Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
Trial Parameters
Brief Summary
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
Eligibility Criteria
Inclusion Criteria: 1. Willing and capable of providing informed consent. 2. Age \> 18 years. 3. Gestational age \> 36 weeks. 4. Singleton pregnancy. 5. Vertex presentation, 6. In latent or active labor, 7. Category I or II tracings, 8. Epidural anesthesia, and 9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower. Exclusion Criteria: 1. Age \< 18 years. 2. Gestational age \< 36 weeks 3. Multiple gestation 4. Nonvertex fetal presentation 5. Suspected vasa previa 6. Category III CTG tracing 7. Fetal anomalies and/or chromosomal disorders 8. Chorioamnionitis 9. Placenta previa 10. HIV, genital Herpes, or other infection precluding transvaginal monitoring 11. Unable to provide informed consent (e.g., cognitively impaired) 12. Low anterior placenta, or 13. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.