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.

Study Overview

• Status: Unknown
• Conditions: Surgical Abortion
• Intervention / Treatment: Drug: Mifegyne ®; Drug: Gymiso®

• Study Type: Interventional
• Enrollment (Anticipated): 198
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Recruiting
    • Assistance Publique Hopitaux de Marseille
    • Contact: Aubert AGOSTINI; Email: aubert.agostini@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mifepristone/misoprostol	Drug: Mifegyne ®; Drug: Gymiso®
Active Comparator: misoprostol	Drug: Gymiso®
Active Comparator: mifepristone	Drug: Mifegyne ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
reduction of the bleeding	24month

Secondary Outcome Measures

Outcome Measure	Time Frame
reduction of the complications	24 MONTHS

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: February 18, 2013
• First Submitted That Met QC Criteria: February 18, 2013
• First Posted (Estimate): February 20, 2013

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 29, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Abortifacient Agents; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Mifepristone
• Other Study ID Numbers: 2012-005276-34; 2012-36 (Other Identifier: AP HM)