Comparison · NCT01235546-c06378e9
Placebo and Standard of Care vs Azithromycin and Standard of Care: Neonatal Intensive Care Unit (NICU) Admission
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. Placebo and Standard of Care vs Azithromycin and Standard of Care: Neonatal Intensive Care Unit (NICU) Admission. Trial comparisons, record NCT01235546-c06378e9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01235546-c06378e9
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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 | 0.17 | 0.148 | 0.195 | wilson | |
| Risk in group 2 | 0.168 | 0.146 | 0.192 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00239 | -0.0304 | 0.0352 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.836 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.806 | 1.28 | log | |
| Number needed to treat, for one more participant with the outcome on Placebo and Standard of Care than on Azithromycin and Standard of Care | 419 | 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 | Placebo and Standard of Care | 250 cc normal saline~Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin) | 169 | 992 | OG000 |
| Group 2 | Azithromycin and Standard of Care | Azithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin) | 171 | 1,018 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Neonatal Intensive Care Unit (NICU) Admission
- Description
- Neonates who are admitted to the NICU due to morbidities diagnosed from birth and up to three months of life. Morbidities as defined in the Neonatal morbidities outcome measure.
- Time frame
- Up to 3 months after birth
- Population
Source ClinicalTrials.gov
Trial
- Title
- Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
- NCT number
- NCT01235546
- Phases
- NA
- Conditions
- Endometritis, Wound Infection, Abscess, Surgical Site Infection
- Interventions
- Azithromycin and standard of care, Placebo and standard of care
- Lead sponsor
- Alan Tita
- Results first posted
- 2017-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01235546?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.govNo license 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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