Fetal Pulse Oximetry Trial (FOX)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Clinical Trial of Fetal Pulse Oximetry

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Fetal pulse oximeter


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Fetal pulse oximeter|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesarean delivery (any indication) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cesarean delivery for non-reassuring fetal heart rate |  |  | 
| cesarean delivery for dystocia |  |  | 
| neonatal morbidity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, labor, obstetric, fetal monitoring, oximetry, fetal heart rate, cardiotocography