Breech Presentation in Pregnancy Clinical Trial
— MEOREVOfficial 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.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Nantes University Hospital | Nantes |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Pain during ECV | Just after ECV: pain during ECV with Visual Analogue Scale |
20 minutes | Yes |
| Secondary | Frequency of nausea/vomiting | Just after ECV: Frequency of nausea / vomiting between the two groups |
1 hour | Yes |
| Secondary | Number of interrupted procedures | Just after ECV: number of interrupted procedures due to pain |
20 minutes | No |
| Secondary | Number of cephalic presentation at birth | At birth: rate of cephalic presentation between the two groups |
2 month | No |
| Secondary | Number of cesarean at birth | At birth: cesarean rate between the two groups |
2 month | No |