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NCT04296396 · ClinicalTrials.gov registry record · Phase 3
Opioid Prescription After Cesarean Trial
A Phase 3 study, sponsored by The George Washington University Biostatistics Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,521
- Enrollment target
NCT04296396: Completed Phase 3 study, sponsored by The George Washington University Biostatistics Center.
NCT04296396 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 5,521 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (615% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04296396, a Phase 3 study, has completed, sponsored by The George Washington University Biostatistics Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,521 participants
- Enrollment target
Study Summary
Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
Primary Outcome
Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the "Worst Pain" question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.
Interventions
- DRUG 0 to 20 tablets of oxycodone 5mg
- DRUG Fixed opioid prescription
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,521 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 3 |
What the finished NCT04296396 record still lists
NCT04296396 is an interventional study that assigns participants to a tested intervention. Its 5,521 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (615% higher).
The record links to 0 conditions, and to 2 interventions - of which 0 to 20 tablets of oxycodone 5mg is the first listed.
NCT04296396 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04296396 about?
NCT04296396 is a clinical study titled "Opioid Prescription After Cesarean Trial". Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
What is the current status of trial NCT04296396?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,521 participants. The study started on 2020-09-21. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT04296396?
The interventions under investigation include: 0 to 20 tablets of oxycodone 5mg (DRUG), Fixed opioid prescription (DRUG).
Who is sponsoring clinical trial NCT04296396?
This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04296396's enrollment target sits among peer trials
5,521 44th of 2000 higher than 1,957 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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