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Home use of medical abortion with mifepristone + misoprostol up to 49 D.A. Istanbul congress 2006 ESC. Dr E. AUB E NY, FIAPAC, Paris. Home use of medical abortion with mifepristone + misoprostol up to 49 D.A. Definition Home use involves taking misoprostol at home Why ?
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Home use of medical abortion with mifepristone + misoprostol up to 49 D.A. Istanbul congress 2006 ESC Dr E. AUBENY, FIAPAC, Paris
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
D 1:600 mg mifepristoneimmediate departure from the center 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. Use up to 63 days – I will not speak of thıs because gemeprost is unstable and needs to be kept deep frozen dıffıcult for home use Dr E. AUBENY, Paris - Fiapac
D 1:600 mg mifepristoneimmediate departure from the center 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. I will speak only of the approved following protocol up to 49 D.A. Efficacy rate : 95.4 % Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. With thisprotocol 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
Home use of medical abortion up to 49 D.A. 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
Hemorrhage at expulsion Secondary effects Home use of medical abortion up to 49 D.A. Actually women stay at the hospital after misoprostol because doctors have Prostaglandıns FEAR 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. 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 In 1992 ın France problems with sulprostone (Nalador) happend (fatal cardiovascular reactions).It was replaced by misoprostol taken orally 400 µg For 20 years, misoprostol ıs used to prevent gastric ulcers when taking NSAIDs Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. • 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 Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. • Fear of misoprostol orally Suspicion about home use of 400µg of misoprostoltaken orally for abortion does not seem justified Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. • Fear of hemorrhage at the time of expulsion Trials* and experience show : • bleeding at the time of expulsion are non-cataclysmic.less abundant than wıthspontaneous abortions which are not hospitalized 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 * R. Petron 1995; Spitz, 1999 Dr E. AUBENY, Paris - Fiapac
Patients who expel at the hospital During the 3 hour stay 60% 38% Patients who expel out of the hospital 2% Beyond the 3 hours Before misoprostol Home use of medical abortion up to 49 D.A. • Fear of hemorrhage at the time of expulsion Actually 40% of women expel outside of the center after the 3-hour hospitalization • Fear of hemorrhage at the time of expulsion • does not seem justified Dr E. AUBENY, Paris - Fiapac
pelvic pains : gastro-intestinal disturbance : Home use of medical abortion up to 49 D.A. • Fear of secondary effects 400 µg misoprostol taken orally is well tolerated 20% require non narcotic pain killers, they can be taken at home transient and not severe, treatment (rarely needed) can be taken at home Fear of secondary effectsdoes not seem justified Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. So, after 15 years experience of hospital supervision it seems possible to take oral misoprostol at home Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. Is it possible to take oral misoprostol at home from a medical point of view ? 2- Trials performed to study home use Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A 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 Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. CHOICE French* and Swedish trials** Women were asked to choose between having misoprostol at home or in the hospital ? ? 120 (Fr) and 100 (Swe) women chose to go home • Dagousset I. et all. Gyn Obs et Fertilité 2004 ** Fiala C. et all. Contraception 2004; Dr E. AUBENY, Paris - Fiapac
French trial Results from 120 patients: Efficacy : 100% Unscheduled visits: 0 patients Swedish trial Results from 100 patients: Efficacy : 98% Unscheduled visıts: 5 patients Home use of medical abortion up to 49 D.A. Results from a medical point of view : From these trials, no medical problem with home use Dr E. AUBENY, Paris - Fiapac
In Guadeloupe (J. Bangou) up to 49 D.A. Publication of 100 cases without complications In reality, many more than 1 000 cases Home use of medical abortion up to 49 D.A. 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. Is home use of misoprostol possible from a psychological point of view ? Dr E. AUBENY, Paris - Fiapac
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 ofpain 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 Home use of medical abortion up to 49 D.A. Very good acceptability when women choose home use Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. 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 Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. To summarize Medical experience and trials show that from a medical and psychological point of view Hospitalization is not justified for oral mısoprostol Home use is possible Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. 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 Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A 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 Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A Home use of medical abortion is approved +/-,but used • 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 asurgıcal center Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. • 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 Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion up to 49 D.A. In some countries home use of medical abortion is not authorized, but used • InAustria, 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. Dr E. AUBENY, Paris - Fiapac
Home use of medical abortion in early pregnancy 3. Conclusion Dr E. AUBENY, Paris - Fiapac
From a medical point of view Up to 49 D.A. with the authorized European protocol :mifepristone 600 mg + misoprostol 400 orallyIt seemspossible that women can take misoprostol at home without significant risk Home use of medical abortion up to 49 D.A. Conclusion 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. 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