Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
EU CTIS ID: 2024-517302-29-00
What this study is testing
is to show that spinal anaesthesia allows a higher success rate than simple sedation for programmed VME, i.e. to transform a podalic or transverse foetal presentation into a cephalic presentation, the presentation being defined by the foetal pole closest to the cervix.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Patient presenting with a dystocic (podalic or transverse) fetus at 36 weeks' gestation
- Patient covered by a social insurance system
- Signed informed consent
You likely can't join if
- Obstetrical contraindications : - Placenta previa ; - 3rd trimester metrorrhagia; - Suspicion of foetal anoxia; - Patient who has already had more than one caesarean section; - Twin pregnancies; - HIV+; - Anticoagulant treatment in progress
- Anaesthetic contraindications : - Infection at the puncture site, generalised infection or severe septic state; - Intracranial hypertension; - Uncompensated heart failure; - Constitutive or acquired coagulation anomalies, including curative anticoagulant treatments; - Neuropathy with demyelination of nerve fibres in advanced stages or in the process of unstabilised recovery; - Syringomyelia
- Patient deprived of liberty, under legal protection (guardianship or curatorship), unable to read or write.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.