CompletedPhase 3

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

France150 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥ 18 years * pregnancy at term (≥36 weeks) * singleton foetus in breech or transverse presentation * acceptance of ECV * signature of informed consent Exclusion Criteria: * contraindications of ECV: placenta praevia, obstacle praevia, multiple pregnancy, foetal death, foetal heart rhythm disorder, lack of amniotic fluid, HIV-positive patient * contraindications of equimolar mixture of oxygen and nitrous oxide : patient who require pure oxygen ventilation, disorders of consciousness that impede the cooperation of the patient, pneumothorax, pulmonary embolism, ocular surgery

What they're measuring

Number of women with success after ECV

Timeframe: 20 minutes

Trial details

NCT IDNCT01948115

SponsorNantes University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Breech Presentation in Pregnancy trials