Open Group vs Masked Group: Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
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 | 0.00307 | 0.00192 | 0.00492 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.00108 | 0.000493 | 0.00235 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.002 | 0.000282 | 0.00393 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 2.86 | 1.13 | 7.24 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 2.86 | 1.13 | 7.26 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Open Group than on Masked Group | 501 | 254 | 3,550 | from the risk difference interval | 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 | 17 | 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. | 6 | 5,576 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) | ClinicalTrials.gov |
| Description | The Apgar score is a simple method of quickly assessing the health and vital signs of a newborn baby created by and named after Dr. Virginia Apgar. Apgar testing assesses Appearance, Pulse, Grimace and Activity in a newborn and is typically done at one and five minutes after a baby is born, and it may be repeated at 10, 15, and 20 minutes if the score is low. The five criteria are each scored as 0, 1, or 2 (two being the best), and the total score is calculated by then adding the five values obtained. Agar scores of 0-3 are critically low, 4-6 are below normal, and indicate that the baby likely requires medical intervention, scores of 7+ are considered normal. The lower the Apgar score, the more alert the medical team should be to the possibility of the baby requiring intervention. Some components of the Apgar score are subjective, and there are cases in which a baby requires urgent medical treatment despite having a high Apgar score. The lowest score is 0, the highest score is 10. | ClinicalTrials.gov |
| Time frame | 5 minutes after delivery | ClinicalTrials.gov |
| Population | 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.