Breech Presentation in Pregnancy
Conditions
Keywords
Breech presentation, equimolar mixture of oxygen and nitrous oxide, external cephalic version
Brief 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.
Interventions
DRUGequimolar 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.
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of women with success after ECV | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during ECV | 20 minutes | Just after ECV: pain during ECV with Visual Analogue Scale |
| Frequency of nausea/vomiting | 1 hour | Just after ECV: Frequency of nausea / vomiting between the two groups |
| Number of interrupted procedures | 20 minutes | Just after ECV: number of interrupted procedures due to pain |
| Number of cephalic presentation at birth | 2 month | At birth: rate of cephalic presentation between the two groups |
| Number of cesarean at birth | 2 month | At birth: cesarean rate between the two groups |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORJulie ESBELIN, Dr
Nantes University Hospital
Outcome results
None listed