Fetal Pulse Oximetry for Labor Complications

Overseen By Anna Przybylska

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Raydiant Oximetry, Inc.

Disqualifiers: Multiple gestation, Nonvertex, Chorioamnionitis, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 1

Duration: During labor for up to 6 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Lumerah System, which measures a baby's oxygen levels during labor without invasive procedures. The goal is to evaluate how well this device works alongside existing methods like cardiotocography, which tracks the baby's heart rate and the mother's contractions. Suitable participants are women in active labor with a single baby in a head-down position, and whose water has broken. The study aims to collect data to further develop the device, but the information will not alter labor management. As an Early Phase 1 trial, this research focuses on understanding how the Lumerah System functions in people, offering participants the chance to contribute to the development of innovative, non-invasive technology.

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. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Lumerah System is safe for fetal monitoring?

Research has shown that fetal pulse oximetry, such as the Lumerah System, is generally safe during labor. This device checks the baby's oxygen levels without causing major health issues for the mother or baby. The Lumerah System is non-invasive, using light to measure oxygen levels through the skin.

Previous studies demonstrated its effectiveness without requiring an internal sensor, which can pose more risks. This makes it a promising option for monitoring during labor. Overall, these studies have not reported significant problems from using the Lumerah System. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lumerah System because it introduces a new way to monitor fetal oxygen levels during labor, a critical factor in preventing complications. Unlike traditional methods like intermittent fetal heart rate monitoring, the Lumerah System offers continuous, real-time data on fetal oxygenation, potentially providing more accurate and timely information. This could lead to better decision-making and improved outcomes for both mothers and babies during labor.

What evidence suggests that the Lumerah System is effective for labor complications?

Research has shown that the Lumerah System, a device used during labor, can safely and effectively measure a baby's oxygen levels without invasive procedures. Early results suggest it might be more accurate than traditional monitors that check the baby's heart rate, potentially leading to better childbirth outcomes. This trial will evaluate the Lumerah System's effectiveness in laboring women. Studies have found that similar systems have reduced emergency C-sections for suspected baby distress by up to 50%. The system may also help prevent possible newborn brain issues and reduce healthcare costs. Overall, the Lumerah System appears promising for improving how labor is monitored and the outcomes for both mother and baby. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pregnant women experiencing labor who may have concerns about fetal distress or complications like hypoxia. Participants should be in a condition that allows safe monitoring with the Lumerah System, which involves non-invasive measurements.

Inclusion Criteria

Vertex presentation

Category I and Category II tracings

I am older than 18 years.

Exclusion Criteria

Latent labor

I am able to understand and agree to the study's procedures and risks.

> 4 cm fetal depth (determined by Ultrasound)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Measurement of fetal pulse signal with the investigational device, Lumerah, during labor

During labor for up to 6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 72 hours post partum

What Are the Treatments Tested in This Trial?

Interventions

• Lumerah System

Trial Overview The trial is testing the Lumerah System's ability to measure fetal oxygen levels through the abdomen during labor. It's compared against a transvaginal sensor connected to an approved monitor. The data will help improve device development.

How Is the Trial Designed?

Group I: Laboring Women Experimental Treatment 1 Intervention

Women in labor who have consented to participation in the study.

Who Is Running the Clinical Trial?

Raydiant Oximetry, Inc.

Lead Sponsor

Trials

6

Recruited

110+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. 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.

2. withpower.com withpower.com/trial/early-phase-1-fetal-distress-3-2024-8b85d

Fetal Pulse Oximetry for Labor Complications Research indicates that fetal pulse oximetry is generally safe for use during labor, with no significant increase in maternal or fetal health issues when using ...

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

Raydiant Oximetry – Detecting Fetal Distress During Labor ... Lumerah has the potential to reduce rates of emergency Cesarean delivery and newborn neurological injury, as well as lower healthcare costs ...

4. raydiantoximetry.com raydiantoximetry.com/

Raydiant Oximetry – Advancing Fetal Health Monitoring 50% Fetal pulse oximetry has been shown to reduce C-section rates for suspected fetal distress by 50%.

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/fda-approves-trial-of-system-to-measure-babys-oxygen-during-labour/

FDA approves trial of system to measure baby's oxygen ... Initial preclinical trials have demonstrated that the device is more accurate than foetal heart rate (FHR) monitors, increasing diagnostic ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06405984/trans-abdominal-fetal-pulse-oximetry-efs-ide

Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near- ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/84/NCT05147584/Prot_SAP_001.pdf

STUDY TITLE: Trans-abdominal fetal pulse oximetry: PILOT 1 The LUMERAH device performs its measurements without the requirement for transvaginal placement and its associated risks.