MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling. (MELIBIO)

January 4, 2018 updated by: Raoul Desbriere, Hospital St. Joseph, Marseille, France

MEOPA (Equimolar Mix of Oxygen and Nitrogen Monoxide) Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Compare anxiety discomfort and side effects

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13008
        • Hôpital St Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant
  • 18 and over
  • monofetal pregnancy
  • chorionic villus sampling medical indication without contra indication
  • informed consent signature

Exclusion Criteria:

  • pregnant under 18
  • multiple pregnancies
  • pregnancy inferior 11 aw
  • no informed consent signature

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxygen/nitrous oxide equimolar mix
96 participants undergoing chorionic villi sampling. self administered inhalation of equimolar mixture of oxygen and nitrous oxide (MEOPA)
Drug: Oxygen/nitrous oxide equimolar mix
an experimental strategy inhalation by means of a breathing mask diffusing MEOPA
Other Names:
  • MEOPA
Active Comparator: Lidocaine
96 participants undergoing chorionic villi sampling infiltrative local anaesthesia of 1% lidocaine
Drug: Lidocaine
standard strategy by local injection anesthesia of lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia efficiency
Time Frame: 5 min after procedure
assessment of pain with visual analog scale
5 min after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of anxiety
Time Frame: 5 min after biopsy
assessment of anxiety with visual analog scale
5 min after biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital St. Joseph, Marseille, France

Investigators

  • Principal Investigator: Raoul Desbriere, MD, Hôpital st Joseph Marseille France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

December 27, 2016

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A121414-31

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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