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 |
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.
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.
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
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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Brown University Located in historic Providence, Rhode Island and founded in 1764, Brown University is...
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