Trial · NCT05236725
Monitoring and Testing of Blood Pressure in Postpartum Women
NCT05236725, Not applicable, Completed, Wake Forest University Health Sciences; results first posted 2026-03-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Monitoring and Testing of Blood Pressure in Postpartum Women. Trials, record NCT05236725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05236725
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Monitoring and Testing of Blood Pressure in Postpartum Women
- NCT number
- NCT05236725
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,607 participants, actual
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Hypertension
- Interventions
- Remote Blood Pressure Cuff, Blood pressure monitoring smart phone app, BabyScripts™, Instructions
- First posted
- 2022-02-11
- Last updated
- 2026-03-19
- Results first posted
- 2026-03-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant | 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 |
| Primary | Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines | 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. |
| Primary | Median Total Cost of Health Care | From discharge through week 8 postpartum | Cost of hospital based medical care of subjects in US dollars. |
| Primary | Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | 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. |
| Primary | Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | 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. |
| Primary | Number of Participants With One or More Urgent or Emergent Care Encounters | 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. |
| Secondary | Median Number of Encounters for Urgent or Emergent Care | Discharge through week 8 postpartum | Study team will use the electronic health record to identify encounters to the Emergency Department, OB Triage, and Urgent Care facilities |
| Secondary | Acceptability of rBPM in Postpartum Period | 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. |
| Secondary | Median Length of Stay (LOS) in Hospital After Delivery | Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum | |
| Secondary | Median Number of Hospital Readmissions | Discharge through week 8 postpartum |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant | Discharge through Week 3 postpartum | 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 | Number of rBPM measurements | MEDIAN |
| PRIMARY | Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines | Discharge through Day 10 postpartum | Proportion of participants | NUMBER | |
| PRIMARY | Median Total Cost of Health Care | From discharge through week 8 postpartum | There were 190 subjects in the SOC group and 157 subjects in the rBPM group that did not have total medical cost data available. | US dollars | MEDIAN |
| PRIMARY | Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Discharge through week 1 postpartum | Number of participants | NUMBER | |
| PRIMARY | Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Discharge through week 3 postpartum | Number of participants | NUMBER | |
| PRIMARY | Number of Participants With One or More Urgent or Emergent Care Encounters | Discharge through week 3 postpartum | Number of subjects | NUMBER | |
| SECONDARY | Median Number of Encounters for Urgent or Emergent Care | Discharge through week 8 postpartum | |||
| SECONDARY | Acceptability of rBPM in Postpartum Period | Week 3 postpartum | |||
| SECONDARY | Median Length of Stay (LOS) in Hospital After Delivery | Baseline (date of delivery) through discharge, assessed for up to 8 weeks postpartum | |||
| SECONDARY | Median Number of Hospital Readmissions | Discharge through week 8 postpartum |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Number of Remote Blood Pressure (rBPM) Measurements Obtained Per Participant | Remote Blood Pressure Monitoring (rBPM) | 6 | Inter-Quartile Range 0 to 22 | Number of rBPM measurements | |
| Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines | Standard of Care (SOC) | 0.308 | Proportion of participants | ||
| Proportion of Participants Monitoring Blood Pressure (BP) According to American College of Obstetricians and Gynecologists (ACOG) Guidelines | Remote Blood Pressure Monitoring (rBPM) | 0.786 | Proportion of participants | ||
| Median Total Cost of Health Care | Standard of Care (SOC) | 1040 | Inter-Quartile Range 402 to 2510 | US dollars | |
| Median Total Cost of Health Care | Remote Blood Pressure Monitoring (rBPM) | 1046 | Inter-Quartile Range 432 to 3386 | US dollars | |
| Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Standard of Care (SOC) | Number of participants having 1 or more severe systolic hypertensive events in a day | 22 | 0 to 0 | Number of participants |
| Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Remote Blood Pressure Monitoring (rBPM) | Number of participants having 1 or more severe systolic hypertensive events in a day | 27 | 0 to 0 | Number of participants |
| Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Standard of Care (SOC) | Number of participants having 1 or more severe diastolic hypertensive events in a day | 4 | 0 to 0 | Number of participants |
| Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Remote Blood Pressure Monitoring (rBPM) | Number of participants having 1 or more severe diastolic hypertensive events in a day | 34 | 0 to 0 | Number of participants |
| Number of Participants Experiencing at Least One Day With a Severe Hypertension Event | Standard of Care (SOC) | Number of participants with severe systolic hypertensive events | 35 | 0 to 0 | Number of participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard of Care (SOC) | 833 | |
| Overall Study | STARTED | Remote Blood Pressure Monitoring (rBPM) | 774 | |
| Overall Study | COMPLETED | Standard of Care (SOC) | 797 | |
| Overall Study | COMPLETED | Remote Blood Pressure Monitoring (rBPM) | 728 | |
| Overall Study | NOT COMPLETED | Standard of Care (SOC) | 36 | |
| Overall Study | NOT COMPLETED | Remote Blood Pressure Monitoring (rBPM) | 46 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | General disorders | Standard of Care (SOC) | 45 | 797 | 57 |
| other | Hypertension | General disorders | Remote Blood Pressure Monitoring (rBPM) | 116 | 728 | 153 |
| serious | Hospital readmission | General disorders | Standard of Care (SOC) | 26 | 797 | 26 |
| serious | Hospital readmission | General disorders | Remote Blood Pressure Monitoring (rBPM) | 34 | 728 | 35 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard of Care (SOC) | 1 | 797 |
| Total, all-cause mortality | Remote Blood Pressure Monitoring (rBPM) | 0 | 728 |
| Total, other adverse events | Standard of Care (SOC) | 45 | 797 |
| Total, other adverse events | Remote Blood Pressure Monitoring (rBPM) | 116 | 728 |
| Total, serious adverse events | Standard of Care (SOC) | 26 | 797 |
| Total, serious adverse events | Remote Blood Pressure Monitoring (rBPM) | 34 | 728 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Remote Blood Pressure Monitoring (rBPM) vs Standard of Care (SOC): deaths from any cause | Trial comparisons |
| Remote Blood Pressure Monitoring (rBPM) vs Standard of Care (SOC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05236725
GET https://conductscience.org/api/trials/v1/NCT05236725/registered