Fetal Complications, Fetal Conditions, Fetal Distress, Fetal Hypoxia, Labor Fetal Anoxia, Labor (Obstetrics)--Complications, Oxygen Deficiency
Conditions
Keywords
fetal hypoxia, fetal distress, oxygen deficiency, labor fetal anoxia
Brief summary
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.
Detailed description
This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.
Interventions
DEVICEFetal Oxygenation Measurements
The Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Raydiant Oximetry, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Masking description
Although it is known what devices are used, all personnel on the investigative team will be masked to fetal oxygenation levels during data collection.
Intervention model description
This is a single-arm, device feasibility study, based on convenience sampling.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Willing and capable to provide informed consent 2. Age \> 18 years 3. \< 4 cm between maternal skin and fetal skin (determined by ultrasound) 4. Gestational age \> 36 weeks 5. Singleton pregnancy 6. Vertex presentation 7. Active labor 8. Category I and Category II tracings, and 9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower
Exclusion criteria
1. Age \< 18 years 2. Gestational age \< 36 weeks 3. Multiple gestation 4. Nonvertex fetal presentation 5. Suspected vasa previa 6. Latent labor 7. Category III CTG tracing (i.e., need for immediate delivery) 8. Fetal anomalies and/or chromosomal disorders 9. Chorioamnionitis 10. Placenta Previa 11. History of HIV, Genital Herpes, or other infection precluding transvaginal monitoring 12. Unable to provide informed consent (e.g., cognitively impaired) 13. \> 4 cm fetal depth (determined by Ultrasound), 14. Low anterior placenta, or 15. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of monitoring fetal signals. | During labor for up to 6 hours | Prototype device feasibility of detecting reflected optical signals at different wavelengths (colors) from the fetus |
| Safety of the prototype device | Up to 72 hours post partum | Rate of adverse events and serious adverse events |
Countries
United States
Outcome results
None listed