Breech Presentation Clinical Trial
— RaVemOfficial title:
Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | November 30, 2019 |
Est. primary completion date | October 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Amiens | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation | 24 hours | ||
Secondary | occurrence of side events due to the manipulation itself | cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes | Day 0 | |
Secondary | occurrence of side events due to anesthesia | 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). | Day 0 | |
Secondary | The pain experienced by the patient: assessed by the Visual Analogic Scale | Day 0 | ||
Secondary | The final delivery mode (caesarian section or vaginal) | Day 0 | ||
Secondary | The presentation in childbirth | Day 0 |
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