Prescription After Cesarean Trial
Status: Completed
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:
• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
• Singleton, twin or triplet gestation
Locations
United States
Alabama
University of Alabama - Birmingham
Birmingham
Illinois
Northwestern University
Chicago
North Carolina
University of North Carolina-Chapel Hill
Chapel Hill
New York
Columbia University
New York
Ohio
Case Western Reserve-Metrohealth
Cleveland
Ohio State University
Columbus
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
Magee Womens Hospital of UPMC
Pittsburgh
Rhode Island
Brown Univeristy
Providence
Texas
University of Texas Medical Branch
Galveston
University of Texas - Houston
Houston
Utah
University of Utah Medical Center
Salt Lake City
Time Frame
Start Date: 2020-09-21
Completion Date: 2022-07-08
Participants
Target number of participants: 5521
Treatments
Experimental: Individualized Opioid Prescription
Individualized opioid prescription protocol and shared decision making
Other: Fixed Opioid Prescription
Fixed opioid prescription of 20 tablets of oxycodone 5mg
Authors
Sponsors
Leads: The George Washington University Biostatistics Center
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)