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Fetal Pulse Oximetry Trial (FOX)

This study has been terminated.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00098709
First received: December 7, 2004
Last updated: November 10, 2012
Last verified: September 2012
  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 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 Clinical Trial of Fetal Pulse Oximetry

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:
  • 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
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: 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
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western University
Cleveland, Ohio, United States, 44109
United States, Pennsylvania
Dexel University
Philadelphia, Pennsylvania, United States, 19107
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 - 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
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00098709     History of Changes
Other 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: November 10, 2012
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 November 24, 2014