2. Dr E. AUBENY, FIAPAC, Paris Istanbul congress 2006 ESC Home use of medical abortion with mifepristone + misoprostol up to 49 D.A.

3. Home use of medical abortion with mifepristone + misoprostol up to 49 D.A Definition Home use involves taking misoprostol at home Why ? It makes medical abortion easier: - for women fewer visits to the hospital more privacy - for doctors less supervision (less physıcal but hıgh level of support) Is it possible ? Dr E. AUBENY, Paris - Fiapac

4. Use up to 63 days – I will not speak of thıs D 1: 600 mg mifepristone  immediate departure from the center because gemeprost is unstable and needs to be kept deep frozen dıffıcult for home use D 3: Gemeprost pessary  taken in the center with 3 h. of medical supervision in the center D 10 to 14  control visit Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

5. I will speak only of the approved following protocol up to 49 D.A. D 1: 600 mg mifepristone  immediate departure from the center Efficacy rate : 95.4 % D 3: 400 µg orally misoprostol  taken in the center with 3 h of medical supervision in the center D 10 to 14:  control visit Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

6. Home use of medical abortion up to 49 D.A. With this protocol is it possible to take misoprostol at home from - a medical point of view ? - a psychological point of view ? To answer these questions I will consider 1- 15 years experience of hospital supervision 2- Trials performed to study home use Dr E. AUBENY, Paris - Fiapac

7. Is it possible to take oral misoprostol at home from a medical point of view ? 1- 15 years experience of hospital supervision Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.

8. Actually women stay at the hospital after misoprostol because doctors have FEAR Prostaglandıns Secondary effects Hemorrhage at expulsion after 15-years experience and more than 1 500 000 abortions performed in Europe with this method are these fears always justified ? Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.

9.  For 20 years, misoprostol ıs used to prevent gastric ulcers when taking NSAIDs In 1992 ın France problems with sulprostone (Nalador) happend (fatal cardiovascular reactions). It was replaced by misoprostol taken orally 400 µg Home use of medical abortion up to 49 D.A.  It ıs use orally very largely worldwide for abortions  1 000 000 women have received mifepristone + misoprostol orally in France  Until now no pharmacovigilance problem with misoprostol taken orally  Fear of prostaglandıns Dr E. AUBENY, Paris - Fiapac

10.  Fear of prostaglandins: misoprostol 6 deaths have occurred in North America (4 in California), due to toxic shock syndrome caused by clostridium sordelli / 550 000 medical abortions. Nobody knows why this happens But toxic syndrome has always been associated with mifepristone 200mg + misoprostol 800µg taken vaginally for pregnancy up to 63 D.A. Symptoms start 2 or 3 days after administration of vaginal misoprostol. Hospital administration may not prevent the problem. Not necessarily related to home use of misoprostol Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

11. Suspicion about home use of 400µg of misoprostol taken orally for abortion does not seem justified Home use of medical abortion up to 49 D.A.  Fear of misoprostol orally Dr E. AUBENY, Paris - Fiapac

12. Home use of medical abortion up to 49 D.A.  bleeding at the time of expulsion are non-cataclysmic. less abundant than wıth spontaneous abortions which are not hospitalized Trials* and experience show : * R. Petron 1995; Spitz, 1999  few haemostatic aspirations : 0.3%, nearly all 10 to 15 days later Anyway women must be able to go to the hospital within one hour  Fear of hemorrhage at the time of expulsion Dr E. AUBENY, Paris - Fiapac

13. 38% Patients who expel out of the hospital Beyond the 3 hours Actually 40% of women expel outside of the center after the 3-hour hospitalization 60% Patients who expel at the hospital During the 3 hour stay 2% Before misoprostol  Fear of hemorrhage at the time of expulsion Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A. Fear of hemorrhage at the time of expulsion does not seem justified

14.  pelvic pains : 400 µg misoprostol taken orally is well tolerated 20% require non narcotic pain killers, they can be taken at home  gastro-intestinal disturbance : transient and not severe, treatment (rarely needed) can be taken at home  Fear of secondary effects Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A. Fear of secondary effects does not seem justified

15. So, after 15 years experience of hospital supervision it seems possible to take oral misoprostol at home Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

16. Is it possible to take oral misoprostol at home from a medical point of view ? 2- Trials performed to study home use Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

17. Trials have been carried out investigating the use of medical abortion up to 49 D.A. - In Europe: 2 reported, one in France, one in Sweden - In Tunisia, in Vietnam also but the protocols were a little different Home use of medical abortion up to 49 D.A Dr E. AUBENY, Paris - Fiapac

18. French* and Swedish trials** ? ? CHOICE Home use of medical abortion up to 49 D.A. Dagousset I. et all. Gyn Obs et Fertilité 2004 ** Fiala C. et all. Contraception 2004; 120 (Fr) and 100 (Swe) women chose to go home Women were asked to choose between having misoprostol at home or in the hospital Dr E. AUBENY, Paris - Fiapac

19. French trial Results from 120 patients: Efficacy : 100% Unscheduled visits: 0 patients Swedish trial Results from 100 patients: Efficacy : 98% Unscheduled visıts: 5 patients From these trials, no medical problem with home use Results from a medical point of view : Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.

20.  In Guadeloupe (J. Bangou)  up to 49 D.A.  Publication of 100 cases without complications  In reality, many more than 1 000 cases Other experiences of home use since 1992 :. No medical problem Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.

21. Is home use of misoprostol possible from a psychological point of view ? Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.

22. French trial Results from 120 patients : Anxiety (measured by the number of phone calls) 1 call : 23 patients 2 or 3 calls : 3 patients no call : 94 patients Use of pain killer : 47 patients 98.5% of patients find the procedure acceptable 77.5% of patients would recommend it : more privacy Swedish trial Results from 100 patients : Anxiety (measured by the number of phone calls) 1 call : 14 patients 2 to 5 calls : 5 patients no call : 80 patients Use of pain killer : 73 patients 96% of patients find the procedure acceptable 98% of patients would choose it again if necessary Very good acceptability when women choose home use Dr E. AUBENY, Paris - Fiapac

23. Women have chosen home use -In French and Swedish trials: - fewer visits to the hospital - more privacy - more comfortable In Tunisian and Vietnamese trials the same reasons for choosing home use were given. Home use of misoprostol seems possible from a psychological point of view Women should have the right to choose Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

24. To summarize Medical experience and trials show that from a medical and psychological point of view Home use of medical abortion up to 49 D.A. Hospitalization is not justified for oral mısoprostol Home use is possible Dr E. AUBENY, Paris - Fiapac

25. So, women could take misoprostol orally at home But things are difficult to change Home use of medical abortion is legal only in Sweden Authorized since 2004 for abortion up to 63 D.A. with mifepristone 200 mg + 800µg vaginally misoprostol, taken at home Limited use as yet Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

26. Home use of medical abortion is approved +/-,but used In France November 2004: approval granted to carry out medical abortion in private practice Patients must take mifepristone and misoprostol in the presence of doctors in their offices. They can leave immediately after. But many doctors know that pelvic pain and expulsion can happen very quickly after the oral intake of misoprostol. They are afraid of these happening on the way back home of the patient so they allow them to take misoprostol at home Home use of medical abortion up to 49 D.A Dr E. AUBENY, Paris - Fiapac

27. In France since November 2004: 14 000 abortions have been carried out by doctors in their private practice. The majority with home use of misoprostol. Until now no problems The procedure for private practice is very strict : - Doctors, to have the right to perform medical abortions, must sign an agreement with a private or public hospital center - Patients must - stay within one hour traveling time of a surgical center - have 24 hour phone access - have 24 hour access to a surgıcal center Home use of medical abortion is approved +/-,but used Home use of medical abortion up to 49 D.A Dr E. AUBENY, Paris - Fiapac

28. In the U.K. One trial has been performed on 49 women with 200mg of mifepristone + 600 µg sublingual misoprostol up to 56 D.A. - 1 woman came back to the hospital after misoprostol because she was worried - 1 woman had an aspiration for retained products of conception and excessive bleeding 98% of women were satisfied But Health Authorities are waiting for further trials to authorize home use Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

29. In some countries home use of medical abortion is not authorized, but used In Austria, Switzerland, Holland, S. Africa, some doctors allow women to take misoprostol at home. Impossible to say how many. In the U.S., it is used systematically. Most medical abortions are done at home up to 63 D.A. : 550 000 have been carried out. But the protocol is different. Home use of medical abortion up to 49 D.A. Dr E. AUBENY, Paris - Fiapac

30. Home use of medical abortion in early pregnancy 3. Conclusion Dr E. AUBENY, Paris - Fiapac

31. Conclusion  From a medical point of view Up to 49 D.A. with the authorized European protocol : mifepristone 600 mg + misoprostol 400 orally It seems possible that women can take misoprostol at home without significant risk  From a psychological point of view The patient must be able to choose: hospitalization or non- hospitalization for medical abortion In this case, abortion at home is very well accepted Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.

32. Conclusion Home use of medical abortion up to 49 D.A. New possibility for women It should be offered as a choice After 49 D.A. we have to be more cautious and to wait for the results of the U.K. trials and Swedish practice Dr E. AUBENY, Paris - Fiapac Home use of medical abortion up to 49 D.A.