Summary

Eligibility
for females ages 18-50 (full criteria)
Location
at La Jolla, California
Dates
study started
completion around
Principal Investigator
by Ukachi Emeruwa
Headshot of Ukachi Emeruwa
Ukachi Emeruwa

Description

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.

Official Title

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

Keywords

Hypertension, Pregnancy-Induced, Hypertension, Postpartum Preeclampsia, Postpartum Complication, Postpartum Pre-Eclampsia, Cardiovascular Diseases, Cardiovascular Morbidity, Morbidity;Perinatal, Pre-Eclampsia, Eclampsia, Pregnancy-Induced Hypertension, Intermediate-risk, Low-risk

Eligibility

You can join if…

Open to females ages 18-50

  • 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

You CAN'T join if...

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

Location

  • Jacobs Medical Center at UC San Diego Health
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Ukachi Emeruwa
    Assistant Adjunct Professor, Ob/Gyn & Reproductive sciences, Vc-health Sciences-schools. Authored (or co-authored) 15 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT06576544
Study Type
Observational
Participants
Expecting 300 study participants
Last Updated