HypertensionSMART-BPNCT05236725
Monitoring and Testing of Blood Pressure in Postpartum Women
A study testing Remote Blood Pressure Cuff, Blood pressure monitoring smart phone app, BabyScripts™ and Instructions in people with Hypertension, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Remote Blood Pressure Cuff, Blood pressure monitoring smart phone app, BabyScripts™ and Instructions
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,607 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 12 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women that received prenatal care at one of the Atrium Health Wake Forest Baptist Obstetrics/Maternal-Fetal Medicine outpatient clinic locations in Forsyth County, North Carolina
- Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
- Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
- Currently resides in Forsyth County, North Carolina
- Able to read and understand either English or Spanish
- Owns or has daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
Who cannot join
- Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
- Resides outside of Forsyth County, North Carolina
- Under 18 years of age
- Unable to read or understand either English or Spanish
- Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women
The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high blood pressure, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high blood pressure can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote blood pressure after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor blood pressures without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their blood pressure remotely after delivery found out that this was both possible and acceptable.
Read the detailed description
This is a randomized control trial. All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, North Carolina that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART-BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit." This nurse home visit occurs via phone call, telehealth visit, or an in person visit approximately 2 weeks after delivery.
- Conditions
- Hypertension
- Being tested
- Remote Blood Pressure Cuff, Blood pressure monitoring smart phone app, BabyScripts™, Instructions
- Keywords
- postpartum, blood pressure, women, blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Blood Pressure CuffDevice
specialized, Bluetooth enabled blood pressure monitoring cuff
Blood pressure monitoring smart phone app, BabyScripts™Device
app that works with the monitoring cuff
InstructionsBehavioural
Verbal and written instructions to conduct blood pressure checks at home
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Subjects randomized to SOC arm are provided with the appropriate standard of care depending upon their risk level (as determined by their individual provider or Atrium Health Wake Forest Baptist Maternal-Fetal Medicine provider) |
| Remote Blood Pressure Monitoring (rBPM) | Experimental | Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote blood pressure monitoring app (BabyScripts) and Bluetooth enabled blood pressure cuff/monitor, and will receive the following equipment and monitoring:
* a specialized, Bluetooth enabled blood pressure monitoring cuff (Clinically Validated, A\&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2)
* Blood pressure monitoring smart phone app, BabyScripts™
* Verbal and written instructions, to conduct blood pressure checks at home Receives: Device: Remote Blood Pressure Cuff; Device: Blood pressure monitoring smart phone app, BabyScripts™; Behavioral: Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant
Used to determine feasibility of remote blood pressure monitoring intervention (rBPM) in postpartum women. This measure represents the median number of remote blood pressure monitoring (rBPM) measurements collected per participant during the study period. The total number of rBPM readings obtained for each participant was calculated, and the median value across all participants in the analysis population was reported
Measured: Discharge through Week 3 postpartum
Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines
This outcome measures the proportion of participants whose postpartum blood pressure monitoring adhered to American College of Obstetricians and Gynecologists (ACOG) recommendations. Adherence includes: Initial Monitoring (first 72 hours postpartum): inpatient or equivalent monitoring for women with pregnancy-related hypertension; and Early Follow-Up (3-10 days postpartum): documentation of a follow-up visit or remote blood pressure check within 3-10 days after hospital discharge. Monitoring data will be obtained from electronic health records and remote blood pressure monitoring logs. Participants are counted once if they met both ACOG-recommended monitoring intervals.
Measured: Discharge through Day 10 postpartum
Median Total Cost of Health Care
Cost of hospital based medical care of subjects in US dollars.
Measured: From discharge through week 8 postpartum
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.
Measured: Discharge through week 1 postpartum
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.
Measured: Discharge through week 3 postpartum
Number of Participants With One or More Urgent or Emergent Care Encounters
The study team will use the electronic health record (EHR) to identify the number of participants who had one or more encounters at Emergency Department, Obstetric Triage, or Urgent Care facilities affiliated with Atrium Health Wake Forest Baptist. Encounters will be identified using visit type classifications and associated encounter codes documented in the EHR. Only encounters occurring within the specified study time frame and attributable to enrolled participants will be included. Each participant will be counted once regardless of the total number of urgent or emergent care visits they experienced.
Measured: Discharge through week 3 postpartum
Secondary outcomes (6)
Median Number of Encounters for Urgent or Emergent Care
Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities
Measured: Discharge through week 8 postpartum
Acceptability of rBPM in Postpartum Period
Survey to determine subject's level of satisfaction with use of the rBPM tools. Survey responses will be compared among subjects from varying demographic and socioeconomic groups. Survey is designed utilizing a Likert-type scale with 1-2 being higher level of acceptability, 3 being neutral, and 4-5 being lower level of acceptability of the rBPM tools. Study team will report the overall proportion and estimate the proportion of women with higher vs. lower levels of acceptability among women of different demographic and socioeconomic groups. This aim only applies to the women in the treatment (rBPM) arm.
Measured: Week 3 postpartum
Median Length of Stay (LOS) in Hospital After Delivery
Measured: Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum
Median Number of Hospital Readmissions
Measured: Discharge through week 8 postpartum
Median Length of Stay (LOS) for Hospital Readmissions
Measured: Discharge through week 8 postpartum
Median Number of Women That Have a Follow-up Encounter Scheduled With Their Primary Care Physician (PCP) Within 12 Months After Delivery
Measured: Discharge through 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Mar 2022
- Primary completion7 Jan 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth T Jensen, MPH PhD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236725
- Sponsor's protocol ID
- IRB00077904
- Acronym
- SMART-BP
- Status last verified
- Sep 2025
- First submitted
- 28 Jan 2022
- Last updated
- 19 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Monitoring and Remote Testing of Blood Pressure in Postpartum Women
- ClinicalTrials.gov ID
- NCT05236725
- Acronym / sponsor ID
- SMART-BP / IRB00077904
- Conditions
- Hypertension
- Keywords
- postpartum, blood pressure, women, blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,607 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 7 Jan 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Posted 2 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out the usefulness of checking a woman's blood pressure remotely (at home) for 3 weeks after being discharged from the hospital after having a baby (or babies). Some women can develop hypertension, or high blood pressure, after delivery even if they have not had this problem before or during their pregnancy. Untreated or unknown high blood pressure can lead to medical complications, and if severe, can be life threatening. Monitoring, or checking, remote blood pressure after a woman has delivered her baby (or babies) has been suggested to be a better way to monitor blood pressures without having to stay in the hospital for a longer time after delivery. Other researchers report that women who have checked their blood pressure remotely after delivery found out that this was both possible and acceptable.
Detailed description
This is a randomized control trial. All women, 18 years of age and older, delivering an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and residing in Forsyth County, North Carolina that have been approached by our Home Visit Coordinators will be eligible for enrollment and invited to participate in the SMART-BP study prior to discharge from the postpartum unit. Per established protocols, the Home Visit Coordinators for the Nurse Education Support Team Program attempt to approach all women that deliver in The Birth Center and who reside in Forsyth County. At this initial introduction, the Home Visit Coordinators determine if the patient has any need for, or interest in, any of the vetted community resources available to her and her family. Information about any of these resources are provided to the patient at that time. Additionally, the Home Visit Coordinators offer to schedule a nurse "home visit." This nurse home visit occurs via phone call, telehealth visit, or an in person visit approximately 2 weeks after delivery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Subjects randomized to SOC arm are provided with the appropriate standard of care depending upon their risk level (as determined by their individual provider or Atrium Health Wake Forest Baptist Maternal-Fetal Medicine provider) |
| Remote Blood Pressure Monitoring (rBPM) | Experimental | Device: Remote Blood Pressure Cuff, Device: Blood pressure monitoring smart phone app, BabyScripts™, Behavioral: InstructionsSubjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote blood pressure monitoring app (BabyScripts) and Bluetooth enabled blood pressure cuff/monitor, and will receive the following equipment and monitoring: * a specialized, Bluetooth enabled blood pressure monitoring cuff (Clinically Validated, A\&D Medical Wireless Blood Pressure Monitor-Upper Arm (Appendix 2) * Blood pressure monitoring smart phone app, BabyScripts™ * Verbal and written instructions, to conduct blood pressure checks at home |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women that received prenatal care at one of the Atrium Health Wake Forest Baptist Obstetrics/Maternal-Fetal Medicine outpatient clinic locations in Forsyth County, North Carolina
- Women that delivered an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist
- Women that delivered an infant(s) at home or outside facility, and were transported to Atrium Health Wake Forest Baptist and received postpartum care in The Birth Center
- Currently resides in Forsyth County, North Carolina
- Able to read and understand either English or Spanish
Key exclusion criteria (5 listed)
- Women that received postpartum care at any location other than The Birth Center at Atrium Health Wake Forest Baptist
- Resides outside of Forsyth County, North Carolina
- Under 18 years of age
- Unable to read or understand either English or Spanish
- Does not own or have daily access to a smart phone (iOS or Android operating system) with available Wi-Fi or monthly mobile data plan
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 |
|---|---|---|
| Remote Blood Pressure Cuffspecialized, Bluetooth enabled blood pressure monitoring cuff | Device | Remote Blood Pressure Monitoring (rBPM) |
| Blood pressure monitoring smart phone app, BabyScripts™app that works with the monitoring cuff | Device | Remote Blood Pressure Monitoring (rBPM) |
| InstructionsVerbal and written instructions to conduct blood pressure checks at home | Behavioural | Remote Blood Pressure Monitoring (rBPM) |
Primary outcome
Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant
Time frame: Discharge through Week 3 postpartum
Used to determine feasibility of remote blood pressure monitoring intervention (rBPM) in postpartum women. This measure represents the median number of remote blood pressure monitoring (rBPM) measurements collected per participant during the study period. The total number of rBPM readings obtained for each participant was calculated, and the median value across all participants in the analysis population was reported
Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines
Time frame: Discharge through Day 10 postpartum
This outcome measures the proportion of participants whose postpartum blood pressure monitoring adhered to American College of Obstetricians and Gynecologists (ACOG) recommendations. Adherence includes: Initial Monitoring (first 72 hours postpartum): inpatient or equivalent monitoring for women with pregnancy-related hypertension; and Early Follow-Up (3-10 days postpartum): documentation of a follow-up visit or remote blood pressure check within 3-10 days after hospital discharge. Monitoring data will be obtained from electronic health records and remote blood pressure monitoring logs. Participants are counted once if they met both ACOG-recommended monitoring intervals.
Median Total Cost of Health Care
Time frame: From discharge through week 8 postpartum
Cost of hospital based medical care of subjects in US dollars.
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
Time frame: Discharge through week 1 postpartum
This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.
Number of Participants Experiencing at Least One Day With a Severe Hypertension Event
Time frame: Discharge through week 3 postpartum
This measure captures the number of participants who experienced one or more days in which a severe hypertension event occurred. A participant is counted once if they had ≥1 day meeting severe hypertension criteria, regardless of the total number of qualifying days. A severe or critical hypertensive event is defined as any blood pressure reading in which the systolic value is ≥160 mmHg and/or the diastolic value is ≥110 mmHg.
Number of Participants With One or More Urgent or Emergent Care Encounters
Time frame: Discharge through week 3 postpartum
The study team will use the electronic health record (EHR) to identify the number of participants who had one or more encounters at Emergency Department, Obstetric Triage, or Urgent Care facilities affiliated with Atrium Health Wake Forest Baptist. Encounters will be identified using visit type classifications and associated encounter codes documented in the EHR. Only encounters occurring within the specified study time frame and attributable to enrolled participants will be included. Each participant will be counted once regardless of the total number of urgent or emergent care visits they experienced.
6 secondary outcomes
Median Number of Encounters for Urgent or Emergent Care
Time frame: Discharge through week 8 postpartum
Acceptability of rBPM in Postpartum Period
Time frame: Week 3 postpartum
Median Length of Stay (LOS) in Hospital After Delivery
Time frame: Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum
Median Number of Hospital Readmissions
Time frame: Discharge through week 8 postpartum
Median Length of Stay (LOS) for Hospital Readmissions
Time frame: Discharge through week 8 postpartum
Median Number of Women That Have a Follow-up Encounter Scheduled With Their Primary Care Physician (PCP) Within 12 Months After Delivery
Time frame: Discharge through 12 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Elizabeth T Jensen, MPH PhD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Blood Pressure Cuff, Blood pressure monitoring smart phone app, BabyScripts™ and Instructions in people with Hypertension, run by Wake Forest University Health Sciences 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 5 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: finished, as of the sponsor's last update on 19 Mar 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?
Yes. Results are posted in the registry (first posted 2 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant (time frame: Discharge through Week 3 postpartum). The study lists 6 primary outcomes in all. 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 19 Mar 2026.