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Comparison · NCT01235546-8ecfb4a9

Placebo and Standard of Care vs Azithromycin and Standard of Care: Infant Pyloric Stenosis

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. Placebo and Standard of Care vs Azithromycin and Standard of Care: Infant Pyloric Stenosis. Trial comparisons, record NCT01235546-8ecfb4a9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01235546-8ecfb4a9

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.001010.0001780.00569wilson
Risk in group 20.001960.0005390.00713wilson
Risk difference, group 1 minus group 2-0.000957-0.006190.00394newcombe hybrid score
Risk ratio, group 1 over group 20.5130.04665.65log
Odds ratio, group 1 over group 20.5130.04645.66log
Number needed to treat, for one fewer participant with the outcome on Placebo and Standard of Care than on Azithromycin and Standard of Care1,050from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Placebo and Standard of CarePlacebo: 250 cc normal saline and Standard of care (cefazolin or clindamycin)1992OG000
Group 2Azithromycin and Standard of CareAzithromycin: 500 mg in 250 cc normal saline 1 time dose and Standard of care (cefazolin or clindamycin)21,018OG001

Outcome

Type
OTHER_PRE_SPECIFIED
Title
Infant Pyloric Stenosis
Description
Any diagnosis of pyloric stenosis based on clinical presentation and radiological and/or surgical confirmation
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

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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