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COMPLETED
NCT02801201
PHASE3

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

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2016-05-31

Completion Date

2025-12-08

Last Updated

2026-06-11

Healthy Volunteers

No

Interventions

DRUG

Midazolam

DRUG

Bupivacaine

Locations (1)

CHU Amiens

Amiens, France