Trial Outcomes & Findings for Fetal ST Segment and T Wave Analysis in Labor (NCT NCT01131260)
NCT ID: NCT01131260
Last Updated: 2019-07-15
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11108 participants
Primary outcome timeframe
From Delivery through 1 month of age
Results posted on
2019-07-15
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
5532
|
5576
|
|
Overall Study
COMPLETED
|
5488
|
5529
|
|
Overall Study
NOT COMPLETED
|
44
|
47
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Randomization error
|
5
|
1
|
|
Overall Study
Declined to continue participation
|
8
|
13
|
|
Overall Study
Physician Decision
|
22
|
24
|
|
Overall Study
Technical problems
|
7
|
6
|
|
Overall Study
Staff error
|
2
|
1
|
|
Overall Study
Ineligible
|
0
|
2
|
Baseline Characteristics
Pre-pregnancy BMI was not able to be obtained for all participants.
Baseline characteristics by cohort
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
Total
n=11108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.4 years
STANDARD_DEVIATION 5.9 • n=5532 Participants
|
27.2 years
STANDARD_DEVIATION 5.8 • n=5576 Participants
|
27.3 years
STANDARD_DEVIATION 5.8 • n=11108 Participants
|
|
Sex: Female, Male
Female
|
5532 Participants
n=5532 Participants
|
5576 Participants
n=5576 Participants
|
11108 Participants
n=11108 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5532 Participants
|
0 Participants
n=5576 Participants
|
0 Participants
n=11108 Participants
|
|
Race/Ethnicity, Customized
Black
|
1326 Participants
n=5532 Participants
|
1350 Participants
n=5576 Participants
|
2676 Participants
n=11108 Participants
|
|
Race/Ethnicity, Customized
White
|
3297 Participants
n=5532 Participants
|
3281 Participants
n=5576 Participants
|
6578 Participants
n=11108 Participants
|
|
Race/Ethnicity, Customized
Other
|
909 Participants
n=5532 Participants
|
945 Participants
n=5576 Participants
|
1854 Participants
n=11108 Participants
|
|
Week of pregnancy at randomization
|
39.4 weeks
STANDARD_DEVIATION 1.2 • n=5532 Participants
|
39.4 weeks
STANDARD_DEVIATION 1.2 • n=5576 Participants
|
39.4 weeks
STANDARD_DEVIATION 1.2 • n=11108 Participants
|
|
Body-mass index before pregnancy
|
27.4 kg/m^2
STANDARD_DEVIATION 7.2 • n=5498 Participants • Pre-pregnancy BMI was not able to be obtained for all participants.
|
27.4 kg/m^2
STANDARD_DEVIATION 7.0 • n=5533 Participants • Pre-pregnancy BMI was not able to be obtained for all participants.
|
27.4 kg/m^2
STANDARD_DEVIATION 7.1 • n=11031 Participants • Pre-pregnancy BMI was not able to be obtained for all participants.
|
|
Educational level
|
12.8 years
STANDARD_DEVIATION 2.6 • n=5484 Participants • Schooling based on self report. Unable to obtain for all participants.
|
12.8 years
STANDARD_DEVIATION 2.7 • n=5516 Participants • Schooling based on self report. Unable to obtain for all participants.
|
12.8 years
STANDARD_DEVIATION 2.6 • n=11000 Participants • Schooling based on self report. Unable to obtain for all participants.
|
|
Cervical dilation at randomization
|
5 centimeters
n=5532 Participants
|
5 centimeters
n=5576 Participants
|
5 centimeters
n=11108 Participants
|
|
Type of labor
Spontaneous
|
2259 Participants
n=5532 Participants
|
2311 Participants
n=5576 Participants
|
4570 Participants
n=11108 Participants
|
|
Type of labor
Induced
|
3273 Participants
n=5532 Participants
|
3265 Participants
n=5576 Participants
|
6538 Participants
n=11108 Participants
|
|
Nulliparous
|
2354 Participants
n=5532 Participants
|
2373 Participants
n=5576 Participants
|
4727 Participants
n=11108 Participants
|
PRIMARY outcome
Timeframe: From Delivery through 1 month of agePopulation: Umbilical cord artery blood was not able to be obtained from all participants.
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
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Participants With Primary Composite Outcome
|
52 Participants
|
40 Participants
|
PRIMARY outcome
Timeframe: During labor and through delivery of the babyDeath of the fetus during the intrapartum period.
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Intrapartum Fetal Deaths (Primary Outcome Component)
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Delivery through1 month of ageDeath of the newborn between delivery and1 month of age
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Neonatal Deaths (Primary Outcome Component)
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after deliveryThe 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.
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
|
17 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Birth through hospital dischargeNumber of infants who experienced Neonatal Seizure
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: DeliveryUmbilical-artery blood pH \< = 7.05 and base deficit in extracellular fluid \> = 12 mmol/liter
Outcome measures
| Measure |
Open Group
n=5362 Participants
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
|
Masked Group
n=5359 Participants
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.
|
|---|---|---|
|
Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)
|
3 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: DeliveryNeonatal intubation for ventilation in the delivery room
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)
|
42 Participants
|
27 Participants
|
PRIMARY outcome
Timeframe: Delivery through hospital dischargeNeonatal encephalopathy experienced between delivery and discharge
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: DeliveryMethod of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Participants by Delivery Method
Spontaneous
|
4269 Participants
|
4348 Participants
|
|
Number of Participants by Delivery Method
Forceps
|
128 Participants
|
103 Participants
|
|
Number of Participants by Delivery Method
Vacuum-Assisted
|
201 Participants
|
224 Participants
|
|
Number of Participants by Delivery Method
Cesarean
|
934 Participants
|
901 Participants
|
SECONDARY outcome
Timeframe: At any time from randomization through deliveryindication for the cesarean delivery
Outcome measures
| Measure |
Open Group
n=934 Participants
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
|
Masked Group
n=901 Participants
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.
|
|---|---|---|
|
Number of Participants by Indication for Cesarean
Fetal Indication
|
287 Participants
|
298 Participants
|
|
Number of Participants by Indication for Cesarean
Dystocia
|
621 Participants
|
583 Participants
|
|
Number of Participants by Indication for Cesarean
Other
|
26 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: During labor through deliveryIndication for delivery by forceps or vacuum
Outcome measures
| Measure |
Open Group
n=329 Participants
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
|
Masked Group
n=327 Participants
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.
|
|---|---|---|
|
Number of Participants With an Indication for Forceps or Vacuum Delivery
Dystocia
|
95 Participants
|
101 Participants
|
|
Number of Participants With an Indication for Forceps or Vacuum Delivery
Fetal indication
|
225 Participants
|
218 Participants
|
|
Number of Participants With an Indication for Forceps or Vacuum Delivery
Other
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Onset of Labor through deliveryDuration of labor in hours after randomization through delivery
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Median Duration of Labor Post-randomization
|
3.8 Hours
Interval 2.1 to 6.4
|
3.9 Hours
Interval 2.2 to 6.7
|
SECONDARY outcome
Timeframe: DeliveryPresence of shoulder dystocia during delivery
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Neonates With Shoulder Dystocia During Delivery
|
141 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Any time from Randomization through DeliveryChorioamnionitis
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Participants With Chorioamnionitis
|
286 Participants
|
269 Participants
|
SECONDARY outcome
Timeframe: Delivery through hospital dischargeBlood transfusion from delivery and through hospital stay until discharge
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Participants Who Had a Postpartum Blood Transfusion
|
80 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Delivery through hospital dischargePostpartum endometritis
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Participants Experiencing Postpartum Endometritis
|
71 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: From admission to labor and delivery through hospital dischargeDays of stay in the hospital
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Median Length of Hospital Stay
|
2 Days
Interval 2.0 to 2.0
|
2 Days
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: Delivery and 1 month of ageIntermediate care nursery or neonatal intensive care (anything more than well-baby nursery)
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Infants Admitted to Special Care Nursery
|
498 Participants
|
470 Participants
|
SECONDARY outcome
Timeframe: 5 minutes after DeliveryThe 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.
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Median Apgar Score at 5 Minutes
|
9 score on a scale
Interval 9.0 to 9.0
|
9 score on a scale
Interval 9.0 to 9.0
|
SECONDARY outcome
Timeframe: Delivery through dischargeMeconium aspiration syndrome
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Infants With Meconium Aspiration Syndrome
|
20 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: DeliveryMajor congenital malformation
Outcome measures
| Measure |
Open Group
n=5532 Participants
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
|
Masked Group
n=5576 Participants
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.
|
|---|---|---|
|
Number of Infants With a Major Congenital Malformation
|
38 Participants
|
23 Participants
|
Adverse Events
Open Group
Serious events: 35 serious events
Other events: 0 other events
Deaths: 0 deaths
Masked Group
Serious events: 21 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Group
n=5532 participants at risk
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
|
Masked Group
n=5576 participants at risk
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.
|
|---|---|---|
|
Reproductive system and breast disorders
Postpartum Hemorrhage
|
0.13%
7/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.07%
4/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Reproductive system and breast disorders
Uterine Rupture
|
0.04%
2/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.00%
0/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Infections and infestations
Maternal Infection (bacteremia)
|
0.00%
0/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.02%
1/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Nervous system disorders
Maternal Seizure (eclampsia)
|
0.00%
0/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.02%
1/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.02%
1/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Congenital, familial and genetic disorders
Congenital malformation
|
0.20%
11/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.07%
4/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Infections and infestations
Scalp abscess/pustules (neonatal)
|
0.04%
2/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.04%
2/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Congenital, familial and genetic disorders
Neonatal death
|
0.05%
3/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.02%
1/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Nervous system disorders
Neonatal Encephalopathy
|
0.02%
1/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.00%
0/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Nervous system disorders
Neonatal Seizure
|
0.04%
2/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.02%
1/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Vascular disorders
Subgaleal hematoma (neonate)
|
0.05%
3/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.05%
3/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Nervous system disorders
Brachial plexus injury
|
0.04%
2/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.02%
1/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Infections and infestations
Infection/sepsis (neonate)
|
0.00%
0/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.04%
2/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
2/5532 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
0.00%
0/5576 • Data on adverse events was collected on a continuous basis for each participant from the time of randomization up through the time of hospital discharge.
|
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Clifton, Ph.D.
The George Washington University Biostatistics Center
Phone: 301-881-9260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place