- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00769912
Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
May 4, 2026 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
-
-
-
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
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
|
50% N2O- 50%O2 mixture administration
|
|
Placebo Comparator: 2
Placebo (air) during the intervention
|
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.
Investigators
- Principal Investigator: Aubert AGOSTINI, MD, Assistance Publique des Hôpitaux de Marseille
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Estimated)
October 9, 2008
Study Record Updates
Last Update Posted (Actual)
May 7, 2026
Last Update Submitted That Met QC Criteria
May 4, 2026
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
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.