NCT02801201

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breech Presentation

Interventions

Type	Name	Description
DRUG	Midazolam
DRUG	Bupivacaine

Timeline

• Start date: 2016-05-31
• Primary completion: 2019-10-30
• Completion: 2019-11-30
• First posted: 2016-06-15
• Last updated: 2018-08-08

Locations

1 site across 1 country: France