Prescription After Cesarean Trial

HD036801-PACT

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.

2020-09-21

2022-04-07

2022-07-08

Completed

Early phase I

5521

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 5521, 'type': 'ACTUAL'}}

2023-10-03