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Opioid Prescription After Cesarean Trial

NCT04296396 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5521

Last updated 2023-10-03

Study results available
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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.

Conditions

  • Pregnancy Related
  • Opioid Use
  • Pain

Interventions

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The George Washington University Biostatistics Center

    lead OTHER

Principal Investigators

  • Monica Longo, MD · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2022-04-07
Completion
2022-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04296396 on ClinicalTrials.gov