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NCT04612920 · ClinicalTrials.gov registry record · Early Phase 1
Towards Enhanced Recovery After Cesarean
A Early Phase 1 study, sponsored by University of Oklahoma.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 33
- Enrollment target
NCT04612920: Completed Early Phase 1 study, sponsored by University of Oklahoma.
NCT04612920 is a Early Phase 1 study that has completed, run by University of Oklahoma. The registered enrollment target is 33 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04612920, a Early Phase 1 study, has completed, sponsored by University of Oklahoma.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean delivery is the most common surgical procedure in the United States, representing 31.9% of the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of post-operative care while adjusting to motherhood and completing activities of daily living. Often when they return home, they are also tasked with other domestic roles which compounds the challenge of this post-operative period. With a potential impact just in the US on 1.2 million mothers each year, optimizing post-operative pain management in order to reduce the risk of persistent opioid use represents an urgent unmet public health goal. To this end, there are national efforts to reduce the cesarean rate and optimize post-cesarean pain management (3,4). The majority of efforts in the last few years have focused on home-going medications and alterations in prescription practices. Recent recommendations from the Enhanced Recovery After Surgery Society indicate that patients should receive multi-modal analgesia on a regular basis, along with early post-delivery mobilization (3). However, the efficacy of scheduled non-steroidal anti-inflammatory medications (NSAID) along with acetaminophen in the immediate post-operative period and after going home have not been systematically studied in the cesarean population. We hypothesize that patients who receive scheduled medications in the post-operative period are less likely to require opioids for pain relief both in the hospital and after they return home.
Primary Outcome
Patient's inpatient chart will be reviewed to calculate the amount of oxycodone the patient used, converted to morphine milligram equivalents and recorded.
Interventions
- DRUG Ibuprofen, acetaminophen, oxycodone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-12-12 |
| Est. Completion | 2023-03-08 |
| Phase | Early Phase 1 |
What the finished NCT04612920 record still lists
NCT04612920 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Ibuprofen, acetaminophen, oxycodone is the first listed.
NCT04612920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04612920 about?
NCT04612920 is a clinical study titled "Towards Enhanced Recovery After Cesarean". One in 300 women will become persistent opioid users after cesarean delivery (1). Cesarean delivery is the most common surgical procedure in the United States, representing 31.9% of the 3,788,235 deliveries in 2018 (2). Patients have to cope with the pain and challenges of post-operative care while ...
What is the current status of trial NCT04612920?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 33 participants. The study started on 2020-12-12. Estimated completion is 2023-03-08.
What interventions are being tested in trial NCT04612920?
The interventions under investigation include: Ibuprofen, acetaminophen, oxycodone (DRUG).
Who is sponsoring clinical trial NCT04612920?
This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04612920's enrollment target sits among peer trials
33 763rd of 2000 higher than 1,227 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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