Clinical trialNCT04296396CompletedPhase 3Interventional

Opioid Prescription After Cesarean Trial

SponsorThe George Washington University Biostatistics CenterEnrollment5,521Opioid UsePainPregnancy Related

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Monica Longo, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Alabama - Birmingham
Birmingham, Alabama, United States
Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve-Metrohealth
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Womens Hospital of Upmc
Pittsburgh, Pennsylvania, United States
Brown Univeristy
Providence, Rhode Island, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - Houston
Houston, Texas, United States
University of Utah Medical Center
Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

0 to 20 tablets of oxycodone 5mgFixed opioid prescription

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 21 Sept 2020
Primary completion: 7 Apr 2022
Completion: 8 Jul 2022
Last update posted: 3 Oct 2023
Registered enrollment: 5,521
Registry id: NCT04296396

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.