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New treatment option for Fetal Hypoxia
Official title Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
ClinicalTrials.gov ID: NCT07296419
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- Willing and capable of providing informed consent.
- Age \> 18 years.
- Gestational age \> 36 weeks.
- Singleton pregnancy.
- Vertex presentation,
You likely can't join if
- Age \< 18 years.
- Gestational age \< 36 weeks
- Multiple gestation
- Nonvertex fetal presentation
- Suspected vasa previa
- Category III CTG tracing
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shreveport, Louisiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shreveport, Louisiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.