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Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

RecruitingNAAges 18 Years - anyFemaleRaydiant Oximetry, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Willing and capable of providing informed consent. 2. Age \> 18 years. 3. Gestational age \> 36 weeks. 4. Singleton pregnancy. 5. Vertex presentation, 6. In latent or active labor, 7. Category I or II tracings, 8. Epidural anesthesia, 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. Category III CTG tracing 7. Fetal anomalies and/or chromosomal disorders 8. Chorioamnionitis 9. Placenta previa 10. HIV, genital Herpes, or other infection precluding transvaginal monitoring 11. Unable to provide informed consent (e.g., cognitively impaired) 12. Low anterior placenta, or 13. Any condition (temporary or permanent) in which the investigator deems the patient unsuitable for the study procedures.
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What it tests

  • Fetal Pulse Oximetery
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Where

1 site
LSU Health Science Center-Shreveport
Shreveport, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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