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Clinical Trials/NCT00098709
NCT00098709
Terminated
Phase 3

A Randomized Clinical Trial of Fetal Pulse Oximetry

The George Washington University Biostatistics Center13 sites in 1 country10,000 target enrollmentMay 2002
ConditionsPregnancy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pregnancy
Sponsor
The George Washington University Biostatistics Center
Enrollment
10000
Locations
13
Primary Endpoint
cesarean delivery (any indication)
Status
Terminated
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2002
End Date
February 2005
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
The George Washington University Biostatistics Center
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

cesarean delivery (any indication)

Secondary Outcomes

  • cesarean delivery for non-reassuring fetal heart rate
  • cesarean delivery for dystocia
  • neonatal morbidity

Study Sites (13)

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