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

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

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

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

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

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

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

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

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 hours Visit 2 After hours Prostaglandins (misoprostol) Prostaglandins (misoprostol) 400 mgr per os 400 mgr per os Visit days later after mifespristone Visit days later after mifespristone administration administration Efficacy of induced abortion Efficacy of induced abortion (clinical exam, ultrasound). (clinical exam, ultrasound).

Clinical description of induced abortion I period - latent Characterized by absence of clinical manifestations of pregnancy termination during 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

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

Dynamic in decrease of the hormone’s levels

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

Mifepristone concentration in serum after its using

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%

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

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

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

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