Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fetal Pulse Oximetery.
- Who it may be relevant to
- Registry conditions: Fetal Hypoxia, Fetal Acidemia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.
Detailed description
The Raydiant Data Collection System (DCS) captures red and infrared waveforms that can be post-processed to calculate fetal functional oxygen saturation of arterial oxygen saturation (SpO2) and pulse rate. These waveforms are acquired from the fetus when the sensor is placed at the cheek, temple, or forehead. Acquisition of these waveforms is a necessary step toward signal qualification and data processing algorithms. The Raydiant DCS is a similar device to the original Nellcor N-400 System. Clinical research with the N-400 System demonstrated that fetal pulse oximetry values provide 54.2% positive predicative value and 92.9% sensitivity for detecting newborn metabolic acidosis (defined by pH\<7.15).1 This provided a significant aid to clinicians for diagnosing endangering states of fetal hypoxia.
In this study, both the participants and the health-care providers are blinded to the oximetry data; therefore, clinical decisions regarding interventions are made based on routine clinical monitoring. The primary analysis will be performed by comparing the post-processed waveforms. Other than device placement and a period of monitoring not to exceed 6 hours, there is no change to the standard of care procedures for fetal monitoring. As stated above, the sensor displays will not be used to guide or alter patient management.
Interventions
- Device Fetal Pulse Oximetery
Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.
Primary outcome measures
- Rate of device-related adverse events [Time frame: Periprocedural]
Secondary outcome measures (2)
- Maternal Outcomes [Time frame: Periprocedural]
- Neonatal Outcomes [Time frame: Periprocedural]
Eligibility criteria
Inclusion criteria
- Willing and capable of providing informed consent.
- Age > 18 years.
- Gestational age > 36 weeks.
- Singleton pregnancy.
- Vertex presentation,
- In latent or active labor,
- Category I or II tracings,
- Epidural anesthesia, and
- Ruptured amniotic sac with cervical dilation of >2 cm and a station of -2 or lower.
Exclusion criteria
- Age < 18 years.
- Gestational age < 36 weeks
- Multiple gestation
- Nonvertex fetal presentation
- Suspected vasa previa
- Category III CTG tracing
- Fetal anomalies and/or chromosomal disorders
- Chorioamnionitis
- Placenta previa
- HIV, genital Herpes, or other infection precluding transvaginal monitoring
- Unable to provide informed consent (e.g., cognitively impaired)
- Low anterior placenta, or
- Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- LSU Health Science Center-Shreveport — Shreveport
Identifiers
NCT: NCT07296419 · CP2555