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: Active NA study of Postpartum Hemorrhage, Immediate, sponsored by Denver Health and Hospital Authority.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
total blood loss includes output from the intrauterine balloon plus blood loss from sanitary pads
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 |
What the registry record for NCT04467996 still lists
NCT04467996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT04467996's enrollment target sits among peer trials
64 1147th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01853631 · 64 participants · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
- NCT03739502 · 64 participants · Phase 2
A Randomized Phase II Study of Hyperbaric Oxygen in Improving Engraftment in Umbilical Cord Blood Stem Cell Transplant
- NCT03739814 · 64 participants · Phase 2
Inotuzumab Ozogamicin and Blinatumomab With or Without Ponatinib in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia
- NCT03866408 · 64 participants · Early Phase 1
Insulin Regulation of Lipolysis and Lipolysis Proteins
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI