Christian Fiala
Profession: Specialist in Obstetrics and Gynaecology, General Pracitioner
Affiliation: Gynmed Clinic, Vienna
Past President
- Specialist in Obstetrics and Gynaecology, General Pracitioner
- PhD at the Karolinska Institutet in Stockholm, http://diss.kib.ki.se/2005/91-7140-458-9/
- Medical Director, Gynmed Clinic for Contraception and Abortion, Vienna and Salzburg, Austria: www.gynmed.at
- Member of the Research Group in Reproductive Health at the Karolinska University Hospital, Stockholm, Swedenwww.reproductivehealthresearch.org
- Past-president of the International Federation of Professional Abortion and Contraception Providers, FIAPAC
- Founder and Director of the Museum of Contraception and Abortion, Vienna, www.muvs.org
- Organising a website on the life-saving drug misoprostol to make it more available: www.misoprostol.org
Speeches:
-
Are the laws patient centred?
Christian Fiala, MD, PhD, Gynmed Clinic, Vienna, AustriaFor most women the diagnosis of an unwanted pregnancy is unexpected. The women are
therefore unprepared, be it for carrying the pregnancy to term or having an abortion. They
need a great deal of information within a very short space of time. In case they have taken
the decision to terminate the pregnancy, it is crucial for them to get fast access to medical
facilities.
It is interesting to analyse legal requirements and regulations in European countries, as to
how far they support the women in this crisis situation in finding a solution.
Societies react differently to the needs of the women, although the past was dominated by
a rigid paternalism, coupled with beliefs that pregnant women could not responsibly make
decisions regarding their own pregnancy. Society therefore “had” to intervene in order to
ensure that the “right” decision was taken.
A huge progress has been made over the last decades to overcome this approach and the
legalisation of abortion has been a corner stone. However there are still many remnants of
the old thinking like obligatory waiting (“cool off”) periods of an arbitrary number of days or
an obligatory counselling.
So far there is no evidence that these restrictions are of any benefit. They do, however,
lead to a delay in the provision of the treatment and have negative effects on the physical
and psychological experience of those affected.
Examples and comparions of european coutries are given in the presentation. -
Cervical dilatation with misoprostol in pre- and postmenopausal non-pregnant women
Kevin Sunde Oppegaard, MD, Ph.D., Hammerfest Hospital, Norway
Two randomised controlled trials to investigate whether misoprostol is effective for cervical ripening in non-pregnant women were conducted between 2006 and 2009 at Ullevål University hospital, Oslo, Norway.
In the first trial, one thousand micrograms of self-administered vaginal misoprostol taken 12 hours before day-care operative hysteroscopy showed a significant cervical ripening effect, compared with placebo. However, this effect is limited to premenopausal women; in postmenopausal women, there was no difference in cervical dilatation between the placebo and misoprostol groups. This trial was the first to allocate women referred to hysteroscopy according to their menopausal status and therefore provided a conclusion that was not subject to sub-group nor post-hoc analysis. In premenopausal women receiving misoprostol, a greater number had a satisfactory preoperative cervical dilatation, as compared with women receiving placebo. Dilatation of the cervix was easier and quicker in premenopausal women
receiving misoprostol.
In the second trial, one thousand micrograms of self-administered vaginal misoprostol taken 12 hours before day-care operative hysteroscopy results in significant cervical ripening in postmenopausal women, compared with placebo, after 14 days pre-treatment with vaginal estradiol tablets. Cervical dilatation in the postmenopausal study participants was easier and comparable to the premenopausal women from the first trial. Self-administered vaginal misoprostol at home the evening before operative hysteroscopy is safe and highly acceptable. Few side effects were reported. There is a risk of moderate lower abdominal pain and light preoperative bleeding with this regimen, which is inexpensive and easy to use.
-
Closing remarks: How to move forward
Christian Fiala (Austria)
Gynmed Clinic, Vienna, Austria
christian.fiala@aon.at
When applying evidence-based medicine, it becomes obvious that there is no sensible alternative to unrestricted access to effective contraception and safe, legal abortion paid for by social security. In fact, these provisions are inseparably connected with respect for women and their needs. But respecting women implies giving them the power to decide over every aspect of their fertility. History provides us with an abundance of examples and social experiments where societies have patronised women to various degrees. Even forced routine gynaecological examinations have been tried in an attempt to compel women to carry their unwanted pregnancies to term.
All these initiatives have led to a complete failure in fulfilling the intended goal: To bring a country to glory by increasing its population and military power. However, all these attempts had negative or even catastrophic consequences for the health and survival of women, as well as for societies as a whole.
Respecting women therefore implies that we truly give women and couples full power to decide over their reproductive choices. It also implies that we must eliminate all remaining obstacles and patronizing restrictions.
Since women get pregnant by men’s actions, men have a special obligation to provide the legal setting and financial support so that women can decide and act freely on a pregnancy.
-
Future perspectivesThe current situation in abortion care should be
improved on two levels: medical and social. On
both levels the focus needs to be the pregnant
woman rather than external factors.
On the medical level we need to give more
autonomy to the woman coming for an abortion.
The procedure still is very much controlled by
the medical system and women are forced to
follow the rules. There is a huge potential for
more autonomy especially in medical abortion,
which will be done at home in the future, only
the drug needs to be bought in the pharmacy
or drugstore, just like the pregnancy test. This is
already reality for example in India.
Also we urgently need better means to effectively
control pain associated with the medical and
surgical procedure and for medical abortion we
need to reduce duration of bleeding.
Equally important are improvements on a social
level: real self-determination. Women and couples
need the legal framework to freely decide on a
pregnancy and as well all necessary means to
execute their decision. We have made a huge
progress from archaic interdiction of abortion to the
current legal status. However there still are many
paternalistic remnants when it comes to abortion. -
Christian Fiala, MD, PhD, Gynmed clinic, Vienna, Austria
During her 35 years of fertility, a woman experiences an average of 15 pregnancies and 8-10 deliveries, resulting in 6-8 surviving children that she breastfeeds for 2 years each. Then she finally arrives at menopause, if she is still alive. This is natural fertility, undisturbed by artificial interventions. Understandably, such abundant fertility is far too much for most people, men included. Therefore, women desperately sought ways to reduce fertility to the best of their ability.
It was not until the last century that this goal was finally reached. The first step was to understand how fertility works, which was accomplished with the discovery of fertile days by Knaus and Ogino in the 1920s. The second step was to provide means of effective fertility control with hormonal contraception and safe IUDs in the 1960s. With the introduction of effective contraception, the dream of humanity - to separate fertility from sex - came true. Obviously, this could only be done with pro-active and artificial interventions to overcome the natural course of maximum fertility.
50 years later, much of the world's population not only enjoys sexual freedom as a consequence of effective artificial contraception, but also an impressive standard of living and an unprecedented degree of self-determination. But instead of enjoying this advance, an increasing number of people reject effective contraceptive methods. They don’t want to ‘pump hormones in their body’, don’t want to have a foreign body (IUD) in their uterus, or don’t want to mess around with diaphragms or condoms. Instead they strive for a ‘natural’ way, which has never existed on this earth. Such futile striving can only be understood as a search for a lost paradise.
As health professionals, we must revive and reinforce the knowledge that limiting natural fertility can only be done by using an effective and ongoing means of artificial contraception. We need to develop ways to achieve that goal.
-
How to diagnose a complete medical abortion
Christian Fiala (Austria)
Gynmed Clinic, Vienna, Austria
christian.fiala@aon.at
The most widely used definition of a successful medical abortion is the avoidance of a surgical intervention.
Treatment will result in complete abortion in the vast majority of patients (³95%). However, a small percentage will experience incomplete abortion, missed abortion or continuing pregnancy.
The following methods are used for evaluating the outcome of treatment at follow-up:
- Visual verification of expulsion following intake of misoprostol,
- history of clinical events (heavy or continuous bleeding and pain),
- gynaecological examination,
- hCG in serum measured quantitatively,
- hCG in urine, using a rapid test with a high cut-off value,
- ultrasound examination.
The gestational age at the beginning of treatment must also be taken into consideration when considering the diagnostic method used at follow-up. This is because an intrauterine pregnancy becomes difficult or even impossible to diagnose prior to 5 weeks gestation.
So far no standard has been described for the evaluation of successful treatment and various methods are used in clinical practice. Also, the time delay between mifepristone intake and the follow-up visit varies widely. There is no consensus about a recommended time delay and different providers offer various delays between a few days to 3 weeks.
-
How to verify success hCG or ultrasound
Christian Fiala, MD, PhD, Gynmed Clinic, Vienna, Austria
Objectives: Medical abortion with Mifepristone and Misoprostol is effective in 95-98.6% of
cases. We compared ultrasound examination and HCG testing to determine the
effectiveness of the treatment.
Study Methods: 217 women with an unwanted pregnancy up to 49 days of amenorrhea
were treated between 26 April and 10 November 1999. They received 600mg Mifepristone
and 400µg Misoprostol 48 hours later. Expulsion was not verified routinely. An ultrasound
examination and HCG test was performed on day one and between days 6-18.
Results: The treatment was successful in 98.6 % of cases. A total of three curettages had
to be performed; one for continued pregnancy, missed abortion and haemorrhage
respectively. One patient had a missed abortion but expelled after hormone withdrawal.
Expulsion of the sac was verified in six patients. HCG levels at the control visit dropped to
3 % in average (SD 3) ranging from 1-17 % in all cases of successful abortion, with three
exeptions of 27%, 32% and 44%. The two missed abortions and the persistent pregnancy
led to an HCG rate of 91%, 159 % and 7900% respectively.Endometrium measured 10 mm on average (SD 4) at the control visit in the cases of
successful abortion, ranging from 1-24 mm. Diagnosis of successful treatment could be
based on ultrasound examination in only 66% of cases, owing to the early stage of the
pregnancy in the remaining cases.
Conclusion: Measuring HCG level before and after treatment gave a reliable result in
98.5% of successful abortions, compared to 66% with ultrasound examination. -
Management of follow up/ need of backup curettage
Christian Fiala, MD, PhD, Gynmed Clinic, Vienna, Austria
Currently there is no generally accepted standard for follow up after a surgical first
trimester abortion. Some providers perform an ultrasound immediately after the aspiration
in order to verify that the uterine cavity is empty. The patient can be discharged then andthere is no medical reason for a routine follow-up in these cases where the completeness
of the abortion has been verified.
However most providers do not have an ultrasound machine in the operation theatre and
they estimate completeness during aspiration based on their clinical experience. Many of
them also check the products of conception (POC) in the aspiration bag for foetal parts.
This old routine is rarely questioned although most post-abortion complications are caused
by remnants of endometrial tissue or placenta which can not be discovered by inspection
of the POC.
It is therefore suggested that an ultrasound should be done immediately after aspiration to
verify that the uterine cavity is empty. The ultrasound can be done abdominally in more
than 90% of cases and the speculum can remain in place. If residua or endometrium is
discovered, aspiration can be repeated under ultrasound guidance. An immediate post-
operative ultrasound is the only situation where a truly empty uterine cavity can and should
be found. At any time later there can be some blood in the uterine cavity which might
be indistinguishable from residua by ultrasound examination. Therefore any diagnosis of
residua which is based exclusively on ultrasound needs to be interpreted with caution. The
decission for a backup curettage might not be based on such a finding alone. It should
rather take into consideration clinical symptoms. And even sparse villi in the histological
examination of a re-curettage can be a normal finding after complete surgical abortion. -
Austria: only in hospitals
Germany: not available under study
Greece: hospital
Holland: judged not useful
Spain: price not yet defined
Switzerland: RU486 = poison so forbidden
In France:
Reminder of the law. 75% of cost paid back.
A week to think over before taking MIFEPRISTONE as well as a psycho-social
counselling session. Ultrasound between D10 D14 if there is a doubt. Result: 98.5% success rate. Continued pregnancy 1 0/00.Doctors are badly paid.
In Austria:
Abortions are carried out by doctors in their private surgeries with out time given
to think it over. The Church puts pressure on the public hospital system.
40 000 abortions per year.
Only one public hospital prescribes MIFEPRISTONE.
Consultations take place by phone. There is a lack of information.
Success rate of 97%.Choice of method:
In France:
The method is perceived as being less aggressive, "natural .
It represents 14% of the legal abortions in 1990 and 30 to 40% in 1998.
In Austria:
The choice is made in relation to how early in pregnancy the request is made.
A non-surgical method with the possibility of the partner being present.
The question as to whether the method should be available up to the 63rd day is
being asked.
The discussion showed the advantages that would arise from "de-medicalising
this method and using it at home (defended by A. BUREAU France) up to the
49th day of amenorrhe.
It was accepted that studies must be carried out to reduce the dose of
MIFEPRISTONE to 200mg and to look into different protocol.
This third seminar ended after a series of rich and formative exchanges on the
practices of the different participants.
A change in the statutes was decided by the founder members. From now on the
F.I.A.P.A.C. , for democratic and voting reasons, is no longer an association of
associations but an association of individual members. The membership fee for
2000 is 250 F.
It was decided to meet again in Paris for the 4th seminar on 24th and 25th
November 2000. -
Contraceptive development has taken place in
3 milestones:
1. Discovery of the fertile days by Knaus and Ogino
in the 1920s. – For the first time ever, women
were able to understand what was happening in
their bodies and roughly identify the fertile days.
But they were not able to control their fertility.
2. Controlling fertility according to the individual
desire and possibilities (pill and IUD) in the
’60s. - The dream of humankind came true:
separate fertility from sexual activity. For the
first time ever, women were able to control their
fertility themselves and make their own choices
concerning the number of children. Regular
menstruation, however, continued. Even in
women who take the pill and thus have no
ovulation have their monthly bleeding.
3. Limiting menstruation to the fertile cycles by
continuous intake of oral contraception or the
intrauterine system. – Women can effectively
control both their fertility and menstruation
according to their own wishes and limits.
Currently we are in the process of making the 3rd
milestone widely accessible and a free choice for
women. The medical knowledge and technology
are there. But social acceptance is a slow process,
which will accompany us for some time to come. -
Medication After Medical Abortion -
NSAIDs in pain treatment, Rh-immunoglobulin
Christian Fiala
Management of pain during medical abortion has been hampered by recommendations in the product information and guidelines from various sources that non-steroidal anti-inflammatory drugs (NSAIDS) should not be given to women at least until the follow-up visit eight to 12 days after mifepristone administration. Currently the summary of product characteristics for mifepristone includes advice that, ‘A decrease of the efficacy of the method can theoretically occur due to the antiprostaglandin properties of NSAIDS. Use preferably non-NSAI agents.’ The published evidence does not support these recommendations against the use of NSAIDs.
Furtheromore NSAIDS are prostaglandin synthetase inhibitors and should have no adverse effect on exogenous prostaglandins. Stated alternatively, NSAIDs don't interfere with misoprostol and there are some good arguments for their use.
The efficacy of medical abortion in Karolinska Institute and in the General Public Hospital in Korneuburg/Austria has been the same when NSAIDS are used
Anti-D immune globulin is given in most places after early abortion, although evidence is lacking for the usefulness of this intervention at this early stage of pregnancy. Evidence-based guidelines for the administration of anti-D immune globulin (anti-D IgG) for women undergoing early spontaneous or induced abortions are missing. This is especially true for medical abortion, which is increasingly used in recent years.
An ongoing study in Sweden is presented.
-
Diagnosing gestational age, viability and location
Christian Fiala, MD, PhD, Gynmed clinic, Vienna, Austria
The best method to diagnose a pregnancy depends on gestational age and on the setting.
hCG in serum or urine is highly reliable in diagnosing a pregnancy and the only way of doing so in very early gestation. But it gives very little information about gestational age and tells us nothing about viability or location of the pregnancy. In very early pregnancy, before it can be seen on ultrasound, it is useful to have a baseline serum hCG for comparison at follow-up.
Ultrasound examination (abdominal is sufficient in most cases) is very fast and gives a very reliable result about gestational age and location. But it can only be done in pregnancies over 6 weeks gestation. It also needs a trained provider and the machine might be expensive in some settings. Bi-manual examination is cheap and easy to do but unreliable in early pregnancy.
Therefore a combination of ultrasound and hCG testing is most reliable.
Blood grouping (Rhesus)
This is done in most places in Europe and North America because we want to find those women who are rhesus negative and give them an Rh-immunoprophylaxis. Rhesus negativity is a Kaukasian trait usually not found elsewhere. However there is no evidence for the need of Rhesus-prophylaxis for a first trimester abortion. Foeto-maternal blood transfusion seems unlikely given the small amount of fetal blood, especially in very early pregnancy.
So far only the health authorities in Sweden (Board of Health and Welfare) have issued a recommendation not to give Rh-prophylaxis in medical and spontaneous abortion.
-
Christian Fiala (A)
Easy access to safe and effective contraception as well as to legal and safe abortion – both free of charge for those in financial need: no other intervention in human history has had a similarly strong effect in improving women’s health and survival. But it is not women alone who profit from this cultural achievement: men too feel the positive impact of a better health of their mother, sister, partner or daughter. Not to talk about children who need their mother. And even society as a whole is benefiting from improved health status of women. It is safe to say that we would never have reached the high standard of living we currently enjoy, if half of the population would still be at serious risk of health and even life.
We have succeeded in making most of Europe a safe place for women. But there is still a lot to do. A few countries still have no legal access to voluntary abortion: Ireland, Nothern Ireland, Portugal, Malta and Poland. But even in those countries which have a provision for legal access, an unacceptable number of various obstacles do exist resulting in an unnecessary delay in access to abortion. And there is even a high number of women in Europe who have no access to medical abortion, 15 years after it’s first marketing in France.
Looking beyond Europe, most parts of the world still stick to medieval European laws on reproductive health. These laws had been introduced by the former colonial powers and have not been changed so far. Consequently women in their daily life run a high risk for the terrible consequences of illegal abortion, including death.
It is in this context that the association of FIAPAC has been founded, following the congress “Abortion Matters” in Amsterdam in 1995. During this congress it became obvious how much there is to do to overcome the prevailing barriers in access to contraception and abortion and to guarantee a standard of care in “reproductive health”. A few professionals working in the field, recognised the urgent need for regular meetings on this topic. The association was founded thanks to their engagement. Since, 5 congresses have been organised with an increasing number of participants.
This conference would not have been possible without the engagement and support of many dedicated individuals. The FIAPAC board which has already organised 5 other conferences, has planned since two years. Very important, the team of our clinic which has calmly managed the additional workload while continuing to run the clinic and being dedicated to every single patient. These are mainly Barbara Laschalt, Leila Akinyemi and Margot Schaschl. Some of you may remember being in contact with Florian Hahn who has done all the registrations with admirable patience. Finally I would like to thank the friendly staff of the technical University.
Nobody is perfect although all of us have tried to come as close as possible. But some mistakes may have occurred during the preparation of the congress and some are probably going to occur during these 2 days. May I kindly ask you for you to forgive us and please let us know or note them on the evaluation form.
My special thanks go to the pharmaceutical companies who understand that our patients need a reliable and safe contraception after the abortion. It is my hope that more contraceptive producers will be present at the next congress.
There are some special events I would like to briefly mention:
We are working very hard to open a museum of contraception and abortion. It will be located very centrally in Vienna. Furthermore all items will be displayed on the website, together with old books. Unfortunately we did not succeed to open the museum until this congress. But we brought 4 panels displaying a small part of what the museum will be. You may have a look in the entrance hall.
I would like to take the opportunity to kindly ask you to donate or let us any historic objects or publication.
There is a list of films dealing with abortion, which will be displayed during these days. They cover a long range of time from 1929 to a new one about the impact of the policy by President Bush. The films are very touching and make clear why we engage in this field. Please find the films on the separate program. It has not been easy to bring together all these films together. Therefore a website abortionfilms.org will soon be online with a list of different films dealing with abortion. Please let us know in case you know of any other important film on abortion.
There is the training model for vaginal ultrasound during early pregnancy and medical abortion. We have worked hard to finalise in time and you may be able to try it during the congress for a small fee. This is a new device allowing training without a patient. This system is routinely used in Germany since some time, but it can be used for training for medical abortion and early pregnancy. Tomorrow there is also a presentation about this device.
Concerning the program, one small mistake has made it in the final version. Please note that tomorrow we will start at 14 00 and not at 14 30 as stated in the printed program.
Before giving the word to the next speaker I would like to make a short remark on the role of men in this debate.
As we all know, men cannot become pregnant nor can they have an abortion. Preserving the reproductive health of women is nevertheless in our very own interest and we directly feel the consequences.
It is therefore our duty to ensure a legal framework and easy access to standard of care abortion services so that women, who after all got pregnant by us, can terminate an unwanted pregnancy without unnecessary delay and suffering.
To further improve women’s health has been the motivation for all of us to come together. We are looking forward to exchange experiences, listen to each other, learn from each other and find ways to further improve the standard of care of our patients or clients. The success of the congress depends mainly on your engagement. We have been careful in the planning to let enough time for “networking” between the presentations. I hope we will use this opportunity and make these two days an occasion worth to remember.
Please let me underline how much we appreciate the support, moral and financial of the city of Vienna. Reproductive health is not an empty word in this city, as shown by the impressive engagement in this field. I am therefore very happy to announce Sybille Straubinger, member of the local parliament who is representing the city
-
Society’s responsibility to provide a legal setting
Christian Fiala (Austria)
Gynmed Clinic, Vienna, Austria
christian.fiala@aon.at
For most women, the diagnosis of an unwanted pregnancy is unexpected. Women are therefore unprepared for either carrying the pregnancy to term or having an abortion. They need a great deal of information within a very short space of time. If they decide to terminate the pregnancy, they must have fast access to medical facilities.
This presentation analyses legal requirements and regulations in European countries to see how far they support women in finding a solution.
Societies react differently to the needs of women, but the past was largely dominated by a rigid paternalism, coupled with the belief that pregnant women could not responsibly make decisions regarding their own pregnancy. Society therefore “had” to intervene in order to ensure that the “right” decision was made. People who were not directly involved with these unwanted pregnancies dominated the public debate and decided on the relevant laws. Not surprisingly, they operated on wrong assumptions or basic misunderstandings of how a pregnant woman should be treated and cared for.
Huge progress has been made in the last few decades to overcome this approach and respect women and their needs, including the legalisation of contraception and abortion. However, there are still many remnants of the old thinking, such as obligatory waiting (“cool off”) periods of an arbitrary number of days or mandatory ‘counselling’, even though counselling is voluntary by definition.
There is no evidence that these restrictions are of any benefit. They do, however, cause delays in the provision of treatment and have negative effects on the physical and psychological health of those affected. Examples and comparisons of European countries are given in the presentation.
-
Today, a dream has come true: for the first time in human history we have the ability to effectively separate fertility from sexuality due to an unprecedented number of highly effective contraceptive methods and the availability of safe abortion. This has allowed us to effectively limit natural fertility to the individually desired number of children.
It began with the introduction of the birth control pill in 1960, which was hailed at the time as one of the biggest revolutions in human history. The development of effective and safe IUDs quickly followed. The ability to have sex without getting pregnant was very much welcomed by women and their partners and hormonal contraception became the standard within a few years. As a consequence, abortion rates began to decline.
While abortion continued to decline in some countries with good contraceptive access, rates have remained stable or even increased in other countries with reliable abortion statistics, such as the UK, France and Sweden. This is even more surprising as significant further improvements in hormonal contraception have been made since the introduction of the pill, namely with long acting reversible contraceptives (LARC).
This contraceptive paradox and the underlying reasons need to be analyzed if we want to use currently available contraceptive methods up to their full potential and effectively reduce unwanted pregnancies. -
The effects of bad storage conditions on the
quality and the related effectiveness of Cytotec﷿﷿
Be´rard, V1; Fiala, C2
1 University of Bourgogne, France; 2 Gynmed Ambulatorium, Vienna,
Austria
Cytotec﷿ (Misoprostol 200 lg tablet) has been extensively studied
in reproductive health, and is widely used for various indications
including induction of pregnancy termination (MToP).Misoprostol, a PEG1 is chemically unstable except under very
specific conditions. This is due to susceptibility to relative
humidity and temperature factors. If these factors are not strictly
respected until the moment of intake, misoprostol turns into three
main degradation products: A-form and B-form prostaglandin
and 8-epimer.
Whenusedduringmedicalabortions,thecliniciangivesthe
patient2ormore200 lgtabletsofCytotec﷿ totake24–48 hours
aftertakingmifepristone.Cytotec﷿ tabletsarepackagedinboxesof
50or60tabletsof200 lgeach.Thetabletsarepackagedinheat-
sealedaluminumblisterpacks,eachcontaining10tablets.Each
tabletisseparatelysealedinanalveolusandtheblisterisnotpre-cut.
Thedoctorwillgiveapatient2ormoretablets,whichhavetobecut
fromthisaluminiumblister.Howeverthetabletsarearrangedin
suchawaythatitisalmostimpossibletocuttabletsfromablister
withoutinadvertentlydamaging/openingoneormorealveoli.
The aim of this research is to study the effect on the stability of
misoprostol if a tablet has been exposed to normal air/humidity if
the alveoli has inadvertently been opened when 2 or more tablets
have been cut from the blister. A possible instability would have a
potential negative effect on the treatment of MToP.
Methods: To study the changes of Cytotec﷿ tablets from a
technical-pharmaceutical and analytical viewpoint, once they have
been taken out of their blister pack, they are stored over a period
of time (a few hours to 1 month) at 25 ﷿C and 60% RH
(standard condition of ambient air in Europe),
After the time elapsed, the pharmaco-technical characteristics of
Cytotec﷿ tablets were studied according to the European
Pharmacopeia i.e. Mass uniformity, friability, disintegrating time,
dissolution time (by HPLC). The dimensional measure of tablets
were also measured.
Furthermore Cytotec﷿ tablets were analysed to determine the
uniformity of dosage units of misoprostol (by HPLC),
decomposition products dosage (by HPLC): A-form misoprostol
(Pharm. Eur. impurity C), B-form misoprostol (Pharm. Eur.
Impurity D) and 8-epi misoprostol (Pharm. Eur. impurity A).
Water content by Karl Fischer determination was also done.
Conclusions: The results of this research clearly show that
Cytotec﷿ tablets suffered from a significant time dependentdecrease in their technical-pharmaceutical characteristics and
effectiveness if they come into contact with normal air because
they were either taken out of their blister or kept in a blister
which was damaged during cutting out some tablets. As early as
the first day of storage, (with a maximum 48 hours after) in
humidity and temperature corresponding to normal conditions in
Europe the mass (+4.3%), the diameter (+1.2%), and the
thickness (+4.8%) of the tablets increases, which is a sign of the
swelling of the HPMC. However the hardness of the tablets
decreases dramatically ()32.0%).
The water dosage by Karl Fischer clearly shows that there is a
rapid increase of water inside each tablet (+78.8% after 48 hours).
This water penetration, associated with a storage temperature
of 25 ﷿C speeds up the process of transforming the misoprostol
into decomposition compounds. This leads to a decrease in
Cytotec﷿’s active ingredient dosage ()5.1% after 48 hours) with
related consequence on effectiveness. It is clear that under the
current conditions of Cytotec﷿ use for MToP, cutting up theblister packs should not be recommended because the risk of
damaging the heat formed alveoli around the tablets is too high
(we have no data to make such a strong statement, even if it is
true). This drastic change is observed in chemical composition
after 6 hours only of storage and reaching a maximum on the 2nd
day, which is the day the patient normally takes the tablet.
If a Cytotec﷿ tablet is kept in a damaged blister (previously cut
to deliver tablets to the previous patient) and stored in normal
environmental conditions, its effectiveness will be likely seriously
decreased for the next patient.
This research concerns all uses of Cytotec﷿ for MToP and even
when used as gastric protection, where the tablets, which can be
divided into equal parts, can be taken by halves, the second half is
stored in the open alveoli for an undetermined period.
In conclusion, special caution must be taken in delivering
Cytotec﷿ tablets. -
The Evolution of Abortion Access in Europe: “Where is the 'European standard'
Christian Fiala, MD, PhD, Gynmed clinic, Vienna, Austria
Europe is far from united when it comes to abortion and a ‘European standard’ is not in sight.
The historical timeline of legalizing abortion reveals the reluctance of most countries to do so, even though abortion laws originated centuries ago in monarchies, dictatorships, and war-leading countries. In 1920, the former Soviet Union became the first modern nation to change its laws, with Portugal the most recent in 2007. But abortion remains illegal in Ireland, Poland, and Malta until today.
Huge variations exist in allowable gestational limits (12 to 24 weeks) as well as other access restrictions like waiting periods (from none to 3, 5, or 7 days), written permission from two doctors, obligatory counselling, and more. All such restrictions are rooted in tradition and morality, with no scientific evidence of any benefit. But negative consequences are well-documented, such as women being forced to delay the procedure or travel long distances to find care. Consequently, countries with the easiest access to abortion have the lowest average gestational age at the abortion, and vice versa.
Countries in Western Europe do provide coverage of abortion as part of universal healthcare, with the exception of Austria. However, the regulations vary widely, unlike the straightforward funding of procedures for other medical treatments.
Given these huge underlying differences, it is no surprise that the frequency of abortions also varies widely between countries. The abortion rate is not linked to legal restrictions, but rather mirrors the use of effective contraception. Switzerland, The Netherlands, and Belgium lead the way, while most Eastern European countries, together with Sweden and the UK, sit at the bottom with abortion rates 3 times higher.
Three main reasons explain the persistence of high abortion rates: lack of sexual education, difficulty in accessing contraceptives, and failure to use effective contraceptives regularly. The last aspect is a new phenomenon that explains the high abortion rate in Sweden.
The slow historic process of women and couples gaining reproductive and sexual autonomy continues. Despite religious and conservative forces doing everything possible to prevent it, most people are determined to control their own lives, including their sexuality and reproduction. The most recent step forward was in Spain, where until last year women seeking abortion were intimidated by a requirement to obtain a psychiatric diagnosis, but can now receive an abortion on request.In 2008 the Council of Europe issued a report, requesting all member states not only to "decriminalise abortion" but also to "guarantee women's effective exercise of their right to abortion and lift restrictions which hinder, de jure or de facto, access to safe abortion". This landmark report came decades after most countries had already legalised abortion, although all of them had left some restrictions in access. However for the first time in history a European political body has decided on a common European recommendation. It will be interesting to see how long it takes for all European countries to apply and to put into practice what seems to be a basic human right, self determination about one's own body.
-
Practical aspects of abortion
Who is paying for abortions in Europe?
A comparative study
Christian Fiala, Sophie Hengl, Chantal Birman
Christian Fiala, MD
Gynmed Ambulatorium, Vienna
Karolinska Institute, Division of Woman Child Health, Stockholm
Introduction: Despite the steadily growing attention for abortion practices, little is known about the economic aspects of abortion. Although medical, psychological, political and legal issues have been recurrently raised within an international context, there clearly remains a lack of comparative data on the actual costs of abortions. The present study provides an overview on abortion costs throughout Europe including cost coverage and refund policies of national health care systems.
Material and Methods: Data were collected with a questionnaire, which was sent out to abortion providers, gynecologists, hospitals, family planning centers, and health care organizations. Responses were processed qualitatively as well as descriptively. The costs of abortions in each country were interpreted relatively to the per capita indicator of the Gross Domestic Product (GDP); this allowed for more accurate comparisons of the results.
Results:Abortion costs vary considerably throughout Europe. Even within the European Union, patients’ costs for the abortion range from € 0 to € 517,-. However most countries in Western Europe provide full or almost full refund to a majority of women. In contrast, most women in Eastern Europe as well as in Austria have to pay by themselves. And there are still a few countries where due to the persisting pressure of the Catholic church women have no access to abortion at all because of its illegal status: Ireland, Malta, Poland, and Portugal.
Conclusion: We are currently engaged in the application of evidence-based medicine as well as in joint international efforts to further improve the health care systems. With regard to the access to abortion in Europe, the particularly heterogeneous economic conditions seem to reflect an “evidence-free zone”. There seems to be insufficient communication and cooperation among health care professionals regarding the practical aspects of abortion. It seems essential to recall that easy access to free contraception and abortion services is not a mere luxury; rather, it is the very basis for the high standards both of women’s reproductive health and generally, life in society.
-
LS01.2
Comprehensive pain management in early medical abortion – A follow up
Christian Fiala
Gynmed Clinic, Vienna, AustriaIntroduction: Medical abortion is increasingly used. But most women will experience some pain that requires intervention, while satisfaction with medical abortion may be limited by differences between women’s expectations of pain and their actual symptoms. Pain is still a neglected issue in many settings and even studies. So far, no evidence-based comprehensive pain management protocol has been published. Therefore, a group of experts has developed recommendations based on the following principles: avoidance of pain, non-pharmacological strategies and medical pain treatment.
Background: Pain usually starts following administration of misoprostol. It is caused by contractions, with a peak around expulsion decreasing thereafter. Several associations between various factors and pain can be found. However, the predictive value of these factors is insufficient to define pain management for an individual woman.
Avoidance of pain and non-pharmacological strategies are a cornerstone, including:
· Facilitating access so that women can have the abortion at an early gestational age
· Giving detailed information to women on what to expect during the procedure
· Using the lowest effective dose of misoprostol
· Taking misoprostol at home in a relaxing environment with a support person present
Medical pain treatment: Treatment for pain in first trimester MToP should be systematic and women should have easy access to additional stepwise pain treatment. The limited data do not show prophylactic treatment to be superior compared with curative administration. However, experts’ recommendation is to give prophylactic analgesia using NSAIDs like ibuprofen. Pain treatment should be given stepwise using
· 1st line,: ibuprofen 400 to 800 mg
· Use of Paracetamol alone is not recommended.
· In addition, 2nd line analgesia for break through pain should be offered and be accessible easily and without delay, consisting of opioids like codeine, dihydrocodeine, or morphine. -
CS12.3
Refusal to treat is not ‘Conscientious Objection’
Christian Fiala
Gynmed Clinic, Vienna, AustriaHealth Care Professional’s (HCP) refusal to treat or serve patients in Reproductive Health based on personal or religious reasons is frequently and misleadingly called ‘Conscientious Objection’ (‘CO’). In many countries ‘CO’ is lawful but almost always unregulated. HCP invoking ‘CO’ are misusing their position of power and trust but expecting to keep their job and salary, even if they deceive their patients and refuse to comply with part of their professional duty. ‘CO’ is mainly a phenomenon in public health services because private institutions rarely engage, pay and keep employees who do not fulfil all their professional duties. Consequently ‘CO’ is abuse of the public service and taxpayers money. The significant negative impact on women’s basic healthcare and human rights is well known and has been published repeatedly. The impact is strong especially in those countries where abortion and contraception are mainly provided by public institutions, whereas it is negligible in countries:
- with a predominantly private health care
- where the law obliges all hospitals to provide abortion or
- where ‘CO’ is not tolerated (Sweden, Finland, Iceland).
The debate around ‘CO’ is characterized by
- one side defending an eminence based position with faith based arguments giving HCP the right to refuse patients versus
- the other side arguing for an evidence based position with arguments based on facts and in favour of giving patients the right to a legal treatment for which they pay either directly or indirectly via a health care insurance.
No country has regulated ‘CO’ in a way that would satisfy women and their need for basic medical care as well as HCP’s personal or religious beliefs. What is misleadingly called ‘CO’ is a remnant of a patriarchal social model and incompatible with evidence based medicine as well as current human rights standards.
www.conscientious-objection.info -
Comprehensive pain management in medical abortion
Christian Fiala
Gynmed Clinic, Vienna, Austria - christian.fiala@aon.at
Management of pain during medical abortion has been given insufficient attention in clinical practice as well as in research. For example neither pain nor its treatment are systematically reported in clinical trials: a literature research on Pubmed revealed 1 459 publications on medical abortion from 1988 until 2011, but only 18 trials reported pain when comparing different treatment regimens using mifepristone and misoprostol in first trimester. This shortcoming reflects a neglect of the individual pain perception, yet pain remains a decisive factor for women in the decision making process of abortion. Comprehensive pain management in medical abortion should be based on the principles of general pain management:
Avoidance of pain
As a first step, measures should be taken to avoid pain as far as possible:
* Unrestricted access to abortion would enable women to come as early as possible. Studies show that women’s experience of pain increases with gestational age. Reducing restrictions in access are therefore an important pain reduction measure.
* Induction of contractions should be limited as far as possible. Therefore the lowest effective dosage of the prostaglandin should be given.
* Free choice of the method is important because women report less pain when the choice of early medical abortion has been their own decision.
* Full and accurate information should be given on what to expect and what to do in case of pain.
* Women should feel relaxed and safe. Taking misoprostol at home is a pain reducing measure for many women.
Non-medical pain treatment
Classical hot water bottle, choosing the preferred body position and activity are effective aspect.
Medical pain treatment
* NSAIDs such as ibuprofen or diclofenac should be an integral part of pain management. They do not interfere with medical abortion treatment.
* Codein or tramadol should be available as backup.
Medication should be started as early as possible or even be given as prophylaxis before intake of misoprostol. (absorption of misoprostol is very fast and the first contractions can occur already within 15 minutes.) Providers should also make sure that patients have analgesics at home.
Reference: Pain during medical abortion, the impact of the regimen: A neglected issue? A review.
Fiala C, Cameron S, Bombas T, Parachini M, Saya L, Gemzell-Danielsson K.
Eur J Contracept Reprod Health Care. 2014 Sep 2:1-17.
-
FC03
Pain management for up to 9 weeks medical abortion – An international survey among providers
Christian Fiala1 ,8, Sharon Cameron2, Teresa Bombas3, Mirella Parachini4, Aubert Agostini5, Roberto Lertxundi6, Laurence Saya7, Kristina Gemzell-Danielsson8
1Gynmed Clinic, Vienna, Austria, 2Chalmers Centre, NHS Lothian, Edinburgh, UK, 3Obstetric Service A, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal, 4San Filippo Neri Hospital, Rome, Italy, 5Obstetric and Gynecology Department, La Conception hospital, Marseille, France, 6Clinica Euskalduna, Bilbao, Spain, 7Altius Pharma CS, Paris, France, 8Department of Women’s and Children’s Health, Division of Obstetrics and Gynaecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, SwedenIntroduction: There is no consensus about pain management for medical abortion (MToP) and evidence based guidelines give different recommendations. A survey among providers was done to analyse regimens being used in clinical routine.
Methods: A questionnaire on details of pain management for first trimester MToP was developed by a group of experts. Health care providers all over the world offering MToP were invited to complete it through a FIAPAC dedicated website.
Results: 283 health care professionals from all regions of the world completed the questionnaire: Europe 59%, North America 21%, Asia 8%, Australia and New Zealand 6%, Africa 4%, Latin America 2%. Most respondents (n= 267, 94%) reported analgesic prescription/provision for all women, either prophylactic for 82% (n=233) or upon request for 12% (n=34). WHO Step I analgesics (NSAIDs, paracetamol) were the most often used in both cases. A total of 16 (6%) respondents indicated that they never provided analgesics (or prescriptions for them). Only 24 providers (10%) started pain treatment after mifepristone. Female providers of abortion care were significantly more likely to prescribe systematic analgesia for patients than male providers (85% vs 74%, p<0.04). Most practitioners did not adapt the analgesic treatment to gestational age or according to place of intake of misoprostol (home or at the clinic/hospital). The majority of respondents (69%, n=195) did not conduct formal assessments of women’s pain.
Conclusion: There is widespread variation in the assessment and management of pain during MToP, reflecting the lack of evidence based guidelines. This is a clear indication for improvement of using available and effective pain treatment to avoid unnecessary pain by women.