General Maternal Population (Facility Level) vs General Neonate Population (Facility Level): 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 | 0.023 | 0.0206 | 0.0255 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0235 | 0.0208 | 0.0265 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.000542 | -0.00434 | 0.00317 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.977 | 0.832 | 1.15 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.976 | 0.828 | 1.15 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with a serious adverse event on General Maternal Population (Facility Level) than on General Neonate Population (Facility Level) | 1,840 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | General Maternal Population (Facility Level) | Serious AEs and Other AEs were collected at the facility level for all patients admitted (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data from the General Maternal Population are reported as it could not be ruled out that enrolled maternal participants were not affected by severe maternal morbidity as a Serious AE and/or postpartum hemorrhage and maternal blood transfusion as an Other AE. Severe maternal morbidity was defined as the composite maternal outcomes measure developed by the Centers for Disease Control and Prevention, which includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. | 328 | 14,286 | EG000 | ClinicalTrials.gov |
| Group 2 | General Neonate Population (Facility Level) | Serious AEs and Other AEs were collected at the facility level for all neonates of admitted patients (inclusive of those enrolled and not enrolled in the study). As surveys were anonymous, data for the General Neonate Population is reported as it could not be ruled out that neonates of enrolled maternal patient participants were not affected by severe or overall unexpected newborn complications as a Serious AE or Other AE, respectively. Unexpected newborn complications was defined as the composite neonatal outcomes measure developed by the California Maternal Quality Care Collaborative and adopted by The Joint Commission, which includes unexpected newborn complications among full term newborns with no preexisting conditions. | 260 | 11,063 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Up to 18 months at the facility level | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | An Evaluation of the Team Birth Project | ClinicalTrials.gov |
| NCT number | NCT03529214 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Pregnancy Complications, Cesarean Section Complications, Maternal Complication of Pregnancy, Communication, Multidisciplinary | ClinicalTrials.gov |
| Interventions | Exposed study site | ClinicalTrials.gov |
| Lead sponsor | Harvard School of Public Health (HSPH) | ClinicalTrials.gov |
| Results first posted | 2025-05-14 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03529214?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.