Comparison · NCT04296396-0ecb8925
Individualized Opioid Prescription vs Fixed Opioid Prescription: Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Individualized Opioid Prescription vs Fixed Opioid Prescription: Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge. Trial comparisons, record NCT04296396-0ecb8925. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04296396-0ecb8925
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0754 | 0.0659 | 0.086 | wilson | |
| Risk in group 2 | 0.0616 | 0.0531 | 0.0713 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0138 | 0.000241 | 0.0274 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.22 | 1 | 1.49 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 1 | 1.54 | log | |
| Number needed to treat, for one more participant with the outcome on Individualized Opioid Prescription than on Fixed Opioid Prescription | 72.5 | 36.5 | 4,150 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Individualized Opioid Prescription | Individualized opioid prescription protocol and shared decision making~0 to 20 tablets of oxycodone 5mg: Individualized opioid prescription protocol (IOPP) that includes shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean. | 200 | 2,654 | OG000 |
| Group 2 | Fixed Opioid Prescription | fixed opioid prescription of 20 tablets of oxycodone 5mg | 166 | 2,696 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Filled One or More Opioid Prescriptions Beyond the Amount Prescribed at Discharge
- Description
- Number of participants who filled one or more opioid prescriptions beyond what was prescribed to them at discharge - measured at ninety days postpartum
- Time frame
- After hospital discharge and up to 90 days postpartum
- Population
Of 2273 participants in the fixed group, 1 was enrolled in the study for a second pregnancy. Only the first pregnancy was included in the analysis. This data was missing for 94 participants in the individualized opioid prescription group and 76 participants in the fixed group.
Source ClinicalTrials.gov
Trial
- Title
- Opioid Prescription After Cesarean Trial
- NCT number
- NCT04296396
- Phases
- PHASE3
- Conditions
- Pregnancy Related, Opioid Use, Pain
- Interventions
- 0 to 20 tablets of oxycodone 5mg, Fixed opioid prescription
- Lead sponsor
- The George Washington University Biostatistics Center
- Results first posted
- 2023-10-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04296396?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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