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Fetal ST Segment and T Wave Analysis in Labor (STAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01131260
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : April 5, 2019
Last Update Posted : July 15, 2019
Sponsor:
Collaborators:
Neoventa Medical
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Prevention
Conditions Pregnancy
Obstetric Labor
Parturition
Intervention Device: fetal STAN monitor
Enrollment 11108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 5532 5576
Completed 5488 5529
Not Completed 44 47
Reason Not Completed
Randomization error             5             1
Declined to continue participation             8             13
Physician Decision             22             24
Technical problems             7             6
Staff error             2             1
Ineligible             0             2
Arm/Group Title Open Group Masked Group Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 5532 5576 11108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5532 participants 5576 participants 11108 participants
27.4  (5.9) 27.2  (5.8) 27.3  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5532 participants 5576 participants 11108 participants
Female
5532
 100.0%
5576
 100.0%
11108
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5532 participants 5576 participants 11108 participants
Black
1326
  24.0%
1350
  24.2%
2676
  24.1%
White
3297
  59.6%
3281
  58.8%
6578
  59.2%
Other
909
  16.4%
945
  16.9%
1854
  16.7%
Week of pregnancy at randomization  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 5532 participants 5576 participants 11108 participants
39.4  (1.2) 39.4  (1.2) 39.4  (1.2)
Body-mass index before pregnancy   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 5498 participants 5533 participants 11031 participants
27.4  (7.2) 27.4  (7.0) 27.4  (7.1)
[1]
Measure Analysis Population Description: Pre-pregnancy BMI was not able to be obtained for all participants.
Educational level   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5484 participants 5516 participants 11000 participants
12.8  (2.6) 12.8  (2.7) 12.8  (2.6)
[1]
Measure Analysis Population Description: Schooling based on self report. Unable to obtain for all participants.
Cervical dilation at randomization  
Median (Inter-Quartile Range)
Unit of measure:  Centimeters
Number Analyzed 5532 participants 5576 participants 11108 participants
5
(4 to 6)
5
(4 to 6)
5
(4 to 6)
Type of labor  
Measure Type: Count of Participants
Unit of measure:  Participants
Spontaneous Number Analyzed 5532 participants 5576 participants 11108 participants
2259
  40.8%
2311
  41.4%
4570
  41.1%
Induced Number Analyzed 5532 participants 5576 participants 11108 participants
3273
  59.2%
3265
  58.6%
6538
  58.9%
Nulliparous  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5532 participants 5576 participants 11108 participants
2354
  42.6%
2373
  42.6%
4727
  42.6%
1.Primary Outcome
Title Number of Participants With Primary Composite Outcome
Hide 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
Time Frame From Delivery through 1 month of age
Hide Outcome Measure Data
Hide Analysis Population Description
Umbilical cord artery blood was not able to be obtained from all participants.
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
52
   0.9%
40
   0.7%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments Analysis on primary composite outcome as a whole.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.87 to 1.98
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Intrapartum Fetal Deaths (Primary Outcome Component)
Hide Description Death of the fetus during the intrapartum period.
Time Frame During labor and through delivery of the baby
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Neonatal Deaths (Primary Outcome Component)
Hide Description Death of the newborn between delivery and1 month of age
Time Frame Delivery through1 month of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.1%
1
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 3.02
Confidence Interval (2-Sided) 95%
0.31 to 29.1
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component)
Hide 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.
Time Frame 5 minutes after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
17
   0.3%
6
   0.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 2.86
Confidence Interval (2-Sided) 95%
1.13 to 7.24
Estimation Comments [Not Specified]
5.Primary Outcome
Title Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component)
Hide Description Number of infants who experienced Neonatal Seizure
Time Frame Birth through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.1%
4
   0.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.17 to 3.38
Estimation Comments [Not Specified]
6.Primary Outcome
Title Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component)
Hide Description Umbilical-artery blood pH < = 7.05 and base deficit in extracellular fluid > = 12 mmol/liter
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5362 5359
Measure Type: Count of Participants
Unit of Measure: Participants
3
   0.1%
8
   0.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
0.10 to 1.41
Estimation Comments [Not Specified]
7.Primary Outcome
Title Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component)
Hide Description Neonatal intubation for ventilation in the delivery room
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
42
   0.8%
27
   0.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.57
Confidence Interval (2-Sided) 95%
0.97 to 2.54
Estimation Comments [Not Specified]
8.Primary Outcome
Title Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component)
Hide Description Neonatal encephalopathy experienced between delivery and discharge
Time Frame Delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
4
   0.1%
5
   0.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
0.22 to 3.00
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants by Delivery Method
Hide Description Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:

• 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.

•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.

Overall Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
Spontaneous
4269
  77.2%
4348
  78.0%
Forceps
128
   2.3%
103
   1.8%
Vacuum-Assisted
201
   3.6%
224
   4.0%
Cesarean
934
  16.9%
901
  16.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .17
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
10.Secondary Outcome
Title Number of Participants by Indication for Cesarean
Hide Description indication for the cesarean delivery
Time Frame At any time from randomization through delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 934 901
Measure Type: Count of Participants
Unit of Measure: Participants
Fetal Indication
287
  30.7%
298
  33.1%
Dystocia
621
  66.5%
583
  64.7%
Other
26
   2.8%
20
   2.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments The p value was calculated based on the entire study cohort.
Method Chi-squared
Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With an Indication for Forceps or Vacuum Delivery
Hide Description Indication for delivery by forceps or vacuum
Time Frame During labor through delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 329 327
Measure Type: Count of Participants
Unit of Measure: Participants
Fetal indication
225
  68.4%
218
  66.7%
Dystocia
95
  28.9%
101
  30.9%
Other
9
   2.7%
8
   2.4%
12.Secondary Outcome
Title Median Duration of Labor Post-randomization
Hide Description Duration of labor in hours after randomization through delivery
Time Frame Onset of Labor through delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Median (Inter-Quartile Range)
Unit of Measure: Hours
3.8
(2.1 to 6.4)
3.9
(2.2 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .32
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
13.Secondary Outcome
Title Number of Neonates With Shoulder Dystocia During Delivery
Hide Description Presence of shoulder dystocia during delivery
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
141
   2.5%
158
   2.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
14.Secondary Outcome
Title Number of Participants With Chorioamnionitis
Hide Description Chorioamnionitis
Time Frame Any time from Randomization through Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
286
   5.2%
269
   4.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
15.Secondary Outcome
Title Number of Participants Who Had a Postpartum Blood Transfusion
Hide Description Blood transfusion from delivery and through hospital stay until discharge
Time Frame Delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:

• 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.

•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.

Overall Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
80
   1.4%
74
   1.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
16.Secondary Outcome
Title Number of Participants Experiencing Postpartum Endometritis
Hide Description Postpartum endometritis
Time Frame Delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:

• 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.

•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.

Overall Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
71
   1.3%
88
   1.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .19
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
17.Secondary Outcome
Title Median Length of Hospital Stay
Hide Description Days of stay in the hospital
Time Frame From admission to labor and delivery through hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Median (Inter-Quartile Range)
Unit of Measure: Days
2
(2 to 2)
2
(2 to 2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.77
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
18.Secondary Outcome
Title Number of Infants Admitted to Special Care Nursery
Hide Description Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery)
Time Frame Delivery and 1 month of age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
498
   9.0%
470
   8.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
19.Secondary Outcome
Title Median Apgar Score at 5 Minutes
Hide 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.
Time Frame 5 minutes after Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
9
(9 to 9)
9
(9 to 9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Number of Infants With Meconium Aspiration Syndrome
Hide Description Meconium aspiration syndrome
Time Frame Delivery through discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
20
   0.4%
20
   0.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
21.Secondary Outcome
Title Number of Infants With a Major Congenital Malformation
Hide Description Major congenital malformation
Time Frame Delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description:
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
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 Number of Participants Analyzed 5532 5576
Measure Type: Count of Participants
Unit of Measure: Participants
38
   0.7%
23
   0.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open Group, Masked Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Group Masked Group
Hide Arm/Group Description 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 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.
All-Cause Mortality
Open Group Masked Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Open Group Masked Group
Affected / at Risk (%) Affected / at Risk (%)
Total   35/5532 (0.63%)   21/5576 (0.38%) 
Congenital, familial and genetic disorders     
Congenital malformation *  11/5532 (0.20%)  4/5576 (0.07%) 
Neonatal death *  3/5532 (0.05%)  1/5576 (0.02%) 
Infections and infestations     
Maternal Infection (bacteremia) *  0/5532 (0.00%)  1/5576 (0.02%) 
Scalp abscess/pustules (neonatal) * [1]  2/5532 (0.04%)  2/5576 (0.04%) 
Infection/sepsis (neonate) *  0/5532 (0.00%)  2/5576 (0.04%) 
Nervous system disorders     
Maternal Seizure (eclampsia) *  0/5532 (0.00%)  1/5576 (0.02%) 
Neonatal Encephalopathy *  1/5532 (0.02%)  0/5576 (0.00%) 
Neonatal Seizure *  2/5532 (0.04%)  1/5576 (0.02%) 
Brachial plexus injury *  2/5532 (0.04%)  1/5576 (0.02%) 
Reproductive system and breast disorders     
Postpartum Hemorrhage *  7/5532 (0.13%)  4/5576 (0.07%) 
Uterine Rupture *  2/5532 (0.04%)  0/5576 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * [2]  0/5532 (0.00%)  1/5576 (0.02%) 
Pneumothorax *  2/5532 (0.04%)  0/5576 (0.00%) 
Vascular disorders     
Subgaleal hematoma (neonate) *  3/5532 (0.05%)  3/5576 (0.05%) 
*
Indicates events were collected by non-systematic assessment
[1]
From site of fetal ECG clip
[2]
Neonatal RDS
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Open Group Masked Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5532 (0.00%)   0/5576 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rebecca Clifton, Ph.D.
Organization: The George Washington University Biostatistics Center
Phone: 301-881-9260
EMail: rclifton@bsc.gwu.edu
Publications:
Rosen KG, Isaksson O. Alterations in the fetal heart rate and ECG correlated to glycogen, creatine phosphate and ATP levels during graded hypoxia. Biol Neonate 1976;30:17-24
Jennison C, Turnbull BW. Statistical approaches to interim monitoring of medical trials: a review and commentary. Statist. Sci. 1990; 229-317.
Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64: 191-199.
Lan KK, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
Layout table for additonal information
Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT01131260    
Other Study ID Numbers: HD36801-STAN
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD053118 ( U.S. NIH Grant/Contract )
U10HD027915 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD053097 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U01HD036801 ( U.S. NIH Grant/Contract )
U10HD068268 ( U.S. NIH Grant/Contract )
U10HD068282 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2010
First Posted: May 26, 2010
Results First Submitted: February 8, 2019
Results First Posted: April 5, 2019
Last Update Posted: July 15, 2019