| Primary | Number of Participants With Primary Composite Outcome | 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 | Umbilical cord artery blood was not able to be obtained from all participants. | Posted | | Count of Participants | | Participants | | From Delivery through 1 month of age | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Analysis on primary composite outcome as a whole. | Chi-squared | | 0.20 | | Risk Ratio (RR) | 1.31 | | | 2-Sided | 95 | 0.87 | 1.98 | | | | | Superiority or Other | | |
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| Primary | Number of Intrapartum Fetal Deaths (Primary Outcome Component) | Death of the fetus during the intrapartum period. | | Posted | | Count of Participants | | Participants | | During labor and through delivery of the baby | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Primary | Number of Neonatal Deaths (Primary Outcome Component) | Death of the newborn between delivery and1 month of age | | Posted | | Count of Participants | | Participants | | Delivery through1 month of age | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Primary | Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) | 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. | | Posted | | Count of Participants | | Participants | | 5 minutes after delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Primary | Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) | Number of infants who experienced Neonatal Seizure | | Posted | | Count of Participants | | Participants | | Birth through hospital discharge | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Primary | Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component) | Umbilical-artery blood pH < = 7.05 and base deficit in extracellular fluid > = 12 mmol/liter | | Posted | | Count of Participants | | Participants | | Delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Primary | Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) | Neonatal intubation for ventilation in the delivery room | | Posted | | Count of Participants | | Participants | | Delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Primary | Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) | Neonatal encephalopathy experienced between delivery and discharge | | Posted | | Count of Participants | | Participants | | Delivery through hospital discharge | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Participants by Delivery Method | Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean | | Posted | | Count of Participants | | Participants | | Delivery | | | | ID | Title | Description |
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| OG000 | Open Group | • Fetal STAN monitor electrode inserted and data available to caregivers fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG. | | OG001 | Masked Group | •Fetal STAN monitor electrode inserted, but data masked to the caregivers fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG. |
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| Secondary | Number of Participants by Indication for Cesarean | indication for the cesarean delivery | | Posted | | Count of Participants | | Participants | | At any time from randomization through delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Participants With an Indication for Forceps or Vacuum Delivery | Indication for delivery by forceps or vacuum | | Posted | | Count of Participants | | Participants | | During labor through delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Median Duration of Labor Post-randomization | Duration of labor in hours after randomization through delivery | | Posted | | Median | Inter-Quartile Range | Hours | | Onset of Labor through delivery | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Neonates With Shoulder Dystocia During Delivery | Presence of shoulder dystocia during delivery | | Posted | | Count of Participants | | Participants | | Delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Participants With Chorioamnionitis | | | Posted | | Count of Participants | | Participants | | Any time from Randomization through Delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Participants Who Had a Postpartum Blood Transfusion | Blood transfusion from delivery and through hospital stay until discharge | | Posted | | Count of Participants | | Participants | | Delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Open Group | • Fetal STAN monitor electrode inserted and data available to caregivers fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG. | | OG001 | Masked Group | •Fetal STAN monitor electrode inserted, but data masked to the caregivers fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG. |
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| Secondary | Number of Participants Experiencing Postpartum Endometritis | | | Posted | | Count of Participants | | Participants | | Delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | Open Group | • Fetal STAN monitor electrode inserted and data available to caregivers fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG. | | OG001 | Masked Group | •Fetal STAN monitor electrode inserted, but data masked to the caregivers fetal STAN monitor: The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG. |
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| Secondary | Median Length of Hospital Stay | Days of stay in the hospital | | Posted | | Median | Inter-Quartile Range | Days | | From admission to labor and delivery through hospital discharge | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Infants Admitted to Special Care Nursery | Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery) | | Posted | | Count of Participants | | Participants | | Delivery and 1 month of age | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Median Apgar Score at 5 Minutes | 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. | | Posted | | Median | Inter-Quartile Range | score on a scale | | 5 minutes after Delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Infants With Meconium Aspiration Syndrome | Meconium aspiration syndrome | | Posted | | Count of Participants | | Participants | | Delivery through discharge | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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| Secondary | Number of Infants With a Major Congenital Malformation | Major congenital malformation | | Posted | | Count of Participants | | Participants | | Delivery | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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. |
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