A Phase 3 interventional study of equimolar mixture of oxygen and nitrous oxide or medical air in Breech Presentation in Pregnancy, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nantes University Hospital · Phase 3, Interventional, and Treatment
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.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's enrollment of 150 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: equimolar mixture of oxygen and nitrous oxide or medical air
Drug: equimolar mixture of oxygen and nitrous oxide or medical air
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.
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
This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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