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Fetal Pulse Oximetry Trial (FOX)

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00098709
First Posted: December 8, 2004
Last Update Posted: October 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:
The George Washington University Biostatistics Center
December 7, 2004
December 8, 2004
October 21, 2015
May 2002
Not Provided
cesarean delivery (any indication)
Same as current
Complete list of historical versions of study NCT00098709 on ClinicalTrials.gov Archive Site
  • cesarean delivery for non-reassuring fetal heart rate
  • cesarean delivery for dystocia
  • neonatal morbidity
Same as current
Not Provided
Not Provided
 
Fetal Pulse Oximetry Trial (FOX)
A Randomized Clinical Trial of Fetal Pulse Oximetry
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pregnancy
Device: Fetal pulse oximeter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10000
February 2005
Not Provided

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
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00098709
HD36801-FOX
HD21410
HD27869
HD27917
HD27860
HD34116
HD34208
HD34136
HD40500
HD40485
HD40544
HD40545
HD40560
HD40512
HD36801
Not Provided
Not Provided
Not Provided
Not Provided
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Director: Cathy 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
The George Washington University Biostatistics Center
October 2015

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