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Sponsored by: |
Assistance Publique Hopitaux De Marseille |
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Information provided by: | Assistance Publique Hopitaux De Marseille |
ClinicalTrials.gov Identifier: | NCT00769912 |
To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.
Condition | Intervention | Phase |
---|---|---|
Abortion |
Drug: 50% N2O- 50%O2 mixture Drug: Placebo (air) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia |
Estimated Enrollment: | 72 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
50% N2O- 50%O2 mixture administration during the intervention
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Drug: 50% N2O- 50%O2 mixture
50% N2O- 50%O2 mixture administration
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2: Placebo Comparator
Placebo (air) during the intervention
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Drug: Placebo (air)
Placebo administration during the intervention
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Service de Gynécologie Obstétrique, Hôpital La Conception | |
MARSEILLE, France, 13005 |
Principal Investigator: | Aubert AGOSTINI, MD | Assistance Publique des Hopitaux de Marseille |
Responsible Party: | Assistance Publique Hopitaux De Marseille ( Assistance Publique Hopitaux De Marseille ) |
Study ID Numbers: | 2008-000799-25, 2008-10 |
Study First Received: | October 8, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00769912 |
Health Authority: | France: Ministry of Health |