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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-54
SponsorUniversity of South Carolina

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Pregnant individuals with hypertensive disorders

Speak English

At least 18 years old

Medicaid coverage

Disqualifiers

Not planning to deliver at Prisma Health Richland

Less than 20 weeks of pregnancy

More than 2 weeks postpartum

Trial population

Individuals who will deliver at Prisma Health Richland.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood pressure cuff

    Device

    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.

Treatment groups

540 Participants
are divided into 2 treatment groups
Group A: Intervention1 intervention
Group B: Historical or Concurrent controls0 interventions

Trial outcomes

Primary outcomes

1

Blood pressure ascertainment

BP ascertainment i.e., percent of patients submitting at least one BP value, the average number of unique BP measures per patient during the first six-weeks postpartum, and percent of patients continuing the program beyond 3 weeks postpartum.

Time frame
First 6 weeks postpartum

Secondary outcomes

1

Percent of patients attending an in-person postpartum visit

Time frame
First 8 weeks postpartum
2

Percent of patients readmitted to the hospital through 12 months postpartum

Time frame
12 months postpartum
3

Survey assessing patient's acceptability and satisfaction with the BP monitoring program

The survey questions will include comfort with the technology and satisfaction with the BP monitoring program. All survey items will be assessed using a 5-item Likert scale (score of 1-strong disagreement, 3-neutral, 5-strong agreement) and will be administered through the telehealth platform starting on day 35 of the program. Patients who do not complete the survey will be contacted to complete it by phone or at their postpartum visit.

Time frame
First 8 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Carolina

Lead sponsor

Prisma Health-Midlands

Collaborator