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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Blood Pressure Cuff | Device | specialized, Bluetooth enabled blood pressure monitoring cuff |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Discharge through Day 10 postpartum |
| Median Total Cost of Health Care | Cost of hospital based medical care of subjects in US dollars. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Discharge through week 8 postpartum |
| Acceptability of rBPM in Postpartum Period |
| Measure | Description | Time Frame |
|---|---|---|
| Validate and Calibrate Previously Developed Predictive Algorithm | Intended to assess the performance of the predictive algorithm in identifying postpartum high blood pressure readmissions. Study team will utilize blood pressure measures obtained through 3 weeks postpartum, as well as any hypertensive disorders of pregnancy events postpartum through 8 weeks postpartum, to include Emergency Department/Urgent Care/Obstetrics Triage encounters and any readmissions. The predictive algorithm is informed by information documented in the electronic health record, prior to delivery and during pregnancy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth T Jensen, MPH PhD | Atrium Health Wake Forest Baptist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | United States |
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All women, 18 years of age and older, who have delivered or are planning to deliver an infant(s) at The Birth Center at Atrium Health Wake Forest Baptist and reside in Forsyth County will be eligible for enrollment and invited to participate in the SMART-BP study. We enrolled women during the prenatal period from the Atrium Health Wake Forest Baptist Obstetrics clinics as well as after delivery. Enrollment period was 3/1/2022 through 8/30/2024
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) | 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) |
| FG001 | Remote Blood Pressure Monitoring (rBPM) | Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 55 subjects were ineligible after randomization due to fetal demise (3), duplicate enrollment (9), residence or delivery outside Forsyth County (7 and 28), lack of smartphone access (7), or inaccurate age reporting (1). Additionally, 23 second-pregnancy enrollments and 5 SOC subjects with missing data were excluded from analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) | 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 WFBMC Maternal-Fetal Medicine provider) |
| BG001 | Remote Blood Pressure Monitoring (rBPM) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Remote blood pressure monitoring was not implemented as part of usual care in the Standard of Care (SOC) arm. Participants assigned to the SOC arm did not receive remote BP devices, and no remote BP measurements were collected from this group. Therefore, no data for this outcome are available for SOC participants | Posted | Median | Inter-Quartile Range | Number of rBPM measurements | Discharge through Week 3 postpartum |
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All adverse events excluding severe hypertensive events were assessed from the time of hospital discharge through 8 weeks (56 days) postpartum. For severe hypertensive events, systolic and diastolic blood pressure measurements were evaluated from discharge through 3 weeks (21 days) postpartum.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SOC) | 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 WFBMC Maternal-Fetal Medicine provider) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital readmission | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | General disorders | Systematic Assessment | Grade 3 hypertension or severe hypertension of hypertensive disorders of pregnancy. Number of days with one or more hypertensive events defined as a systolic measure of >/= 160 mmHg and/or a diastolic measure of >/= 110 mmHg |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth T. Jensen, MPH PhD, Professor of Epidemiology | Wake Forest University School of Medicine and Atrium Health Wake Forest Baptist | 336-713-3132 | elizabeth.jensen@wfusm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 12, 2023 | Jan 6, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 1, 2023 | Dec 10, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Blood pressure monitoring smart phone app, BabyScripts™ | Device | app that works with the monitoring cuff |
|
| Instructions | Behavioral | Verbal and written instructions to conduct blood pressure checks at home |
|
| 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. | 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. | Discharge through week 3 postpartum |
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. |
| Week 3 postpartum |
| Median Length of Stay (LOS) in Hospital After Delivery | Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum |
| Median Number of Hospital Readmissions | Discharge through week 8 postpartum |
| Median Length of Stay (LOS) for Hospital Readmissions | 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 | Discharge through 12 months postpartum |
| Discharge through week 8 postpartum |
| Subjects did not reside in Forsyth County North Carolina at the time of delivery |
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| Subjects had duplicate enrollments |
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| Subjects did not have daily access to a smartphone and/or available Wifi or data plan |
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| Subjects that inaccurately reported age at time of enrollment |
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| Subjects that enrolled during their second pregnancy during the study period |
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| Death |
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Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring:
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnicity and Race data is self-reported via online REDCap questionnaire. Subjects with ethnicity of Hispanic or Latino includes one or more of the following categories: Mexican, Mexican American, Chicano/a/x; Puerto Rican; Cuban; Another Hispanic, Latino/a/x, or Spanish origin. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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 WFBMC Maternal-Fetal Medicine provider) |
| OG001 | Remote Blood Pressure Monitoring (rBPM) | Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring:
|
|
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| Primary | 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. | Posted | Number | Proportion of participants | Discharge through Day 10 postpartum |
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|
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| Primary | Median Total Cost of Health Care | Cost of hospital based medical care of subjects in US dollars. | There were 190 subjects in the SOC group and 157 subjects in the rBPM group that did not have total medical cost data available. | Posted | Median | Inter-Quartile Range | US dollars | From discharge through week 8 postpartum |
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|
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| Primary | 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. | Posted | Number | Number of participants | Discharge through week 1 postpartum |
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| Primary | 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. | Posted | Number | Number of participants | Discharge through week 3 postpartum |
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| Primary | 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. | Posted | Number | Number of subjects | Discharge through week 3 postpartum |
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| Secondary | 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 | Not Posted | Discharge through week 8 postpartum | Participants |
| Secondary | 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. | Not Posted | Week 3 postpartum | Participants |
| Secondary | Median Length of Stay (LOS) in Hospital After Delivery | Not Posted | Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum | Participants |
| Secondary | Median Number of Hospital Readmissions | Not Posted | Discharge through week 8 postpartum | Participants |
| Secondary | Median Length of Stay (LOS) for Hospital Readmissions | Not Posted | Discharge through week 8 postpartum | Participants |
| Secondary | Median Number of Women That Have a Follow-up Encounter Scheduled With Their Primary Care Physician (PCP) Within 12 Months After Delivery | Not Posted | Discharge through 12 months postpartum | Participants |
| Other Pre-specified | Validate and Calibrate Previously Developed Predictive Algorithm | Intended to assess the performance of the predictive algorithm in identifying postpartum high blood pressure readmissions. Study team will utilize blood pressure measures obtained through 3 weeks postpartum, as well as any hypertensive disorders of pregnancy events postpartum through 8 weeks postpartum, to include Emergency Department/Urgent Care/Obstetrics Triage encounters and any readmissions. The predictive algorithm is informed by information documented in the electronic health record, prior to delivery and during pregnancy. | Not Posted | Discharge through week 8 postpartum | Participants |
| 1 |
| 797 |
| 26 |
| 797 |
| 45 |
| 797 |
| EG001 | Remote Blood Pressure Monitoring (rBPM) | Subjects randomized to rBPM arm receive the appropriate standard of care depending upon their risk level, as well as the remote BP monitoring app (BabyScripts) and Bluetooth enabled BP cuff/monitor, and will receive the following equipment and monitoring:
| 0 | 728 | 34 | 728 | 116 | 728 |
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