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N/A N=1,607 Randomized Supportive Care

Monitoring and Testing of Blood Pressure in Postpartum Women

Hypertension

Enrolled (actual)
1,607
Serious AEs
3.9%
Results posted
Mar 2026
Primary outcome: Primary: Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant — 6 Number of rBPM measurements

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Remote Blood Pressure Cuff (Device); Blood pressure monitoring smart phone app, BabyScripts™ (Device); Instructions (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Wake Forest University Health Sciences
Primary completion
Jan 2025

Outcome Measures

OutcomeResultp-value
PRIMARY
Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant
6
PRIMARY
Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines
0.308; 0.786
PRIMARY
Median Total Cost of Health Care
1040; 1046
PRIMARY
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
35; 66; 10; 50
PRIMARY
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
35; 66; 10; 50
PRIMARY
Number of Participants With One or More Urgent or Emergent Care Encounters
95; 131
SECONDARY
Median Number of Encounters for Urgent or Emergent Care
SECONDARY
Acceptability of rBPM in Postpartum Period
SECONDARY
Median Length of Stay (LOS) in Hospital After Delivery
SECONDARY
Median Number of Hospital Readmissions
SECONDARY
Median Length of Stay (LOS) for Hospital Readmissions
SECONDARY
Median Number of Women That Have a Follow-up Encounter Scheduled With Their Primary Care Physician (PCP) Within 12 Months After Delivery

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05236725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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