Comparison · NCT04296396-3a5791ba
Individualized Opioid Prescription (IOPP) -Neonates/Infants vs Fixed Opioid Prescription - Neonates/Infants: Infant Hospital Readmissions
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Individualized Opioid Prescription (IOPP) -Neonates/Infants vs Fixed Opioid Prescription - Neonates/Infants: Infant Hospital Readmissions. Trial comparisons, record NCT04296396-3a5791ba. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04296396-3a5791ba
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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 | 0.0214 | 0.0166 | 0.0275 | wilson | |
| Risk in group 2 | 0.0226 | 0.0177 | 0.0288 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00113 | -0.00896 | 0.00669 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.95 | 0.669 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 0.949 | 0.662 | 1.36 | log | |
| Number needed to treat, for one fewer participant with the outcome on Individualized Opioid Prescription (IOPP) -Neonates/Infants than on Fixed Opioid Prescription - Neonates/Infants | 883 | from the risk difference interval | the interval includes no difference |
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 (IOPP) -Neonates/Infants | Neonates/infants of participants in the Individualized opioid prescription protocol (IOPP) with shared decision making group. | 59 | 2,754 | OG000 |
| Group 2 | Fixed Opioid Prescription - Neonates/Infants | Neonates/infants of participants in the fixed opioid prescription group. | 63 | 2,793 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Infant Hospital Readmissions
- Description
- Proportion of infants readmitted to the hospital
- Time frame
- 6 weeks postpartum
- Population
- 2856 and 2889. Data is missing for 102 neonates in the IOPP group and 92 neonates in the fixed opioid 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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