Fetal Pulse Oximetry Trial (FOX)



Status:Terminated
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any
Updated:12/30/2017
Start Date:May 2002
End Date:February 2005

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A Randomized Clinical Trial of Fetal Pulse Oximetry

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.

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.

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
We found this trial at
13
sites
Cleveland, Ohio 44106
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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Dallas, Texas 75235
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Dallas, TX
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Houston, Texas 77030
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Houston, TX
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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69 Brown Street
Providence, Rhode Island 02912
(401) 863-1000
Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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Providence, RI
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Salt Lake City, Utah 84132
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Salt Lake City, UT
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Winston-Salem, North Carolina 26157
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Winston-Salem, NC
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