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Comparison · NCT01222247-2bab6281

Betamethasone vs Placebo: Neonatal Morbidity Composite

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. Betamethasone vs Placebo: Neonatal Morbidity Composite. Trial comparisons, record NCT01222247-2bab6281. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01222247-2bab6281

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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 10.05680.04590.07wilson
Risk in group 20.06430.05260.0784wilson
Risk difference, group 1 minus group 2-0.00752-0.02530.0101newcombe hybrid score
Risk ratio, group 1 over group 20.8830.661.18log
Odds ratio, group 1 over group 20.8760.6431.19log
Number needed to treat, for one fewer participant with the outcome on Betamethasone than on Placebo133from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1BetamethasoneA course of two 2mL intramuscular (IM) injections containing 3 mg of betamethasone, 24 hours apart811,427OG000
Group 2PlaceboA similar course of an identical appearing placebo: two 2 mL IM injections of placebo, 24 hours apart~Placebo: Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.901,400OG001

Outcome

Type
SECONDARY
Title
Neonatal Morbidity Composite
Description
A composite endpoint of morbidities known to be affected by steroid administration will also be evaluated. Specifically, this composite will include RDS, intraventricular hemorrhage (IVH), and NEC
Time frame
Delivery
Population
The number of participants analyzed accounts for the 4 participants for which baseline measures were obtained but who were subsequently lost to follow-up (2 in each group).

Source ClinicalTrials.gov

Trial

Title
Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
NCT number
NCT01222247
Phases
PHASE3
Conditions
Pregnancy, Respiratory Distress Syndrome, Pregnancy Outcomes, Preterm Birth
Interventions
Betamethasone, Placebo
Lead sponsor
The George Washington University Biostatistics Center
Results first posted
2019-01-30

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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