Status:
UNKNOWN
Cervical Preparation for Surgical Abortion at 12-14 Weeks: a Prospective, Randomized, Evaluator-blinded, Multicenter, Controlled Comparison Between Mifepristone, Misoprostol and Their Combination
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Surgical Abortion
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 per...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01795599
Start Date
May 1 2013
End Date
August 1 2015
Last Update
September 1 2014
Active Locations (1)
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1
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354