CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,521 enrolled
Drug / intervention
0 to 20 tablets of oxycodone 5mg +1 moredrug
Likely dose
0 to 20 tablets of oxycodone 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04296396
NCT04296396Phase 3Completed
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Prescription After Cesarean Trial

The George Washington University Biostatistics Center·interventional·Posted Mar 5, 2020·Updated Oct 3, 2023

In Brief

A Phase 3 clinical trial evaluating 0 to 20 tablets of oxycodone 5mg and Fixed opioid prescription for Pregnancy Related and 2 related conditions. Completed, enrolled 5,521 participants across 12 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy Related, Opioid Use, Pain
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 5, 2020
Enrollment StartSep 21, 2020
Primary CompletionApr 7, 2022
Study CompletionJul 8, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.3 years ago

Interventions

0 to 20 tablets of oxycodone 5mgdrug

Individualized opioid prescription protocol (IOPP) that includes shared decision making

Fixed opioid prescriptiondrug

20 tablets of oxycodone 5mg