Fetal Pulse Oximetry for Fetal Hypoxia

Overseen By Laura Kemp

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Raydiant Oximetry, Inc.

Disqualifiers: Age <18, Multiple gestation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters, the calculations will be integrated into software in the final commercial product; (ii) obtain human measurements against which both computational models and animal data can be compared.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment GEN 3 Monitoring of Fetus, Raydiant Oximetry GEN 3, Lumerah System, Trans-abdominal Fetal Pulse Oximetry, Lumerah, Raydiant Oximetry Sensing System for fetal hypoxia?

Research shows that fetal pulse oximetry, which measures the baby's oxygen levels during labor, can help identify when further evaluation is needed if oxygen levels drop. It has been found to be technically feasible and accurate in measuring fetal oxygen levels, suggesting it could be useful in monitoring fetal well-being. ^{1 2 3 4 5}

Is fetal pulse oximetry safe for use in humans?

Fetal pulse oximetry has been used in clinical settings to monitor fetal well-being during labor, and while it shows promise, the accuracy and reliability of the technique are still being evaluated. There is no specific mention of safety concerns such as increased infections in the studies, but the technique's accuracy and reliability need further validation. ^{1 2 3 4 6}

How is the GEN 3 Monitoring of Fetus treatment different from other treatments for fetal hypoxia?

The GEN 3 Monitoring of Fetus treatment, using trans-abdominal fetal pulse oximetry, is unique because it provides a non-invasive way to continuously monitor fetal oxygen levels during labor, unlike traditional methods that rely on indirect measures like fetal heart rate. This technology allows for direct observation of fetal oxygenation, potentially reducing the need for more invasive procedures like fetal blood sampling. ^{2 3 4 5 6}

Research Team

Mark Rosen, MD

Principal Investigator

Raydiant Oximetry

Eligibility Criteria

This trial is for women over 18 years old with a single, healthy pregnancy at or beyond 36 weeks of gestation. Participants must be willing to come in for testing outside regular business hours, including Saturdays. It's not open to those with pregnancies less than 36 weeks, under the age of 18, or carrying multiples like twins.

Inclusion Criteria

I am pregnant with one baby, over 36 weeks along, and the pregnancy is healthy.

I am willing to attend tests on weekends or outside normal hours.

I am older than 18 years.

Exclusion Criteria

I am under 18 years old.

Multiple gestation (twins, triplets)

The baby is not positioned head-down or bottom-first in the womb.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

The Gen 3 device is positioned on the maternal abdomen to measure light scattering and absorption for a period of about 10-20 minutes, with a possible second measurement for a total of up to 40 minutes.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the measurement phase

4 weeks

Treatment Details

Interventions

• GEN 3 Monitoring of Fetus
• Trans-abdominal Fetal Pulse Oximetry

Trial Overview The study aims to evaluate how light scatters through maternal-fetal tissue and improve models predicting fetal oxygen levels using a GEN 3 monitoring device. This could lead to better pulse oximetry technology that accounts for both mother and fetus ('body in a body' problem).

Participant Groups

Group I: Interventional/Observational Experimental Treatment 1 Intervention

The Gen 3 device will be positioned on the maternal abdomen to measure light scattering and absorption for a period of about 10-20 minutes. A second measurement may be obtained for a total of up to 40 minutes. Subject's end their participation in the study after that time period.

Who Is Running the Clinical Trial?

Raydiant Oximetry, Inc.

Lead Sponsor

Trials

6

Recruited

110+

Findings from Research

Fetal pulse oximetry has been challenging to develop due to difficulties in accurately recording fetal data, but recent advancements in instrumentation show promise for improving fetal intrapartum surveillance.

New clinical data suggest that fetal oximetry can provide valuable insights into fetal well-being during labor, with potential applications that could enhance monitoring and outcomes for both mothers and babies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry. Instrumentation and recent clinical experience. Colditz, PB., Begg, LM., East, CE.[2018]

In a study of 63 deliveries monitored with fetal pulse oximetry, there was no increase in maternal or fetal infectious morbidity compared to a control group, indicating the safety of this monitoring method.

Despite higher obstetrical risk factors in the pulse oximetry group, outcomes such as neonatal infections and the need for intensive care were not significantly different from the control group, suggesting that fetal pulse oximetry does not adversely affect neonatal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluating pulse oximetry in the fetus. Case control study for detection of undesirable complications]. Luttkus, A., Schäfer, C., Dudenhausen, JW.[2006]

Fetal pulse oximetry has been used in 150 monitored deliveries and can help identify fetal well-being, with saturation values above 33% indicating a lower risk of hypoxia.

This tool can assist in deciding when further evaluations, like scalp blood sampling, are necessary, and allows for direct observation of how therapeutic measures affect fetal oxygenation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry. Luttkus, AK., Dudenhausen, JW.[2019]

This study demonstrated that noninvasive pulse oximetry can accurately measure fetal arterial oxygen saturation in utero, showing a strong correlation with traditional in vitro measurements.

The technique was tested on acutely instrumented fetal sheep, indicating that in utero pulse oximetry is technically feasible and could be a valuable tool for assessing fetal well-being during labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of arterial oxygen saturation measurements in utero using pulse oximetry. Harris, AP., Sendak, MJ., Chung, DC., et al.[2013]

Fetal pulse oximetry has been developed as a new technology to assess fetal oxygen status, providing additional information when electronic fetal heart rate monitoring shows nonreassuring patterns.

The U.S. Food and Drug Administration approved fetal pulse oximetry for clinical use based on results from a multicenter randomized controlled trial, indicating its potential efficacy in improving fetal monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry: an adjunct to electronic fetal heart rate monitoring. Porter, ML.[2019]

Reflectance pulse oximetry, while a promising method for monitoring fetal oxygen levels during labor, is highly susceptible to inaccuracies due to physiological variations, such as blood volume and flow differences, which can lead to significant errors in readings.

A new sensor using a 735/890 nm wavelength shows improved accuracy with a precision of around 5%, but many existing sensors lack thorough evaluation, highlighting the need for further research to establish reliable clinical use of this technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of fetal pulse oximetry and pitfalls in measurements. Nijland, R., Jongsma, HW., Nijhuis, JG., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry. Instrumentation and recent clinical experience. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Evaluating pulse oximetry in the fetus. Case control study for detection of undesirable complications]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Validation of arterial oxygen saturation measurements in utero using pulse oximetry. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry: an adjunct to electronic fetal heart rate monitoring. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Accuracy of fetal pulse oximetry and pitfalls in measurements. [2019]