AbortionPhase 3NCT00769912
Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
A Phase 3 study testing 50% N2O- 50%O2 mixture in people with Abortion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Abortion
- What is being tested?
- 50% N2O- 50%O2 mixture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient having signed an assent waits having chosen to make the intervention under local anesthetic
Who cannot join
- Minor
- contraindication in the use of the paracetamol, the lidocaine
- Porphyries
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie Obstétrique, Hôpital La Conception
Marseille, 13005
About this study
To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.
- Conditions
- Abortion
- Being tested
- 50% N2O- 50%O2 mixture, Placebo (air)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50% N2O- 50%O2 mixtureDrug
50% N2O- 50%O2 mixture administration
Placebo (air)Drug
Placebo administration during the intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 50% N2O- 50%O2 mixture administration during the intervention Receives: Drug: 50% N2O- 50%O2 mixture |
| 2 | Placebo comparator | Placebo (air) during the intervention Receives: Drug: Placebo (air) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the intervention
Measured: 4 months
Secondary outcomes (1)
Pain at the end of the intervention and 2 hours after. Unwanted events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbortionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aubert AGOSTINI, MD, Principal investigator, Assistance Publique des Hopitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00769912
- Sponsor's protocol ID
- 2008-000799-25
- Other IDs
- 2008-10, 2008
- Status last verified
- Jan 2011
- First submitted
- 8 Oct 2008
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Agostini A, Maruani J, Roblin P, Champion J, Cravello L, Gamerre M. A double-blind, randomized controlled trial of the use of a 50:50 mixture of nitrous oxide/oxygen in legal abortions. Contraception. 2012 Jul;86(1):79-83. doi: 10.1016/j.contraception.2011.11.015. Epub 2012 Jan 20.
PubMed 22264664
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
- ClinicalTrials.gov ID
- NCT00769912
- Acronym / sponsor ID
- 2008-000799-25
- Conditions
- Abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 9 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 50% N2O- 50%O2 mixture50% N2O- 50%O2 mixture administration during the intervention |
| 2 | Placebo comparator | Drug: Placebo (air)Placebo (air) during the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major patient having signed an assent waits having chosen to make the intervention under local anesthetic
Key exclusion criteria (3 listed)
- Minor
- contraindication in the use of the paracetamol, the lidocaine
- Porphyries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 50% N2O- 50%O2 mixture50% N2O- 50%O2 mixture administration | Drug | 1 |
| Placebo (air)Placebo administration during the intervention | Drug | 2 |
Primary outcome
Pain during the intervention
Time frame: 4 months
1 secondary outcome
Pain at the end of the intervention and 2 hours after. Unwanted events
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 22264664Agostini A, Maruani J, Roblin P, Champion J, Cravello L, Gamerre M. A double-blind, randomized controlled trial of the use of a 50:50 mixture of nitrous oxide/oxygen in legal abortions. Contraception. 2012 Jul;86(1):79-83. doi: 10.1016/j.contraception.2011.11.015. Epub 2012 Jan 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aubert AGOSTINI, MD principal investigator
Assistance Publique des Hopitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 50% N2O- 50%O2 mixture in people with Abortion, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during the intervention (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00769912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.