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Keep this study
Lead
The George Washington University Biostatistics Center
With
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
This was a non-inferiority multi-center unblinded randomized trial of 5,500 women undergoing a cesarean delivery who were 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 was the presence/absence of moderate to severe pain at 1 week after discharge. Moderate to severe pain was 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 were 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 was stratified by site. Women were followed through 90 days postpartum.
Age
Any age
Sex
FEMALE
Healthy volunteers
Not accepted
You may not be if
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
Clareo Health | Opioid Prescription After Cesarean Trial
