Dual-system transvaginal fetal pulse oximetry

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

This tests a transvaginal fetal pulse oximetry sensor to collect fetal oxygen saturation and pulse waveforms from women in labor to help develop signal-processing algorithms.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Raydiant Oximetry, Inc. (Industry-sponsored)
• Locations: 1 site (Shreveport, Louisiana)
• Trial ID: NCT07296419 on ClinicalTrials.gov

What this trial studies

The study uses the Raydiant Data Collection System to capture red and infrared waveforms from a fetal sensor placed on the cheek, temple, or forehead during labor. Waveforms are post-processed to calculate fetal SpO2 and pulse rate and to support development of signal qualification and data-processing algorithms. Both participants and care teams are blinded to the oximetry displays so routine clinical monitoring guides care, and monitoring is limited to a period not exceeding six hours. The trial enrolls term, singleton, vertex pregnancies with ruptured membranes and established labor at a single site (LSU Health Shreveport) and excludes conditions that preclude transvaginal monitoring or indicate fetal compromise.

Who should consider this trial

Good fit: Ideal candidates are women ≥18 years with singleton, vertex pregnancies at ≥36 weeks in active or latent labor with ruptured membranes, cervical dilation >2 cm and station −2 or lower, Category I–II tracings, and who have epidural anesthesia.

Not a fit: Patients who are preterm (<36 weeks), have multiple gestations, nonvertex presentation, infections preventing transvaginal monitoring, placenta previa, Category III tracings, or other contraindications are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, the technology could give clinicians a reliable fetal SpO2 signal to help detect fetal hypoxia earlier and reduce missed cases of newborn metabolic acidosis.

How similar studies have performed: Prior clinical research with the Nellcor N-400 system showed 92.9% sensitivity and 54.2% positive predictive value for detecting neonatal metabolic acidosis, so the approach has prior supporting evidence.

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.

Where this trial is running

Shreveport, Louisiana

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

Study contacts

• Principal investigator: Perry S Barrilleaux, MD — Louisiana State University Health Shreveport
• Study coordinator: Shannon Phillips, RN, BSN

Conditions Fetal Hypoxia; Fetal Acidemia