Informations générales (source: ClinicalTrials.gov)
Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination
Interventional
Phase 3
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
mai 2013
août 2015
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille - 13354 - Marseille - France | AUBERT AGOSTINI | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Woman of 18 or more years old;
- Woman presenting a only intra-uterine pregnancy, the term of which is upper to 11
LIMITED COMPANIES 6 days and inferior strictly to 14 LIMITED COMPANIES,
estimated(esteemed) by echography by a measure of the crânio-caudal length included
between 55 and 84 millimeters; ·Woman wishing a TERMINATION OF PREGNANCY;
- Woman of 18 or more years old;
- Woman presenting a only intra-uterine pregnancy, the term of which is upper to 11
LIMITED COMPANIES 6 days and inferior strictly to 14 LIMITED COMPANIES,
estimated(esteemed) by echography by a measure of the crânio-caudal length included
between 55 and 84 millimeters; ·Woman wishing a TERMINATION OF PREGNANCY;
- minor Woman;
- Woman presenting a multiple pregnancy;
- Woman presenting an uterine deformation (compartmentalized womb, cocked hat, fibroid
praevia);
- Woman presenting a disorder of the coagulation defined by biological parameters
(TP(BUSINESS RATE,PRACTICAL CLASS,PRACTICAL CLASSES) < 70 %, TCA
report(relationship) patient / witness < 1,20);
- Woman presenting an allergy or a sentimentality known about one of the active
substances or about one of the excipients;
- Woman presenting a contraindication to the mifepristone: chronic suprarenal
insufficiency, unchecked severe asthma by treatment(processing), porphyrie
hereditary, allergy was known about the active substance or about one of the
excipients;
- Woman presenting a contraindication to the misoprostol: sentimentality in the active
substance, in one of the excipients or in the other prostaglandines;