Fetal Pulse Oximetry Trial (FOX) - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00098709

Purpose

The purpose of this study is to determine if the information provided to the physician by a fetal pulse oximeter during labor will reduce the chances of a cesarean delivery.

Condition	Intervention	Phase
Pregnancy	Device: Fetal pulse oximeter	Phase III

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Clinical Trial of Fetal Pulse Oximetry

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

Primary Outcome Measures:

cesarean delivery (any indication)

Secondary Outcome Measures:

cesarean delivery for non-reassuring fetal heart rate
cesarean delivery for dystocia
neonatal morbidity

Estimated Enrollment:	10000
Study Start Date:	May 2002
Estimated Study Completion Date:	February 2005

Detailed Description:

Information on fetal well-being during labor is of great importance to the managing physician. The current use of the fetal heart rate monitor provides some information on fetal condition, and is the primary tool used to determine if immediate operative delivery is required. The fetal pulse oximeter can provide additional information regarding fetal oxygen saturation.

Intervention: A fetal oxygen saturation sensor is placed in the uterus, between the fetal cheek or forehead and the uterine wall. In half of the patients, the managing physician will have access to fetal oxygen saturation and fetal heart rate monitoring. In the other half of the patients, labor will be monitored by fetal heart rate alone.

Study hypothesis: The additional information provided by the use of the fetal pulse oximeter will reduce the chances of a cesarean delivery. The primary outcome is cesarean section for any indication and secondary outcomes are cesarean delivery for non-reassuring fetal heart rate or dystocia, and neonatal morbidity.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Nulliparous
Singleton, cephalic pregnancy
Gestational age at least 36 weeks, 0 days
Cervical dilatation >= 2 cm
Station -2 or below (5ths scale)
Ruptured membranes
Internal monitoring devices placed

Exclusion criteria:

Need for immediate delivery
Planned cesarean delivery
Cervical dilatation > 6 cm
Known fetal anomaly or demise
Multifetal gestation
Maternal fever
Placenta previa
Previous uterine surgery
Active HSV infection
Known HIV or hepatitis infection
Diabetes requiring insulin
Heart disease requiring medication
Known chronic renal disease
Enrollment in another labor study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098709

Locations

United States, Alabama
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Columbia University
New York, New York, United States, 10032
United States, North Carolina
Wake Forest University School of Medicine
Winston Salem, North Carolina, United States, 27157
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Case Western University
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
University of Pittsburgh Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Dexel University
Philadelphia, Pennsylvania, United States, 19107
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas - Southwest
Dallas, Texas, United States, 75235
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

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

Investigators

Study Director:	Catherine Spong, MD	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator:	Elizabeth A Thom, Ph.D.	George Washington University Biostatistics Center
Study Chair:	Steven L Bloom, M.D.	University of Texas Southwestern

More Information

Additional Information:

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

Publications:

Goffinet F, Langer B, Carbonne B, Berkane N, Tardif D, Le Goueff F, Laville M, Maillard F. Multicenter study on the clinical value of fetal pulse oximetry. I. Methodologic evaluation. The French Study Group on Fetal Pulse Oximetry. Am J Obstet Gynecol. 1997 Nov;177(5):1238-46.

Garite TJ, Dildy GA, McNamara H, Nageotte MP, Boehm FH, Dellinger EH, Knuppel RA, Porreco RP, Miller HS, Sunderji S, Varner MW, Swedlow DB. A multicenter controlled trial of fetal pulse oximetry in the intrapartum management of nonreassuring fetal heart rate patterns. Am J Obstet Gynecol. 2000 Nov;183(5):1049-58.

Publications automatically indexed to this study:

Bloom SL, Spong CY, Thom E, Varner MW, Rouse DJ, Weininger S, Ramin SM, Caritis SN, Peaceman A, Sorokin Y, Sciscione A, Carpenter M, Mercer B, Thorp J, Malone F, Harper M, Iams J, Anderson G; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Fetal pulse oximetry and cesarean delivery. N Engl J Med. 2006 Nov 23;355(21):2195-202.

Study ID Numbers:	HD36801-FOX, HD21410, HD27869, HD27917, HD27860, HD34116, HD34208, HD34136, HD40500, HD40485, HD40544, HD40545, HD40560, HD40512, HD36801
Study First Received:	December 7, 2004
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00098709
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

pregnancy
labor, obstetric
fetal monitoring

oximetry
fetal heart rate
cardiotocography

ClinicalTrials.gov processed this record on February 12, 2009