Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioid Prescription After Cesarean Trial (PACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04296396
Recruitment Status : Not yet recruiting
First Posted : March 5, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5500 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: None (Open Label)
Primary Purpose: Treatment
Official Title: Prescription After Cesarean Trial
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 10, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04296396


Contacts
Layout table for location contacts
Contact: Rebecca Clifton, Ph.D. 301-881-9260 rclifton@bsc.gwu.edu
Contact: Cora MacPherson, Ph.D. 301-881-9260 coram@bsc.gwu.edu

Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Andrew Bremer, MD, PhD, MAS Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT04296396    
Other Study ID Numbers: HD036801-PACT
First Posted: March 5, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
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)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents