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Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

NCT ID: NCT07296419

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% positive predicative value and 92.9% sensitivity for detecting newborn metabolic acidosis (defined by pH\<7.15).1 This provided a significant aid to clinicians for diagnosing endangering states of fetal hypoxia.

In this study, both the participants and the health-care providers are blinded to the oximetry data; therefore, clinical decisions regarding interventions are made based on routine clinical monitoring. The primary analysis will be performed by comparing the post-processed waveforms. Other than device placement and a period of monitoring not to exceed 6 hours, there is no change to the standard of care procedures for fetal monitoring. As stated above, the sensor displays will not be used to guide or alter patient management.

Conditions

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Fetal Hypoxia Fetal Acidemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The Raydiant Oximetry Data Collection System (DCS) generates waveforms representing fetal SpO2. In this study, the objective is to compare the waveforms generated by the DCS to the Nellcor N-400 actual fetal SpO2 values.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dual Sensor Recipients

Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.

Group Type EXPERIMENTAL

Fetal Pulse Oximetery

Intervention Type DEVICE

Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.

Interventions

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Fetal Pulse Oximetery

Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Raydiant Oximetry, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Perry S Barrilleaux, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Shreveport

Locations

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LSU Health Science Center-Shreveport

Shreveport, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shannon Phillips, RN, BSN

Role: CONTACT

Phone: 318-675-7207

Email: [email protected]

Chelsie Liegey, LPC, RN

Role: CONTACT

Phone: 318-675-7064

Facility Contacts

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Shannon Phillips, RN

Role: primary

Chelsie Liegey, RN

Role: backup

Other Identifiers

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CP2555

Identifier Type: -

Identifier Source: org_study_id