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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)

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ClinicalTrials.gov Identifier: NCT01948115
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Breech Presentation in Pregnancy Drug: equimolar mixture of oxygen and nitrous oxide or medical air Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Placebo Comparator: Medical air 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.


Experimental: equimolar mixture of oxygen and nitrous oxide 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.





Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948115


Locations
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France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Julie ESBELIN, Dr Nantes University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01948115    
Other Study ID Numbers: RC13_0254
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: November 2015
Keywords provided by Nantes University Hospital:
Breech presentation
equimolar mixture of oxygen and nitrous oxide
external cephalic version
Additional relevant MeSH terms:
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Breech Presentation
Obstetric Labor Complications
Pregnancy Complications
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents