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

NCT06096701 | Recruiting

• 1 other identifier: 2085188
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertensive Disorder

Keywords

Preeclampsia; Gestational hypertension; Eclampsia; Chronic hypertension

Outcome Measures

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.

  First 6 weeks postpartum

Secondary Outcomes (3)

• Percent of patients attending an in-person postpartum visit

  First 8 weeks postpartum

• Percent of patients readmitted to the hospital through 12 months postpartum

  12 months postpartum

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

  First 8 weeks postpartum

Study Arms (2)

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.

Device: Blood pressure cuff

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.

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who will deliver at Prisma Health Richland.

You may qualify if:

• 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

You may not qualify if:

• Not planning to deliver at Prisma Health Richland
• Less than 20 weeks of pregnancy
• More than 2 weeks postpartum

Sponsors & Collaborators

• Prisma Health-Midlands: collaborator
• University of South Carolina: lead

Study Sites (1)

Prisma Health Richland

Columbia, South Carolina, 29203, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Eclampsia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Research nurse

CONTACT

803-687-9974; Gwendoline.Helin-milgrom@PrismaHealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: February 13, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)