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NCT05849103 · ClinicalTrials.gov registry record · NA
Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy
A NA study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 343
- Enrollment target
NCT05849103 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 343 participants.
The verdict
NCT05849103, a NA study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 343 participants
- Enrollment target
Study Summary
Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health record, 2) blood pressure management directed by a program navigator with guideline and physician support and 3) facilitated transitions of care to primary care clinicians for hypertension management. Investigators will randomize 300 patents with HDP on postpartum day one with follow up through 3 months postpartum. Primary outcome will be blood pressure reporting at 7-10 postpartum. Secondary outcomes include blood pressure control at 7-10 days postpartum, identification and treatment of severe blood pressures, severe maternal morbidity, hospital readmission, triage visits for hypertension, postpartum and primary care visit attendance, and multiple patient-reported outcome measures. All outcomes will be stratified by race (Black and non-Black) to evaluate disparities and by tight versus usual blood pressure control to evaluate the impact of strict postpartum blood pressure control on outcomes. Investigators hypothesize that a comprehensive postpartum HDP management program will improve hypertension control for all patients and reduce disparities that affect Black patients, and that stricter blood pressure control will be associated with fewer adverse outcomes.
Interventions
- OTHER Blood Pressure Control Targets
- OTHER Hypertension Management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2023-05-08 |
| Est. Completion | 2024-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05849103
The ClinicalTrials.gov registry entry for NCT05849103 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Blood Pressure Control Targets is the first listed.
NCT05849103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05849103 about?
NCT05849103 is a clinical study titled "Comprehensive Postpartum Management for Women With Hypertensive Disorders of Pregnancy". Investigators propose a comprehensive management program for postpartum patients with HDP who are at risk for severe maternal morbidity and mortality. Our program will emphasize three key components: 1) self-monitoring of blood pressures with app-based reporting connected to our electronic health re...
What is the current status of trial NCT05849103?
This trial is currently completed. It is a NA study. The enrollment target is 343 participants. The study started on 2023-05-08. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT05849103?
The interventions under investigation include: Blood Pressure Control Targets (OTHER), Hypertension Management (OTHER).
Who is sponsoring clinical trial NCT05849103?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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