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

This study is currently recruiting participants.

Verified September 2012 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 10, 2012

Last verified: September 2012

History of Changes

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:

MedlinePlus related topics: Seizures

U.S. FDA Resources

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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:

The public website of the NICHD Maternal Fetal Medicine Units (MFMU) Network This link exits the ClinicalTrials.gov site

Publications:

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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.

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.

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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.

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.

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.

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.

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.

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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.

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.

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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 10, 2012
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 May 21, 2013

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