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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Centre Hospitalier Universitaire, Amiens

Current Primary Outcome: Successful external version (VME) upon completion gesture : obtaining a fetus in cephalic presentation [ Time Frame: 24 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • occurrence of side events due to the manipulation itself [ Time Frame: Day 0 ]
    cesarean for non resolutive bradycardia, placental abruption, rupture of amniotic membranes
  • occurrence of side events due to anesthesia [ Time Frame: Day 0 ]
    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).
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire, Amiens

Dates:
Date Received: May 27, 2016
Date Started: June 2016
Date Completion: July 2018
Last Updated: June 10, 2016
Last Verified: June 2016