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

This study is currently recruiting participants.
Verified November 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Neoventa Medical
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01131260
First received: May 25, 2010
Last updated: November 15, 2013
Last verified: November 2013

May 25, 2010
November 15, 2013
November 2010
February 2014   (final data collection date for primary outcome measure)
  • Intrapartum fetal death [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Neonatal Death [ Time Frame: Delivery and 1 month of age ] [ Designated as safety issue: No ]
  • Apgar score <= 3 at 5 minutes [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Neonatal seizure [ Time Frame: Delivery and 1 month of age ] [ Designated as safety issue: No ]
  • Cord artery pH <= 7.05 and base deficit >= 12 mmol/L [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Intubation for ventilation at delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Presence of neonatal encephalopathy [ Time Frame: Delivery and 1 month of age ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01131260 on ClinicalTrials.gov Archive Site
  • Cesarean delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Indication for cesarean delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Forceps or vacuum delivery [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Chorioamnionitis [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Postpartum hemorrhage [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Postpartum endometritis [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Duration of labor post-randomization [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]
  • Maternal heart rate [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Maternal blood pressure [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Maternal oxygen saturation [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Intrapartum fetal death [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Neonatal death [ Time Frame: Delivery and 1 month of age ] [ Designated as safety issue: No ]
  • Apgar score at 5 minutes [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Umbilical arterial blood gases [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Need for chest compression or intubation for ventilation in the delivery room [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Special care nursery admission (anything more than well-baby nursery) [ Time Frame: Delivery and 1 month of age ] [ Designated as safety issue: No ]
  • Seizure [ Time Frame: Delivery and 1 month of age ] [ Designated as safety issue: No ]
  • ST events [ Time Frame: Delivery ] [ Designated as safety issue: No ]
    The number, type, and timing of the events.
  • Shoulder dystocia [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Fetal ST Segment and T Wave Analysis in Labor
A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring (STAN)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Pregnancy
  • Obstetric Labor
  • Parturition
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
  • Experimental: Open Group
    Intervention: Device: fetal STAN monitor
  • Masked Group
    Usual fetal heart rate monitoring
    Intervention: Device: fetal STAN monitor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
11000
March 2014
February 2014   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact: Catherine C Spong, MD 301-435-6894 spongc@mail.nih.gov
Contact: Elizabeth A Thom, PhD 301-881-9260
United States
 
NCT01131260
HD36801-STAN, U10HD021410, U10HD027869, U10HD027917, U10HD053118, U10HD027915, U10HD034208, U10HD053097, U10HD040500, U10HD040485, U10HD040544, U10HD040545, U10HD040560, U10HD040512, U01HD036801
Yes
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Neoventa Medical
Study Director: Catherine C Spong, MD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Elizabeth Thom, PhD George Washington University Biostatistics Center
Study Chair: George Saade, MD University of Texas
Study Chair: Michael Belfort, MD University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
November 2013

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