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

NCT01948115 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-12-18

No results posted yet for this study

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.

Conditions

  • Breech Presentation in Pregnancy

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.

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Julie ESBELIN, Dr · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01948115 on ClinicalTrials.gov