Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04467996 · ClinicalTrials.gov registry record · NA
Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage
A NA study of Postpartum Hemorrhage, Immediate, sponsored by Denver Health and Hospital Authority.
- Active
- Registry status
- NA
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04467996 is a NA study of Postpartum Hemorrhage, Immediate that is active but no longer recruiting, run by Denver Health and Hospital Authority. The registered enrollment target is 64 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04467996, a NA study of Postpartum Hemorrhage, Immediate, is active but no longer recruiting, sponsored by Denver Health and Hospital Authority.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study Summary
Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little is known about how long the IUBT should be used once placed. Though it is common to use IUBT for 12-24 hours, the balloon may be equally effective when used for shorter durations of time, which could have beneficial effects for patients and hospitals. The proposed study is a pragmatic randomized controlled trial of non-inferiority comparing two durations of time for intrauterine balloon tamponade placement, 6 and 18 hours, in controlling postpartum hemorrhage. The specific aims of the proposed study are to determine: 1) whether quantitative blood loss significantly differs when the balloon is removed in 6 hours compared to 18 hours, 2) whether hemorrhage-related morbidity differs when the IUBT is kept in place for 6 or 18 hours, and 3) whether shorter duration of IUBT placement has beneficial effects including shortened postpartum hospital stays, improved maternal-infant bonding, and reduced postpartum pain prior to maternal discharge from hospital. We hypothesize that, once hemorrhage control has been achieved with IUBT placement, there is no clinically significant difference in postpartum blood loss when the balloon is removed 6 hours after placement compared to 18 hours after placement.
Conditions Studied
Interventions
- DEVICE Intrauterine balloon tamponade
Study Locations (1)
Colorado
- Denver Health Hospital - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-10-19 |
| Est. Completion | 2026-01-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04467996
The ClinicalTrials.gov registry entry for NCT04467996 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postpartum Hemorrhage, Immediate appearing as the primary indexed condition, and to 1 intervention - of which Intrauterine balloon tamponade is the first listed.
NCT04467996 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT04467996 about?
NCT04467996 is a clinical study titled "Minimum Effective Duration of Intrauterine Balloon Tamponade for the Management of Postpartum Hemorrhage". Intrauterine balloon tamponade (IUBT) is recommended worldwide as the second-line therapy to treat postpartum hemorrhage. While much literature demonstrates the effectiveness of this therapy, little is known about how long the IUBT should be used once placed. Though it is common to use IUBT for 12-2...
What is the current status of trial NCT04467996?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2020-10-19. Estimated completion is 2026-01-01.
What conditions does trial NCT04467996 study?
This clinical trial studies the following conditions: Postpartum Hemorrhage, Immediate.
What interventions are being tested in trial NCT04467996?
The interventions under investigation include: Intrauterine balloon tamponade (DEVICE).
Who is sponsoring clinical trial NCT04467996?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04467996 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.