Medical management of unwanted pregnancy in France: modalities and outcomes. The aMaYa study.

OBJECTIVES

Medical termination of pregnancy (MToP) has become more frequently used, and specific recommendations have been issued by the French Authorities regarding protocols. The aim of this prospective, multicenter, longitudinal observational study was to record actual practices and to describe efficacy and safety of drugs used for MToP in real-life conditions in France.

STUDY DESIGN

The study was performed between 2011 and 2012 in a representative sample of 47 centers dealing with abortions. Pregnant women with less than 14 weeks of amenorrhea, requesting MToP, for whom a drug regimen including mifepristone was decided, were recruited and information was recorded from the center and through the patient's auto questionnaire. The main efficacy parameter was complete abortion without surgical procedure.

RESULTS

A total of 1585 women (mean age: 27.6 ± 6.8 years) were included by 47 centers. At inclusion time, when women were given mifepristone, the mean term of pregnancy was 46.5 ± 7.8 days of amenorrhea (DA), the term was >49 DA for 28.3% of patients, and >63 DA for 1.6%. The most frequently used protocol was the one recommended by the French authorities (mifepristone 600 mg-misoprostol 400 μg oral), used in 35.4% of patients, but other protocols were used (mifepristone 600 mg or 200mg in association with misoprostol 2 × 400 μg per os, for respectively 23.4% and 13.5%). Gemeprost prostaglandin was used by 1.4% of patients only. Of the patients, 10.3% did not return to the center and were considered as lost to follow up. For the 1421 patients for whom information was available, the successful abortion rate was 94.4%. In the remaining 5.6% there were no ongoing pregnancies, but their condition required a secondary surgical procedure. Over 90% of the 1421 patients with follow-up were satisfied with the procedure. Safety was good, with only 16 cases of major bleeding(1%), and one of endometritis (0.1%) reported as serious adverse events.

CONCLUSION

Our study showed, in real-life settings, a high rate of success for MToP. Whatever the protocol used, this approach is effective, well tolerated, and satisfactory for the majority of patients.