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

This study is ongoing, but not recruiting participants.
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: May 8, 2014
Last verified: April 2014
  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: August 2014
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35429
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University - Hutzel Hospital
Detroit, Michigan, United States, 48201
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 17599
United States, Ohio
Case Western University
Cleveland, Ohio, United States, 44109
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pittsburgh - Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas - Galveston
Galveston, Texas, United States, 77555
University of Texas - Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
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: May 8, 2014
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 August 21, 2014