Wearables to Define Postpartum Blood Pressure Trajectories and Facilitate Evidence-based Monitoring Guidelines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BP Watch.
- Who it may be relevant to
- Registry conditions: Hypertension, Pregnancy-Induced, Hypertension, Postpartum Preeclampsia, Postpartum Complication. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension
Overview
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.
Interventions
- Device BP Watch
Participants are given a non-invasive wearable device that monitors blood pressure multiple times daily for 6 weeks postpartum.
Primary outcome measures
- Postpartum blood pressure trends [Time frame: 6 week postpartum period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Jacobs Medical Center at UC San Diego Health — La Jolla
Identifiers
NCT: NCT06576544 · 808180