NCT01795599

Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Surgical Abortion

Interventions

Type	Name	Description
DRUG	Mifegyne ®
DRUG	Gymiso®

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-02-01
• Completion: 2015-08-01
• First posted: 2013-02-20
• Last updated: 2014-09-01

Locations

1 site across 1 country: France