NCT00098709

Fetal Pulse Oximetry Trial (FOX)

A Randomized Clinical Trial of Fetal Pulse Oximetry

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10,000 (planned)
• Sponsor: The George Washington University Biostatistics Center · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DEVICE	Fetal pulse oximeter

Timeline

• Start date: 2002-05-01
• Completion: 2005-02-01
• First posted: 2004-12-08
• Last updated: 2022-03-18

Locations

13 sites across 1 country: United States