Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Analgesia on Success of External Version: Comparison of Spinal Anesthesia Versus Sedation; Prospective, Controlled, Randomized Study

Conditions
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Breech Presentation

Intervention / Treatment
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* Drug: Midazolam
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sedation<br>Midazolam : 0,10 mg/kg | Drug: Midazolam<br> <br> |
| Active Comparator: spinal anesthesia<br>Bupivacain 10 mg | Drug: Bupivacaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of side events due to the manipulation itself | cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes | Day 0 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, spinal anesthesia