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Clinical Trials/NCT06576544
NCT06576544
Enrolling By Invitation
Not Applicable

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

University of California, San Diego1 site in 1 country300 target enrollmentOctober 24, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension, Pregnancy-Induced
Sponsor
University of California, San Diego
Enrollment
300
Locations
1
Primary Endpoint
Postpartum blood pressure trends
Status
Enrolling By Invitation
Last Updated
5 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 24, 2024
End Date
September 1, 2027
Last Updated
5 months ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ukachi Emeruwa

Assistant Professor

University of California, San Diego

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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