Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT07296419

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

Led by Raydiant Oximetry, Inc. · Updated on 2025-12-22

15

Participants Needed

1

Research Sites

16 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Willing and capable of providing informed consent.
  • Age over 18 years.
  • Gestational age over 36 weeks.
  • Singleton pregnancy.
  • Baby positioned head down (vertex presentation).
  • In latent or active labor.
  • Category I or II fetal heart tracings.
  • Receiving epidural anesthesia.
  • Ruptured amniotic sac with cervical dilation greater than 2 cm and fetal station of -2 or lower.
Not Eligible

You will not qualify if you...

  • Age under 18 years.
  • Gestational age under 36 weeks.
  • Multiple pregnancies.
  • Nonvertex fetal presentation.
  • Suspected vasa previa.
  • Category III cardiotocography (CTG) tracing.
  • Fetal anomalies or chromosomal disorders.
  • Chorioamnionitis.
  • Placenta previa.
  • HIV, genital Herpes, or other infections preventing transvaginal monitoring.
  • Unable to provide informed consent (e.g., cognitive impairment).
  • Low anterior placenta.
  • Any condition deemed unsuitable by the investigator for study procedures.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

LSU Health Science Center-Shreveport

Shreveport, Louisiana, United States, 71101

Actively Recruiting

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Research Team

S

Shannon Phillips, RN, BSN

CONTACT

C

Chelsie Liegey, LPC, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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