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

NCT06576544 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-11-04

No results posted yet for this study

Summary

To better understand postpartum blood pressure changes, the investigators are proposing a study to monitor blood pressure after delivery in 100 patients who the investigators expect to have normal blood pressure (i.e. low-risk group), 100 patients who the investigators 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 the investigators 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. The investigators 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.

Conditions

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

Interventions

DEVICE

BP Watch

Participants are given a non-invasive wearable device that monitors blood pressure multiple times daily for 6 weeks postpartum.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-24
Primary Completion
2026-06-30
Completion
2027-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06576544 on ClinicalTrials.gov