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

NCT01795599 | Unknown Phase 3

• 2 other identifiers: 2012-005276-342012-36
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• reduction of the bleeding

  24month

Secondary Outcomes (1)

• reduction of the complications

  24 MONTHS

Study Arms (3)

mifepristone/misoprostol

EXPERIMENTAL

Drug: Mifegyne ®; Drug: Gymiso®

misoprostol

ACTIVE COMPARATOR

Drug: Gymiso®

mifepristone

ACTIVE COMPARATOR

Drug: Mifegyne ®

Interventions

Mifegyne ® DRUG

mifepristone; mifepristone/misoprostol

Gymiso® DRUG

mifepristone/misoprostol; misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Interventions

Mifepristone

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

aubert AGOSTINI

CONTACT

aubert.agostini@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: May 1, 2013
• Primary Completion: February 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

FR (1)