1. Russian experience of medical abortion T. Astakhova, A. Kuzemin, D. Jerdev Research Center for Obstetrics, Gynecology and Perinatology (Director – professor V.I. Kulakov) Moscow 2005

2. Russian experience in medical abortions for pregnancy termination 1975-80 yr. – synthetic analogues of PR 1975-80 yr. – synthetic analogues of PR 15 ме РgF2α, hemeprost, sulproston 15 ме РgF2α, hemeprost, sulproston 1982-90 yr. – synthetic steroid drugs – 1982-90 yr. – synthetic steroid drugs – antiprogestins antiprogestins RU-486 (mifepristone), mifegin RU-486 (mifepristone), mifegin 1993-2005 yr.– antiprogestins + PG 1993-2005 yr.– antiprogestins + PG mifepristone, penkrofton misoprostol mifepristone, penkrofton misoprostol

3. Russian pharmacies MIFEPRISTONE MIFEPRISTONE MIR-PHARMA MIR-PHARMA PENCROFTON PENCROFTON PENCROFT-PHARMA PENCROFT-PHARMA

4. Clinical research of mifepristone Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia Research Center for Obstetrics, Gynecology and Perinatology, Moscow, Russia Sechenov Medical Academy Clinic for Obstetric and Gynecology, Moscow Sechenov Medical Academy Clinic for Obstetric and Gynecology, Moscow Military-medical Academy, St-Petersburg Military-medical Academy, St-Petersburg V.N.Gorodkov’ Research Center for Mother and Child, V.N.Gorodkov’ Research Center for Mother and Child, Ivanovo Ivanovo Professional Association of Gynecologists-oncologists, Professional Association of Gynecologists-oncologists, St-Petersburg St-Petersburg Republican Medical center «Family», Cheboksari Republican Medical center «Family», Cheboksari

5. State Pharmacologic Committee Public Health Service has approved use of mifepristone (Reg. № 002340/0102003 от 07/04/2003 г.). and was recommended for clinical use.

6. INDICATIONS Request of patient Request of patient Uterine pregnancy (less than 6 weeks) confirmed by ultrasound Uterine pregnancy (less than 6 weeks) confirmed by ultrasound Women, who might have some difficulties when performing instrumental evacuation: Women, who might have some difficulties when performing instrumental evacuation: -uterine malformation -uterine malformation -pregnancy and intact uterine hymen -pregnancy and intact uterine hymen

7. CONTRAINDICATIONS Ectopic pregnancy or suspicion on ectopic pregnancy Ectopic pregnancy or suspicion on ectopic pregnancy Adrenal insufficiency Adrenal insufficiency Long-term corticosteroid therapy Long-term corticosteroid therapy Renal and hepatic insufficiency Renal and hepatic insufficiency Allergic reaction on mifepristone and misoprostol Allergic reaction on mifepristone and misoprostol Blood diseases and anticoagulant therapy Blood diseases and anticoagulant therapy Big size uterine myomas Big size uterine myomas STD in acute stage STD in acute stage

8. Recommended check-up Counseling Counseling Gynecologic exam Gynecologic exam Ultrasound Ultrasound Analysis for HIV, syphilis, Hepatitis B, C Analysis for HIV, syphilis, Hepatitis B, C Blood group, Rh Blood group, Rh Vaginal specimen Vaginal specimen Analysis for β-HCG Analysis for β-HCG Coagulogramm Coagulogramm Blood clinical analysis Blood clinical analysis

9. Induced abortion: protocol and dynamic observation Visit 1 Confirmed uterine pregnancy no more than 6 Visit 1 Confirmed uterine pregnancy no more than 6 weeks (42 days of amenorrhea) weeks (42 days of amenorrhea) Informed consent Informed consent Mifepristone (600 mg per os) Mifepristone (600 mg per os) Visit 2 After 36-48 hours Visit 2 After 36-48 hours Prostaglandins (misoprostol) Prostaglandins (misoprostol) 400 mgr per os 400 mgr per os Visit 3 10-14 days later after mifespristone Visit 3 10-14 days later after mifespristone administration administration Efficacy of induced abortion Efficacy of induced abortion (clinical exam, ultrasound). (clinical exam, ultrasound).

10. Clinical description of induced abortion I period - latent Characterized by absence of clinical manifestations of pregnancy termination during 24-48 hours (28,6±2.3) from the mifepriston administration II period - main Characterized by menstrual-like reaction, appearing with mild to moderate bleeding which lasts for 5-18 days

11. EFFICACY CRITERIA - Normal uterine size, absence of painful feelings, there may be mild blood spots - Absence of embryonal sac or its elements in uterine, confirming by ultrasound - Decrease of  -HCG in blood sample

12. Dynamic in decrease of the hormone’s levels

13. Ultrasound examination before and 14 days later after mifepristone administration Before 14 days after

14. Mifepristone concentration in serum after its using

15. CLINICAL EFFICACY MEDICAL ABORTION (%) ACCORDING THE USED PROTOCOLS CLINICAL EFFICACY MEDICAL ABORTION (%) ACCORDING THE USED PROTOCOLS Research Center for Obstetrics, Gynecology and Perinatology 100% 0 % 88%98%

16. SIDE-EFFECTS, % (n=2565) Research Center for Obstetrics, Gynecology and Perinatology

17. Complications after instrumental and medical abortion (%) Complications after instrumental and medical abortion (%) Research Center for Obstetrics, Gynecology and Perinatology %

18. Failure of medical abortion Progressive pregnancy or incomplete abortion Vacuum aspiration/ Surgical curettage

19. ADVANTAGES OF MEDICALLY INDUCED ABORTION High efficacy 98 %, safety and complience High efficacy 98 %, safety and complience Absence of complications vs instrumental abortion: mechanical damage of uterine and uterine vessels, cervix injury Absence of complications vs instrumental abortion: mechanical damage of uterine and uterine vessels, cervix injury Decreases of possibility of ascending infection and complications dealing with it Decreases of possibility of ascending infection and complications dealing with it No risk of anesthesia (no need) No risk of anesthesia (no need) Mifepristone is the drug of choice in nulliparous Mifepristone is the drug of choice in nulliparous No psychogenic sequelae No psychogenic sequelae High acceptability of method results High acceptability of method results