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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to measure oxygen levels in unborn babies using a device placed on the mother's belly, known as Trans-abdominal Fetal Pulse Oximetry. The goal is to improve how doctors understand and monitor oxygen levels in babies still in the womb. The study involves short sessions where the device measures how light passes through the mother's and baby's tissues. Women who are at least 36 weeks pregnant with one healthy baby might be suitable candidates, especially if they can attend testing sessions outside regular hours. As an unphased trial, this study allows participants to contribute to innovative research that could enhance prenatal care.

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 prior data suggests that this fetal pulse oximetry is safe for use?

Research has shown that trans-abdominal fetal pulse oximetry is a safe and non-invasive method to monitor a baby's oxygen levels before birth. Studies have demonstrated that the Lumerah device, which uses this technology, does not harm the mother or baby. It checks the baby’s oxygen levels using light, avoiding the need for needles or other invasive tools.

The Gen 3 Monitoring device, which employs similar technology, has also been used safely in other studies to measure how light interacts with the mother's abdomen. No reports of serious side effects or harm have emerged from using these devices.

Overall, these devices are designed to be safe, providing a non-invasive way to monitor a baby's health before delivery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach using GEN 3 Monitoring of Fetus and Trans-abdominal Fetal Pulse Oximetry for fetal hypoxia because it offers a non-invasive way to monitor fetal oxygen levels directly. Unlike the standard of care, which often relies on indirect methods like fetal heart rate monitoring, this technique measures light scattering and absorption to provide real-time data on oxygen saturation. This could lead to more accurate assessments and timely interventions, potentially improving outcomes for both mothers and babies.

What evidence suggests that this fetal pulse oximetry is effective for fetal hypoxia?

This trial will evaluate the effectiveness of trans-abdominal fetal pulse oximetry, specifically using the GEN 3 Monitoring of Fetus and the Lumerah System. Studies have shown that trans-abdominal fetal pulse oximetry accurately measures a baby's oxygen levels before birth. This technology uses a non-invasive method to determine if a baby receives enough oxygen, helping to identify potential problems early. Some research suggests it can enhance how doctors monitor a baby's health during labor and reduce unnecessary medical procedures. The device functions by shining light through the mother's abdomen to measure the baby's blood oxygen, similar to a finger pulse oximeter. These early findings suggest it could be a valuable tool in monitoring a baby's health. ^{2 3 4 5 6}

Who Is on the Research Team?

Mark Rosen, MD

Principal Investigator

Raydiant Oximetry

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. raydiantoximetry.com raydiantoximetry.com/

Raydiant Oximetry – Advancing Fetal Health Monitoring A noninvasive sensor technology that directly measures fetal oxygen levels, Raydiant Oximetry aims to profoundly reduce the rising mortality and morbidity ...

2. nichd.nih.gov nichd.nih.gov/grants-contracts/SBIR_STTR/showcase/Lumerah

Raydiant Oximetry – Detecting Fetal Distress During Labor ... A non-invasive fetal pulse oximeter that detects fetal distress by directly measuring fetal arterial blood oxygen saturation.

3. investor.gehealthcare.com investor.gehealthcare.com/news-releases/news-release-details/ge-healthcare-and-raydiant-oximetry-accelerate-innovation-fetal

GE HealthCare and Raydiant Oximetry accelerate ... Incorporating oxygen saturation into fetal monitoring can help improve measurements of fetal distress and enhance clinician confidence when ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05147584

NCT05147584 | Trans-abdominal Fetal Pulse Oximetry Lumerah is a fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy.

5. raydiantoximetry.com raydiantoximetry.com/technology/

Raydiant Oximetry Technology - Fetal Monitoring Fetal Monitoring: We are introducing new technology to more accurately detect fetal distress, using noninvasive, transabdominal fetal pulse oximetry.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04876846

Trans-abdominal Fetal Pulse Oximetry; Tissue Light ... 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 ...