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Active, not recruitingNCT06096701BP-MEUpdated Aug 20, 2026

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

An observational study in Hypertensive Disorder, sponsored by University of South Carolina. Active, not recruiting at 1 site in United States. Open to female participants aged 18 Years to 54 Years. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University of South Carolina · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
421
Ages
18 Years to 54 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Hypertensive Disorder

Keywords

  • Preeclampsia
  • Gestational hypertension
  • Eclampsia
  • Chronic hypertension
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 421 is above the median of 350 across 1,163 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 54 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals who will deliver at Prisma Health Richland.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Not planning to deliver at Prisma Health Richland
  • Less than 20 weeks of pregnancy
  • More than 2 weeks postpartum
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
421 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06096701
Collaborators
Prisma Health-Midlands
Responsible party
Nansi Boghossian (Associate Professor, University of South Carolina) — Principal investigator
First posted
Oct 24, 2023
Start date
Feb 13, 2024
Primary completion
Jul 31, 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Aug 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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