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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.


Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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



Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: September 15, 2013
Date Started: November 2013
Date Completion:
Last Updated: December 17, 2015
Last Verified: November 2015