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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Hypertension; Hypertension, Pregnancy-Induced; Cardiovascular Morbidity; Postpartum Preeclampsia; Postpartum Complication; Morbidity;Perinatal; Postpartum Pre-Eclampsia
• Intervention / Treatment: Device: BP Watch

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: BP Watch; Participants are given a non-invasive wearable device that monitors blood pressure multiple times daily for 6 weeks postpartum.
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	Device: BP Watch; Participants are given a non-invasive wearable device that monitors blood pressure multiple times daily for 6 weeks postpartum.
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.	Device: BP Watch; Participants are given a non-invasive wearable device that monitors blood pressure multiple times daily for 6 weeks postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum blood pressure trends	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.	6 week postpartum period

Collaborators and Investigators

• Sponsor: University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Hypertension; Cardiovascular Diseases
• Other Study ID Numbers: 808180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes, IPD will be shared under controlled access
• IPD Sharing Time Frame: IPD will be shared once primary analysis is completed
• IPD Sharing Access Criteria: IPD will be shared under controlled access (e.g. Via DASH: https://catalog.data.gov/dataset/nih-data-and-specimen-hub-dash).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No