Fetal Pulse Oximetry Trial (FOX)
- Conditions
- Pregnancy
- Registration Number
- NCT00098709
- Lead Sponsor
- The George Washington University Biostatistics Center
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 10000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method cesarean delivery (any indication)
- Secondary Outcome Measures
Name Time Method cesarean delivery for non-reassuring fetal heart rate cesarean delivery for dystocia neonatal morbidity
Trial Locations
- Locations (13)
University of Texas - Southwest
🇺🇸Dallas, Texas, United States
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Columbia University
🇺🇸New York, New York, United States
University of Pittsburgh Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Brown University
🇺🇸Providence, Rhode Island, United States
Case Western University
🇺🇸Cleveland, Ohio, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Dexel University
🇺🇸Philadelphia, Pennsylvania, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Texas - Houston
🇺🇸Houston, Texas, United States