Breech Presentation in Pregnancy Clinical Trial
Official title:
Prospective Randomized Controlled Trial to Evaluate the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV) in Singleton Pregnancy in Breech Presentation at Term
The variety of breech presentation at term is about 3-4% of all births. Our study aims to
assess the value of using an equimolar mixture of oxygen and nitrous oxide. Indeed, in some
patients algic or relaxed, the success rate seems more important.
It's a single blind prospective randomized controlled study, comparing success rate of ECV
after an equimolar mixture of oxygen and nitrous oxide or placebo (medical air).
We need to include 150 patients (75 in each arm), for a period of 2 years. After ECV, we
will give the patient a satisfaction questionnaire. We compare the success rate of ECV as
primary outcome.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment