2. Dr E. AUBENY, Paris FIAPAC ESC Budapest Seminar 2003 Medical abortion by mifepristone at home ?

3. Dr E. AUBENY - Fiapac Paris Present protocol of medical abortion by mifepristone is : D 1 : 600 mg mifepristone  immediate departure from the center Efficacy rate : 95.4 % D 3 : 400 µg misoprostol  3 h. of medical supervision in the center D 10 to 14  control visit Medical abortion by mifepristone at home ?

4. Definition What is “medical abortion at home” ? It is the possibility to skip the visit to the hospital in order to take misoprostol (Cytotec), and take it at home This possibility would make medical abortion easier Dr E. AUBENY - Fiapac Paris

5. Dr E. AUBENY - Paris, Fiapac Medical abortion by mifepristone at home ? 1- Is a non-hospitalisation after misoprostol (Cytotec) possible from a medical point of view?

6. Dr E. AUBENY - Paris ’ Fiapac  < 42 D.A. 1983 - 1987 : abortion by mifepristone only Medical abortion by mifepristone at home ?  No hospitalisation  No medical problem  But efficacy rate of 80 %

7. Dr. E. AUBENY, Paris, Fiapac Medical abortion by mifepristone at home ?  < 49 D.A. Since 1987 : abortion by mifepristone + prostaglandins  Efficacy of 95.4 %  hospitalisation of 3 hours at the center

8. Dr E. AUBENY - Paris, Fiapac Why women stay at the hospital after prostaglandins FEAR Prostaglandins Secondary effects Hemorrhages at expulsion Are these fears justified after a 10-year experience with misoprostol ? Medical abortion by mifepristone at home ?

9. Dr E. AUBENY - Paris, Fiapac Why women stay at the hospital after prostaglandins :  For 20 years, daily use all over the world to prevent gastric ulcers when taking AINS Replaced in 1992 by 400 µg misoprostol (Cytotec) taken orally Medical abortion by mifepristone at home ?  Very large use worldwide for abortions  1 000 000 women have received mifépristone + misoprostol orally in France  No pharmacovigilance problem whatsoever  Fear of prostaglandins (problem with sulprostone)

10. Dr E. AUBENY - Paris, Fiapac Why women stay at the hospital after prostaglandins : Misoprostol (Cytotec) Suspicion towards misoprostol taken orally as a drug for abortion is not justified Medical abortion by mifepristone at home ? No need for a medical supervision in hospital  Fear of prostaglandins

11. Dr E. AUBENY, Paris, Fiapac Why women stay at the hospital after prostaglandins :  late bleeding :10 to 15 days later Medical abortion by mifepristone at home ?  few non-cataclysmic bleeding at the time of expulsion French* and American** trials show :  few haemostatic aspirations : 0.3 %  Fear of haemorrhage at the time of expulsion * R. PEYRON, 1995; **Spitz, 1999

12. Dr E. AUBENY, Paris, Fiapac Why women stay at the hospital after prostaglandins : I.V.G.Non-urgent aspiration with mifepristoneon the day 19971 0813 19981 1124 19991 2124 Center Orthogénie Broussais : few hemorrhages non cataclysmic Medical abortion by mifepristone at home ?  Fear of haemorrhage at the time of expulsion *Dagousset I ; non published

13. 38% Patients who expel out of the hospital Beyond the 3 hours Dr E. AUBENY, Paris, Fiapac Why women stay at the hospital after prostaglandins : the 3-hour hospitalisation is not logical 40% of women expel outside of the center 60% Patients who expel at the hospital During the 3 hours Medical abortion by mifepristone at home ? 2% Before Misoprostol  Fear of haemorrhage at the time of expulsion

14. Dr E. AUBENY, Paris, Fiapac Why women stay at the hospital after prostaglandins :  Few haemorrhages, non cataclysmic, less abundant than spontaneous abortions which are not hospitalised To summarise Medical abortion by mifepristone at home ?  But precautions to be taken :  No more than one hour drive from the center  Possibility to go to the centre day and night  Fear of haemorrhage at the time of expulsion

15. Dr E. AUBENY -, Paris, Fiapac Why women stay at the hospital after prostaglandins :  pelvic pains : with 4OO µg misoprostol orally, they are endurable Medical abortion by mifepristone at home ? only 20 % of non morphinic pain killers, they can be taken at home  digestion troubles : non frequent treatment, they that can be taken at home  Fear of secondary effects

16. Dr.E. AUBENY -Paris, Fiapac Why women stay at the hospital after prostaglandins : Fear of prostaglandins Fear of haemorrhage Fear of secondary effects To summarise, the French and U.S trials show from a medical point of view that : Medical abortion by mifepristone at home ? Hospitalisation is not justified, neither by the fear of prostaglandins, nor by fear of haemorrhages, nor by fear of secondary effects

17. Dr E. AUBENY, Paris, Fiapac Foreign experiences go in the direction of misoprostol at home No problem whatsoever  In Guadeloupe (J. Bangou)  Publication about 100 cases without any problem  In reality, more than 1 000 cases  Until 49 D.A. Ambulatory medical abortion  In the U.S.A.  more than 80.000 cases now  until 56 D.A.. Medical abortion by mifepristone at home ?

18. Dr. E. AUBENY, Paris, Fiapac 2 – Is a non-hospitalisation after misoprostol (Cytotec) possible from a psychological point of view? Medical abortion by mifepristone at home ?

19. Dr E. AUBENY - Paris, Fiapac Acceptability by women French trial* ?? Possibility to choose Medical abortion by mifepristone at home ? Dagousset I. and al, in press 120 women chose to go home

20. Medical abortion by mifepristone at home ? Results for 120 patients : No major undesirable event Acceptance of the protocol : 100 % Anxiety (valued by the number of phone calls) - 1 call : 23 patients, 2 to 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 Acceptability by women Dr E. AUBENY - Paris, Fiapac

21. Dr.E. AUBENY - Paris, Fiapac Medical abortion by mifepristone at home ? 3. Conclusion

22. Conclusion  From a medical point of view Until 49 D.A. with the present European protocol : mifépristone 600 mg + misoprostol 400 orally possible to have misoprostol at home without any risk Medical abortion by mifepristone at home ?  From a psychological point of view The patient must be able to choose : hospitalisation or non-hospitalisation In these cases, abortion at home is very well accepted New possibility for women They must be able to choose it Dr.E. AUBENY - Paris, Fiapac