Intervention Group vs Control Group: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0602 | 0.0581 | 0.0624 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0533 | 0.0514 | 0.0553 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00687 | 0.00401 | 0.00974 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.13 | 1.07 | 1.19 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.14 | 1.08 | 1.2 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Intervention Group than on Control Group | 146 | 103 | 249 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Intervention Group | Women and their babies residing in geographic clusters assigned to the intervention group. If the woman was identified as high-risk for preterm birth from 24 - 36 weeks' gestational age by the intervention she received one course of four doses of 6 mg of dexamethasone every 12 hours. If identified outside the intervention, she received standard of care. | 2,932 | 48,698 | EG000 | ClinicalTrials.gov |
| Group 2 | Control Group | Women and their babies residing in geographic clusters assigned to the control group. If the woman was identified as high-risk for preterm birth, she received standard of care. | 2,774 | 52,007 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | During the period that the trial was active in a particular cluster, serious adverse events were captured on each woman from the time the woman was enrolled in the MNH registry until 6 weeks after delivery for each pregnant woman enrolled in the MNH registry and her babies. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Trial of the Use of Antenatal Corticosteroids in Developing Countries | ClinicalTrials.gov |
| NCT number | NCT01084096 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Preterm Birth | ClinicalTrials.gov |
| Interventions | Increasing use of Antenatal Corticosteroids (ACS) | ClinicalTrials.gov |
| Lead sponsor | NICHD Global Network for Women's and Children's Health | ClinicalTrials.gov |
| Results first posted | 2024-12-09 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01084096?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.