drugset / Trial / NCT01948115

Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)

NCT01948115

Phase 3 Completed 150 enrolled Nantes University Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2013-11
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitrous Oxide Other / unclassified Inhaled

Indications

No indication recorded.