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OpenTrials
Enrolling by Invitation

NCT Number: NCT06576544

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

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.

Enrolling by Invitation

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Jacobs Medical Center at UC San Diego Health

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BP Watch

Device

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

Primary outcomes

  1. Postpartum blood pressure trends

    Time frame: 6 week postpartum period

    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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 28, 2024
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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