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

NCT06576544 | Enrolling By Invitation

• 1 other identifier: 808180
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

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

Interventions

BP Watch DEVICE

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

High-risk; Intermediate-risk; Low-risk

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Jacobs Medical Center at UC San Diego Health

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD will be shared once primary analysis is completed
• Access Criteria: IPD will be shared under controlled access (e.g. Via DASH: https://catalog.data.gov/dataset/nih-data-and-specimen-hub-dash).

Locations

US (1)