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NCT03478163 · ClinicalTrials.gov registry record · Phase 4
Antibiotics During Intrauterine Balloon Tamponade Placement
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT03478163: Clinical Trial Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT03478163 is a Phase 4 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478163, a Phase 4 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the likelihood of postpartum endometritis.
Primary Outcome
Number of participants with postpartum endometritis as defined by clinical documentation
Interventions
- DRUG CeFAZolin 1000 MG
- DRUG Clindamycin 900 MG in 6 ML Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2018-03-08 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 4 |
Why NCT03478163 stopped before completion
NCT03478163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which CeFAZolin 1000 MG is the first listed.
NCT03478163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03478163 about?
NCT03478163 is a clinical study titled "Antibiotics During Intrauterine Balloon Tamponade Placement". The goal of this study is to identify whether antibiotics given at the time of placement of an intrauterine balloon tamponade (IBT) will result in reduction of the risk of endometritis. The investigators hypothesize that antibiotics given at the time of intrauterine balloon tamponade will reduce the...
What is the current status of trial NCT03478163?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2018-03-08. Estimated completion is 2021-05-03.
What interventions are being tested in trial NCT03478163?
The interventions under investigation include: CeFAZolin 1000 MG (DRUG), Clindamycin 900 MG in 6 ML Injection (DRUG).
Who is sponsoring clinical trial NCT03478163?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03478163's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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