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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sedation | Active Comparator | Midazolam : 0,10 mg/kg |
|
| spinal anesthesia | Active Comparator | Bupivacain 10 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug |
| ||
| Bupivacaine |
| Measure | Description | Time Frame |
|---|---|---|
| Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation | 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Obstetric contraindications:
Anesthesiologic contraindications:
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| Name | Affiliation | Role |
|---|---|---|
| Julien CHEVREAU, MD | CHU Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
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 |
| D006571 | Heterocyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |