Clinical trial NCT04296396: Opioid Prescription After Cesarean Trial
Official title: Prescription After Cesarean Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pregnancy Related
Opioid Use
Pain
Lead sponsor: The George Washington University Biostatistics Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-03-05
Enrollment: 5521
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were 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: TREATMENT

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 making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
timeFrame: 1 week post hospital discharge
Secondary outcomes:
measure: Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge
timeFrame: After hospital discharge and up to 90 days postpartum
measure: Number of Opioid Prescriptions Filled
timeFrame: 90 days postpartum
measure: Number of Opioid Tablets Unused Since Discharge
timeFrame: 90 days postpartum
measure: Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge
timeFrame: 2 weeks post discharge
measure: Worst Pain Severity Score at 2 Weeks Post Discharge
timeFrame: 2 weeks post discharge
measure: Pain Interference Score ≥ 4 at 2 Weeks Post Discharge
timeFrame: 2 weeks post discharge
measure: Number of Participants Who Indicated an Improved Global Impression of Change
timeFrame: 2 weeks post discharge
measure: Infant Hospital Readmissions
timeFrame: 6 weeks postpartum
measure: Maternal Depression Score ≥ 13
timeFrame: 6 weeks postpartum
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: New York
country: United States
facility: Columbia University
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve-Metrohealth
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
city: Providence
country: United States
facility: Brown Univeristy
state: Rhode Island
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: University of Texas - Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Medical Center
state: Utah
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Monica Longo, MD
role: STUDY_DIRECTOR
References: