Clinical trial NCT06576544: Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines
Official title: Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypertension, Pregnancy-Induced
Hypertension
Postpartum Preeclampsia
Postpartum Complication
Postpartum Pre-Eclampsia
Cardiovascular Diseases
Cardiovascular Morbidity
Morbidity;Perinatal
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The present research study focuses on postpartum hypertension. The target sample size is 300 postpartum patients delivering at UCSD. Within this population, we aim to enroll 100 low-risk participants, 100 intermediate-risk participants, and 100 high-risk participants.

Brief 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.


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.

Primary outcomes:
measure: 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.
timeFrame: 6 week postpartum period
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Jacobs Medical Center at UC San Diego Health
state: California
Study officials:
References: