Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
Recruiting
N/A
Interventional Study
Fetal Hypoxia
Fetal Acidemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 15 (estimated)
- Sponsor
- Raydiant Oximetry, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 cervica…
Contacts
Chelsie Liegey, LPC, RN
318-675-7064
CONTACT