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Opioid Prescription After Cesarean Trial (PACT)

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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

Tracking Information
First Submitted Date  ICMJE March 3, 2020
First Posted Date  ICMJE March 5, 2020
Last Update Posted Date June 18, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Infant hospital readmissions [ Time Frame: 6 weeks postpartum ]
    Proportion of infants readmitted to the hospital
  • Maternal postpartum weight retention [ Time Frame: 6 weeks postpartum ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Opioid Prescription After Cesarean Trial
Official Title  ICMJE Prescription After Cesarean Trial
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Pregnancy Related
  • Opioid Use
  • Pain
Intervention  ICMJE
  • Drug: 0 to 20 tablets of oxycodone 5mg
    Individualized opioid prescription protocol (IOPP) that includes shared decision making
  • Drug: Fixed opioid prescription
    20 tablets of oxycodone 5mg
Study Arms  ICMJE
  • Experimental: Individualized Opioid Prescription
    Individualized opioid prescription protocol and shared decision making
    Intervention: Drug: 0 to 20 tablets of oxycodone 5mg
  • Fixed Opioid Prescription
    fixed opioid prescription of 20 tablets of oxycodone 5mg
    Intervention: Drug: Fixed opioid prescription
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 4, 2020)
5500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Clifton, Ph.D. 301-881-9260 rclifton@bsc.gwu.edu
Contact: Cora MacPherson, Ph.D. 301-881-9260 coram@bsc.gwu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04296396
Other Study ID Numbers  ICMJE HD036801-PACT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrew Bremer, MD, PhD, MAS Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
PRS Account The George Washington University Biostatistics Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP