Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• Willing and capable of providing informed consent.
• Age \> 18 years.
• Gestational age \> 36 weeks.
• Singleton pregnancy.
• Vertex presentation,
• In latent or active labor,
• Category I or II tracings,
• Epidural anesthesia, and
• Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower.
Locations
United States
Louisiana
LSU Health Science Center-Shreveport
RECRUITING
Shreveport
Contact Information
Primary
Shannon Phillips, RN, BSN
shannon.phillips@lsuhs.edu
318-675-7207
Backup
Chelsie Liegey, LPC, RN
318-675-7064
Time Frame
Start Date: 2025-12-08
Estimated Completion Date: 2026-04
Participants
Target number of participants: 15
Treatments
Experimental: Dual Sensor Recipients
Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.
Related Therapeutic Areas
Sponsors
Leads: Raydiant Oximetry, Inc.