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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 is a Phase 3 study that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 5,521 participants.

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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.

Interventions

  • DRUG 0 to 20 tablets of oxycodone 5mg
  • DRUG Fixed opioid prescription

Trial Details

FieldValue
Enrollment Target 5,521 participants
Start Date 2020-09-21
Est. Completion 2022-07-08
Phase Phase 3

What the Registry Record Tells You About NCT04296396

The ClinicalTrials.gov registry entry for NCT04296396 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 5,521 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The George Washington University Biostatistics Center, which has 24 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which 0 to 20 tablets of oxycodone 5mg is the first listed.

NCT04296396 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.