Status:
COMPLETED
Opioid Prescription After Cesarean Trial
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy Related
Opioid Use
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 mak...
Detailed Description
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 pr...
Eligibility Criteria
Inclusion
- Post cesarean delivery (combined vaginal/cesarean deliveries are not eligible)
- Singleton, twin or triplet gestation
Exclusion
- 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
Key Trial Info
Start Date :
September 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2022
Estimated Enrollment :
5521 Patients enrolled
Trial Details
Trial ID
NCT04296396
Start Date
September 21 2020
End Date
July 8 2022
Last Update
October 3 2023
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Columbia University
New York, New York, United States, 10032
4
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 17599