Rome, 13-14 October 2006: „Freedom and Rights in reproductive Health“
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09:00-
10:30Fantasies and reality of abortion and contraception, Aula Magna sala 1+2Chair:- Peter Safar, AT
- Thea Schipper, NL
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- Anne Vérougstraete, BE (all speeches)
- ann.verougstraete@pandora.be
Fears: sterility, sexuality, bleeding, infection
Anne Verougstraete MD
Gynaecologist; Brussels, Belgium
-Sjerp-Dilemma: Family Planning and Abortion Centre: Vrije Universiteit Brussel
-Hôpital Erasme: Université Libre de Bruxelles
What is the influence of fear of “sterility”on contraception use and abortion?
Is there a risk of sterility after induced abortion?
Is there an increased risk of spontaneous abortion, preterm delivery, stillbirth, ectopic
pregnancy, placenta praevia …. in a subsequent pregnancy?
Are women with short-term complications after induced abortion more at risk to have
problems in a subsequent pregnancy?
Is there a link between induced abortion and breast cancer??
What is the influence of sexuality on contraception use and abortion? What about
contraception use and sexuality? And what about sexuality after abortion?
What is the risk of bleeding and infection after abortion? What can we do about it?
The actual knowledge and evidence will be discussed. -
- Elisabeth Aubény, FR (all speeches)
- EAubeny@compuserve.com
Is monthly bleeding optional?
Elisabeth Aubeny, MD, Paris, France
Since prehistoric times women have endured menstruation, whether they liked it or not.
The timing of the bleeding was not necessarily predictable nor could it be modified.
Hormonal contraception has changed all that. For the first time in mankind’s history, it is
possible to manipulate the timing of menstruation and even to stop it altogether. Some pills
have been especially designed to be taken continuously for 3 months or even for a full
year thereby reducing the number of withdrawal bleeds experienced over time. Long term
progestogen contraceptives can, theoretically, give women a break from menstruation for
3 to 5 years. However these regimens are often associated with frequent episodes of
breakthrough bleeding. So research continues in order to try to improve these
methods.But what do European women think about these new options?A survey in 1980
showed that, in U.K, like in many countries, the majority of women wanted to have monthly
menstruation. Recent surveys in Europe indicate that women’s attitudes to menstruation
are changing. In 1999 a survey from Holland found that only 35% of women wanted to
menstruate once a month, and 31.1 % of women of 25 to 34 years would prefer never to
menstruate; in a German survey from 2004 35% of women between 25 to 35 years wanted
a monthly menstruation and 37% would have preferred never to menstruate; in 2005 in
France only 11% of women wanted to menstruate, while 75 % thought that it was a burden
and 57 % would take a pill which would stop menstruation; in 2006 an Italian survey
showed that 50 % of women without menstruation–related symptoms would like to change
the rhythm of their menstruations. So a majority of women would like to modify the timing
of their menstrual periods. The motivation for the changed of attitudes include: the fact that
there less medical problems associated with lack of menstruation, the women feel they
have a better quality of life, with better hygiene and a reduction of blood loss. However a
large minority of women still prefer to have menstruation each month because this
reassures them that they are not pregnant, they think that menstruation is a natural
phenomena, that it allows elimination of “bad blood”, that is a sign of feminity and they are
afraid of the adverse effects of hormones. However it seems that at the beginning of the
21st century, more and more women would prefer to have control over whether or not they
menstruate. In the next years menstruation will probably become entirely optional. -
- Kristina Hänel-Groh, DE (all speeches)
- kh@kristinahaenel.de
Post abortion abstinence – is there any benefit?
Kristina Hänel, MD, Giessen, Germany
“The evidence of recommendations regarding sexual intercourse, tampons, bath and swim
after abortion has not been proven. We have to discuss this topic and to develop new
standards.” Since 2002, when I ended my lecture in Amsterdam with these words, we
never discussed this topic again.
Usually abortion providers - even me four years after Amsterdam - give recommendations
as follows: not to put anything into the vagina, especially not to have vaginal intercourse,
use tampons, take a bath or swim for 2 –3 weeks after the abortion. These
recommendations are given for hygiene reasons and are based on the fear of an
increased risk of infection. This fear is explained by the following arguments:
The cervix is openedThe uterus is a wound
The penis is responsible for infection-rate
Furthermore there are some known factors for an increased risk of postabortional
infections:
Manipulation in the uterus (surgical abortion),
Pre-existing subclinical genital tract infections
Rretained products of conception
However the evidence is lacking whether abstaining from intercourse, bath, tampons etc
actually reduces the risk of postabortion. On the other hand, there are potential benefits of
sexual intercourse after abortion which should not be neglected like: emotional and
psychological aspects, cognitive aspects e.g. the feeling to be „normal“, assisting uterus
contraction, pain reduction through relaxation of the genital organs after orgasm. -
- Lotti Helström, SE (all speeches)
- lotti.helstrom@ks.se
Should ultrasound be shown to the woman?
Lotti Helström, MD, PhD, Department of Women’s Health, Stockholm South Hospital,
Sweden
There is an ongoing discussion whether to show the ultrasound screen or picture to the
woman and/or her male partner at the pre abortion medical examination or not. It has been
clamed that the picture might influence her in her decision and force her to feel guilt or
shame of her wish to terminate her pregnancy. On the other hand the picture might help
her to realize and clearly view her situation and thus help to the right choice. There is a
point in regarding the woman as the only individual able to make the right choice and see
the medical staff only as her servants, serving her with the information that she needs for
making the complex decision about how to realize her maternity in this specific situation.
Hers is the choice, to see or not, and to choose the information necessary.
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10:30-
11:00
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11:00-
12:30Workshop 5 Practical aspects of medical abortion/FAQ: Part 2, Aula Magna sala 3Chair:Workshop 6 Perception of professionals performing abortions, Aula Magna sala 1+2- Elisabeth Aubény, FR
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- Marge Berer, GB (all speeches)
- mberer@rhmjournal.org.uk
Access to medical abortion
Marge Berer, Editor, Reproductive Health Matters and Chair, International Consortium for
Medical Abortion, London, UK
Although more than one method of abortion has been available for many years, in most
countries the provider chooses the method and may be skilled in one method only. This
paper discusses choice and acceptability of medical abortion from the perspective of both
women and abortion providers and argues that choice of method is important for both.
Safety, efficacy, number of visits, how the method works, how long it takes for the abortion
to be complete and cost all affect acceptability. Medical abortion is considered more
natural because it happens in women’s own bodies and can take place at home before
nine weeks of pregnancy; surgical abortion with vacuum aspiration is simple and over
quickly. Unless the costs of both methods are similar, however, women and providers will
tend towards whichever is the cheaper option, limiting choice. Medical abortion is effective
from when a woman misses her period through 24 weeks of pregnancy, and more women
and providers need to be made aware of this. In legally restricted situations, complications
tend to be less serious and easier to treat with early medical abortion than after unsafe
invasive methods. Ideally, both medical and surgical methods should be available, but
each can be provided without the other. -
- Mary Fjerstadt, US (all speeches)
- fjerstadm@ipas.org
Infection related mortality following medical abortion in North America
Mary Fjerstadt, Clinical Training Director, Planned Parenthood
Consortium of Abortion Providers, El Cajon, USA
Among an estimated 560,000 women who have had medical abortion with mifepristone
and misoprostol in North America, there have been 6 deaths related to infection:
One death in Canada during clinical trials: C. sordellii
Four deaths in California: C. sordellii
One death in western U.S.- C. perfringens
FDA and CDC held a meeting in May 2006 to discuss what is known and unknown about
C. sordelii. Since the FDA/CDC meeting and the publication of the article in the New
England Journal of Medicine about the C. sordellii deaths and mifepristone abortion,
reports of C. sordellii following spontaneous abortion and childbirth have emerged.
This presentation will discuss the conclusions of the FDA/CDC meeting, the clinical
presentation of the cases, the hypotheses that have been put forward to explain why these
infectious deaths have occurred, and the system of adverse event reporting in the U.S.
and Planned Parenthood. -
- Mary Fjerstadt, US (all speeches)
- fjerstadm@ipas.org
Medical abortion with home administration of misoprostol
Mary Fjerstadt, Clinical Training Director, Planned Parenthood
Consortium of Abortion Providers, El Cajon, USA
There are now over 250 Planned Parenthood clinics in the U.S. providing mifepristone
medical abortion. Since initiation of medical abortion in 2000, women have received
mifepristone in the clinic on Day One, and also receive misoprostol to self-administer at
home. 230,000 women have received medical abortion with home administration of
misoprostol. Women are given information about how to administer the medication, what
to expect, and when they should call the medical provider.
The presentation will discuss the efficacy of regimens used in the U.S., the rate of surgical
intervention and the rate of emergency department visits. Most bleeding events requiring
emergency treatment occur later in the process and would not have been prevented by
using misoprostol in the clinic setting. -
- Kristina Gemzell-Danielsson, SE (all speeches)
- Kristina.Gemzell@ki.se
Recent developments
Kristina Gemzell MD, PhD, Professor
Dept. of OB/Gyn, Karolinska University Hospital/Institutet, Stockholm, Sweden
Medical abortion using the antiprogestin mifepristone (Exelgyn; Paris, France) combined
with a prostaglandin has been available in Europe since 1988 for termination of pregnancy
up to 49 days of amenorrhea. In the UK (1991), Sweden (1992) and later on Norway the
method is approved up to 63 days of amenorrhea. Further development of the method will
be discussed in the workshop and include reduced doses of mifepristone, research on the
optimal type, dose and route of administration of the prostaglandin analogue and reduced
treatment intervals. Furthermore home-use of misoprostol allows women more flexibility,
privacy and control in their abortions. More recently medical abortion has also become
increasingly used in the interval 9 to 13 weeks as well as for midtrimester terminations with
an increased need to optimise pain management.
Anti-D immune globulin is given in most places after early abortion, although evidence is
lacking for the need of this intervention. As a result of the lack of evidence-based data, a
high number of women are receiving foreign immune globulins based on a questionable
indication. Furthermore this practice increases the costs of induced abortion. The need for
studies to clarify the indication of RH-prophylaxis is obvious especially when it comes to
medical abortion.
The generally accepted obligation in medicine to offer every patient the best evidence
based care should also apply to women with an unwanted pregnancy. An increasing
number of women in Europe now opt for medical instead of surgical abortion. A shift which
is expected to continue during the next year’s world-wide.
The need for more research to further improve the procedure, reduce side effects and
facilitate access is obvious.
Chair:Workshop 7 Current problems and solutions on abortion in Eastern Europe, Aula Magna sala 4- Lucie Van Crombrugge, BE
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- Giovanna Scasselatti, IT (all speeches)
- gscassellati@sancamilloforlanini.rm.it
Doctors working in a public hospital
Giovanna Scassellati, MD,
Hopsitial St. Camillo, Rome
Abortion is legal and part of medical practice in Italy since 1978.
In these 28 years it is allowed only if interruptions of pregnancy are performed in public
hospitals.
Pharmacological abortion, widely used in many countries in Europe, is not allowed in Italy
and this because mifepristone (RU 486) is not registered yet.
This limitation causes frustration on doctors and nurses and it is necessary operate on
patients all the times even though a lot of patients could succeed using medical abortion.
In Turin, northern Italy, in S. Anna Hospital, Dr. Viale has been the first doctor who
received special permission by the Ministry of Health to start a clinical trial with RU 486, on
October 2005.
It seems a little strange to start experimentations using a drug well known in the whole
medical world since 1980.
Italian women are not different from the French or Spanish ones. -
- Carry J. Hekket, NL (all speeches)
- carryhekket@planet.nl
Non-doctors
Carry J. Hekket, RN, Bloemenhovekliniek, Heemstede, The Netherlands
Through a short personal impression, and by using material from Sherman de Jesus´
(Memphis films NL) acclaimed documentary about the ´Bloemenhovekliniek´, this
presentation will give an insight in to the dilemmas faced by staff working in a specialised
second-trimester clinic in their day to day work. -
- Dominique Roynet, BE (all speeches)
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- Mike Vidot, ES (all speeches)
- mfvsey@yahoo.com
Why abortion is performed in Spain until 26 weeks
Mike Vidot, MD, Clinica El Sur, Sevilla, Spain
In Spain abortions can be performed based on a law of indications (Decree 9/1985; article
417), which has not been modified in posterior reforms of the Penal Code of Conduct.
This law states that abortion will not be pursued in Spain if it is practiced by a doctor or
under his or her supervision when certain circumstances are given:
- A pregnancy which results in a serious risk for the mothers’ physical and psychological
health, diagnosed by a specialized physician, without gestational age limits.
- Pregnancies resulting from rape can be performed up to 12 weeks.
- Pregnancies up to 22 weeks when the foetus presents a high probability of having
physical and psychological alterations certified by 2 different specialized physicians.
These physicians under no circumstances should be the ones who perform the
abortion.
Hence, that’s why we think that in Spain we can consider that induced abortion is not
voluntary, but a necessity derived from a situation.
Also the WHO defines health as: a state of physical, psychological and social wellbeing,
not the mere absence of diseases.
Based on these 2 aspects (without gestational age limits where the mothers health is
concerned and the definition of health by the WHO), in Spain, the private specialised
clinics in abortion, interpret that if there is a criteria which estimates that a pregnancy is of
high risk for the mothers health, this can be performed without a gestational age limit,
understanding that an unwanted pregnancy alters the psychological and social welfare and
that her health is at risk.
On the other hand WHO in its Technical Resolution 461 defines abortion as ¨the
interruption of pregnancy before its viability¨.
The clinics of ACAI (Association of Accredited Clinics for Voluntary Interruption of
Pregnancy) interpret that according to WHO, as soon as foetal viability is given, it is not an
abortion and that the law could not be applied. Hence, based on the fact that foetal viability
is considered from 25 to 26 weeks onwards, pregnancies with healthy foetuses up to 26weeks can be interrupted if there is a psychiatric report certifying that there is a risk for the
mothers mental health. Also, estimating that abortion is the best option in such cases
pregnancies are interrupted beyond 26 weeks when a foetal malformation is not
compatible with extra uterine survival or human dignity. In such cases a certificate of none
viability signed by 2 different obstetricians is required. This legal interpretation of the law
has not been questioned judicially until now.
This has converted Spain in a destination for abortion, mostly from the European
countries with Voluntary Interruption of Pregnancy laws which complicate the access of
women who are more than 12 weeks pregnant or those countries which have restrictive
laws regarding abortion above 22 weeks.The Private Specialized Abortion Clinics have assumed also abortions which are not being
performed in Spanish public hospitals. They only accept those with foetal pathology until
22 weeks, pregnancies derived from rape or which puts in danger the mothers’ health.
Chair:Workshop 8 Symposium von → IPAS: Early Vacuum Aspiration, Tarragona room- Irina Savelieva, RU
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- Rodica Comendant, MD (all speeches)
- comendantrodica@yahoo.com
Current problems and solutions on abortion in Eastern Europe (EE)
Rodica Comendant MD,
Reproductive Health Training Center, Director, ICMA Coordinator, Chisinau, Moldova
Description of the problem: Despite the widespread availability of abortion on legal
grounds for 50 years in most of the EE countries, the quality of services remain poor: the
main method is D&C, no patient centered care concept. Unsafe abortions account for 24%
of maternal deaths in region. Abortion rates remain high, and is commonly used as a
primary means to regulate fertility. Access to abortion services has been challenged in
recent years. Concerns about declining birth rates, pressure from religious groups have
reduced support for family planning and abortion in the region.
MVA project: The goal of the project was to improve the quality of abortion care with of
institutionalization of Manual Vacuum Aspiration (MVA), and promote patient centered
care concepts within the framework of clinical safety and reproductive rights. This project
was initiated by NAF, funded by the Open Society Institute, and in collaboration with Ipas.
The seven selected countries included Moldova, Macedonia, Kyrgyzstan, Georgia,
Albania, and Russia. The training project was successful in the goals of introducing MVA
in the countries and presenting a model of comprehensive evidence-based abortion care
with a woman-centered approach.
Medical abortion implementation: Mifepristone is currently registered in 10 EE
countries, Misoprostol is used off-label in ob/gyn practice in whole region. But still the MA
method is expensive and unavailable for general population. Introductory studies, with
seminars and trainings for policymakers and health providers have been conducted by
Gynuity Health Project in the region, with the aim to offer practical clinical experience with
evidence-based protocols and provide useful data to revise existing guidelines and
protocols or to establish new one.
A need for creative, individual, country-level, sustainable strategies: Strategic
assessment of the contraception and abortion, currently taking place in some countries in
the region will assist in improving the quality of services. Trainings of providers;
development of standards and guidelines; IEC, targeting potential users, to increase the
demand for better and affordable services among women, advocacy campaigns forwomen right to the access to the fruits of modern science, could be listed.
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- Gunta Lazdane, DK (all speeches)
- GLA@euro.who.int
Recent developments in Eastern Europe
Gunta Lazdane, MD WHO Regional office for Europe, Regional Adviser
for Reproductive Health and Research, Copenhagen, Denmark
During the last two years, several countries in the eastern part of the WHO European
Region have developed and approved national reproductive health strategies and
programmes including the component of reproductive choice and access to abortion
services. The analysis of the present situation has been made based on the official
statistics as well as results of surveys and research projects carried out in these countries.
The trend of declining in abortion rates is obvious in eastern Europe; however, the number
of abortions in adolescents and young women remains high. Different barriers have led to
discrepancies between official and survey-based abortion rate, for instance, in Georgia
according to official data the number of induced abortions per woman in 2005 was 0.3, but
it was 3.1 according to the Reproductive Health Survey carried out by the Ministry of
Labour, Health and Social Affairs of Georgia, Center for Disease Control USA, United
Nations Population Fund and United States Agency for International Development.
The number of death cases from unsafe abortion has decreased as well, however, it some
countries it is still almost 20 per 100 000 live births: the quantitative target of the WHO
European Regional Strategy on Sexual and Reproductive Health (2001) is less than 5 per
100 000 live births.
Since 2003 when “Safe Abortion: Technical and Policy Guidance for Health Systems” was
published by WHO, it has been translated into Russian and used in many countries
(Armenia, Georgia, Kyrgyzstan, the Republic of Moldova, the Russian Federation,
Tajikistan, Ukraine, etc.) to develop national guidelines and to improve access to
reproductive health services and the quality of care.
With WHO assistance, strategic assessment of reproductive health services, including
those for abortion, has been carried out in the Republic of Moldova and the outcomes will
play an important role in further development of the plan to implement the recently
approved National Reproductive Health Strategy. In 2006-2007 strategic assessment
projects are planned in the Russian Federation and Ukraine.
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- Marijke Alblas, ZA (all speeches)
- malblas@iafrica.com
Comparison of the safety and satisfaction of first trimester abortions performed by
physicians and mid-level providers using MVA in South Africa
Marijke Alblas
Hoffman M*, Harries J*, Morroni C*, Beksinka M**, Kunene B**, Warriner I.***
* Women’s Health Research Unit, University of Cape Town, South Africa
** Reproductive Health Research and HIV Unit, Durban, South Africa
*** World Health Organization, Geneva, Switzerland
Background: In countries where legislation permits the termination of early pregnancy,
limited resources, including available trained personnel, often restrict access to safe
abortion services. In some countries in order to improve access, trained mid-level
providers (nurses, midwives and physician assistants) perform first trimester abortions.
This WHO collaborative study was conducted in South Africa and Vietnam to evaluate the
safety and effectiveness of first trimester abortions performed by mid-level providers
(MLPs) as compared to those performed by physicians. The South African component of
the study will be presented.
Methods: A randomised controlled equivalence trial was conducted between September
2003 and June 2004 in four Marie Stopes International clinics in South Africa. All women
seeking a first trimester abortion were invited to participate in the study. Eligibility criteria
included: gestational age of no more than 12 weeks, age 18 years or above, and
willingness to return for a follow-up visit, or to have a telephone, home or outside clinic
interview. Women were randomly assigned to a mid-level provider or physician for the
abortion and were followed-up by study staff 14 days later. The primary outcomes of
interest were complications occurring within two weeks of the abortion procedure. These
complications, immediate or delayed, were clinically verified. Patients’ satisfaction with the
service was assessed.
Results: Six physicians and six MPLs participated in the study. A total of 1160 women
consented to participate, 581were randomised to a physician and 579 to a mid-level
provider. Six women withdrew from the study and one was lost to follow up. There were
no complications among the physicians and eight (seven retained products and one
infection) among the mid-level providers. Measures of equivalence of complication ratebetween providers was 1.4% (95% CI 0.4-2.7) This was well below the a priori margin of
equivalence which was set at 4.8%. More than 96% of women reported satisfaction with
quality of care.
Conclusion: Overall the quality of care was excellent and there was no difference
between physicians and mid-level providers. The complication rate was low and met the
criteria for equivalence. Given appropriate training and in a supportive environment MLPs
provide first trimester MVAs as safely as physicians. -
- Mike Vidot, ES (all speeches)
- mfvsey@yahoo.com
Vacuum aspiration before 7 weeks
Mike Vidot, Clinica El Sur. Sevilla. Spain
Until now pharmacological termination of pregnancy has been considered the method of
choice in pregnancies below 7 weeks. In our experience surgical vacuum aspiration is also
a safe and alternative method which can be used before 7 weeks, as long as a proper
preoperative surgical assessment is performed. This technique has numerous advantages
compared to the pharmacological method. It is as safe as the pharmacological method, but
with more advantages for the patient. The procedure is immediate, less cost effective for
both the clinic and the patient, reduces the psychological effects that an unwanted
pregnancy can cause, gives the patient the opportunity for immediate contraception after
termination of pregnancy and can be implemented in countries whereby anti-
prostaglandins are not available.
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12:30-
14:00
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14:00-
15:30Workshop 09 Practical aspects of first trimester surgical abortion, Aula Magna sala 3Chair:Workshop 10 Misoprostol an essential drug in OB/Gyn, Aula Magna sala 1+2- Pedro Peña Coello, ES
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- Annette Aronsson, SE (all speeches)
- annette.aronsson@karolinska.se
Is preoperative vaginal cleansing necessary for control of infection after first
trimester vacuum aspiration?
Annette Aronsson MD, Karolinska University Hospital, Division of Gynecology and
Obstetrics, Stockholm, Sweden,
Traditionally, the vagina is cleansed before a vacuum aspiration or a dilatation and
curettage is performed.
In the effort to give evidence based recommendations a review of the literature was
performed to find out if this practice could be supported or safely omitted.
Available data did not support any increased incidence of infections in women who had not
undergone any presurgical cleansing compared to the group of women in which cleansing
was performed.
Based on the studies reviewed, preoperative cleansing can be safely omitted at first
trimester surgical abortion without risk for the patient, provided that genital infections are
excluded. -
- Christian Fiala, AT (all speeches)
- christian.fiala@aon.at ,http://www.gynmed.at
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. -
- Stephen Searle, GB (all speeches)
- Stephen.searle@highpeakanddalespct.nhs.uk
Why is local anaesthesia done so rarely?
Stephen Searle, MD, Clinical Director/Consultant in Contraception & Sexual Health, UK
The talk will cover:
The Technique
MVA, Evidence Worldwide
Practical Advantages & disadvantages of LA TOP>
Complications
Practical Advantages of MVA:
Effective up to 12/40 & down to 5/40; Moves TOPs out of theatre; Less frightening for
women; One visit, short stay; Inexpensive, low-tech; Enables non-gynaecologists to
evacuate Ut; Simple, safe & effective for ERPC; No need to undress; No need to be
starved; Can drive home; Less risk of uterine damage - GENTLE; Often suitable when GA
STOP or MTOP are relatively contraindicated eg gross obesity, oral steroid treatment
Disadvantages:
Pain: Audit indicates there is less pain with LA than with MTOP and possibly less than
after women awake from GA STOP
Pain more likely with Primips, teenagers, if frightened or depressed, higher gestations.
However: 70-90% would choose LA again
Evidence on Analgesia
Observational studies:
less pain with Cx block than none
20ml better than smaller vol
inj @ 4 and 8 o'clock
N2 O. x2 RCTs:Entonox: BPAS 1st 501
22% used N2 O - of these:
28% - very helpful
58% - Moderately helpful/some help
11% - no help
CONCLUSION: After 1st 250, staff were reminded to routinely offer N2 O.
Recommendation
"..hospitals should abandon curettage.. and adopt the aspiration methods, selecting
manual evacuation and/or electric aspiration, according to the expertise available."
Ref: Final Report, FIGO/WHO Task Force, March 1997
Contraindications to MVA:
Gestation > 12/40
Anticoagulant Rx/Prolonged bleeding time
Haematocrit < 30%
Active PID
HEALTH ECONOMICS
GA STOP £430
MTOP £260
LA VTOP £190 (4 on list)
Appendix. USA Complications
Local vs. General Anaesthetic. Grimes 1979, Am J Ob Gyn.
36,430 LA vs 17,725 GA
Blood Transfusion, Cervical Tears, Perforations: x3 - x4 greater with GA
Anaesthetic deaths: a GA complication
BPAS + MSI: 1998-2000. N = 2,026
ERPC = 6 (0.29%)Blood transfusion = 0
Hospital admission = 2 (0.09%)
1 confirmed ectopic
1 pain, anxiety, continuing pregnancy
Chair:Workshop 11 Free communications- Marc Bygdeman, SE
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- Oi-Shan Tang, CN (all speeches)
- ostang@graduate.hku.hk
Different routes of administration
Oi-Shan Tang, MD
Department of Obstetrics and Gynaecology,
The University of Hong Kong, Pokfulam, Hong Kong
Misoprostol is widely used in obstetrics and gynaecology. It is a prostaglandin E1
analogue licensed for oral use. However, vaginal administration has become a common
practice. However, women prefer to take the drug by mouth as this can avoid the
uncomfortable vaginal examination and provide more privacy during medical abortion.
Therefore, other ways of administration like sublingual route have been explored.
A pharmacokinetics study has compared the absorption kinetics of these three commonly
used routes of administration of misoprostol. It was shown that both the sublingual and
oral administrations have the quickest onset of action. Sublingual administration achieves
the highest plasma concentration. The systemic bioavailability as measured by the area
under the curve (AUC) is also highest among the three routes. The AUC360 after oral
administration was only 54 % of that after sublingual administration.
Many clinical studies have shown that vaginal misoprostol performed better than similar
doses of oral misoprostol in medical abortion. This is probably due to the more sustained
serum concentration after vaginal administration. The new sublingual route has been
shown to have a similar complete abortion rate to vaginal misoprostol in first trimester
medical abortion. However, it might be associated with higher incidences of side effects.
This may be related to its higher peak concentration. On the other hand, a short time to
Tmax and a higher Cmax make the sublingual misoprostol a good cervical priming agent. Its
clinical efficacy as a cervical priming agent has been proven. Sublingual misoprostol has
also been used for the management of postpartum haemorrhage. Its unique way of
administration makes it the route of choice in the presence of vaginal bleeding and when
oral intake is not desirable.
In conclusion, pharmacokinetics studies have demonstrated the absorption kinetics of
various routes of administration of misoprostol. More studies are required to find out the
best way of administration of misoprostol for various clinical applications. -
- Beverly Winikoff, US (all speeches)
- bwinikoff@gynuity.org
Misoprostol alone for abortion
Beverly Winikoff, MD, MPH,
Gynuity Health Projects, New York, USA
In places where mifepristone is unavailable, misoprostol has emerged as an important
basis of alternative medical abortion regimens. Both methotrexate + misoprostol and
misoprostol alone have been used successfully for this purpose. While it appears that
regimens of methotrexate + misoprostol may be more effective than misoprostol alone,
other considerations have made misoprostol alone a more commonly used alternative
outside of established services. The most effective regimens of misoprostol alone for early
first trimester abortion have efficacy >85% and < 90%. Misoprostol may also be used
alone for induction of abortion after 63 days’ LMP. So far, the vaginal route has been the
most widely studied and commonly used route of administration for this indication, but it is
likely that other routes, such as buccal and sublingual misoprostol, will have similar
efficacy. This presentation will discuss the efficacy, safety, and side-effects of such
alternative medical abortion regimens, as well as issues of cost. The role of non-
mifepristone medical abortion will be explored in circumstances where abortion services
are poor or non-existent as well as in circumstances where abortion services are well-
developed but mifepristone is unavailable. -
- Helena von Hertzen, CH (all speeches)
- vonhertzenh@who.ch
Summary of current evidence
Helena von Hertzen, MD, WHO, Geneva
During the last ten years the use of misoprostol has escalated in the area of reproductive
health due to its many advantages compared to other prostaglandins, and a substantive
scientific evidence has accumulated suggesting that misoprostol is safe and effective for
various indications, provided the dosage is correct. However, with very few exceptions,
misoprostol has not been licensed for use in obstetrics and gynaecology and this has left
many doctors unsure of their position regarding the use of an off-label drug.
Depending on the indication the strength of scientific evidence varies: experts will agree
e.g. on the benefits of misoprostol compared to other available options for labour induction
and medical abortion. Consequently, misoprostol has been included in the complementary
list of WHO Essential Medicines Library: 25 microgram tablet for the induction of at-termlabour; and the termination of pregnancy of up to 9 weeks (200 microgram tablets) to be
used after mifepristone pretreatment.
More research results may be needed to assess whether evidence-based guidance can be
given regarding other indications. Clinicians agree that cervical priming prior to vacuum
aspiration, or other gynaecological procedures, has become easier thanks to misoprostol.
In addition to the sequential regimen with mifepristone, misoprostol may be used alone to
induce abortion in settings where mifepristone is not available, provided a somewhat lower
effectiveness is acceptable. Misoprostol may also be useful in the treatment of incomplete
abortion, intrauterine fetal death, or in the prevention, and perhaps also in the treatment, of
postpartum haemorrhage, but experts need to agree whether there is enough evidence to
recommend its routine use for these indications.
Chair:Workshop 12 Post-abortion contraception, Aula Magna sala 4- Carolyn Phillips, GB
-
- Joyce Arthur, CA (all speeches)
- writer@direct.ca
Exposing Anti-Abortion "Counselling" Centres
Joyce Arthur, Abortion Rights Coalition of Canada, Vancouver, BC
Thousands of "fake clinics" in North America try to prevent women from having abortions.
These religious centres provide misinformation about abortion and treat women
unprofessionally, often making them feel confused, afraid, and guilty for seeking an
abortion. This presentation summarizes a project to research and expose fake clinics in
British Columbia, Canada. -
- Jieshuang Xu, CN (all speeches)
- xujieshuang@hotmail.com
Knowledge and usage of Emergency Contraception among pregnant teenagers, a
Shanghai survey
Jieshuang Xu, MD; Yi Chen, Linan Cheng, MD, Prof.
Shanghai Institute of Family Planning Technical Instruction, Shanghai International Peace MCH hospital of
China Welfare, Shanghai
Objective To determine the level of knowledge and usage of emergency contraception
(EC) among pregnant teenagers.
Design Cross-sectional survey. Setting 3 district, 2 municipal MCH hospitals and 1
municipal general hospital in Shanghai. Participants 591 pregnant teenagers who
volunteer to request termination of pregnancy.
Results The average age of subjects was 17.86±0.99 years. 49.1% previously
experienced contraception failure, 99.3% already had sex without any contraception in the
past, and 92.6% reported being “worried” about pregnancy when these happened. Backup
‘methods' they previously used included EC 36.1%, urinating 32.1%, shower 15.4%,
vaginal douche 10.5%, and jumping up and down 5.9%. 47.7% of the girls had heard of
EC, among them 44.1% had already used it at least once. 91.4% of the girls used no
contraception, and 8.6% experienced contraception failure within the pregnancy cycle, but
only 8.3% of them actually used EC. Among the latter, 81.6% correspond to user failure,
the other 18.4% to method failure. Girls who were aware of EC were more likely to use EC
in the past, or to prevent current pregnancy, than those who were not_P<0.01_. They were
also more likely to use a contraceptive method, and less likely to have sex without any
contraception_P<0.01_, but not more likely to use unreliable contraception_P>0.5_.
Conclusions: The awareness of EC among adolescents doesn’t have negative impact on
their contraceptive behavior. Unawareness of EC and underestimating the risk of being
pregnant are the main reasons for not using it after unprotected intercourse. Most
teenagers are willing to use EC in the future if needed after health education. Pharmacy is
their first choice for confidentiality reasons. Training pharmacists is critically important, as
they are the first EC provider in direct contact with sexually active adolescents and should
take the responsibility to offer information about correct usage of EC and other more
reliable contraceptive methods. -
- Marie Duriez, FR (all speeches)
Risk factors for failure in medical abortion
Marie Duriez, MD, Philippe Lefebvre, MD
Service d’Orthogénie (Hospital Family Planning Service), Roubaix, France
Aim: To identify potential risk factors of inefficiency for elective medical termination of
pregnancy based on records of failures of this technique in a hospital environment.
Patients and methods: A retrospective study was conducted on elective medical
pregnancy terminations performed up to 49 days post amenorrhoea in the Family Planning
Service of Roubaix hospital between January 1st 2001 and December 31st 2005. The
service's termination protocol consists in an oral dose of 600mg mifepristone, followed by
an oral dose of 400µg misoprostol 48 hours later. A 2nd oral dose of misoprostol (400µg) is
given 3 hours later if there has been no expulsion.
Every patient is required to return 15 days later to check their βHCG levels.
Failure is defined as ongoing pregnancies, total or partial retentions, and cases requiring
emergency surgery. Success is defined as complete abortion requiring no additional
surgical or medical treatment.
Five items were analysed: patient age, patient parity, duration of pregnancy, βHCG levels
on the day mifepristone (D1) was given, and the dose of misoprostol received.
Results: 1,975 medical terminations were performed during this period. 125 (6.33%) of
these patients did not return to be checked and have been excluded from the study. The
analysis was thus performed on 1,850 patients.
The method was a success in 97.08% of cases (1,796/1,850). 54 failures (2.92%) were
recorded, including 7 ongoing pregnancies (0.38%) .
Patients for whom the method resulted in a success compared to patients who had failures
have a significantly lower age.The duration of pregnancy was not different for the two
groups.
Nulliparous (873/1,850) patients had significantly fewer failures (12/873: 1.37%) than
multiparous patients (42/977: 4.30%).
Age is significantly higher for failures amongst the nulliparous patients. Conversely, for
patients who have had at least one child, age is not a determining factor.
28 patients did not receive any misoprostol because they expulsed prior to the 48th hour
(1.51%). Amongst the 673 patients who received only a single dose of misoprostol, 11
(1.63%) required additional actions including one emergency admission for haemorrhage.
Amongst those who received two doses of misoprostol, 43 failed (3.74%), including 2 re-admitted the same day for haemorrhages and 1 for pelvic pains.
Discussion and conclusion: The overall efficiency results for the method are excellent
despite an exhaustive and detailed analysis of the failures.
The various studied factors have demonstrated that there is an increase in failure rates for
the method with parity and, to a lesser extent, with the patient's age.
High plasma beta HCG levels also seem to be more often associated with failures of the
method. The addition of a second dose of misoprostol is likely to increase the chances of
an expulsion during the hospital stay but, this non-comparative retrospective study can not
conclude on the beneficial effect of a second dose of misoprostol on overall efficiency.
Finally, it should be noted that none of the criteria evaluated in this study can be used as a
diagnosis factor to predict the outcome of an elective termination as none of them has the
sensitivity / specificity that is required to identify 'at risk' patients from amongst other
patients. -
- Meta Lindström, SE (all speeches)
- Meta.lindstrom@obgyn.umu.se
Selfperception of Swedish gynaecologists performing abortions
Meta Lindström, Umeå University, Department of Clinical Sciences, Obstetrics and
Gynecology, Sweden
Background. The Swedish gynecologists possess three decades of experiences of
working with legal abortion. It is of great importance both for women in society and for the
gynecologists themselves to learn from their experiences. The aim of our study was to
describe Swedish gynecologists’ clinical and emotional experiences when working in
abortion care. Further aims were to elucidate their perception of women’s motives for
having abortion as well as looking for possible demographic and gender differences.
Methods. A questionnaire comprising both structured and semi-structured questions was
sent to a random sample of 269 Swedish gynecologists. The response rate was 85%.
Results. The female gynecologists were younger (27-59 yrs) and numerically more than
the males (33-66 yrs). Almost all believed that gynecologists should be involved in abortion
care, and half were opposed to the privilege of refusing to work with TOP (termination of
pregnancy). The gynecologists supported the shift from surgical to medical abortions but
not to them being managed in primary healthcare. A few gynecologists (n=42) had
considered changing their job because of TOP being part of their work. Misgivings
occurred sometimes in connection with surgical and late abortions (n=60 and n=108
respectively). Few gynecologists (n=33) had felt inadequate when encountering abortion
patients and more than half thought that working with TOP was a positive experience. The
gynecologists expressed that continuing professional development and ongoing guidance
of TOP matters were important.
Conclusions. In general, Swedish gynecologists have no doubts about taking part in and
performing TOP. However, there are differences in opinions especially regarding surgical
and late term abortions. Due to the fact that female gynecologists were younger and
therefore had fewer years of work with TOP comparisons of females’ and males’
experiences could not be done. Trends of gender differences were noticed concerning the
right of having possibility to refuse taking part in TOP on personal grounds and with male
gynecologists feeling to a higher extent inadequacy compared with females meeting the
abortion seeking women. Gynecologists’ clinical and emotional experience, as expressed
in this study, as well as their perception of women’s motives for abortions, indicate that
they have gained deep insights and developed their professionalism in their work with
TOP. -
- Rebecca Gomperts, NL (all speeches)
- info@womenonwaves.org
Women on Waves
Rebecca Gomperts, MD, Amsterdam, The Netherlands
Women on Waves, a Dutch non-profit organization, operates a mobile reproductive health
clinic on board a Dutch ship. Outside the territorial waters of countries where abortion is
illegal , the abortion pill can be provided safely and legally to women with unwanted
pregnancies. Women on Waves set sail to Ireland in 2001 and to Poland in June 2003 and
in August 2004 to Portugal. The three campaigns created enormous public interest. The
presentation will address the obstacles, successes and failures of the 3 campaigns. It will
also present Women on Web, a online abortion help service.
Chair:- Maria Francès- Kircz, NL
-
- Catharina Zätterström, SE (all speeches)
- catharina.zatterstrom@all.se
Counselling aspects
Catharina Zätterström, Midwife, supervisor for Family Planning Clinics and Youth Clinics in
SLSO South-West Stockholm, Sweden, catharina.zatterstrom@sll.se
Contraceptive counselling is usually given to the woman both before the abortion, by a
physicians or a midwife and after, at the post-aborton visit by a midwife. Roughly 50–60%
of the women will come back for a check-up 3-4 weeks after the abortion.
Women applying for repeat abortions have experienced more psychological problems
during their lifetime compared with women applying for their first abortion. Women who
have had previous abortion/abortions seem to need for special attention, which should
include not only efficient and acceptable contraception but also social and psychological
support based on the individual woman’s need.
In several studies the use of contraceptives amongst women applying for repeat abortion
had been affected by family circumstances more than amongst women applying for their
first abortion. This could indicate the need for including men in family planning programs.
In Sweden immigrant status seems to be an independent risk factor for induced abortion.
Immigrant women also have more early pregnancies and less knowledge and experience
of contraceptives. Immigrant status is also an independent risk factor for repeat abortions.
Although immigrant women after 10 years in Sweden are more socioeconomically equal to
the Swedish-born women regarding education, employment and marital status but they still
have more children and have experienced more induced abortions than Swedish-born
women.
Post-abortion check-up in Sweden is focused on the woman’s medical condition and on
her need for efficient contraceptives. It is seldom designed to suit the individual woman. -
- Silvana Agatone, IT (all speeches)
- s.agatone@libero.it
IUD insertion immediately post abortion
Silvana Agatone M.D.,P.Facco M.D, M GiovanniniM.D. M.Carlos MW T.Malatesta MW,
P.Proietti MW, Operating Unity for voluntary abortion, Obstetrics and Gynaecology
Deparment, S:Pertini Hospital Rome Italy
To evoid recurrent abortion and to provide an acceptable and fast contraception, from the
year 2005 we started to insert 100 IUD (MLCu 3,75) immediately after uterine aspiration
for the termination of pregnancy of less then 12 weeks duration.
A control by ultrasound was carried after 1 and 3 months from the insertion.We had 3
expulsion and 2 cases of metrorraghia, so that the response rate was 95%.
No pregnancy,perforations o cases of pelvic inflammatory deseases were recorded.We
concluded that insertion of IUD immediately post abortion is an acceptable contraceptive
solution -
- Oskari Heikinheimo, FI (all speeches)
- oskari.heikinheimo@helsinki.fi
Risk factors for repeated abortion
Oskari Heikinheimo, MK, Prof., Department of Ob&Gyn, Helsinki University Central
Hospital, Helsinki, Finland
The frequency of repeated abortion varies in different countries and depends greatly on
the overall abortion incidence. In Finland the annual abortion incidence is ~9/1000 fertile
aged women; the proportion of repeated abortion has been ~30% of all abortions for
several years. Low socioeconomic status, parity and older age have emerged as risk
factors for repeat abortion in previous studies.
In order to further characterize the risk factors for repeated abortion we have initiated two
large scale cohort studies employing the national abortion register, where 99% of all
abortions performed in Finland are being reported. Woman’s age, previous pregnancies,
duration of pregnancy, method of pregnancy termination as well as planned future
contraception are reported to the national register.
Helsinki study comprises of ~1400 women chosing medical abortion at our institute
between 2000-2002. At 2-3 weeks following abortion, all women attended the clinic for a
control visit, where the outcome, as well as compliance and initiation of contraception was
assessed. Detailed demographic, life-style and abortion related data of the subjects have
been collected. Also, the contraceptive method and the date when contraception was
initiated have been recorded. The first assessment of repeat abortion until the end of year
2005, and it’s risk factors is being performed. However, the study will continue until 2012.Similarly, a nationwide study employing the national abortion register has been initiated. In
the nationwide study cohorts of ~23.500 women choosing medical abortion and 65.000
women choosing surgical abortion between 2000-2005 are being followed. The first
assessement of repeat abortion will be performed until the end of year 2005. Among other
things, the study allows estimation of the true risk for repeat abortion following different
methods of pregnancy termination.
It is hoped that these register based strategies will be valuable in identifying the incidence
and risk factors for repeat abortion. In addition, true efficacy and cost-benefit ratio of
various contraceptive methods can be assessed. These data are valuable when
developing and designing family planning services aiming to shift from abortion to effective
contraception.
-
15:30-
16:00
-
16:00-
17:00Chair:- Maurizio Bologna, IT
- Christian Fiala, AT
-
- Jean-Jacques Amy, BE (all speeches)
- bea.pion@az.vub.ac.be
How do we move forward
Jean-Jacques Amy, MD, DTM, Prof.
Co-President, Fédération Laïque de Centres de Planning Familial, Brussels.
Anne Verougstraete, Lucie Van Crombrugge, Pierre Moonens, Dominique Roynet
Family planning was given an impetus in the late sixties, following the cultural and sexual
revolution that took place at that time. People stood up and claimed their right to an
unrestricted sexuality. Simultaneously, they rejected constraints with regard to the control
of their fertility. These fights were part of a more ambitious undertaking that aimed at
restructuring society, making this latter more humane and more equalitarian.
Contraception, then abortion gained acceptance in many countries, but not without eliciting
much anger in reactionary circles that correctly perceived that these new freedoms would
endanger the power they had exerted until then. Various issues are indeed raised by
abortion: sexuality, the meaning of life and, first and foremost, free will, which is anathema
to extreme right and religious fundamentalists. We should be on the alert because, since
the early nineties, the powers of darkness are gaining momentum in the United States, in
Poland, and elsewhere. We must define strategies, not only to drive back these raging
opponents, but to further develop the availability of contraception and safe abortion, to
enforce the right of women to control their bodies, and by doing so, to reduce infant and
maternal mortalities, which are scourges in many parts of the world. To this end, we might
1. have the European Parliament legislate on the mandatory implementation by the
various countries of their existent, liberal abortion law: in many such countries the
access to abortion centres is limited or non-existent;
2. write a book on the advantages of liberalizing and de-penalizing abortion;
3. create a working party that would assess the situation in Portugal, Ireland, Poland,
and Malta;
4. create an international centre for training doctors and other health personnel with
regard to voluntary termination of pregnancy;
5. propagate the use of mifepristone as a “once-a-month” pill, which would result in a
much smaller release of steroids in the environment than that associated with the
widespread use of currently used hormonal contraceptives;
6. pay much more attention to analgesia during induced abortion;
7. link European and African countries to increase the safety of abortion in these latter;
8. elect decent and honest citizens to positions of power, and then control them. -
- Marcel Vekemans, GB (all speeches)
- mvekemans@ippf.org
Who is afraid of a woman’s right to self-determination?
Marcel Vekemans, MD, Ob/Gyn, IPPF Central Office, London, UK
For the species survival, new human life has to be protected: we all are “pro-life”.
However, humans can interfere with procreation, using abstinence, contraception,
abortion, infanticide, assisted reproduction. Decisions have to be made; limits have to be
set for health, financial, and ethical considerations. Societal organizations, religions and
individuals all want to interfere and take decisions based on tradition, cultural values and
beliefs, family and community goals, legality, religion, morality, philosophy, power, and
ambiguous “natural laws”. By definition, those who set limitative norms are opposed to, or
concerned by, a woman’s right to self-determination. With regard to abortion, the issue is
not about protecting life. This is easy to show: most so-called “pro-lifers” do not actively
oppose the death penalty, war, or environmental degradation, nor do they support
contraception and universal access to health care, or do they fight neonatal death (4
million mostly preventable deaths yearly, globally), or infant killing diseases such as
malaria.
The issue in patriarchal societies is to guarantee a man’s paternity (“sola mater certa est”)
by controlling the female reproductive function and sexuality, imposing prenuptial virginity,
arranged marriages, dowry systems (a reason for sex selection), absolute fidelity and
harsh punishment of female adultery, confinement of women in-house, and abstinence-
only education. Contraception is made difficult accessing, violence against women (up to
“honour killing”) is used, women are humiliated by lower wages, genital cut-ting, denial of
general education. Traditional patriarchal systems are still protected by laws,
governments, judicial systems, religions, and by most men and women. However, more
and more leaders and governments understand that the death toll related to unsafe
abortion is not acceptable, and that imposed child-bearing is a serious denial of women’s
rights. Traditions being slow to reverse, many governments, parliamentarians, judges,
international and professional organizations, and most men and women, are still afraid of a
woman’s self-determination. Only for one-self, if confidentiality is ensured, is the right to
self-determination almost universally accepted.
-
17:00-
17:45Chair:- Christian Fiala, AT
-
- Mirella Parachini, IT (all speeches)
- mparachini@gmail.com
How to overcome the resistance against medical abortion
Mirella Parachini, MD
San Filippo Neri Hospital, Rome, Italy
OBJECTIVE: To understand how it is possible to overcome the resistance against medical
abortion in order to improve the right of women to choose.
RESULTS: Since the introduction of a pharmacological method to induce early abortion
there has been a strong resistance to it, even in those countries where legal abortion is
allowed with surgical techniques. Today the question about the choice of the method
seems to replace the historical debate about the interruption of an unwanted pregnancyamong pro-life groups and conservative politicians. Many claim that the “abortion pill”
makes women less responsible for their behaviour. On the other hand, even among those
not ideologically against abortion, there is a refusal of medical abortion concerning the lack
of health care assumed with a “self abortion”. Moreover in some countries abortion clinics
are refusing to offer it for fear of legal repercussions. Both medical and surgical abortion
are currently safe and effective when performed by trained practitioners according to
tested protocols under adequate conditions. However anti-choice campaigners try to
involve the public opinion and doctors about the risks of the drug, in an attempt to oppose
the access of the drugs in some countries, like in Canada, Australia and Italy. It is
therefore necessary to increase the information, considering that any medical procedures
is submitted to a scientific control, but keeping out of the debate ideological aims to
maintain restrictions on women’s right to choose.
CONCLUSIONS. There is a strong resistance at various levels against medical abortion
and a continuous scientific debate is requested from the abortion providers, beyond
ideological arguments.
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17:45-