Surgical Abortion Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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