Open Group vs Masked Group: Number of Participants With Primary Composite Outcome
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 | 0.0094 | 0.00718 | 0.0123 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00717 | 0.00527 | 0.00975 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00223 | -0.00118 | 0.0057 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.869 | 1.98 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.31 | 0.868 | 1.99 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Open Group than on Masked Group | 449 | 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 | Open Group | S31 monitors in the open mode displayed ECG ST-segment information intended for use when uncertain fetal heart-rate patterns were detected. Management of the labor and delivery for women in this group was dictated by the ST-segment analysis guidelines | 52 | 5,532 | OG000 | ClinicalTrials.gov |
| Group 2 | Masked Group | The masked S31 monitors functioned as conventional electronic fetal heart-rate monitors. The care of patients in the masked group was managed at the discretion of the attending physician or midwife. | 40 | 5,576 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With Primary Composite Outcome | ClinicalTrials.gov |
| Description | Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score \<=3 at 5 minutes, neonatal seizure, umbilical artery blood pH \<= 7.05 with base deficit \>=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy | ClinicalTrials.gov |
| Time frame | From Delivery through 1 month of age | ClinicalTrials.gov |
| Population | Umbilical cord artery blood was not able to be obtained from all participants. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Fetal ST Segment and T Wave Analysis in Labor | ClinicalTrials.gov |
| NCT number | NCT01131260 | ClinicalTrials.gov |
| Phases | NA | ClinicalTrials.gov |
| Conditions | Pregnancy, Obstetric Labor, Parturition | ClinicalTrials.gov |
| Interventions | fetal STAN monitor | ClinicalTrials.gov |
| Lead sponsor | The George Washington University Biostatistics Center | ClinicalTrials.gov |
| Results first posted | 2019-04-05 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT01131260?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.