Trial · NCT05236725
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 | |
| Secondary | Median Length of Stay (LOS) for Hospital Readmissions | Discharge through week 8 postpartum | |
| Secondary | 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 | |
| Other | Validate and Calibrate Previously Developed Predictive Algorithm | Discharge through week 8 postpartum | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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