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

35 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Lumerah System for labor complications?

Research shows that fetal pulse oximetry, which is part of the Lumerah System, can improve the accuracy of fetal assessment during labor and may help reduce unnecessary cesarean deliveries when there are concerns about the baby's heart rate. ^{1 2 3 4 5}

Is fetal pulse oximetry safe for use during labor?

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 the device to monitor fetal oxygen levels. ^{1 2 3 6 7}

How is fetal pulse oximetry different from other treatments for labor complications?

Fetal pulse oximetry is unique because it provides a noninvasive way to continuously monitor the baby's oxygen levels during labor, using a sensor placed on the baby's back. This method is different from traditional fetal monitoring techniques, like fetal electrocardiography, as it directly measures oxygen saturation, which can help assess fetal well-being more accurately during labor. ^{1 2 4 6 8}

What is the purpose of this trial?

The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

European experience with a novel noninvasive sensor for intra-amniotic or extra-amniotic evaluation of fetal oxygen saturation. [2019]

2. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of pulse oximetry versus fetal electrocardiography for the intrapartum evaluation of nonreassuring fetal heart rate. [2013]

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

The safety of fetal pulse oximetry in parturients requiring fetal scalp blood sampling. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Clinical value of antenatal fetal pulse oximetry. [2019]

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

A multicenter controlled trial of fetal pulse oximetry in the intrapartum management of nonreassuring fetal heart rate patterns. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Is the correlation between fetal oxygen saturation and blood pH sufficient for the use of fetal pulse oximetry? [2013]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Fetal pulse oximetry: a critical appraisal. [2005]

8. Bulgaria pubmed.ncbi.nlm.nih.gov

[Fetal pulse oximetry: a clinical methodological study]. [2013]