Comparison · NCT01235546-8c26fe85
Azithromycin vs Placebo: Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)
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. Azithromycin vs Placebo: Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery). Trial comparisons, record NCT01235546-8c26fe85. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01235546-8c26fe85
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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 | 0.0609 | 0.0478 | 0.0773 | wilson | |
| Risk in group 2 | 0.12 | 0.101 | 0.142 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0591 | -0.0844 | -0.0341 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.508 | 0.378 | 0.681 | log | |
| Odds ratio, group 1 over group 2 | 0.476 | 0.345 | 0.655 | log | |
| Number needed to treat, for one fewer participant with the outcome on Azithromycin than on Placebo | 16.9 | 11.8 | 29.3 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Azithromycin | Azithromycin: 500 mg in 250 cc normal saline 1 time dose | 62 | 1,018 | OG001 |
| Group 2 | Placebo | 250 cc normal saline~Placebo: 250 cc normal saline | 119 | 992 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Participants With Endometritis and/or Wound Infection and/or Other Post-cesarean Infections (Occurring Within 6 Weeks of Delivery)
- Description
Endometritis was defined as the presence of at least two of the following signs with no other recognized cause: fever (temperature of at least 38°C \[100.4°F\]), abdominal pain, uterine tenderness, or purulent drainage from the uterus. Wound infection was defined as the presence of either superficial or deep incisional surgical-site infection characterized by cellulitis or erythema and induration around the incision or purulent discharge from the incision site with or without fever and included necrotizing fasciitis. Wound hematoma, seroma, or breakdown alone in the absence of the preceding signs did not constitute infection.
- Time frame
- Up to 6 weeks after delivery
- Population
The specific characteristics related to the cesarean delivery, including indications for cesarean delivery, receipt of standard prophylaxis, timing of receipt of study medication, and type of surgical skin preparation, were similar in the two groups.
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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