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.
- Pregnancy Related
- Opioid Use
- Eligible Ages
- All ages
- Eligible Genders
- Accepts Healthy Volunteers
- Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible) - Singleton, twin or triplet gestation
- 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
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized 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.
- Primary Purpose
- None (Open Label)
Individualized Opioid Prescription
|Individualized opioid prescription protocol and shared decision making||
Fixed Opioid Prescription
|fixed opioid prescription of 20 tablets of oxycodone 5mg||
- The George Washington University Biostatistics Center
Study ContactRebecca Clifton, Ph.D.
This is a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who are randomized before 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. The primary endpoint is the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain is defined as a value of 4 or higher on the Brief Pain Inventory worst pain scale (0 to 10) in the last 24 hours. Consenting women will be assigned in a 1:1 ratio to one of the two arms using a secure internet based randomization system maintained centrally by the Data Coordinating Center (DCC). Randomization will be stratified by site. Women will be followed through 90 days postpartum.