Mifepriston in emergencycontraception V.N.Prilepskay., А.А.Kuzemin, Т.А.Nazarenko, Т.М.Astakhova Research Centre of Obstetrics, Gynecology & Perinatology Moscow,Russia
Мifepriston Synthetic steroid, derivative of nortetisteron with antigestagen activity. Main indication for the use in medical abortion Additional indications: • Treatment of uterine leiomyoma • Emergency contraception
Three regimens were studied for emergency contraception during 120 hrs after unprotected coitus • Single dose of Mifepriston – 10mg • Single dose of levonorgestrel – 1,5 мg • Two doses of levonorgestrel with an interval of 12 hrs
Exclusion criteria: • Other methods of contraception used at the moment • Pospartum period • Adrenal insufficiency • Thromboses in аnamnesis • Severe diabetes mellitus • Genital masses
Study design included four visits • Screening • On days 7-8 after the intended menstruation onset • On days 7-8 of the following menstrual cycle • Two months later the 3-rdvisit
Drawbacks: • Small number of cases • Absence of control group
Main directions in the study of emergency contraception: • Objective :improvement of emergency methods • Creation of international consortium on emergency contraception. • Enhancement of the WHO studies on that theme. • Study of efficacy and comparison of different methods (Youzpe method, levonorgestrel and mifepriston in different doses). • Prolongation of an interval after an unprotected coitus (from 72 tо 120 hrs).
Inclusion criteria: • Unprotected coitus not more than 72 hrs tо visit. • Reproductive age • Regular menstrual cycle during the last three months • None of psychic pathology • Patient”s consent
Results: • No pregnanciesin any of 30 patients. • Side effects in 5 (16%) patients on 2 – 3 visits in the form of long (in average up to 46 days) or postponed cycles- 34-36 days. • By the 4 visit cycle was regylar in all patients • None of any other side effects V.N.Prilepskay., А.А.Kuzemin,Т.А.Nazarenko, Т.М.Astakhova2004.
Clinical Trials Clinical trials os these indications were carried out in Russia for the first time at the Research center of Obstetrics, Gynecology and Perinatology of the Russian Academy of Medical Sciences. Coordinator of the trial was academican Vladimir I.Kulakov A total of 30 women were investigated.
Mifepriston (tablets10 мg) (Мir-Pharm) • As a means of emergency contraception it was registered in Russia in 2004 after clinical trials and was approved for clinical practice.
Indications for emergency contraception • Absence of any contraception in regular sexual contacts • Rupture of condom • IUD expulsion during the cycle of the study • Sexual abuse Age from 18 till 33 лет, mean age 23,8+/-1,7.
Methods of study • Clinical (anamnesis data, examinations etc.) • Blood tests,urine tests, biochemical tests • Bacterioscopy of vaginal discharge • Tests for genital infections,IVF. • Sonography of pelvis minor with Doppler modes. • Tests for CG in blood. • Interrogation
Major parameters of effficiency • No pregnancies А) verified by ultrasonography В) verified by tests for Chorionic gonadotropin in blood plasma General criterion of is a number of pregnancies/number of women using Mifepriston
Objectives • To assess efficacy and safety of a low-dose mifepristone(10мг) in emergency contraception.
Conclusion • «Mifepriston retards ovulation that mean prolonged cycle and later onset of the following menstruation»
Conclusion • «The per cent of pregnancies occuringin the following cycle after Mifepriston used for emergency contraception is high in case of unprotected coitus (22%),that determines the necessity to use contraception or continence.»
Conclusion • «All three regimens are very efficient for emergency contraception and prevents a high per cent of pregnancies if taken during the first 5 days.» (Randomized double blind study in 15 family planning clinics in 10 сountries (4136 healthy women with regylar menstrual cycle)). Helene von Hertzen et al. Lancet 2002, 360:1803-10
Further investigations • Comparison of Mifepriston effect in the dose of 10 мgin different regimens of use: 72 and 120 hrs after unprotected coitus. Intended design: 150 patients in each group
Conclusion • Results of the study tesify of a high effect of a single dose • Of Мifepriston (10 мг) as a method of emergency contraception and rather good tolerance of it. Most typical side effect (in 6 patiens, 20 %) –is menstrual disoders during the first two cycles after the witgdrawal of it.