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




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



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 ?



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


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


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



Suspicion about home use

of 400µg of misoprostol taken orally for abortion

does not seem justified


Fear of misoprostol orally



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


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





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



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



Is it possible to take oral misoprostol at home from a medical point of view ?

2- Trials performed to study home use



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


French* and Swedish trials**

? ? CHOICE


•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


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 :



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



Is home use of misoprostol possible from a psychological point of view ?




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


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



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


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 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



• 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



• 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



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 in early pregnancy

3. Conclusion


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



Conclusion


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, fiapac, paris istanbul congress 2006 esc home use of medical abortion with...

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