Opioid Prescription After Cesarean Trial

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Washington University Biostatistics Center
• Treatments: Analgesics, Opioid; Oxycodone

Criteria

Inclusion Criteria:

• Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)

• Singleton, twin or triplet gestation

Exclusion Criteria:

• 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