Breech Presentation
Conditions
Keywords
sedation, spinal anesthesia
Brief summary
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.
Interventions
DRUGMidazolam
DRUGBupivacaine
Sponsors
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* age ≥ 18 years * patient with 36 weeks of amenorrhea (SA) a fetus breech or transverse presentation * covered by a an insurance system * signed contentment
Exclusion criteria
Obstetric contraindications: * placenta previa * 3rd trimester bleeding * suspicion of fetal anoxia * patient has already received more than one caesarean section * multi-fetal pregnancy * HIV + * anticoagulant therapy Anesthesiologic contraindications: * infection at the puncture site, systemic infection or severe sepsis * intracranial hypertension * 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 * syringomyelia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of side events due to the manipulation itself | Day 0 | cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes |
| occurrence of side events due to anesthesia | 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 | Day 0 | — |
| The final delivery mode (caesarian section or vaginal) | Day 0 | — |
| The presentation in childbirth | Day 0 | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJulien CHEVREAU, MD
CHU Amiens
Outcome results
None listed