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Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

Raydiant Oximetry, Inc. · NCT07296419

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
15
US sites recruiting
1
Study start
December 8, 2025
Record last updated
December 22, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Fetal Pulse Oximetery

Conditions: Fetal Hypoxia; Fetal Acidemia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • LSU Health Science Center-Shreveport

    Shreveport, LA 71101

    Site contact: Shannon Phillips, RN · 318-675-7207 · shannon.phillips@lsuhs.edu

Study contacts (from the official record)

  • Shannon Phillips, RN, BSN · 318-675-7207 · shannon.phillips@lsuhs.edu
  • Chelsie Liegey, LPC, RN · 318-675-7064
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