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

N

Nantes University Hospital (NUH)

Status and phase

Completed
Phase 3

Conditions

Breech Presentation in Pregnancy

Treatments

Drug: equimolar mixture of oxygen and nitrous oxide or medical air

Study type

Interventional

Funder types

Other

Identifiers

NCT01948115
RC13_0254

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups, including a placebo group

Medical air
Placebo Comparator group
Treatment:
Drug: equimolar mixture of oxygen and nitrous oxide or medical air
equimolar mixture of oxygen and nitrous oxide
Experimental group
Treatment:
Drug: equimolar mixture of oxygen and nitrous oxide or medical air

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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