Pregnancy
Conditions
Keywords
pregnancy, labor, obstetric, fetal monitoring, oximetry, fetal heart rate, cardiotocography
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.
Interventions
DEVICEFetal pulse oximeter
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The George Washington University Biostatistics Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cesarean delivery (any indication) | — |
Secondary
| Measure | Time frame |
|---|---|
| cesarean delivery for non-reassuring fetal heart rate | — |
| cesarean delivery for dystocia | — |
| neonatal morbidity | — |
Countries
United States
Outcome results
None listed