Trans-abdominal Fetal Pulse Oximetry
Primary Purpose
Fetal Hypoxia, Fetal Distress, Fetal Acidemia
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dual fetal oxygen sensors
Sponsored by
About this trial
This is an interventional other trial for Fetal Hypoxia
Eligibility Criteria
Inclusion Criteria:
- Willing and capable to provide informed consent
- Age > 18 years
- BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)
- Gestational age > 36 weeks
- Singleton pregnancy
- Vertex presentation
- Active labor
- Category I or Category II tracings
- Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower
Exclusion Criteria:
- Age <18 years
- BMI > 50 third trimester
- Gestational age < 36 weeks
- Multiple gestation
- Nonvertex fetal presentation
- Suspected vasa previa
- Latent labor
- Category III CTG tracing (i.e., need for immediate delivery)
- Fetal anomalies and/or chromosomal disorders
- Chorioamnionitis
- Placenta Previa
- History of HIV, Genital Herpes, or other infection precluding internal monitoring
- Unable to provide informed consent (e.g., cognitively impaired)
Sites / Locations
- University of Texas Medical Branch (UTMB)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional/Observational
Arm Description
The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively.
Outcomes
Primary Outcome Measures
Fetal oxygen levels
Concurrence of internal and external fetal oxygen sensors
Adverse events
Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum.
Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.
Secondary Outcome Measures
Full Information
NCT ID
NCT05147584
First Posted
November 23, 2021
Last Updated
December 20, 2022
Sponsor
Raydiant Oximetry, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05147584
Brief Title
Trans-abdominal Fetal Pulse Oximetry
Official Title
Trans-abdominal Fetal Pulse Oximetry: PILOT 1
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Suspended
Why Stopped
Study paused for interim data analysis.
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raydiant Oximetry, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.
Detailed Description
Raydiant Oximetry, Inc. is developing a novel and non-invasive fetal pulse oximetry device to fundamentally improve how fetuses are monitored during labor. The Raydiant Oximetry Sensing System (Lumerah) is a fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah performs its measurements without the requirement for transvaginal placement and its associated risks. Lumerah is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation which is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The severe consequences associated with newborn metabolic acidosis and the lack of availability of an effective tool to support its early diagnosis led to the development of Lumerah.
In this study, women in labor will be simultaneously monitored with proven (previously FDA-approved) technology as a "ground truth". These women will be simultaneously monitored with both an external and internal oxygen sensor. Obstetric health-care providers are blinded to oximetry data presented by both devices; therefore, clinical decisions regarding interventions are made based on the standard factors, including cardiotocography. The primary efficacy analysis will be performed retrospectively by comparing data of fetal oxygenation displayed and recorded by both devices. Results of either the Lumerah external sensor or the internal sensor will not be used to guide or alter patient management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Hypoxia, Fetal Distress, Fetal Acidemia, Fetal or Neonatal Effect of Complication of Labor
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, investigator-blinded study that is for data collection only. The primary purpose is to verify accuracy during the training of the algorithm by comparing the external sensor to a known internal sensor.
Masking
None (Open Label)
Masking Description
Results of either the external sensor or the internal sensor will not be shown to the subject, the care provider, or the investigator and will not be used to guide or alter patient management. The "outcomes assessor" will review the subject CTG and sensor data retrospectively.
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional/Observational
Arm Type
Experimental
Arm Description
The internal and external oxygen sensors will be used to record fetal oxygen during active labor and these will be be compared to the CTG retrospectively.
Intervention Type
Device
Intervention Name(s)
Dual fetal oxygen sensors
Intervention Description
Placement of both internal and external fetal oxygen sensors
Primary Outcome Measure Information:
Title
Fetal oxygen levels
Description
Concurrence of internal and external fetal oxygen sensors
Time Frame
During labor
Title
Adverse events
Description
Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor. Note: In this study, use of the device provides additional clinical information, but clinical judgement is based on standard fetal monitoring, including cardiotocography, and investigators are blinded to oximetry readings. The maternal skin at the sensor site will be examined intra and postpartum.
Rate of device-related adverse events such as erythema or rash on the maternal abdomen at the location of the sensor.
Time Frame
During labor
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who are in labor
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willing and capable to provide informed consent
Age > 18 years
BMI < 50 (with no more than 4 cm between maternal skin and fetal skin)
Gestational age > 36 weeks
Singleton pregnancy
Vertex presentation
Active labor
Category I or Category II tracings
Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower
Exclusion Criteria:
Age <18 years
BMI > 50 third trimester
Gestational age < 36 weeks
Multiple gestation
Nonvertex fetal presentation
Suspected vasa previa
Latent labor
Category III CTG tracing (i.e., need for immediate delivery)
Fetal anomalies and/or chromosomal disorders
Chorioamnionitis
Placenta Previa
History of HIV, Genital Herpes, or other infection precluding internal monitoring
Unable to provide informed consent (e.g., cognitively impaired)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Rosen, MD
Organizational Affiliation
Raydiant Oximetry
Official's Role
Study Director
Facility Information:
Facility Name
University of Texas Medical Branch (UTMB)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is for device development only, there is no plan to share IPD.
Learn more about this trial
Trans-abdominal Fetal Pulse Oximetry
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