Comparison · NCT01235546-sae
Placebo and Standard of Care vs Azithromycin and Standard of Care: serious adverse events
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: serious adverse events. Trial comparisons, record NCT01235546-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01235546-sae
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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 | 0.0292 | 0.0204 | 0.0417 | wilson | |
| Risk in group 2 | 0.0147 | 0.00895 | 0.0242 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0145 | 0.0016 | 0.0282 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.98 | 1.07 | 3.68 | log | |
| Odds ratio, group 1 over group 2 | 2.01 | 1.07 | 3.78 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Placebo and Standard of Care than on Azithromycin and Standard of Care | 69 | 35.4 | 627 | 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 | Placebo and Standard of Care | Placebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin) | 29 | 992 | EG000 |
| Group 2 | Azithromycin and Standard of Care | Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin) | 15 | 1,018 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 6 weeks after delivery
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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