Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation (RaVem)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
At the time of birth, nearly 5% of children are in breech presentation. This type of presentation requires a medical environment and leads to more frequent use of Caesarean sections. This is why the external version can be proposed, usually from the 36th week. Its success rate is 40%, and is usually performed under simple sedation. One of the causes of failure is the lack of relaxation of the uterus, which could be higher in case of deeper anesthesia, as is the case in spinal anesthesia. The study project is to demonstrate superiority of spinal anesthesia compared to the usual protocol sedation in terms of primary and secondary objectives.
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation [ Time Frame: 24 hours ]
Secondary Outcome Measures :
occurrence of side events due to the manipulation itself [ Time Frame: Day 0 ]
cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
occurrence of side events due to anesthesia [ Time Frame: Day 0 ]
hypotension, maternal bradycardia, desaturation, nausea / vomiting, number of punctures greater than 1 (failure of the first puncture for spinal anesthesia leading to the necessity to perform one or more others).
The pain experienced by the patient: assessed by the Visual Analogic Scale [ Time Frame: Day 0 ]
The final delivery mode (caesarian section or vaginal) [ Time Frame: Day 0 ]
The presentation in childbirth [ Time Frame: Day 0 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
age ≥ 18 years
patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation
covered by a an insurance system
3rd trimester bleeding
suspicion of fetal anoxia
patient has already received more than one caesarean section
infection at the puncture site, systemic infection or severe sepsis
uncompensated heart failure
constitute or acquired coagulation abnormalities, including anticoagulant therapy with curative intent
neuropathy with demyelination of nerve fibers in thrust or unstabilized during recovery
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Additional relevant MeSH terms:
Layout table for MeSH terms
Obstetric Labor Complications
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action