Week 3 postpartum ]

Locations (1)

FacilityCityStateZIPSite coordinators
Atrium Health Wake Forest BaptistWinston-SalemNorth Carolina27157-

Find similar trials in Winston-Salem, NC

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Atrium Health Wake Forest Baptist· Winston-Salem, NC

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