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NCT06096701 · ClinicalTrials.gov registry record

Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women

A clinical trial of Hypertensive Disorder, sponsored by University of South Carolina.

Recruiting
Registry status
540
Enrollment target
1
Study location

NCT06096701: Recruiting study of Hypertensive Disorder, sponsored by University of South Carolina.

NCT06096701 is a study of Hypertensive Disorder that is actively recruiting participants, run by University of South Carolina. The registered enrollment target is 540 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06096701, a study of Hypertensive Disorder, is actively recruiting participants, sponsored by University of South Carolina.

RECRUITING
Registry status
540 participants
Enrollment target
1
Study location

Study 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 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DEVICE Blood pressure cuff

Study Locations (1)

South Carolina

  • Prisma Health Richland - Columbia

Trial Details

FieldValue
Enrollment Target 540 participants
Start Date 2024-02-13
Est. Completion 2028-07
University of South Carolina

157 total trials

What NCT06096701 shows while recruiting

NCT06096701 is an observational study that tracks outcomes without assigning an intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap.

The record links to 1 condition, with Hypertensive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Blood pressure cuff is the first listed.

NCT06096701 reports a single indexed study location in South Carolina.

Frequently Asked Questions

What is clinical trial NCT06096701 about?

NCT06096701 is a clinical study titled "Use of a Cloud-connected Remote Blood Pressure Monitoring Program During the Postpartum Period for Hypertensive Women". 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, particular...

What is the current status of trial NCT06096701?

This trial is currently recruiting. The enrollment target is 540 participants. The study started on 2024-02-13. Estimated completion is 2028-07.

What conditions does trial NCT06096701 study?

This clinical trial studies the following conditions: Hypertensive Disorder.

What interventions are being tested in trial NCT06096701?

The interventions under investigation include: Blood pressure cuff (DEVICE).

Who is sponsoring clinical trial NCT06096701?

This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06096701 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06096701, the US trial registry maintained by the National Library of Medicine. NCT06096701 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.