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Fetal Pulse Oximetry Trial (FOX)

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.
 
ClinicalTrials.gov Identifier: NCT00098709
Recruitment Status : Terminated
First Posted : December 8, 2004
Last Update Posted : December 28, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Tracking Information
First Submitted Date  ICMJE December 7, 2004
First Posted Date  ICMJE December 8, 2004
Last Update Posted Date December 28, 2017
Study Start Date  ICMJE May 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
cesarean delivery (any indication)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • cesarean delivery for non-reassuring fetal heart rate
  • cesarean delivery for dystocia
  • neonatal morbidity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fetal Pulse Oximetry Trial (FOX)
Official Title  ICMJE A Randomized Clinical Trial of Fetal Pulse Oximetry
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pregnancy
Intervention  ICMJE Device: Fetal pulse oximeter
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: June 23, 2005)
10000
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00098709
Other Study ID Numbers  ICMJE HD36801-FOX
U10HD021410 ( U.S. NIH Grant/Contract )
U10HD027869 ( U.S. NIH Grant/Contract )
U10HD027917 ( U.S. NIH Grant/Contract )
U10HD027860 ( U.S. NIH Grant/Contract )
U10HD034116 ( U.S. NIH Grant/Contract )
U10HD034208 ( U.S. NIH Grant/Contract )
U10HD034136 ( U.S. NIH Grant/Contract )
U10HD040500 ( U.S. NIH Grant/Contract )
U10HD040485 ( U.S. NIH Grant/Contract )
U10HD040544 ( U.S. NIH Grant/Contract )
U10HD040545 ( U.S. NIH Grant/Contract )
U10HD040560 ( U.S. NIH Grant/Contract )
U10HD040512 ( U.S. NIH Grant/Contract )
U10HD036801 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
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
PRS Account The George Washington University Biostatistics Center
Verification Date December 2017

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