1. Elisabeth AUBENY, M.D. FIAPAC Broussais Hospital Paris - France The Western European experience of medical termination of early pregnancy

2. Presentation includes overview of : - Drug regimens - Procedure - Acceptability - General considerations E. AUBENY M.D. – FIAPAC, Paris

3. The Western European experience of medical termination of early pregnancy 1- Drug regimens two regimens are approved

4. E. AUBENY M.D. – FIAPAC, Paris The Western European experience of medical termination of early pregnancy 1-The regimen authorised since 1992 in France and since 1999 in all Western European countries where abortion is legal except Italie (Austria, Belgium, Denmark, Finland, Germany, Greece, Luxembourg, Norway, Spain,The Netherlands) Mifepristone 600mg + 48 h later, misoprostol 400µg taken orally up to 49 D.A. The success rate is 95.6%* 2-The regimen authorized since 1991 in U.K. and 1992 in Sweden Mifepristone 600mg ( 200mg may also now be used in U.K. ) + 48 h later gemeprost ( ONE PESSARY) up to 63 D.A. The success rate is 95%** Why two regiments ? During the development of medical abortion the first prostaglandin authorised in France was sulprostone. It was not registered in UK and another pg had to be tried. Gemeprost was available and was tested for use up to 63 days gestation. In 1992 sulprostone was changed for misoprostol in France, but not in U.K. * PeyronR,UlmannA, **Urquhart 1997

5. The Western European experience of medical termination of early pregnancy With these regimens more than 1.800 000 medical abortions have been carried out in Europe (1 000 000 in France) with only one major problem (woman who had prolonged and heavy bleeding and did not seek help) E. AUBENY, M.D. - FIAPAC, Paris

6. The Western European experience of medical termination of early pregnancy Two regimens are also used but are not approved E. AUBENY, M.D. - FIAPAC, Paris

7. E. AUBENY M.D. – FIAPAC, Paris The Western European experience of medical termination of early pregnancy 1- Mifepristone 200mg + misoprostol 800µg vaginally (often repeated twice) up to 63 D.A. The success rate is 96-98%* The decrease in the dose of mifepristone is compensated by an increased dose of misoprostol and vaginal administration. - But misoprostol is not approved for vaginal use.and this regimen has been associated with serious side effects in the USA - This dosage is also very painful 2 - Mifepristone 600mg + misoprostol oraly 400µg + 400µg 3 hours later (if no expulsion has happened) up to 49 D.A. The success rate is 99% This method gives a high rate of success with misoprostol taken oraly and has been used without any major problem since 10 years. It should be developed until 56 D. A. * (Ashok 1998) ** (Aubény E. Chatelier.G, 2000)

8. 2 - The procedure E. AUBENY, M.D. - FIAPAC, Paris The Western European experience of medical termination of early pregnancy

9. Day 1- decision of medical abortion and mifepristone administration pregnancy is under 49 D.A. Diagnosis based on last menstruation, physical exam, HCG dosage or ultrasound or both no contra-indication blood group, RH are known First Is medical abortion possible medically ? Possible if Choice of the patient (importance of explanation of the method) Second Is medical abortion possible psychologically ? Possible if patient returns home immediately E. AUBENY, M.D. - FIAPAC, Paris The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. - If the answer to these questions is yes  mifepristone 600mg, 3 tablets is administred - If some exams are missing or woman not decided about medical abortion  mifepristone administration is reported until results of exams and decision of woman Two questions have to be answered before starting medical abortion

10. D 3 - (48 h later) misoprostol administration E. AUBENY, M.D. - FIAPAC, Paris The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. Patient come back to the center and Misoprostol 400µg is taken oraly (two tablets) with 3 hours of monitoring at the centre patient leaves when she had expelled, or three hours later if she had not expelled at that time with contraception, vaccination RH if necessary Misoprostol administration at home is not yet legal in Europe

11. D 14 - 20 : confirmation of uterine vacuity E. AUBENY, M.D. - FIAPAC, Paris The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. if expulsion has not taken place in the centre uterine vacuity uterine vacuity is confirmed by ultrasound exam or by HCG level (decrease of 80% ten days after misoprostol) Physical exam to investigate complications ( infection rare)

12. E. AUBENY, M.D. - FIAPAC, Paris The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. Results: evaluation criteria pregnancy interruption with complete expulsion of the conceptus without need for any surgical procedure Success is ongoing pregnancy incomplete abortion requiring surgical procedure need for an haemostatic surgical procedure Failure is

13. Success rate  95.4% Failure rate  4.6%  Ongoing pregnancy  1.5%  Incomplete expulsion  2.8%  Need for haemostatic procedure  0.3% E. AUBENY, M.D. - FIAPAC, Paris The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. Results Success rate

14. Details of expulsion Blood loss E. AUBENY, M.D. - FIAPAC, Paris Bleeding  lasted12-14 days (more than with aspiration) The mean variation of haemoglobin  0.7mg Haemostatic curettage  0.8% Blood transfusion  0.1% The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. Results

15.  Nausea :42.8%need for treatment 1.2%  Vomiting :17.2%need for treatment 3.6% Digestive symptoms Pelvic pain No pelvic pain Need for minor analgesics Pelvic pain 60% 20% Immediate side effects E. AUBENY, M.D. - FIAPAC, Paris The procedure 1- Mifepristone 600mg + misoprostol 400µg taken orally up to 49 D.A. Results

16. Theprocedure 2- Mifepristone 600mg (or 200mg in UK) + gemeprost up to 63 D.A. (U.K., Sweden) The procedure is the same than with misoprostol

17. The procedure 2- Mifepristone 600mg (or 200mg in U.K.) + gemeprost up to 63 D.A. (U.K., Sweden) Success rate  94.8% Failure rate  6.2%  Ongoing pregnancy  0.3%  Incomplete expulsion  3.6%  Need for haemostatic procedure  2.3% Results E. AUBENY, M.D. - FIAPAC, Paris Success rate

18. The procedure 2- Mifepristone 600mg (or 200mg in U.K.) + gemeprost up to 63 D.A. (U.K., Sweden) Duration of bleeding  median of 12 days Pain  58.1% received analgesics which 28.5% narcotic analgesic Gemeprost is effective up to 63 D. A. but it is very expensive, can be more painful and must be kept in freezer E. AUBENY, M.D. - FIAPAC, Paris Details of expulsion

19. E. AUBENY M.D. – FIAPAC, Paris The Western European experience of medical termination of early pregnancy The procedure Places where medical abortions are performed  In most countries : The procedure is only allowed in public or private centres accredited by the government  Exceptions: Germany  Medical abortion is allowed in private practices  Mifepristone is directly delivered to doctors by the supplier France  Medical abortion is allowed in private practices if doctors have an agreement with an authorized centre  Mifepristone is bought by doctors in pharmacies

20. Women who have chosen medical abortion are very satisfied:  95% (Baird, U.K. 1992)  92% (Broussais Hospital, Paris) All French and UK studies show : Patients satisfaction E. AUBENY, M.D. - FIAPAC, Paris The Western European experience of medical termination of early pregnancy The acceptability

21. Reasons for patients’ choice of medical abortion (Broussais Hospital, 1998) E. AUBENY, M.D. - FIAPAC, Paris The Western European experience of medical termination of early pregnancy The acceptability It allows earlier abortion It is more natural there is no surgery or anesthesia It is on control of the woman It allows more privacy (very appreciated factor)

22. Two general considerations E. AUBENY, M.D. - FIAPAC, Paris The Western European experience of medical termination of early pregnancy

23. 1- Availability of medical abortion does not increase rate of abortion 80 82 84 86 88 90 91 92 93 94 95 96 Sweden UK France Year of introduction of MIFEGYNE ® Source: The Alan Guttmacher Institute New York From C.Fiala 25 20 15 10 5 Abortions per 1000 women aged 15 to 45

24. E. AUBENY, M.D. - FIAPAC, Paris Availability of medical abortion does not increase rate of abortion Total abortions Medical abortions In France 1997-2004 : the total number of abortions remains stable even with the increased use of medical abortion. 2004: 40% of all abortions +16%+20%+9%+15%+11% 0%+13% Use of medical abortion:

25. 2 - Medical abortion allows earlier abortions which are safer for example : Switzerland Percentage of abortions <8 weeks in Bern county (CH) From C.Fiala

26. E. AUBENY M.D. – FIAPAC, Paris The Western European experience of medical termination of early pregnancy In conclusion In all Western European countries where abortion is legal - medical abortion is authorised (except Italy) - it has been used for more many years with only one major problem The regimen used is generally that authorized by the medical authorities: mifepristone 600mg + misoprostol 400µg orally < 49 D.A. Medical abortion does not increase the number of abortions It allows for early abortion which is better medically and psychologically It is It is preferred by many women to surgical method Patients should be able to use it when they need it “Give them the choice”