Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines

• Conditions: Postpartum Pre-Eclampsia; Cardiovascular Diseases; Cardiovascular Morbidity; Hypertension, Pregnancy-Induced; Hypertension; Postpartum Preeclampsia; Morbidity;Perinatal; Postpartum Complication

• Registration Number: NCT06576544
• Lead Sponsor: University of California, San Diego

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 (i.e. low-risk group), 100 patients who we expect to be at risk of new-onset high blood pressure postpartum (i.e. 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 (i.e. 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

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Study Start: 2024-09-16
• Primary Completion: 2025-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Postpartum birthing person 18 years of age or older
• At least 20 weeks gestation at time of delivery
• Meeting criteria for 1 of 3 risk categories for PP HTN and hypertensive morbidity
• Planned postpartum care at UCSD

Exclusion Criteria

• Inability to give informed consent
• Institutionalization for psychiatric disorder, mental deficiency or incarcerated
• Initiation of antihypertensive therapy prior to discharge from delivery hospitalization.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Define the differences in longitudinal trends in blood pressure during the 6-week postpartum period between (a) subjects at low-risk for postpartum hypertension, (b) an intermediate-risk group, and (c) those at high-risk for postpartum hypertension.	6 week postpartum period

Trial Locations

Locations (1)

Jacobs Medical Center at UC San Diego Health; 🇺🇸 La Jolla, California, United States