Trans-abdominal Fetal Pulse Oximetry

Fetal Distress Clinical Trial

Official title:

Trans-abdominal Fetal Pulse Oximetry: PILOT 1

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05147584
• Other study ID #: PILOT 1
• Status: Terminated
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: November 2023
• Source: Raydiant Oximetry, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

Description:

Raydiant Oximetry, Inc. is developing a novel and non-invasive fetal pulse oximetry device to fundamentally improve how fetuses are monitored during labor. The Raydiant Oximetry Sensing System (Lumerah) is a fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah performs its measurements without the requirement for transvaginal placement and its associated risks. Lumerah is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation which is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The severe consequences associated with newborn metabolic acidosis and the lack of availability of an effective tool to support its early diagnosis led to the development of Lumerah.

In this study, women in labor will be simultaneously monitored with proven (previously FDA-approved) technology as a "ground truth". These women will be simultaneously monitored with both an external and internal oxygen sensor. Obstetric health-care providers are blinded to oximetry data presented by both devices; therefore, clinical decisions regarding interventions are made based on the standard factors, including cardiotocography. The primary efficacy analysis will be performed retrospectively by comparing data of fetal oxygenation displayed and recorded by both devices. Results of either the Lumerah external sensor or the internal sensor will not be used to guide or alter patient management.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Willing and capable to provide informed consent

2. Age > 18 years

3. BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)

4. Gestational age > 36 weeks

5. Singleton pregnancy

6. Vertex presentation

7. Active labor

8. Category I or Category II tracings

9. Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower

Exclusion Criteria:

1. Age <18 years

2. BMI > 50 third trimester

3. Gestational age < 36 weeks

4. Multiple gestation

5. Nonvertex fetal presentation

6. Suspected vasa previa

7. Latent labor

8. Category III CTG tracing (i.e., need for immediate delivery)

9. Fetal anomalies and/or chromosomal disorders

10. Chorioamnionitis

11. Placenta Previa

12. History of HIV, Genital Herpes, or other infection precluding internal monitoring

13. Unable to provide informed consent (e.g., cognitively impaired)

Related Conditions & MeSH terms

• Fetal Acidemia
• Fetal Distress
• Fetal Hypoxia
• Hypoxia
• Obstetric Labor Complications

Intervention

Device:
• Dual fetal oxygen sensors
Placement of both internal and external fetal oxygen sensors

Locations

Country	Name	City	State
United States	University of Texas Medical Branch (UTMB)	Galveston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Raydiant Oximetry, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fetal oxygen levels	Concurrence of internal and external fetal oxygen sensors	During labor
Primary	Adverse events	Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum.; Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.	During labor