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
  Purpose

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 Intervention Phase
Pregnancy
Obstetric Labor
Parturition
Device: fetal STAN monitor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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)

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 11000
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Group 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
Masked Group
Usual fetal heart rate monitoring
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131260

Contacts
Contact: Catherine C Spong, MD 301-435-6894 spongc@mail.nih.gov
Contact: Elizabeth A Thom, PhD 301-881-9260

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35429
Contact: Stacy Harris, BSN    205-934-1322    slharris@uabmc.edu   
Principal Investigator: Alan Tita, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN BSN    312-926-2475    g-mallett@northwestern.edu   
Principal Investigator: Alan M Peaceman, MD         
United States, Michigan
Wayne State University - Hutzel Hospital Active, not recruiting
Detroit, Michigan, United States, 48201
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, RNC MSN    212-305-4348    sb1080@columbia.edu   
Principal Investigator: Ronald Wapner, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 17599
Contact: Kelly Clark, RN    919-350-6117    kelly_clark@med.unc.edu   
Principal Investigator: John M Thorp, Jr., MD         
United States, Ohio
Case Western University Recruiting
Cleveland, Ohio, United States, 44109
Contact: Cynthia Milluzzi, RN    216-778-8094    cmilluzzi@metrohealth.org   
Principal Investigator: Brian Mercer, MD         
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Francee Johnson, RN BSN    614-293-5632    johnson.126@osu.edu   
Principal Investigator: Jay Iams, MD         
United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh - Magee Womens Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Peggy Cotroneo, RN    412-641-4055    mcotroneo@mail.magee.edu   
Principal Investigator: Steve N Caritis, MD         
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02905
Contact: Catherine Mansell, MSN    401-274-1122 ext 8514    cmansell@wihri.org   
Principal Investigator: Dwight Rouse, MD         
United States, Texas
University of Texas - Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, RNC MSN    409-772-0312    assalazar@utmb.edu   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN    713-500-6467    Felecia.Ortiz@uth.tmc.edu   
Principal Investigator: Baha Sibai, MD         
United States, Utah
University of Utah Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN BSN    801-585-5586    Kim.Hill@hsc.utah.edu   
Principal Investigator: Michael W Varner, MD         
Sponsors and Collaborators
Neoventa Medical
Investigators
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
  More Information

Additional Information:
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.

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01131260     History of Changes
Other Study ID Numbers: HD36801-STAN, U10HD021410, U10HD027869, U10HD027917, U10HD053118, U10HD027915, U10HD034208, U10HD053097, U10HD040500, U10HD040485, U10HD040544, U10HD040545, U10HD040560, U10HD040512, U01HD036801
Study First Received: May 25, 2010
Last Updated: November 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
STAN
Fetal monitoring
Fetal acidosis
Fetal heart rate monitoring
Perinatology

ClinicalTrials.gov processed this record on April 23, 2014