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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
We need to include 150 patients for a period of 2 years. Patients will be randomized: 75 patients in each arm: 75 patients in group "placebo" (medical air), 75 patients in group "treatment" (equimolar mixture of oxygen and nitrous oxide). Patients will be single-blind. The ECV be started at least 3 minutes after the start of administration. The maximum time of administration of the gas will be 15 minutes. Just after ECV, we compare success rate of intervention.
Nantes University Hospital
Nantes, France
Number of women with success after ECV
Success rate just after ECV between the two groups (equimolar mixture of oxygen and nitrous oxide group, and medical air group) with ultrasound.
Time frame: 20 minutes
Pain during ECV
Just after ECV: pain during ECV with Visual Analogue Scale
Time frame: 20 minutes
Frequency of nausea/vomiting
Just after ECV: Frequency of nausea / vomiting between the two groups
Time frame: 1 hour
Number of interrupted procedures
Just after ECV: number of interrupted procedures due to pain
Time frame: 20 minutes
Number of cephalic presentation at birth
At birth: rate of cephalic presentation between the two groups
Time frame: 2 month
Number of cesarean at birth
At birth: cesarean rate between the two groups
Time frame: 2 month
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