STAN: Fetal ST Segment and T Wave Analysis in Labor
Sponsor
The George Washington University Biostatistics Center (Other)
Overall Status
Completed
CT.gov ID
NCT01131260
Collaborator
Neoventa Medical (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
11,108
13
2
45
854.5
19
Study Details
Study Description
Brief Summary
The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic
Fetal Heart Rate Monitoring (STAN):
Fetal ECG analysis of the ST segment (STAN) is now FDA-approved and clinically available in the United States as an adjunct for the interpretation of electronic fetal heart rate patterns. There have been a number of randomized controlled trials as well as observational studies in Europe documenting utility of this modality in terms of reducing fetal acidosis at birth, and decreasing the need for operative vaginal delivery. However, despite these endorsements, there remain concerns with the application of the technology to the United States. None of the randomized trials were performed in the United States where patient case-mix and obstetrical practice, such as the use of fetal scalp pH, differ from Europe, which may affect the impact of this technology on perinatal outcomes. Moreover, the results of the European studies are not uniformly positive.
This protocol describes a randomized controlled trial of the STAN technology as an adjunct to electronic fetal heart rate monitoring versus fetal heart rate monitoring alone.
Study Design
Study Type:
Interventional
Actual Enrollment
:
11108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study is a randomized, controlled clinical trial of 11,000 women in labor at > 36.0 weeks gestation randomized to one of two groups using the STAN S31 system:
Fetal STAN electrode inserted and data available to caregivers (open device group)
Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)The study is a randomized, controlled clinical trial of 11,000 women in labor at > 36.0 weeks gestation randomized to one of two groups using the STAN S31 system:Fetal STAN electrode inserted and data available to caregivers (open device group)
Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)
Masking:
Single (Care Provider)
Masking Description:
The study is a randomized, controlled clinical trial of 11,000 women in labor at > 36.0 weeks gestation randomized to one of two groups using the STAN S31 system:
Fetal STAN electrode inserted and data available to caregivers (open device group)
Fetal STAN electrode inserted, but data masked to the caregivers (masked device group)
Primary Purpose:
Prevention
Official Title:
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
Study Start Date
:
Nov 1, 2010
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Aug 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Open Group • Fetal STAN monitor electrode inserted and data available to caregivers |
Device: 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.
Other Names:
|
| Other: Masked Group •Fetal STAN monitor electrode inserted, but data masked to the caregivers |
Device: 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Primary Composite Outcome [From Delivery through 1 month of age]
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
- Number of Intrapartum Fetal Deaths (Primary Outcome Component) [During labor and through delivery of the baby]
Death of the fetus during the intrapartum period.
- Number of Neonatal Deaths (Primary Outcome Component) [Delivery through1 month of age]
Death of the newborn between delivery and1 month of age
- Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) [5 minutes after delivery]
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.
- Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) [Birth through hospital discharge]
Number of infants who experienced Neonatal Seizure
- Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component) [Delivery]
Umbilical-artery blood pH < = 7.05 and base deficit in extracellular fluid > = 12 mmol/liter
- Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) [Delivery]
Neonatal intubation for ventilation in the delivery room
- Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) [Delivery through hospital discharge]
Neonatal encephalopathy experienced between delivery and discharge
Secondary Outcome Measures
- Number of Participants by Delivery Method [Delivery]
Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean
- Number of Participants by Indication for Cesarean [At any time from randomization through delivery]
indication for the cesarean delivery
- Number of Participants With an Indication for Forceps or Vacuum Delivery [During labor through delivery]
Indication for delivery by forceps or vacuum
- Median Duration of Labor Post-randomization [Onset of Labor through delivery]
Duration of labor in hours after randomization through delivery
- Number of Neonates With Shoulder Dystocia During Delivery [Delivery]
Presence of shoulder dystocia during delivery
- Number of Participants With Chorioamnionitis [Any time from Randomization through Delivery]
Chorioamnionitis
- Number of Participants Who Had a Postpartum Blood Transfusion [Delivery through hospital discharge]
Blood transfusion from delivery and through hospital stay until discharge
- Number of Participants Experiencing Postpartum Endometritis [Delivery through hospital discharge]
Postpartum endometritis
- Median Length of Hospital Stay [From admission to labor and delivery through hospital discharge]
Days of stay in the hospital
- Number of Infants Admitted to Special Care Nursery [Delivery and 1 month of age]
Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery)
- Median Apgar Score at 5 Minutes [5 minutes after Delivery]
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.
- Number of Infants With Meconium Aspiration Syndrome [Delivery through discharge]
Meconium aspiration syndrome
- Number of Infants With a Major Congenital Malformation [Delivery]
Major congenital malformation
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Singleton, cephalic pregnancy
-
Gestational age at least 36 weeks, 1 day
-
Cervical dilation of at least 2 cm and no more than 7 cm
-
Ruptured membranes
Exclusion Criteria:
-
Multifetal gestation
-
Planned cesarean delivery
-
Need for immediate delivery
-
Absent variability or sinusoidal pattern at any time, or a Category II fetal heart rate pattern with absent variability in the last 20 minutes before randomization
-
Inability to obtain or maintain an adequate signal within 3 trials of electrode placements
-
Occurrence of any ST event during attempt to obtain adequate signal
-
Patient pushing in the first stage of labor
-
Known major fetal anomaly or fetal demise
-
Previous uterine surgery
-
Placenta previa on admission
-
Maternal fever greater than or equal to 38 C or 100.4 F
-
Active HSV infection
-
Known HIV or hepatitis infection
-
Other maternal and fetal contraindications for using the STAN monitor
-
Enrollment in another labor study
-
Participation in this trial in a previous pregnancy
-
No certified or authorized provider available
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama - Birmingham | Birmingham | Alabama | United States | 35429 |
| 2 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 3 | Wayne State University - Hutzel Hospital | Detroit | Michigan | United States | 48201 |
| 4 | Columbia University | New York | New York | United States | 10032 |
| 5 | University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | United States | 17599 |
| 6 | Case Western University | Cleveland | Ohio | United States | 44109 |
| 7 | Ohio State University | Columbus | Ohio | United States | 43210 |
| 8 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 9 | University of Pittsburgh - Magee Womens Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
| 10 | Brown University | Providence | Rhode Island | United States | 02905 |
| 11 | University of Texas - Galveston | Galveston | Texas | United States | 77555 |
| 12 | University of Texas - Houston | Houston | Texas | United States | 77030 |
| 13 | University of Utah Medical Center | Salt Lake City | Utah | United States | 84132 |
Sponsors and Collaborators
- The George Washington University Biostatistics Center
- Neoventa Medical
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Study Director: Menachem Miodovnik, MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Principal Investigator: Rebecca Clifton, PhD, George Washington University Biostatistics Center
- Study Chair: George Saade, MD, University of Texas
- Study Chair: Michael Belfort, MD, University of Utah
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Amer-Wåhlin I, Bördahl P, Eikeland T, Hellsten C, Norén H, Sörnes T, Rosén KG. ST analysis of the fetal electrocardiogram during labor: Nordic observational multicenter study. J Matern Fetal Neonatal Med. 2002 Oct;12(4):260-6.
- Amer-Wåhlin I, Hellsten C, Norén H, Hagberg H, Herbst A, Kjellmer I, Lilja H, Lindoff C, Månsson M, Mårtensson L, Olofsson P, Sundström A, Marsál K. Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial. Lancet. 2001 Aug 18;358(9281):534-8.
- Bloom SL, Spong CY, Thom E, Varner MW, Rouse DJ, Weininger S, Ramin SM, Caritis SN, Peaceman A, Sorokin Y, Sciscione A, Carpenter M, Mercer B, Thorp J, Malone F, Harper M, Iams J, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Fetal pulse oximetry and cesarean delivery. N Engl J Med. 2006 Nov 23;355(21):2195-202.
- Dagbjartsson A, Herbertsson G, Stefansson TS, Kjeld M, Lagercrantz H, Rosen KG. Beta-adrenoceptor agonists and hypoxia in sheep fetuses. Acta Physiol Scand. 1989 Oct;137(2):291-9.
- Demets DL. Practical aspects in data monitoring: a brief review. Stat Med. 1987 Oct-Nov;6(7):753-60. Review.
- Devoe LD, Ross M, Wilde C, Beal M, Lysikewicz A, Maier J, Vines V, Amer-Wåhlin I, Lilja H, Norén H, Maulik D. United States multicenter clinical usage study of the STAN 21 electronic fetal monitoring system. Am J Obstet Gynecol. 2006 Sep;195(3):729-34.
- Gelli MG, Bergström J, Hultman E, Thalme B. Heart muscle and plasma electrolytes in normal and glucose-loaded rabbit foetuses under anoxia. Acta Obstet Gynecol Scand. 1969;48(1):34-55.
- Greene KR, Dawes GS, Lilja H, Rosén KG. Changes in the ST waveform of the fetal lamb electrocardiogram with hypoxemia. Am J Obstet Gynecol. 1982 Dec 15;144(8):950-8.
- Greene KR, Rosen KG. Long-term ST waveform changes in the ovine fetal electrocardiogram: the relationship to spontaneous labour and intrauterine death. Clin Phys Physiol Meas. 1989;10 Suppl B:33-40.
- Hökegård KH, Eriksson BO, Kjellmer I, Magno R, Rosén KG. Myocardial metabolism in relation to electrocardiographic changes and cardiac function during graded hypoxia in the fetal lamb. Acta Physiol Scand. 1981 Sep;113(1):1-7.
- Hökegård KH, Karlsson K, Kjellmer I, Rosén KG. ECG-changes in the fetal lamb during asphyxia in relation to beta-adrenoceptor stimulation and blockade. Acta Physiol Scand. 1979 Feb;105(2):195-203.
- Jennison C, Turnbull BW. Statistical approaches to interim monitoring of medical trials: a review and commentary. Statist. Sci. 1990; 229-317.
- Kwee A, van der Hoorn-van den Beld CW, Veerman J, Dekkers AH, Visser GH. STAN S21 fetal heart monitor for fetal surveillance during labor: an observational study in 637 patients. J Matern Fetal Neonatal Med. 2004 Jun;15(6):400-7.
- Lan KK, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika 1983; 70: 659-63.
- Lan KK, Wittes J. The B-value: a tool for monitoring data. Biometrics. 1988 Jun;44(2):579-85.
- Luttkus AK, Norén H, Stupin JH, Blad S, Arulkumaran S, Erkkola R, Hagberg H, Lenstrup C, Visser GH, Tamazian O, Yli B, Rosén KG, Dudenhausen JW. Fetal scalp pH and ST analysis of the fetal ECG as an adjunct to CTG. A multi-center, observational study. J Perinat Med. 2004;32(6):486-94.
- Macones GA, Hankins GD, Spong CY, Hauth J, Moore T. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. J Obstet Gynecol Neonatal Nurs. 2008 Sep-Oct;37(5):510-5. doi: 10.1111/j.1552-6909.2008.00284.x.
- Neilson JP. Fetal electrocardiogram (ECG) for fetal monitoring during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD000116. Review. Update in: Cochrane Database Syst Rev. 2012;4:CD000116.
- Norén H, Amer-Wåhlin I, Hagberg H, Herbst A, Kjellmer I, Marşál K, Olofsson P, Rosén KG. Fetal electrocardiography in labor and neonatal outcome: data from the Swedish randomized controlled trial on intrapartum fetal monitoring. Am J Obstet Gynecol. 2003 Jan;188(1):183-92.
- Norén H, Blad S, Carlsson A, Flisberg A, Gustavsson A, Lilja H, Wennergren M, Hagberg H. STAN in clinical practice--the outcome of 2 years of regular use in the city of Gothenburg. Am J Obstet Gynecol. 2006 Jul;195(1):7-15. Epub 2006 Apr 27.
- O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.
- Ojala K, Vääräsmäki M, Mäkikallio K, Valkama M, Tekay A. A comparison of intrapartum automated fetal electrocardiography and conventional cardiotocography--a randomised controlled study. BJOG. 2006 Apr;113(4):419-23.
- Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64: 191-199.
- Pocock SJ. When to stop a clinical trial. BMJ. 1992 Jul 25;305(6847):235-40.
- Rosén KG, Dagbjartsson A, Henriksson BA, Lagercrantz H, Kjellmer I. The relationship between circulating catecholamines and ST waveform in the fetal lamb electrocardiogram during hypoxia. Am J Obstet Gynecol. 1984 May 15;149(2):190-5.
- Rosén KG, Hökegård KH, Kjellmer I. A study of the relationship between the electrocardiogram and hemodynamics in the fetal lamb during asphyxia. Acta Physiol Scand. 1976 Nov;98(3):275-84.
- 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
- Rosén KG, Kjellmer I. Changes in the fetal heart rate and ECG during hypoxia. Acta Physiol Scand. 1975 Jan;93(1):59-66.
- Ross MG, Devoe LD, Rosen KG. ST-segment analysis of the fetal electrocardiogram improves fetal heart rate tracing interpretation and clinical decision making. J Matern Fetal Neonatal Med. 2004 Mar;15(3):181-5.
- Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84.
- Siggaard-Andersen O. An acid-base chart for arterial blood with normal and pathophysiological reference areas. Scand J Clin Lab Invest. 1971 May;27(3):239-45.
- Stallones RA. The use and abuse of subgroup analysis in epidemiological research. Prev Med. 1987 Mar;16(2):183-94.
- Vayssière C, David E, Meyer N, Haberstich R, Sebahoun V, Roth E, Favre R, Nisand I, Langer B. A French randomized controlled trial of ST-segment analysis in a population with abnormal cardiotocograms during labor. Am J Obstet Gynecol. 2007 Sep;197(3):299.e1-6.
- Vayssiere C, Haberstich R, Sebahoun V, David E, Roth E, Langer B. Fetal electrocardiogram ST-segment analysis and prediction of neonatal acidosis. Int J Gynaecol Obstet. 2007 May;97(2):110-4. Epub 2007 Mar 26.
- Watanabe T, Okamura K, Tanigawara S, Shintaku Y, Akagi K, Endo H, Yajima A. Change in electrocardiogram T-wave amplitude during umbilical cord compression is predictive of fetal condition in sheep. Am J Obstet Gynecol. 1992 Jan;166(1 Pt 1):246-55.
- Westgate J, Harris M, Curnow JS, Greene KR. Plymouth randomized trial of cardiotocogram only versus ST waveform plus cardiotocogram for intrapartum monitoring in 2400 cases. Am J Obstet Gynecol. 1993 Nov;169(5):1151-60.
- Westgate JA, Bennet L, Brabyn C, Williams CE, Gunn AJ. ST waveform changes during repeated umbilical cord occlusions in near-term fetal sheep. Am J Obstet Gynecol. 2001 Mar;184(4):743-51.
- Widmark C, Hökegård KH, Lagercrantz H, Lilja H, Rosén KG. Electrocardiographic waveform changes and catecholamine responses during acute hypoxia in the immature and mature fetal lamb. Am J Obstet Gynecol. 1989 May;160(5 Pt 1):1245-50.
- Widmark C, Jansson T, Lindecrantz K, Rosén KG. ECG waveform, short term heart rate variability and plasma catecholamine concentrations in response to hypoxia in intrauterine growth retarded guinea-pig fetuses. J Dev Physiol. 1991 Mar;15(3):161-8.
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Responsible Party:
The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier:
NCT01131260
Other Study ID Numbers:
- HD36801-STAN
- U10HD021410
- U10HD027869
- U10HD027917
- U10HD053118
- U10HD027915
- U10HD034208
- U10HD053097
- U10HD040500
- U10HD040485
- U10HD040544
- U10HD040545
- U10HD040560
- U10HD040512
- U01HD036801
- U10HD068268
- U10HD068282
First Posted:
May 26, 2010
Last Update Posted:
Jul 15, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by The George Washington University Biostatistics Center
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Open Group | Masked Group | Total |
|---|---|---|---|
| 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 Participants | 5532 | 5576 | 11108 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
27.4
(5.9)
|
27.2
(5.8)
|
27.3
(5.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5532
100%
|
5576
100%
|
11108
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Black |
1326
24%
|
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 (weeks) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [weeks] |
39.4
(1.2)
|
39.4
(1.2)
|
39.4
(1.2)
|
| Body-mass index before pregnancy (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
27.4
(7.2)
|
27.4
(7.0)
|
27.4
(7.1)
|
| Educational level (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
12.8
(2.6)
|
12.8
(2.7)
|
12.8
(2.6)
|
| Cervical dilation at randomization (centimeters) [Median (Inter-Quartile Range) ] | |||
| Median (Inter-Quartile Range) [centimeters] |
5
|
5
|
5
|
| Type of labor (Count of Participants) | |||
| Spontaneous |
2259
40.8%
|
2311
41.4%
|
4570
41.1%
|
| Induced |
3273
59.2%
|
3265
58.6%
|
6538
58.9%
|
| Nulliparous (Count of Participants) | |||
| Count of Participants [Participants] |
2354
42.6%
|
2373
42.6%
|
4727
42.6%
|
Outcome Measures
| Title | Number of Participants With Primary Composite Outcome |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Umbilical cord artery blood was not able to be obtained from all participants. |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
52
0.9%
|
40
0.7%
|
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 | ||
| Statistical Test of Hypothesis | p-Value | 0.20 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 1.31 | |
| Confidence Interval |
(2-Sided) 95% 0.87 to 1.98 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Intrapartum Fetal Deaths (Primary Outcome Component) |
|---|---|
| Description | Death of the fetus during the intrapartum period. |
| Time Frame | During labor and through delivery of the baby |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Neonatal Deaths (Primary Outcome Component) |
|---|---|
| Description | Death of the newborn between delivery and1 month of age |
| Time Frame | Delivery through1 month of age |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
3
0.1%
|
1
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.37 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 3.02 | |
| Confidence Interval |
(2-Sided) 95% 0.31 to 29.1 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Infants With Apgar Score < = 3 at 5 Minutes (Primary Outcome Component) |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
17
0.3%
|
6
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.02 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 2.86 | |
| Confidence Interval |
(2-Sided) 95% 1.13 to 7.24 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Infants Who Experienced Neonatal Seizure (Primary Outcome Component) |
|---|---|
| Description | Number of infants who experienced Neonatal Seizure |
| Time Frame | Birth through hospital discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
3
0.1%
|
4
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.76 | |
| Confidence Interval |
(2-Sided) 95% 0.17 to 3.38 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Infants With Umbilical-artery Blood pH < = 7.05 and Base Deficit in Extracellular Fluid > = 12 mmol/Liter (Primary Outcome Component) |
|---|---|
| Description | Umbilical-artery blood pH < = 7.05 and base deficit in extracellular fluid > = 12 mmol/liter |
| Time Frame | Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5362 | 5359 |
| Count of Participants [Participants] |
3
0.1%
|
8
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.13 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.37 | |
| Confidence Interval |
(2-Sided) 95% 0.10 to 1.41 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Neonates Intubated for Ventilation at Delivery (Primary Outcome Component) |
|---|---|
| Description | Neonatal intubation for ventilation in the delivery room |
| Time Frame | Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
42
0.8%
|
27
0.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.07 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 1.57 | |
| Confidence Interval |
(2-Sided) 95% 0.97 to 2.54 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) |
|---|---|
| Description | Neonatal encephalopathy experienced between delivery and discharge |
| Time Frame | Delivery through hospital discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
4
0.1%
|
5
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Risk Ratio (RR) |
| Estimated Value | 0.81 | |
| Confidence Interval |
(2-Sided) 95% 0.22 to 3.00 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants by Delivery Method |
|---|---|
| Description | Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean |
| Time Frame | Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Spontaneous |
4269
77.2%
|
4348
78%
|
| Forceps |
128
2.3%
|
103
1.8%
|
| Vacuum-Assisted |
201
3.6%
|
224
4%
|
| Cesarean |
934
16.9%
|
901
16.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .17 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants by Indication for Cesarean |
|---|---|
| Description | indication for the cesarean delivery |
| Time Frame | At any time from randomization through delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 934 | 901 |
| Fetal Indication |
287
5.2%
|
298
5.3%
|
| Dystocia |
621
11.2%
|
583
10.5%
|
| Other |
26
0.5%
|
20
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.45 |
| Comments | The p value was calculated based on the entire study cohort. | |
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With an Indication for Forceps or Vacuum Delivery |
|---|---|
| Description | Indication for delivery by forceps or vacuum |
| Time Frame | During labor through delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 329 | 327 |
| Fetal indication |
225
4.1%
|
218
3.9%
|
| Dystocia |
95
1.7%
|
101
1.8%
|
| Other |
9
0.2%
|
8
0.1%
|
| Title | Median Duration of Labor Post-randomization |
|---|---|
| Description | Duration of labor in hours after randomization through delivery |
| Time Frame | Onset of Labor through delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Median (Inter-Quartile Range) [Hours] |
3.8
|
3.9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .32 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Neonates With Shoulder Dystocia During Delivery |
|---|---|
| Description | Presence of shoulder dystocia during delivery |
| Time Frame | Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
141
2.5%
|
158
2.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.35 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants With Chorioamnionitis |
|---|---|
| Description | Chorioamnionitis |
| Time Frame | Any time from Randomization through Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
286
5.2%
|
269
4.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.40 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants Who Had a Postpartum Blood Transfusion |
|---|---|
| Description | Blood transfusion from delivery and through hospital stay until discharge |
| Time Frame | Delivery through hospital discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
80
1.4%
|
74
1.3%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.59 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Participants Experiencing Postpartum Endometritis |
|---|---|
| Description | Postpartum endometritis |
| Time Frame | Delivery through hospital discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
71
1.3%
|
88
1.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .19 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Median Length of Hospital Stay |
|---|---|
| Description | Days of stay in the hospital |
| Time Frame | From admission to labor and delivery through hospital discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Median (Inter-Quartile Range) [Days] |
2
|
2
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.77 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Infants Admitted to Special Care Nursery |
|---|---|
| Description | Intermediate care nursery or neonatal intensive care (anything more than well-baby nursery) |
| Time Frame | Delivery and 1 month of age |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
498
9%
|
470
8.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.28 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Median Apgar Score at 5 Minutes |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Median (Inter-Quartile Range) [score on a scale] |
9
|
9
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.54 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Title | Number of Infants With Meconium Aspiration Syndrome |
|---|---|
| Description | Meconium aspiration syndrome |
| Time Frame | Delivery through discharge |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
20
0.4%
|
20
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.98 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Number of Infants With a Major Congenital Malformation |
|---|---|
| Description | Major congenital malformation |
| Time Frame | Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Open Group | Masked Group |
|---|---|---|
| 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. |
| Measure Participants | 5532 | 5576 |
| Count of Participants [Participants] |
38
0.7%
|
23
0.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Open Group, Masked Group |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .05 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Adverse Events
| 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 | ||||
| Arm/Group Title | Open Group | Masked Group | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Open Group | Masked Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/5532 (0.6%) | 21/5576 (0.4%) | ||
| Congenital, familial and genetic disorders | ||||
| Congenital malformation | 11/5532 (0.2%) | 4/5576 (0.1%) | ||
| Neonatal death | 3/5532 (0.1%) | 1/5576 (0%) | ||
| Infections and infestations | ||||
| Maternal Infection (bacteremia) | 0/5532 (0%) | 1/5576 (0%) | ||
| Scalp abscess/pustules (neonatal) | 2/5532 (0%) | 2/5576 (0%) | ||
| Infection/sepsis (neonate) | 0/5532 (0%) | 2/5576 (0%) | ||
| Nervous system disorders | ||||
| Maternal Seizure (eclampsia) | 0/5532 (0%) | 1/5576 (0%) | ||
| Neonatal Encephalopathy | 1/5532 (0%) | 0/5576 (0%) | ||
| Neonatal Seizure | 2/5532 (0%) | 1/5576 (0%) | ||
| Brachial plexus injury | 2/5532 (0%) | 1/5576 (0%) | ||
| Reproductive system and breast disorders | ||||
| Postpartum Hemorrhage | 7/5532 (0.1%) | 4/5576 (0.1%) | ||
| Uterine Rupture | 2/5532 (0%) | 0/5576 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute Respiratory Distress Syndrome | 0/5532 (0%) | 1/5576 (0%) | ||
| Pneumothorax | 2/5532 (0%) | 0/5576 (0%) | ||
| Vascular disorders | ||||
| Subgaleal hematoma (neonate) | 3/5532 (0.1%) | 3/5576 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Open Group | Masked Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5532 (0%) | 0/5576 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | Rebecca Clifton, Ph.D. |
|---|---|
| Organization | The George Washington University Biostatistics Center |
| Phone | 301-881-9260 |
| rclifton@bsc.gwu.edu |
Responsible Party:
The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier:
NCT01131260
Other Study ID Numbers:
- HD36801-STAN
- U10HD021410
- U10HD027869
- U10HD027917
- U10HD053118
- U10HD027915
- U10HD034208
- U10HD053097
- U10HD040500
- U10HD040485
- U10HD040544
- U10HD040545
- U10HD040560
- U10HD040512
- U01HD036801
- U10HD068268
- U10HD068282
First Posted:
May 26, 2010
Last Update Posted:
Jul 15, 2019
Last Verified:
Jul 1, 2019