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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2015

Interventions

  • Drug: equimolar 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Medical air
  • Experimental: equimolar mixture of oxygen and nitrous oxide

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nantes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julie ESBELIN, Dr, Principal Investigator, Nantes University Hospital

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