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

University of California San Diego

Status: Invitation-only

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

Treatments: Device: BP Watch

Study type: Observational

Funder types: Other

Identifiers

NCT06576544

808180

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 3 patient groups

High-risk

Description:

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

Treatment:

Device: BP Watch

Intermediate-risk

Description:

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

Treatment:

Device: BP Watch

Low-risk

Description:

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.

Treatment:

Device: BP Watch