NCT00769912

Brief Summary

To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

May 7, 2026

Status Verified

January 1, 2011

Enrollment Period

4 months

First QC Date

October 8, 2008

Last Update Submit

May 4, 2026

Conditions

Abortion

Outcome Measures

Primary Outcomes (1)

  • Pain during the intervention

    4 months

Secondary Outcomes (1)

  • Pain at the end of the intervention and 2 hours after. Unwanted events

    4 months

Study Arms (2)

1

EXPERIMENTAL

50% N2O- 50%O2 mixture administration during the intervention

Drug: 50% N2O- 50%O2 mixture

2

PLACEBO COMPARATOR

Placebo (air) during the intervention

Drug: Placebo (air)

Interventions

50% N2O- 50%O2 mixtureDRUG

50% N2O- 50%O2 mixture administration

1
Placebo (air)DRUG

Placebo administration during the intervention

2

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Gynécologie Obstétrique, Hôpital La Conception

Marseille, 13005, France

Location

Related Publications (1)

  • 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.

    PMID: 22264664RESULT

MeSH Terms

Interventions

Air

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Aubert AGOSTINI, MD

    Assistance Publique des Hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

February 1, 2009

Study Completion

June 1, 2009

Last Updated

May 7, 2026

Record last verified: 2011-01

Locations

FR(1)