Dr E. AUBENY, FIAPAC, Paris Istanbul congress 2006 ESC Home use of medical abortion with...
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Transcript of Dr E. AUBENY, FIAPAC, Paris Istanbul congress 2006 ESC Home use of medical abortion with...
Dr E. AUBENY, FIAPAC, Paris
Istanbul congress 2006ESC
Home use of medical abortion with mifepristone + misoprostol up to 49 D.A.
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
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
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
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
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.
Actually women stay at the hospital after misoprostol because doctors have
FEARProstaglandıns
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.
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
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
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
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
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
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
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
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
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
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
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.
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.
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.
Home use of medical abortion up to 49 D.A.
French trialResults from 120 patients :
• Anxiety (measured by the number of phone calls)
1 call : 23 patients2 or 3 calls : 3 patientsno call : 94 patients
• Use of pain killer : 47 patients
98.5% of patients find the procedureacceptable
77.5% of patients would recommend it :more privacy
Swedish trialResults 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 procedureacceptable
98% of patients would choose it againif necessary
Very good acceptability when women choose home use
Dr E. AUBENY, Paris - Fiapac
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
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
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
Home use of medical abortion is approved +/-,but used
• In FranceNovember 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
• 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
• 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
In some countries home use of medicalabortion 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
Home use of medical abortion in early pregnancy
3. Conclusion
Dr E. AUBENY, Paris - Fiapac
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.
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.