Comparison · NCT00201643-sae
Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): serious adverse events
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. Rescue Course of Betamethasone or Dexamethasone vs Placebo (Normal Saline): serious adverse events. Trial comparisons, record NCT00201643-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00201643-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 | 0.0781 | 0.0579 | 0.105 | wilson | |
| Risk in group 2 | 0.0817 | 0.0608 | 0.109 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00355 | -0.0375 | 0.0302 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.957 | 0.63 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 0.953 | 0.605 | 1.5 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rescue Course of Betamethasone or Dexamethasone than on Placebo (Normal Saline) | 282 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rescue Course of Betamethasone or Dexamethasone | Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart. | 40 | 512 | EG000 |
| Group 2 | Placebo (Normal Saline) | Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart. | 41 | 502 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 years and (&) 9 months
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids (ACS) on Neonatal Outcome
- NCT number
- NCT00201643
- Phases
- PHASE4
- Conditions
- Preterm Delivery
- Interventions
- Betamethasone or Dexamethasone (2nd course of ACS), Placebo
- Lead sponsor
- Obstetrix Medical Group
- Results first posted
- 2011-03-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00201643?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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