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

Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Device: Remote Blood Pressure Cuff; Device: Blood pressure monitoring smart phone app, BabyScripts™; Behavioral: Instructions

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.

• Study Type: Interventional
• Enrollment (Actual): 1607
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

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, 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Number of Encounters for Urgent or Emergent Care	Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities	Discharge through week 8 postpartum
Acceptability of rBPM in Postpartum Period	Survey to determine subject's level of satisfaction with use of the rBPM tools. Survey responses will be compared among subjects from varying demographic and socioeconomic groups. Survey is designed utilizing a Likert-type scale with 1-2 being higher level of acceptability, 3 being neutral, and 4-5 being lower level of acceptability of the rBPM tools. Study team will report the overall proportion and estimate the proportion of women with higher vs. lower levels of acceptability among women of different demographic and socioeconomic groups. This aim only applies to the women in the treatment (rBPM) arm.	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
Median Number of Women That Have a Follow-up Encounter Scheduled With Their Primary Care Physician (PCP) Within 12 Months After Delivery		Discharge through 12 months postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validate and Calibrate Previously Developed Predictive Algorithm	Intended to assess the performance of the predictive algorithm in identifying postpartum high blood pressure readmissions. Study team will utilize blood pressure measures obtained through 3 weeks postpartum, as well as any hypertensive disorders of pregnancy events postpartum through 8 weeks postpartum, to include Emergency Department/Urgent Care/Obstetrics Triage encounters and any readmissions. The predictive algorithm is informed by information documented in the electronic health record, prior to delivery and during pregnancy.	Discharge through week 8 postpartum

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Elizabeth T Jensen, MPH PhD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): January 7, 2025
• Study Completion (Actual): November 12, 2025

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: blood pressure; postpartum; women; blood pressure monitoring
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physical Examination; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Blood Pressure
• Other Study ID Numbers: IRB00077904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No