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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06576544
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 24, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: High-risk
    Individuals having chronic HTN, according to ACOG guidelines, as either SBP ≥140 mmHg or DBP ≥90 mmHg on at least 2 occasions, ≥4 hours apart, prior to 20 weeks gestation
  • Arm: Intermediate-risk
    Individuals who are at risk of de novo PP HTN; these are individuals who are at risk for preeclampsia based on an adapted USPSTF algorithm but who did not develop HTN by the time of delivery. The algorithm is as follows: -One or more of the following high risk conditions and/or two or more of the following moderate risk conditions for development of de novo postpartum hypertension: i. High risk conditions: pregestational diabetes mellitus, renal disease, autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome), multifetal gestation, gestational diabetes mellitus A2 (i.e. medication-dependent), history of preeclampsia in a prior pregnancy (not including the index pregnancy) ii. Moderate risk conditions: primiparity, obesity (BMI ≥ 35 kg/m2), age ≥ 35 years, Black or African-American race, family history of preeclampsia
  • Arm: Low-risk
    Having no diagnosis of HTN/HDP by the time of delivery and not meeting criteria for increased risk of HDP or de novo PP HTN.

Primary Outcome Measure

Postpartum blood pressure trends [ Time Frame: 6 week postpartum period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Jacobs Medical Center at UC San Diego HealthLa JollaCalifornia92037-

Find similar trials in La Jolla, CA

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Jacobs Medical Center at UC San Diego Health· La Jolla, CA

Related Studies