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New treatment option for Obstetrics: Elective Caesarean Delivery
Official title Effects of Spinal Anesthesia on the Fetal Autonomic Nervous System
ClinicalTrials.gov ID: NCT07333729
What this study is testing
- What it's testing
- Elective cesarean deliveries account for over 10% of births in France and are often scheduled around 39 weeks of gestation. When feasible, spinal anesthesia is considered the gold standard in such a clinical situation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- Pregnant woman scheduled for elective cesarean delivery
- Age: over 18 and under 45 years
- Gestational age ≥ 37 weeks of amenorrhea
- Singleton pregnancy
- Proficient in the French language
You likely can't join if
- Requirement for general anesthesia or combined epidural-spinal analgesia
- Fetal malformation
- Intrauterine fetal demise
- Maternal and/or fetal cardiac rhythm disorders
- History of heart transplantation
- Open wound in an area covered or enclosed by one of the study devices
See the full eligibility criteria
- Pregnant woman scheduled for elective cesarean delivery
- Age: over 18 and under 45 years
- Gestational age ≥ 37 weeks of amenorrhea
- Singleton pregnancy
- Proficient in the French language
- Participant has provided written informed consent to take part in the study
- Affiliated with a national health insurance scheme
- Requirement for general anesthesia or combined epidural-spinal analgesia
- Fetal malformation
- Intrauterine fetal demise
- Maternal and/or fetal cardiac rhythm disorders
- History of heart transplantation
- Open wound in an area covered or enclosed by one of the study devices
- Risk of viral or infectious contamination of any component of the device
- Hospitalization for medical termination of pregnancy
- Sensory disorders resulting in lack of pain perception on the skin
- Ongoing treatment that may alter autonomic nervous system activity (e.g., beta-blockers, anticholinergics, atropine)
- Participant with an implanted medical device (e.g., pacemaker)
- Known allergy to any component of the devices: polyamide, polyester, elastane, silver, or other synthetic materials
- Participant whose anatomical area intended for ClearSight sensor placement is insufficient to allow proper application
- Concurrent participation in another treatment research study
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
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 to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. 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.