National Institute of Child Health and Human Development
Maternal Fetal Medicine Units Network

A Randomized Clinical Trial of Fetal Pulse Oximetry

Related Publications & Presentations

Objective

To test the hypothesis that fetal pulse oximetry reduces the risk of cesarean delivery

Conclusion

The results concluded that knowledge of fetal oxygen saturation is not associated with a reduction in the rate of cesarean delivery.

Clinical Centers

Magee Womens, University of Alabama-Birmingham, Wayne State, Wake Forest, Ohio State University, University of Texas-Southwestern, University of Utah, MCP Hahnemann, Brown University, Columbia University, Case Western University, University of Texas - Houston, UNC - Chapel Hill, Northwestern

Major Eligibility Criteria

• 36⁰ gestation
• Singleton pregnancy
• Nulliaparous
• Cephalic presentation
• 2-5 cm dilated with ruptured membranes
• Informed consent

Design Type

Randomized clinical trial

Sample Size

• Goal = 10,000 patients (5,000 per group)

Management Protocols

• Standard fetal heart rate monitor
• Interpretation of oximetry reading
• Labor management at physician's discretion

Outcome Measures

• Primary:
• Cesarean delivery (any indication)
• Secondary:
• Cesaren delivery for non reassuring fetal heart rate
• Cesarean delivery for dystocia
• Fetal vulnerability index (stillbirth, neonatal death, 5-min Apgar < 3, seizures,cord pH ≤ 7, intubation, intubation, NICU admission ≥ 24 hours)
• Other neonatal morbidity

Timetable

• Training phase: 07/2001-02/2002 (7 months)
• Randomization: 02/2002-02/2004 (2 years)
• Data Collection: 02/2002 - 07/2004
• Closeout/Final Analysis: 07/2004-01/2005