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

NCT ID: NCT01795599

Last Updated: 2014-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

mifepristone/misoprostol

Group Type: EXPERIMENTAL

Mifegyne ®

Intervention Type: DRUG

Gymiso®

Intervention Type: DRUG

misoprostol

Group Type: ACTIVE_COMPARATOR

Gymiso®

Intervention Type: DRUG

mifepristone

Group Type: ACTIVE_COMPARATOR

Mifegyne ®

Intervention Type: DRUG

Interventions

Mifegyne ®

Intervention Type: DRUG

Gymiso®

Intervention Type: DRUG

Eligibility Criteria

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;

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LOIC MONDOLONI

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

aubert AGOSTINI

Role: CONTACT

aubert.agostini@ap-hm.fr

Facility Contacts

AUBERT AGOSTINI

Role: primary

aubert.agostini@ap-hm.fr

Other Identifiers

2012-36

Identifier Type: OTHER

Identifier Source: secondary_id

2012-005276-34

Identifier Type: -

Identifier Source: org_study_id