Monitoring and Testing of Blood Pressure in Postpartum Women

NCT05236725 | Completed Results FDA Device

• 1 other identifier: IRB00077904
• Study Type: interventional
• Target: 1,607
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

postpartum; blood pressure; women; blood pressure monitoring

Outcome Measures

Primary Outcomes (6)

• Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant

  Used to determine feasibility of remote blood pressure monitoring intervention (rBPM) in postpartum women. This measure represents the median number of remote blood pressure monitoring (rBPM) measurements collected per participant during the study period. The total number of rBPM readings obtained for each participant was calculated, and the median value across all participants in the analysis population was reported

  Discharge through Week 3 postpartum

• Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines

  This outcome measures the proportion of participants whose postpartum blood pressure monitoring adhered to American College of Obstetricians and Gynecologists (ACOG) recommendations. Adherence includes: Initial Monitoring (first 72 hours postpartum): inpatient or equivalent monitoring for women with pregnancy-related hypertension; and Early Follow-Up (3-10 days postpartum): documentation of a follow-up visit or remote blood pressure check within 3-10 days after hospital discharge. Monitoring data will be obtained from electronic health records and remote blood pressure monitoring logs. Participants are counted once if they met both ACOG-recommended monitoring intervals.

  Discharge through Day 10 postpartum

• Median Total Cost of Health Care

  Cost of hospital based medical care of subjects in US dollars.

  From discharge through week 8 postpartum

• Number of Participants Experiencing at Least One Day With a Severe Hypertension Event

  This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.

  Discharge through week 1 postpartum

• Number of Participants Experiencing at Least One Day With a Severe Hypertension Event

  This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.

  Discharge through week 3 postpartum

• Number of Participants With One or More Urgent or Emergent Care Encounters

  The study team will use the electronic health record (EHR) to identify the number of participants who had one or more encounters at Emergency Department, Obstetric Triage, or Urgent Care facilities affiliated with Atrium Health Wake Forest Baptist. Encounters will be identified using visit type classifications and associated encounter codes documented in the EHR. Only encounters occurring within the specified study time frame and attributable to enrolled participants will be included. Each participant will be counted once regardless of the total number of urgent or emergent care visits they experienced.

  Discharge through week 3 postpartum

Secondary Outcomes (6)

• Median Number of Encounters for Urgent or Emergent Care

  Discharge through week 8 postpartum

• Acceptability of rBPM in Postpartum Period

  Week 3 postpartum

• Median Length of Stay (LOS) in Hospital After Delivery

  Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum

• Median Number of Hospital Readmissions

  Discharge through week 8 postpartum

• Median Length of Stay (LOS) for Hospital Readmissions

  Discharge through week 8 postpartum

Other Outcomes (1)

• Validate and Calibrate Previously Developed Predictive Algorithm

  Discharge through week 8 postpartum

Study Arms (2)

Standard of Care (SOC)

NO 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 Atrium Health Wake Forest Baptist Maternal-Fetal Medicine provider)

Remote Blood Pressure Monitoring (rBPM)

EXPERIMENTAL

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

Device: Remote Blood Pressure Cuff; Device: Blood pressure monitoring smart phone app, BabyScripts™; Behavioral: Instructions

Interventions

Remote Blood Pressure Cuff DEVICE

specialized, Bluetooth enabled blood pressure monitoring cuff

Remote Blood Pressure Monitoring (rBPM)

Instructions BEHAVIORAL

Verbal and written instructions to conduct blood pressure checks at home

Remote Blood Pressure Monitoring (rBPM)

Blood pressure monitoring smart phone app, BabyScripts™ DEVICE

app that works with the monitoring cuff

Remote Blood Pressure Monitoring (rBPM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women that received prenatal care at one of the Atrium Health Wake Forest Baptist Obstetrics/Maternal-Fetal Medicine outpatient clinic locations in Forsyth County, North Carolina
• 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, North Carolina
• 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

You may not qualify if:

• Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
• Resides outside of Forsyth County, North Carolina
• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Elizabeth T. Jensen, MPH PhD, Professor of Epidemiology
• Organization: Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist

elizabeth.jensen@wfusm.edu

336-713-3132

Study Officials

• Elizabeth T Jensen, MPH PhD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 11, 2022
• Study Start: March 1, 2022
• Primary Completion: January 7, 2025
• Study Completion: November 12, 2025
• Last Updated: March 19, 2026
• Results First Posted: March 2, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)