Smartwatch tracks blood pressure in new mothers after delivery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women after childbirth, from 18 to 50 years old, who delivered at 20 weeks or later and will have postpartum care at UCSD. They wear a blood pressure smartwatch for 6 weeks.

Age

18 Years to 50 Years

Sex

Women only

Disease stage

Delivered at least 20 weeks into pregnancy. Must fit 1 of 3 risk groups for high blood pressure after birth: low, intermediate or high risk.

Earlier treatment

Must not have started blood pressure medicine before leaving the hospital after delivery.

Main reasons for not taking part

• Cannot give informed consent
• Living in an institution for a psychiatric disorder or mental deficiency, or in prison
• Started blood pressure medicine before leaving the delivery hospital

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 50 years old?YesNo

What the trial wants to find out

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.

The 3 groups in the trial

• 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

  Treatment: 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

  Treatment: 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.

  Treatment: BP Watch