Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination
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|ClinicalTrials.gov Identifier: NCT01795599|
Recruitment Status : Unknown
Verified August 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : February 20, 2013
Last Update Posted : September 1, 2014
More than 100 000 surgical abortions are annually performed in France. About four in ten women will have an abortion in their life. Abortion complications are cervical tearing (0.1-1.18%), uterine perforation (0.09-19.8‰), hemorrhage (1.5‰) and infection (5-20%). These complications can first compromise the vital prognosis and are involved in 10% of the worldwide maternal mortality (20 000 women by year), then lead to infertility which is hard to treat (uterine synechiae) or impossible to treat (hysterectomy for control of bleeding), and are finally responsible for obstetrical pathologies as late miscarriages or premature delivery due to cervical insufficiency. All that complications are linked to cervical laceration of the surgical abortion, that can be reduced by the recommended use of mifepristone or misoprostol as cervical preparation for the abortions after 12 weeks. However, it does not exist data evaluating the superiority of one of the two molecules or their combination. These data could optimize the cervical preparation and thus reduce the abortion complications with a direct impact on maternal mortality, infertility and obstetrical complications. Thus, it seems to be important to evaluate these two molecules and their combination.
Objectives To compare mifepristone, misoprostol and their combination in the cervical preparation of the surgical abortion between 12 and14 weeks for their efficacy, complications and side-effects.
|Condition or disease||Intervention/treatment||Phase|
|Surgical Abortion||Drug: Mifegyne ® Drug: Gymiso®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||August 2015|
Drug: Mifegyne ®
|Active Comparator: misoprostol||
|Active Comparator: mifepristone||
Drug: Mifegyne ®
- reduction of the bleeding [ Time Frame: 24month ]
- reduction of the complications [ Time Frame: 24 MONTHS ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795599
|Contact: aubert AGOSTINIemail@example.com|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: AUBERT AGOSTINI firstname.lastname@example.org|
|Study Director:||LOIC MONDOLONI||Assistance Publique Hopitaux De Marseille|