A Phase 3 interventional study of Midazolam and Bupivacaine in Breech Presentation, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Obstetric contraindications:
Anesthesiologic contraindications:
Midazolam : 0,10 mg/kg
Drug: Midazolam
Bupivacain 10 mg
Drug: Bupivacaine
Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation
Time frame: 24 hours
occurrence of side events due to the manipulation itself
cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
Time frame: 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).
Time frame: Day 0
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
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens