RecruitingNCT06096701

Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women


Sponsor

University of South Carolina

Enrollment

540 participants

Start Date

Feb 13, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Hypertensive disorders (HD), including preeclampsia, gestational hypertension, chronic hypertension, and chronic hypertension with superimposed preeclampsia, affect around 10-20% of pregnant women in the United States and are significantly associated with maternal mortality and morbidity, particularly in the postpartum period. The prevalence of HD is on the rise in the United States and has increased from 13% in 2017 to 16% in 2019 owing to an increase in advanced maternal age, obesity, and diabetes. There are major racial disparities in HD and subsequent maternal mortality and morbidity. HD affect more than 1 in 5 delivery hospitalizations of Black women. Black women with HD are also more likely than white women with HD to have more adverse postpartum blood pressure trajectories which leads to a higher incidence of hypertension related hospital readmissions (readmission for hypertension during the first 6-weeks postpartum: 16.9% among Black women vs. 9.5% among white women, p=0.02) and cardiovascular-related adverse events. However, most of the management recommendations have been centered around blood pressure targets during the antepartum period with significantly less attention paid to the postpartum period despite evidence showing that hypertensive disorders are the most common reason for postpartum readmissions and are associated with increased maternal mortality and morbidity and a significant cost burden.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 54 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a cloud-based, remote blood pressure monitoring program can help women with high blood pressure during or after pregnancy (hypertensive disorders of pregnancy) manage their condition more safely at home during the postpartum period — when risks of complications are often highest. **You may be eligible if...** - You have a hypertensive disorder of pregnancy (such as preeclampsia, gestational hypertension) - You are at least 18 years old - You are between 20 weeks pregnant and 2 weeks postpartum - You have Medicaid insurance - You are delivering or have recently delivered at Prisma Health Richland - You speak English **You may NOT be eligible if...** - You are not planning to deliver at Prisma Health Richland - You are less than 20 weeks pregnant - You are more than 2 weeks postpartum at the time of enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBlood pressure cuff

The BP cuff is connected in a Health Insurance Portability and Accountability Act-compliant fashion to the patient's medical record, allowing for documentation and communication with the nurse and the care team. Alerts are triggered if a patient has not checked her BP for 3 days or when readings fall outside a specific threshold (high or low BP alerts). Based on these alerts, the nurse follows up with these patients and reminds them to take a reading. The nurse will also notify participants with elevated BP values to repeat their BP and will contact the participants by phone to discuss symptoms and antihypertensive medications. Patients will be managed based on a clinical algorithm for initiation of antihypertensive medications without the need for an outpatient visit if considered appropriate by the clinical provider.


Locations(1)

Prisma Health Richland

Columbia, South Carolina, United States

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NCT06096701