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Remote Blood Pressure Monitoring for Postpartum Women (SMART-BP Trial)
N/A
Recruiting
Led By Elizabeth T Jensen, MPH PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up discharge through 12 months postpartum
Awards & highlights
SMART-BP Trial 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.
Who is the study for?
This trial is for women over 18 in Forsyth County, NC who've recently given birth and received postpartum care at The Birth Center at Atrium Health Wake Forest Baptist. Participants need daily access to a smartphone with Wi-Fi or data and must be able to read English or Spanish.Check my eligibility
What is being tested?
The study tests if monitoring blood pressure using a smart phone app, BabyScripts™, along with remote BP cuff instructions can effectively track BP levels in new mothers for three weeks after leaving the hospital.See study design
What are the potential side effects?
There are no direct side effects from participating as it involves non-invasive blood pressure monitoring. However, there may be indirect consequences such as anxiety from self-monitoring or data privacy concerns.
SMART-BP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
SMART-BP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ discharge through 12 months postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~discharge through 12 months postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median number of Severe Hypertension events
Median number of rBPM measures obtained
Median total cost of health care
+1 moreSecondary outcome measures
Acceptability of rBPM in postpartum period
Median Length of Stay (LOS) for hospital readmissions
Median Length of Stay (LOS) in hospital after delivery
+3 moreOther outcome measures
Validate and calibrate previously developed predictive algorithm
SMART-BP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Remote Blood Pressure Monitoring (rBPM)Experimental Treatment3 Interventions
Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring:
a specialized, Bluetooth enabled BP monitoring cuff (Clinically Validated, A&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2)
BP monitoring smart phone app, BabyScripts™
Verbal and written instructions, to conduct BP checks at home
Group II: Standard of Care (SOC)Active Control1 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 WFBMC Maternal-Fetal Medicine provider)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Instructions
2021
N/A
~110
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,002,487 Total Patients Enrolled
Elizabeth T Jensen, MPH PhDPrincipal InvestigatorAtrium Health Wake Forest Baptist
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am younger than 18 years old.Women who have given birth at The Birth Center at Atrium Health Wake Forest Baptist.Women who received pregnancy care at certain Atrium Health Wake Forest Baptist clinics in Forsyth County, NC.I am 18 years old or older.Criterion: Women who gave birth at home or another facility and then got postpartum care at Atrium Health Wake Forest Baptist in The Birth Center.Women who did not receive postpartum care at The Birth Center at Atrium Health Wake Forest Baptist are excluded.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Remote Blood Pressure Monitoring (rBPM)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being recruited for this experiment?
"Confirmatively, clinicaltrials.gov reveals that this medical experiment is actively seeking participants; it was first advertised on March 1st 2022 and the details were most recently revised on March 30th 2022. For successful completion of this trial, 3500 patients must be found from a single site."
Answered by AI
Are there currently any openings for participants to join this experiment?
"Per the information on clinicaltrials.gov, this experiment is still in need of enrollees. This research was initially published on March 1st 2022 and has been recently amended as of March 30th 2021."
Answered by AI
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