Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia

August 28, 2014 updated by: Assistance Publique Hopitaux De Marseille
To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 3

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, 13005
        • Service de Gynécologie Obstétrique, Hôpital La Conception

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Major patient having signed an assent waits having chosen to make the intervention under local anesthetic

Exclusion Criteria:

  • Minor
  • contraindication in the use of the paracetamol, the lidocaine
  • Porphyries

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
50% N2O- 50%O2 mixture administration during the intervention
Drug: 50% N2O- 50%O2 mixture
50% N2O- 50%O2 mixture administration
Placebo Comparator: 2
Placebo (air) during the intervention
Drug: Placebo (air)
Placebo administration during the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain during the intervention
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain at the end of the intervention and 2 hours after. Unwanted events
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Aubert AGOSTINI, MD, Assistance Publique des Hôpitaux de Marseille

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

October 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

January 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • 2008-000799-25
  • 2008-10

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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