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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

Tracking Information
First Submitted Date  ICMJE May 25, 2010
First Posted Date  ICMJE May 26, 2010
Results First Submitted Date  ICMJE February 8, 2019
Results First Posted Date  ICMJE April 5, 2019
Last Update Posted Date July 15, 2019
Study Start Date  ICMJE November 2010
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Number of Participants With Primary Composite Outcome [ Time Frame: 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) [ Time Frame: During labor and through delivery of the baby ]
    Death of the fetus during the intrapartum period.
  • Number of Neonatal Deaths (Primary Outcome Component) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Delivery ]
    Neonatal intubation for ventilation in the delivery room
  • Number of Infants Experiencing Neonatal Encephalopathy (Primary Outcome Component) [ Time Frame: Delivery through hospital discharge ]
    Neonatal encephalopathy experienced between delivery and discharge
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
  • Intrapartum fetal death [ Time Frame: Delivery ]
  • Neonatal Death [ Time Frame: Delivery and 1 month of age ]
  • Apgar score <= 3 at 5 minutes [ Time Frame: Delivery ]
  • Neonatal seizure [ Time Frame: Delivery and 1 month of age ]
  • Cord artery pH <= 7.05 and base deficit >= 12 mmol/L [ Time Frame: Delivery ]
  • Intubation for ventilation at delivery [ Time Frame: Delivery ]
  • Presence of neonatal encephalopathy [ Time Frame: Delivery and 1 month of age ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Number of Participants by Delivery Method [ Time Frame: Delivery ]
    Method of delivery of the baby: spontaneous, vacuum assisted, forceps, cesarean
  • Number of Participants by Indication for Cesarean [ Time Frame: At any time from randomization through delivery ]
    indication for the cesarean delivery
  • Number of Participants With an Indication for Forceps or Vacuum Delivery [ Time Frame: During labor through delivery ]
    Indication for delivery by forceps or vacuum
  • Median Duration of Labor Post-randomization [ Time Frame: Onset of Labor through delivery ]
    Duration of labor in hours after randomization through delivery
  • Number of Neonates With Shoulder Dystocia During Delivery [ Time Frame: Delivery ]
    Presence of shoulder dystocia during delivery
  • Number of Participants With Chorioamnionitis [ Time Frame: Any time from Randomization through Delivery ]
    Chorioamnionitis
  • Number of Participants Who Had a Postpartum Blood Transfusion [ Time Frame: Delivery through hospital discharge ]
    Blood transfusion from delivery and through hospital stay until discharge
  • Number of Participants Experiencing Postpartum Endometritis [ Time Frame: Delivery through hospital discharge ]
    Postpartum endometritis
  • Median Length of Hospital Stay [ Time Frame: From admission to labor and delivery through hospital discharge ]
    Days of stay in the hospital
  • Number of Infants Admitted to Special Care Nursery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Delivery through discharge ]
    Meconium aspiration syndrome
  • Number of Infants With a Major Congenital Malformation [ Time Frame: Delivery ]
    Major congenital malformation
Original Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2010)
  • Cesarean delivery [ Time Frame: Delivery ]
  • Indication for cesarean delivery [ Time Frame: Delivery ]
  • Forceps or vacuum delivery [ Time Frame: Delivery ]
  • Chorioamnionitis [ Time Frame: Delivery ]
  • Postpartum hemorrhage [ Time Frame: Delivery ]
  • Postpartum endometritis [ Time Frame: Delivery ]
  • Duration of labor post-randomization [ Time Frame: Delivery ]
  • Length of hospital stay [ Time Frame: Discharge from hospital ]
  • Maternal heart rate [ Time Frame: Delivery ]
  • Maternal blood pressure [ Time Frame: Delivery ]
  • Maternal oxygen saturation [ Time Frame: Delivery ]
  • Intrapartum fetal death [ Time Frame: Delivery ]
  • Neonatal death [ Time Frame: Delivery and 1 month of age ]
  • Apgar score at 5 minutes [ Time Frame: Delivery ]
  • Umbilical arterial blood gases [ Time Frame: Delivery ]
  • Need for chest compression or intubation for ventilation in the delivery room [ Time Frame: Delivery ]
  • Special care nursery admission (anything more than well-baby nursery) [ Time Frame: Delivery and 1 month of age ]
  • Seizure [ Time Frame: Delivery and 1 month of age ]
  • ST events [ Time Frame: Delivery ]
    The number, type, and timing of the events.
  • Shoulder dystocia [ Time Frame: Delivery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fetal ST Segment and T Wave Analysis in Labor
Official Title  ICMJE A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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)
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
Condition  ICMJE
  • Pregnancy
  • Obstetric Labor
  • Parturition
Intervention  ICMJE 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 Name: STAN S31
Study Arms  ICMJE
  • Experimental: Open Group
    • Fetal STAN monitor electrode inserted and data available to caregivers
    Intervention: Device: fetal STAN monitor
  • Masked Group
    •Fetal STAN monitor electrode inserted, but data masked to the caregivers
    Intervention: Device: fetal STAN monitor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2015)
11108
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2010)
11000
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01131260
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE
  • Neoventa Medical
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
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
PRS Account The George Washington University Biostatistics Center
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP