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NCT Number: NCT06096701

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

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.

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Key information

Age range

18 year–54 year

Sex eligibility

Female

Study type

Observational

Primary location

Prisma Health Richland

Columbia, South Carolina, 29203, United States

Location status: Recruiting

Location contact

Research Nurse

CONTACT

[email protected]

803-687-9974

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

Primary outcomes

  1. Blood pressure ascertainment

    Time frame: First 6 weeks postpartum

    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.

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

    Time frame: First 8 weeks postpartum

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Research nurse

CONTACT

[email protected]

803-687-9974

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Prisma Health-Midlands

Registry information

Acronym: BP-ME

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Oct 24, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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