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Completed

NCT Number: NCT01948115

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

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.

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Key information

Conditions

Breech Presentation in Pregnancy Breech Presentation Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

equimolar mixture of oxygen and nitrous oxide or medical air

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. Pain during ECV

    Time frame: 20 minutes

    Just after ECV:

    pain during ECV with Visual Analogue Scale

  2. Frequency of nausea/vomiting

    Time frame: 1 hour

    Just after ECV:

    Frequency of nausea / vomiting between the two groups

  3. Number of interrupted procedures

    Time frame: 20 minutes

    Just after ECV:

    number of interrupted procedures due to pain

  4. Number of cephalic presentation at birth

    Time frame: 2 month

    At birth:

    rate of cephalic presentation between the two groups

  5. Number of cesarean at birth

    Time frame: 2 month

    At birth:

    cesarean rate between the two groups

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: MEOREV

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 23, 2013
Registry last updated
Dec 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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