Fetal Acidemia, Fetal Distress, Fetal Hypoxia, Fetal or Neonatal Effect of Complication of Labor
Conditions
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.
Interventions
DEVICEDual fetal oxygen sensors
Placement of both internal and external fetal oxygen sensors
Sponsors
Raydiant Oximetry, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
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.
Intervention 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.
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. BMI \< 50 (with no more than 4 cm between maternal skin and fetal skin) 4. Gestational age \> 36 weeks 5. Singleton pregnancy 6. Vertex presentation 7. Active labor 8. Category I or Category II tracings 9. Ruptured amniotic sac with cervical dilation of \>2 cm and a station of -2 or lower
Exclusion criteria
1. Age \<18 years 2. BMI \> 50 third trimester 3. Gestational age \< 36 weeks 4. Multiple gestation 5. Nonvertex fetal presentation 6. Suspected vasa previa 7. Latent labor 8. Category III CTG tracing (i.e., need for immediate delivery) 9. Fetal anomalies and/or chromosomal disorders 10. Chorioamnionitis 11. Placenta Previa 12. History of HIV, Genital Herpes, or other infection precluding internal monitoring 13. Unable to provide informed consent (e.g., cognitively impaired)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Oxygen Levels | During labor | Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors. |
| Adverse Events | During labor | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interventional/Observational 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.
Dual fetal oxygen sensors: Placement of both internal and external fetal oxygen sensors | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subjects consented but did not fully meet inclusion /exclusion criteria | 8 |
Baseline characteristics
| Characteristic | Interventional/Observational | — |
|---|---|---|
| Age, Continuous Age | 27.4 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 23 participants | — |
| Sex: Female, Male Female | 23 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| Skin color according to Fitzpatrick Scales Type III Skin Color | 12 Participants | — |
| Skin color according to Fitzpatrick Scales Type II Skin Color | 6 Participants | — |
| Skin color according to Fitzpatrick Scales Type I Skin Color | 2 Participants | — |
| Skin color according to Fitzpatrick Scales Type IV Skin Color | 2 Participants | — |
| Skin color according to Fitzpatrick Scales Type VI Skin Color | 1 Participants | — |
| Skin color according to Fitzpatrick Scales Type V Skin Color | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
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.
Time frame: During labor
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interventional/Observational | Adverse Events | 0 participants |
Primary
Fetal Oxygen Levels
Assessment of the adequacy of fetal signals from both internal and external fetal oxygen sensors.
Time frame: During labor
Population: All 23 subject files were analyzed. Of the 23 participants who completed the monitoring period, 15 were considered to have adequate paired data for analysis of fetal signal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interventional/Observational | Fetal Oxygen Levels | 15 Participants |