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.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 186 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Exclusion Criteria:
Obstetric :
Anesthesiologic contraindications:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The human immunodeficiency virus, which weakens the immune system.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from May 2016 to primary completion in Dec 2024, 102 months.
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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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Studies of the drugs tested here: Midazolam · Bupivacaine
Centre Hospitalier Universitaire, Amiens →