drugset / Trial / NCT02801201

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

NCT02801201

Phase 3 Completed 186 enrolled Centre Hospitalier Universitaire, Amiens
RandomizedParallel-groupTreatment

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.

Timeline

Start
2016-05-31
Primary completion
2024-12-26
Completion
2025-12-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupivacaine Other / unclassified 10 mg
Comparator Midazolam Small molecule 0.1 mg/kg

Indications

No indication recorded.