This clinical trial is focused on the effectiveness of different types of anaesthesia during a procedure called external version, which is used to change the position of a baby in the womb from a breech or sideways position to a head-down position. The study compares two methods: spinal anaesthesia and sedation. The main goal is to determine if spinal anaesthesia leads to a higher success rate in repositioning the baby compared to sedation.
The study involves the use of two medications: Midazolam, also known by its code name USL-261, which is used for sedation, and Bupivacaine, which is used for spinal anaesthesia. Midazolam is administered as a solution for injection or infusion, while Bupivacaine is given as an injectable solution. Participants in the study will receive either spinal anaesthesia or sedation during the procedure, and the outcomes will be compared to see which method is more effective.
Throughout the study, participants will be monitored for the success of the procedure, which is defined as the baby being in a head-down position after the procedure. Additionally, any side effects related to the procedure or the anaesthesia, such as changes in blood pressure or heart rate, will be recorded. The study aims to provide valuable information on the best anaesthesia method to use for this procedure, potentially improving outcomes for both mothers and babies.



France