Status:
TERMINATED
Fetal Pulse Oximetry Trial (FOX)
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pregnancy
Eligibility:
FEMALE
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT00098709
Start Date
May 1 2002
End Date
February 1 2005
Last Update
March 18 2022
Active Locations (13)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35233
2
Northwestern University
Chicago, Illinois, United States, 60611
3
Wayne State University
Detroit, Michigan, United States, 48201
4
Columbia University
New York, New York, United States, 10032