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Opioid Analgesic

Fixed Opioid Prescription for Pregnancy (PACT Trial)

Phase 3
Waitlist Available
Research Sponsored by The George Washington University Biostatistics Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days postpartum
Awards & highlights

PACT Trial Summary

This trial found that an IOPP is non-inferior to a fixed opioid prescription for post-cesarean pain management.

Eligible Conditions
  • Pregnancy
  • Opioid Use Disorder
  • Pain

PACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
Secondary outcome measures
Infant Hospital Readmissions
Maternal Depression Score ≥ 13
Number of Morphine Milligram Equivalents Used at 2 Weeks Post Discharge
+6 more

PACT Trial Design

2Treatment groups
Experimental Treatment
Group I: Individualized Opioid PrescriptionExperimental Treatment1 Intervention
Individualized opioid prescription protocol and shared decision making
Group II: Fixed Opioid PrescriptionExperimental Treatment1 Intervention
Fixed opioid prescription of 20 tablets of oxycodone 5mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0 to 20 tablets of oxycodone 5mg
2020
Completed Phase 3
~5530
Fixed opioid prescription
2020
Completed Phase 3
~5530

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,958 Previous Clinical Trials
2,667,994 Total Patients Enrolled
The George Washington University Biostatistics CenterLead Sponsor
23 Previous Clinical Trials
97,439 Total Patients Enrolled
Andrew Bremer, MD, PhD, MASStudy DirectorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4 Previous Clinical Trials
39,654 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Opioid Prescription After Cesarean Trial
2020. "Opioid Prescription After Cesarean Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04296396.
~1227 spots leftby Apr 2025
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