Breech Presentation in PregnancyPhase 3MEOREVNCT01948115
Evaluation of the Efficacy and Safety of an Equimolar Mixture of Oxygen and Nitrous Oxide in External Cephalic Version (ECV)
A Phase 3 study testing equimolar mixture of oxygen and nitrous oxide or medical air in people with Breech Presentation in Pregnancy, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breech Presentation in Pregnancy
- What is being tested?
- equimolar mixture of oxygen and nitrous oxide or medical air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- pregnancy at term (≥36 weeks)
- singleton foetus in breech or transverse presentation
- acceptance of ECV
- signature of informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Breech Presentation in Pregnancy
- Being tested
- equimolar mixture of oxygen and nitrous oxide or medical air
- Keywords
- Breech presentation, equimolar mixture of oxygen and nitrous oxide, external cephalic version
- Medical subject headings
- Breech Presentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
equimolar mixture of oxygen and nitrous oxide or medical airDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Medical air | Placebo comparator | Not described Receives: Drug: equimolar mixture of oxygen and nitrous oxide or medical air |
| equimolar mixture of oxygen and nitrous oxide | Experimental | Not described Receives: Drug: equimolar mixture of oxygen and nitrous oxide or medical air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Secondary outcomes (5)
Pain during ECV
Just after ECV:
pain during ECV with Visual Analogue Scale
Measured: 20 minutes
Frequency of nausea/vomiting
Just after ECV:
Frequency of nausea / vomiting between the two groups
Measured: 1 hour
Number of interrupted procedures
Just after ECV:
number of interrupted procedures due to pain
Measured: 20 minutes
Number of cephalic presentation at birth
At birth:
rate of cephalic presentation between the two groups
Measured: 2 month
Number of cesarean at birth
At birth:
cesarean rate between the two groups
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breech Presentation in PregnancyStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie ESBELIN, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948115
- Sponsor's protocol ID
- RC13_0254
- Acronym
- MEOREV
- Status last verified
- Nov 2015
- First submitted
- 15 Sep 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dochez V, Esbelin J, Misbert E, Arthuis C, Drouard A, Badon V, Fenet O, Thubert T, Winer N. Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial. Acta Obstet Gynecol Scand. 2020 Mar;99(3):391-398. doi: 10.1111/aogs.13753. Epub 2019 Nov 18.
PubMed 31630398
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01948115
- Acronym / sponsor ID
- MEOREV / RC13_0254
- Conditions
- Breech Presentation in Pregnancy
- Keywords
- Breech presentation, equimolar mixture of oxygen and nitrous oxide, external cephalic version
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical air | Placebo comparator | Drug: equimolar mixture of oxygen and nitrous oxide or medical air |
| equimolar mixture of oxygen and nitrous oxide | Experimental | Drug: equimolar mixture of oxygen and nitrous oxide or medical air |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years
- pregnancy at term (≥36 weeks)
- singleton foetus in breech or transverse presentation
- acceptance of ECV
- signature of informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| equimolar mixture of oxygen and nitrous oxide or medical airWe 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. | Drug | Medical air, equimolar mixture of oxygen and nitrous oxide |
Primary outcome
Number of women with success after ECV
Time frame: 20 minutes
Success rate just after ECV between the two groups (equimolar mixture of oxygen and nitrous oxide group, and medical air group) with ultrasound.
5 secondary outcomes
Pain during ECV
Time frame: 20 minutes
Frequency of nausea/vomiting
Time frame: 1 hour
Number of interrupted procedures
Time frame: 20 minutes
Number of cephalic presentation at birth
Time frame: 2 month
Number of cesarean at birth
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 31630398Dochez V, Esbelin J, Misbert E, Arthuis C, Drouard A, Badon V, Fenet O, Thubert T, Winer N. Effectiveness of nitrous oxide in external cephalic version on success rate: A randomized controlled trial. Acta Obstet Gynecol Scand. 2020 Mar;99(3):391-398. doi: 10.1111/aogs.13753. Epub 2019 Nov 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie ESBELIN, Dr principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing equimolar mixture of oxygen and nitrous oxide or medical air in people with Breech Presentation in Pregnancy, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of women with success after ECV (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.