Opioid Prescription After Cesarean Trial (PACT)

• ClinicalTrials.gov Identifier: NCT04296396
• Recruitment Status: Completed
• First Posted: March 5, 2020
• Last Update Posted: March 24, 2023
• Sponsor: The George Washington University Biostatistics Center
• Information provided by (Responsible Party): The George Washington University Biostatistics Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy Related; Opioid Use; Pain	Drug: 0 to 20 tablets of oxycodone 5mg; Drug: Fixed opioid prescription	Phase 3

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5521 participants
• Allocation: Randomized
• 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.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Prescription After Cesarean Trial
• Actual Study Start Date: September 21, 2020
• Actual Primary Completion Date: April 7, 2022
• Actual Study Completion Date: July 8, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Individualized Opioid Prescription; Individualized opioid prescription protocol and shared decision making	Drug: 0 to 20 tablets of oxycodone 5mg; Individualized opioid prescription protocol (IOPP) that includes shared decision making
Fixed Opioid Prescription; fixed opioid prescription of 20 tablets of oxycodone 5mg	Drug: Fixed opioid prescription; 20 tablets of oxycodone 5mg

Outcome Measures

Primary Outcome Measures :

1. Moderate to Severe Worst Pain Score at 1 week post discharge [ Time Frame: 1 week post hospital discharge ]
   Proportion of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the Brief Pain Inventory worst pain in the last 24 hours numeric scale (from 0 to 10)

Secondary Outcome Measures :

1. Opioid prescription filled beyond that prescribed at discharge [ Time Frame: 2 weeks post discharge, 6 weeks postpartum, and 90 days postpartum ]
   Proportion of participants with opioid prescription filled (beyond that prescribed at discharge) between one week post discharge and 1) two weeks post-discharge, 2) six weeks postpartum, and 3) ninety days postpartum
2. Number of opioid prescriptions filled [ Time Frame: 1week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum ]
   Total number of opioid prescriptions filled by one and two weeks post-discharge, and six weeks and ninety days postpartum
3. Number of opioid tablets prescribed and unused [ Time Frame: 1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum ]
   Number of opioid tablets prescribed and unused from discharge to 1 week and 2 weeks post discharge, and 6 weeks and 90 days postpartum
4. Number of morphine milligram equivalents used [ Time Frame: 1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum ]
   Total morphine milligram equivalents (MME) used from discharge to 1 week and 2 weeks post-discharge, and 6 weeks and 90 days postpartum
5. Pain severity scores (worst, least, average, current) [ Time Frame: 2 weeks post discharge and 6 weeks postpartum and 90 days postpartum ]
   Pain severity scores (worst, least, average, current) in last 24 hours assessed on the Brief Pain Inventory numeric scale from 0 to 10 at 2 weeks post-discharge, and 6 weeks and 90 days postpartum
6. Pain interference scores [ Time Frame: 1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum ]
   Pain interference scores in the last week assessed on the Brief Pain Inventory (numeric scale from 0 to 10) at 1 and 2 weeks post-discharge, and 6 weeks and 90 days postpartum
7. Global impression of change in overall pain [ Time Frame: 1 week post discharge, 2 weeks post discharge, 6 weeks postpartum, 90 days postpartum ]
   Proportion of participants with global impression of change in overall pain (improved, no change, worse) at 1 and 2 weeks post-discharge, and 6 weeks and 90 days postpartum
8. Infant hospital readmissions [ Time Frame: 6 weeks postpartum ]
   Proportion of infants readmitted to the hospital
9. Maternal postpartum weight retention [ Time Frame: 6 weeks postpartum ]
10. Maternal depression score ≥ 13 [ Time Frame: 6 weeks postpartum ]
    The proportion of participants with a score of 13 or higher on the Edinburgh Postnatal Depression Scale. The minimum score is 0 and the maximum score is 30. Higher scores indicate worse outcomes, where persons scoring about 13 are likely to be suffering from a depressive illness. The scale indicates how the respondent has felt during the previous week.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Alabama

University of Alabama - Birmingham

Birmingham, Alabama, United States, 35233

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

United States, New York

Columbia University

New York, New York, United States, 10032

United States, North Carolina

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States, 17599

United States, Ohio

Case Western Reserve-Metrohealth

Cleveland, Ohio, United States, 44109

Ohio State University

Columbus, Ohio, United States, 43210

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States, 15213

United States, Rhode Island

Brown Univeristy

Providence, Rhode Island, United States, 02905

United States, Texas

University of Texas Medical Branch

Galveston, Texas, United States, 77555

University of Texas - Houston

Houston, Texas, United States, 77030

United States, Utah

University of Utah Medical Center

Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

The George Washington University Biostatistics Center

Investigators

• Study Director: Monica Longo, MD; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

• Responsible Party: The George Washington University Biostatistics Center
• ClinicalTrials.gov Identifier: NCT04296396
• Other Study ID Numbers: HD036801-PACT
• First Posted: March 5, 2020
• Last Update Posted: March 24, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents