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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 54
Healthy Volunteers: f
View:

• Pregnant individuals with hypertensive disorders

• Speak English

• At least 18 years old

• Medicaid coverage

• Between 20 weeks of pregnancy and 2 weeks postpartum

• Postpartum admission at Prisma Health Richland with hypertensive disorder within 2 weeks postpartum

Locations
United States
South Carolina
Prisma Health Richland
RECRUITING
Columbia
Contact Information
Primary
Research nurse
Gwendoline.Helin-milgrom@PrismaHealth.org
803-687-9974
Time Frame
Start Date: 2024-02-13
Estimated Completion Date: 2026-02
Participants
Target number of participants: 540
Treatments
Intervention
Intervention group will receive blood pressure (BP) cuffs. 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.
Historical or Concurrent controls
Individuals who had hypertensive disorders during pregnancy but who did not receive the BP cuffs will serve as the control group.
Related Therapeutic Areas
Sponsors
Leads: University of South Carolina
Collaborators: Prisma Health-Midlands

This content was sourced from clinicaltrials.gov