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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breech Presentation in Pregnancy

Intervention / Treatment
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* Drug: equimolar mixture of oxygen and nitrous oxide or medical air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Medical air<br> | Drug: equimolar mixture of oxygen and nitrous oxide or medical air<br>* 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.<br>|
| Experimental: equimolar mixture of oxygen and nitrous oxide<br> | Drug: equimolar mixture of oxygen and nitrous oxide or medical air<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during ECV | Just after ECV: pain during ECV with Visual Analogue Scale | 20 minutes | 
| Frequency of nausea/vomiting | Just after ECV: Frequency of nausea / vomiting between the two groups | 1 hour | 
| Number of interrupted procedures | Just after ECV: number of interrupted procedures due to pain | 20 minutes | 
| Number of cephalic presentation at birth | At birth: rate of cephalic presentation between the two groups | 2 month | 
| Number of cesarean at birth | At birth: cesarean rate between the two groups | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breech presentation, equimolar mixture of oxygen and nitrous oxide, external cephalic version