Fetal Pulse Oximetry for Fetal Hypoxia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to improve how doctors monitor oxygen levels in babies during birth. Researchers will use a new tool called fetal pulse oximetry to gather data that could enhance newborn care. The trial includes women in labor with a single baby, whose water has broken, and who are at least 36 weeks pregnant. Special sensors will monitor participants to evaluate the effectiveness of this new method. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve newborn care.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that fetal pulse oximetry is safe for women in labor?
Research has shown that using fetal pulse oximetry during labor is generally safe. This method checks the baby's oxygen levels without major risks and has been linked to fewer cesarean deliveries when there are concerns about the baby's health.
For safety, small, sterile sensors are placed on the baby's head during labor, causing little discomfort. While studies have examined the effectiveness of this technique, they report no major problems from its use.
Overall, research suggests that fetal pulse oximetry is well-tolerated. Although further studies could confirm its safety, current evidence supports its use without significant safety concerns.12345Why are researchers excited about this trial?
Fetal pulse oximetry is unique because it offers a direct way to monitor a baby's oxygen levels during labor, unlike traditional methods that rely on indirect fetal heart rate monitoring. This method uses sensors placed directly on the fetus, providing real-time and precise data about potential hypoxia. Researchers are excited because it could lead to earlier interventions during labor, potentially improving outcomes for both mothers and babies.
What evidence suggests that fetal pulse oximetry is effective for fetal hypoxia?
Research has shown that fetal pulse oximetry can help assess a baby's condition during labor. This method offers a simple and safe way to measure the baby's oxygen levels. In this trial, participants will be monitored using dual sensors as part of the experimental treatment arm. One study found that combining fetal pulse oximetry with heart rate monitoring reduced the number of cesarean sections when concerns about the baby’s health arose. Another study found that it improved the accuracy of fetal assessments. Overall, fetal pulse oximetry appears promising in enhancing labor safety by providing better information about a baby's well-being.14678
Who Is on the Research Team?
Perry S Barrilleaux, MD
Principal Investigator
Louisiana State University Health Shreveport
Are You a Good Fit for This Trial?
This trial is for women in labor who may be experiencing complications like fetal anoxia, hypoxia, or acidemia. Specific eligibility criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monitoring
Participants are monitored using two sterile fetal sensors and two separate data collection systems for up to 6 hours
Follow-up
Participants are monitored for safety and effectiveness after the monitoring phase
What Are the Treatments Tested in This Trial?
Interventions
- Fetal Pulse Oximetery
Trial Overview
The study aims to collect and compare fetal oxygen saturation (SpO2) waveforms during labor using transvaginal fetal pulse oximetry to develop algorithms for better monitoring.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Women in labor who consent to participation are monitored using two sterile fetal sensors and two separate data collection systems.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Raydiant Oximetry, Inc.
Lead Sponsor
Citations
Fetal pulse oximetry for fetal assessment in labour - PMC
One study found a higher caesarean section rate in the group monitored with fetal pulse oximetry plus CTG, compared with fetal ECG plus CTG. The data provide ...
897: Maternal pulse oximetry to prevent misidentification ...
Compared to CTG alone, monitoring women in the second stage of labor with maternal pulse oximetry improves outcomes and decreases total costs.
Association between intrapartum fetal pulse...
They concluded that FPO with fetal heart rate monitoring in selected cases of non-reassuring fetal status may reduce the caesarean section rate. While Uchida ...
Association between intrapartum fetal pulse oximetry and ...
Fetal pulse oximetry may improve intrapartum fetal evaluation by providing a non-invasive measurement of fetal oxygen saturation (FSpo2).
Non-invasive detection of fetal hypoxemia in large animal model
EFM is highly sensitive for the detection of fetal hypoxia, i.e., virtually no significantly hypoxic baby will have a normal CTG tracing. The ...
Fetal Pulse Oximetry and Cesarean Delivery
Specifically, fetal oximetry was associated with a significant reduction in the rate of cesarean delivery among patients with a nonreassuring ...
Intrapartum fetal pulse oximetry: Past, present, and future
This article reviews the evolution of intrapartum fetal oxygen saturation monitoring and proposes directions for future investigation.
Fetal pulse oximetry: 8 vital questions
It revealed a fetal oxygen saturation rate between 45% and 50%, and labor was allowed to continue. After 3.5 hours in the second stage, the patient was deliv- ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.