Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576544
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To better understand postpartum blood pressure changes we are proposing a study to monitor blood pressure after delivery in 100 patients who we expect to have normal blood pressure ie low-risk group 100 patients who we expect to be at risk of new-onset high blood pressure postpartum ie intermediate-risk group and 100 patients who had high blood pressure prior to pregnancy or very early before 20 weeks in pregnancy who we know are at high risk of blood-pressure related complications postpartum ie high-risk group Patients will be given a non-invasive wearable device that monitors blood pressure continuously for 6 weeks postpartum We expect that the daily changes in blood pressure will be different between these groups which may allow us to better predict who is at risk how much monitoring is needed and when to intervene before the blood pressure abnormalities cause complications The blood pressure device that will be given to patients is the YHE BP Doctor Med Blood Pressure Smartwatch This is a highly-accurate medical grade device that has not received FDA clearance As such the device is not being used to make blood pressure management and treatment decisions but rather to gather data on postpartum cardiovascular physiology Safety stops are built into the protocol such that elevated readings detected by the watch will trigger clinical referrals and validation by standard blood pressure cuffs prior to determine need for treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None