Study Summary
This trial is testing whether or not checking a woman's blood pressure remotely for 3 weeks after childbirth is an effective way to monitor BP without having to extend their hospital stay.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 6 Secondary · Reporting Duration: Discharge through 12 months postpartum
Week 8
Median Length of Stay (LOS) in hospital after delivery
Day 10 postpartum
Proportion of women monitoring blood pressure (BP) according to American College of Obstetricians and Gynecologists (ACOG) guidelines
Month 12
Median number of women that have a follow-up encounter scheduled with their Primary Care Physician (PCP) within 12 months after delivery
Week 3
Median number of rBPM measures obtained
Week 3
Median number of Severe Hypertension events
Week 8
Median Length of Stay (LOS) for hospital readmissions
Median number of encounters for urgent or emergent care
Median number of hospital readmissions
Validate and calibrate previously developed predictive algorithm
Week 8
Median total cost of health care
Week 3 postpartum
Acceptability of rBPM in postpartum period
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Standard of Care (SOC)
1 of 2
Remote Blood Pressure Monitoring (rBPM)
1 of 2
Active Control
Experimental Treatment
1750 Total Participants · 2 Treatment Groups
Primary Treatment: Instructions · No Placebo Group · N/A
Remote Blood Pressure Monitoring (rBPM)Experimental Group · 3 Interventions: Blood Pressure (BP) monitoring smart phone app, BabyScripts™, Instructions, Remote Blood Pressure Cuff · Intervention Types: Device, Behavioral, Device
Standard of Care (SOC)NoIntervention Group · 1 Intervention: Standard of Care (SOC) · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Instructions
2021
N/A
~110
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: discharge through 12 months postpartum
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,121 Previous Clinical Trials
1,125,264 Total Patients Enrolled
Elizabeth T Jensen, MPH PhDPrincipal InvestigatorAtrium Health Wake Forest Baptist
Eligibility Criteria
Age 18+ · Female Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a female who received antenatal care from one of Atrium Health Wake Forest Baptist's obstetrics/maternal-fetal medicine outpatient clinics in Forsyth County, North Carolina.
You are a female who has previously given birth at The Birth Center at Atrium Health Wake Forest Baptist.
Women who gave birth at home or another location, and subsequently sought postpartum care from Atrium Health Wake Forest Baptist's Birth Center.
You presently inhabit Forsyth County, NC.
You are at least 18 years of age.
You have the ability to comprehend either English or Spanish.
You possess or can regularly avail yourself of a smartphone (iOS or Android OS) with either Wi-Fi access or a mobile data plan.
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Conditions
Cancer Related
Treatments