Hypertensive DisorderBP-MENCT06096701
Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women
An observational study of Hypertensive Disorder, run by University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 54 years, women only
- Conditions the study is for
- Hypertensive Disorder
- What is being tested?
- Blood pressure cuff
- Type of treatment
- Medical device
- How many people
- 421 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- Women only
- No healthy volunteers
- Adult
Study population: Individuals who will deliver at Prisma Health Richland.
Who may be able to join
- 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
Who cannot join
- Not planning to deliver at Prisma Health Richland
- Less than 20 weeks of pregnancy
- More than 2 weeks postpartum
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Richland
Columbia, South Carolina, 29203
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.
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.
- Conditions
- Hypertensive Disorder
- Being tested
- Blood pressure cuff
- Keywords
- Preeclampsia, Gestational hypertension, Eclampsia, Chronic hypertension
- Medical subject headings
- Hypertension, Pre-Eclampsia, Hypertension, Pregnancy-Induced, Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure cuffDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 6 weeks postpartum
Secondary outcomes (3)
Percent of patients attending an in-person postpartum visit
Measured: First 8 weeks postpartum
Percent of patients readmitted to the hospital through 12 months postpartum
Measured: 12 months postpartum
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.
Measured: First 8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start13 Feb 2024
- Primary completion31 Jul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive DisorderStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Prisma Health-Midlands
- Responsible party
- Principal investigator, Nansi Boghossian, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096701
- Sponsor's protocol ID
- 2085188
- Acronym
- BP-ME
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women
- ClinicalTrials.gov ID
- NCT06096701
- Acronym / sponsor ID
- BP-ME / 2085188
- Conditions
- Hypertensive Disorder
- Keywords
- Preeclampsia, Gestational hypertension, Eclampsia, Chronic hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 421 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Prisma Health-Midlands
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Device: Blood pressure cuffIntervention 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. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals who will deliver at Prisma Health Richland.
Key inclusion criteria (6 listed)
- Pregnant individuals with hypertensive disorders
- Speak English
- At least 18 years old
- Medicaid coverage
- Between 20 weeks of pregnancy and 2 weeks postpartum
Key exclusion criteria (3 listed)
- Not planning to deliver at Prisma Health Richland
- Less than 20 weeks of pregnancy
- More than 2 weeks postpartum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure cuffThe 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 | Intervention |
Primary outcome
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.
3 secondary outcomes
Percent of patients attending an in-person postpartum visit
Time frame: First 8 weeks postpartum
Percent of patients readmitted to the hospital through 12 months postpartum
Time frame: 12 months postpartum
Survey assessing patient's acceptability and satisfaction with the BP monitoring program
Time frame: First 8 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorder, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure ascertainment (time frame: First 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.