Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

Recruiting now · Not applicable

Conditions studied: Fetal Hypoxia, Fetal Acidemia

In brief

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.

Key facts

Study ID

NCT07296419

Run by

Raydiant Oximetry, Inc.

People needed

15

Starts

2025-12-08

Expected to finish

2026-04-01

Last updated by the study team

2025-12-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• Age < 18 years.
• Gestational age < 36 weeks
• Multiple gestation
• Nonvertex fetal presentation
• Suspected vasa previa
• Category III CTG tracing
• Fetal anomalies and/or chromosomal disorders
• Chorioamnionitis
• Placenta previa
• HIV, genital Herpes, or other infection precluding transvaginal monitoring
• Unable to provide informed consent (e.g., cognitively impaired)
• Low anterior placenta, or
• Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.

Where it is running

• LSU Health Science Center-Shreveport — Shreveport, Louisiana, United States (enrolling)

Full record on ClinicalTrials.gov

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