Measuring fetal oxygen levels using light scattering technology
Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity
NA · Raydiant Oximetry, Inc. · NCT04876846
This study is testing a new way to measure fetal oxygen levels using light from a special device on the mother's belly to help improve care for pregnant women in their late third trimester.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Raydiant Oximetry, Inc. (industry) |
| Drugs / interventions | radiation |
| Locations | 1 site (Walnut Creek, California) |
| Trial ID | NCT04876846 on ClinicalTrials.gov |
What this trial studies
This study evaluates the properties of maternal-fetal tissue light scattering to improve the accuracy of fetal pulse oximetry. It involves non-invasive measurements taken from the maternal abdomen using a customized device that combines multiple laser sources and detectors. The study aims to gather human measurements to validate computational models against animal data, focusing on women in their late third trimester. Data collected will include maternal statistics and fetal depth measurements, ensuring minimal discomfort during the process.
Who should consider this trial
Good fit: Ideal candidates are women aged over 18 with a singleton, healthy pregnancy at 36 weeks of gestation or later.
Not a fit: Patients with multiple gestations or those under 36 weeks of gestation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate monitoring of fetal oxygen levels, potentially improving outcomes for pregnancies at risk of fetal hypoxia.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in non-invasive fetal monitoring techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks 2. Age \> 18 years 3. Willing to come in for testing outside of routine business hours (including Saturdays) Exclusion Criteria: 1. Age \<18 2. Multiple gestation (twins, triplets) 3. Presentation other than vertex or breech 4. \< 36 weeks of gestation
Where this trial is running
Walnut Creek, California
- Yaron Friedman, MD, Inc. — Walnut Creek, California, United States (RECRUITING)
Study contacts
- Study coordinator: Laura Kemp
- Email: laurakemp@raydiantoximetry.com
- Phone: 4083751465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fetal Hypoxia