Opioid Prescription After Cesarean Trial

Completed · Phase 3

Conditions studied: Pregnancy Related, Opioid Use, Pain

In brief

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.

Key facts

Study ID

NCT04296396

Run by

The George Washington University Biostatistics Center

People needed

5521

Starts

2020-09-21

Expected to finish

2022-07-08

Last updated by the study team

2023-10-03

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
• Singleton, twin or triplet gestation

You may not qualify if…

• An opioid prescription filled during the current pregnancy
• Known history of opioid use disorder, by medical record review
• Contraindication to opioids (oxycodone)
• Contraindications to both acetaminophen and ibuprofen
• Significant surgical procedures (e.g., hysterectomy) prior to randomization as pain trajectory will be completely different
• Fetal or neonatal death prior to randomization
• Inability to randomize within 1 day before planned discharge from the hospital
• Inability to participate in shared decision making as assessed by research staff
• Language barrier (non-English or Spanish speaking)
• Participation in this trial in a previous pregnancy
• Participation in another intervention study that influences the primary outcome in this trial

Where it is running

• 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

Full record on ClinicalTrials.gov

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