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Fetal Pulse Oximetry for Fetal Hypoxia

N/A

Recruiting

Research Sponsored by Raydiant Oximetry, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks

Age > 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 36 weeks of pregnancy

Awards & highlights

Study Summary

This trial is studying how well a new way of measuring blood oxygen levels in pregnant women and their fetuses works.

Who is the study for?

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.Check my eligibility

What is being tested?

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).See study design

What are the potential side effects?

Since this trial involves non-invasive monitoring with light scattering technology similar to standard pulse oximeters, significant side effects are not anticipated. However, specific risks related to the procedure will be detailed by the research team.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 36 weeks of pregnancy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 36 weeks of pregnancy

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 36 weeks of pregnancy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fetal Signal

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interventional/ObservationalExperimental Treatment1 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Raydiant Oximetry, Inc.Lead Sponsor

4 Previous Clinical Trials

46 Total Patients Enrolled

1 Trials studying Fetal Hypoxia

23 Patients Enrolled for Fetal Hypoxia

Mark Rosen, MDStudy DirectorRaydiant Oximetry

1 Previous Clinical Trials

23 Total Patients Enrolled

1 Trials studying Fetal Hypoxia

23 Patients Enrolled for Fetal Hypoxia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities currently available to enroll in this trial?

"Affirmative. The clinicaltrials.gov portal shows that this research is currently seeking participants, with an initial posting date of April 24th 2021 and most recent update occurring on April 25th 2022. 10 patients are needed to be recruited from a single medical centre."

Answered by AI

How many participants are being recruited for this medical research?

"Affirmative, the clinical trial is presently seeking individuals. The research was first posted on April 24th 2021 and recently amended on April 25th 2022. This study requires enlistment of 10 patients from a single centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity

2021. "Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04876846.