Meeting the needs of grieving families after induced abortion for fetal abnormality in Slovenia
Vislava Globevnik Velikonja University Medical centre, Ljubljana, Slovenia - vislava.velikonja@guest.arnes.si
The detection of fetal abnormalities in the first and second trimesters is increasingly common due to advances in technology. Parents need counselling to be prepared for the difficult decisions that must be made if their unborn children are diagnosed with a life-limiting condition. Termination after fetal anomaly forces parents to take an active part in the life and death of a nearly-viable fetus. Regardless of the option taken, they often experience intense grief reactions. Both giving birth to a child with a life-limiting condition as well as termination of pregnancy for fetal anomaly can be emotionally traumatic life events. Abortions for fetal abnormality are statistically rare, therefore there is little societal understanding and minimal support for those who experience them. The grieving family should be provided with assistance by professionals at multiple levels, aiming at reaching two main target groups: the grieving family by providing direct counselling and support in the hospital and in the community, and those assisting the bereaved by providing training and support. At our department both parents can be hospitalized together during the period of pregnancy termination. The possibility of seeing the dead baby, to hold it and to say farewell may help the parents afterwards. They are informed about cremation and the day of the funeral in a memorial park named Snowdrop Garden, about the mourning process and the possible psychosocial support during it. If the birth weight of the baby is over 500 grams, we use the protocol for perinatal death. Most parents are able to cope with the decisions they made. Feelings such as doubt, guilt, failure, shame, anger, relief, anxiety and depression are common during the process of abortion, the following weeks and sometimes even months. Only a few couples still need psychotherapeutic help and a support group after one year.
Midlevel versus physician provision of medical
termination of pregnancy– a randomised controlled
study
Gemzell-Danielsson, K1; Johansson, M1;
Salomonsson, E2; Gomperts, R1; Kopp Kallner, H1
1 Department of Obstetrics and Gynaecology, Karolinska Institute,
Stockholm, Sweden; 2 Karolinska University Hospital, Stockholm,
Sweden
Objective: To evaluate feasibility, efficacy and acceptability of
midlevel provision of medical termination of pregnancy (TOP) in
clinical practice through a randomised study of midwife or
physician examination and counselling prior to medical TOP.
Background: Midlevel provision of medical TOP is common in
less developed countries and has been shown to be acceptable.
However, access to a gynaecologist is a limiting factor in medical
TOP also in developed countries and causes unnecessary waiting
periods. In developed countries vaginal or abdominal ultrasound
is routinely performed before TOP and has been an obstacle to
midlevel provision of medical TOP.
Methods: Two midwives highly experienced in TOP care with no
previous training in ultrasound were trained in vaginal ultrasound
of early pregnancy. Inclusion criteria for this study were being
healthy with no ongoing medication and willing to participate.
Women signed informed consent and were randomised
accordingly. All patients with pregnancy longer than 63 days
gestational age or without having visible intrauterine pregnancy
were referred to a gynecologist.
Results: So far 1200 patients have been included. A total of 1260
women will be randomised. No serious adverse events have been
recorded. Preliminary results show that acceptability of midlevel
provision of medical TOP is higher than physician provision.
Conclusion: Midlevel provision of medical TOP in a clinical
setting in a developed country is highly feasible. Midwives can be
trained in vaginal ultrasound and thereby provide the complete
spectrum of early TOP services.
Objectives: In the United States, many women struggle to obtain an abortion due to ever-increasing barriers to access. The TelAbortion Project provides medical abortion directly to women in their homes using telemedicine and mail, enabling them to receive services without going to a clinic. We will report on interim findings from the first two years of the project.
Methods: TelAbortion is available in Hawaii, New York, Maine, Oregon, and Washington. Interested women contact implementing sites and interact with clinicians by videoconference. After obtaining screening tests at radiology and lab facilities close to them, eligible women are mailed packages containing mifepristone and misoprostol. Women take the medications at home, obtain follow-up tests and have another consultation with the clinician.
Results: Through June 2018, 200 women had received medication through the project. Of the 70% who were followed to completion, 5% had a surgical completion. The vast majority of packages were sent within two weeks after the initial study contact, and all women reported taking the mifepristone at gestational ages of 72 days LMP or less. No related serious adverse events were reported. All women reported being very satisfied or satisfied, and the most commonly reported best features of the service were the convenience and privacy.
Conclusions: Direct-to-patient telemedicine abortion is feasible and can potentially increase access to abortion care in a safe and acceptable manner. Although telemedicine bans and other restrictions are on the rise, TelAbortion could plausibly be legally implemented in about half of the 50 states, where about 56% of the female reproductive-age population reside.
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.
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.
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.
Ivar Brod, Pan Am Pharmaceuticals, Inc., New York, USA
Christian Fiala MD, Gynmed Ambulatorium, Vienna, Austria
Misoprostol has been widely used in Ob/Gyn practice since the early days of its appearance on the market. However, Pfizer, the current manufacturer, so far has rejected continuous requests to add these indications. Moreover, in countries like Estonia and Latvia where registration expired, manufacturer refused to prolong it. We believe that the company’s reasons were financial only, since the price of Misoprostol is more than 10 times lower than the price of other prostaglandins, injectable or jelly, produced by this company. This reason overweighs the fact that other prostaglandins (E2 and F2a analogs) can cause heavy adverse effects, like myocardial infarction and bronchospasm, which is not the case for Misoprostol (E1 analog).
The use of Misoprostol in Ob/Gin in USA is based on FDA’s general recognition that off-label use of approved medicine is acceptable, if it’s based on published scientific evidence. Similar recommendations have been accepted by the European Community Pharmaceutical Directive as well as by British National Formulary. There are no such policies in countries of Eastern Europe - Russia and other post-communist countries. Data that is being analyzed is mainly from Russia, which is typical for all of these countries. Existing legislation there does not provide any positive information about the off-label use of medicine. Moreover, in case of Misoprostol, medical authorities periodically issue directions prohibiting the access to it, due to the lack of indication by the manufacturer. The first of such Directive Letters was issued in April 1999 by Russian Ministry of Health forbidding the use of prostaglandins for off-label indications. The last Directive Letter as of July 2003 forbids directly the Ob/Gyn use of Misoprostol. The breach of these directives can be assumed as a criminal case.
One of the biggest problems for countries like Russia, where 60% of pregnant women prefer abortion and 15% of women in reproductive age are sterile, is to conduct a gentle abortion procedure in order to avoid any harm to female’s reproductive system. Many experts acknowledge that medical termination of pregnancy, using mifepristone followed by Misoprostol, is the most merciful abortion method. Mifegyne (mifepristone), known as the most excellent medicine for medical termination of pregnancy, has been registered in Russia in 1999. Ban of Misoprostol use significantly deprived Russian women the right to choose this method of medical abortion.
There is one more serious aspect resulted from Misoprostol ban in obstetrics in Russia. Help to pregnant women during childbirth is particularly important in this country where more than 10% of deliveries present with high risk of complications for mother and a baby. More than 1/3 of those caused by failure to progress in labor. Russian Ob/Gyn specialists found direct correlation between using Mifegyne and Misoprostol and raising the Bishop range from 0-3 to 4-7. As a result, this method was patented and these indications were formulated in the instruction. Misoprostol ban in obstetrics makes it impossible to use this remarkable mode.
The literature supporting Misoprostol Ob/Gyn use is rather vast – more then 400 publications in leading medical journals. Among them there are publications of experts in Russia, Ukraine, Latvia, Lithuania, and others. Moreover, in Russia in 2004 is published a spacious monograph devoted to Ob/Gyn use of Misoprostol. However, most of all reported brilliant results were based on the use of Misoprostol in research institutions, not in general practice.
We have to stress, that the situation with Misoprostol is special because it is officially recommended to be used in Ob/Gyn by World Health Organization issuing in May 2003 the guidance “Safe Abortion: Technical and Policy Guidance for Health Systems”. We believe that these recommendations allow us to call upon medical authorities in countries of Eastern Europe to acknowledge that Misoprostol was proven to be a prominent drug in Ob/Gyn and to define the way of its appropriate use. Women should not be held hostage by the economic considerations of a private pharmaceutical company in the United States.
Misoprostol-only compared with solution of NaCl 20%for induction of second trimester abortion
A. Manaj, A. Musta (Albania)
Obsetric Gynecological Hospital Mbreteresha Xheraldine, Tirana, Albania
amusta@acpd-al.org
Objective. The effect of Misoprostol in induced abortions of second trimester as treatment of choice.
Design & Method. In our country, the main method to terminate the second trimester pregnancies was the solution of NaCl 20%. These five last years this method is being replaced with misoprostol-only regimen. This was a comperative study. During a 12-month period, were selected and voluntary involved, two groups of healthy pregnant women (13-24 weeks) wishing to terminate their pregnancy due to medical reasons. A total of 80 patients, treated with misoprostol (experiment group) were compared with 77 patients treated with NaCl 20% (control group). Chi Square test for comparison of these proportions was used.
In the first group of 80 women the abortion was induced by misoprostol (Cytotec) 400 mcg vaginally 3-hourly (x5). The abortion time varied from 18 hours and 20 (pluripara) to 25 hours and 5 minutes (primigravida) hours. In the second group of 77 women abortion induced by intramniotic transabdominal instillation of 20 % NaCl, amounting to 250 ml. The shortest abortion-instillation time was 28 hours and 10 minutes (pluripara), while the longest was 36 hours and 8 minutes (primipara). 2 cases pertaining the first group and 8 cases pertaining to the second one, experienced haemorrhage due to partial retention of the placenta which were subsequently removed by curettage. In the second group we experienced two cases of distacco placenta.
Results. From data analyses resulted that patients treated with misoprostol have a much lower rate of haemorrhage P=0.01, cramps P=0.02 and curettage after misoprostol/ NaCl administration P=0.3.
There is no statistically significant difference in the rates of infections P=0.6, pelvic pain P=0.7, diarrhoea P=0.67, and the difference in the amniotic fluid embolism P=0.7 and distacco placenta P=0.7.
Kristina Gemzell-Danielsson, Professor, MD, PhD, Dept. of Woman and Child Health, Div. of Obstetrics
and Gynecology, Karolinska Institutet/ Karolinska University Hospital, Stockholm, Sweden
Misoprostol, a synthetic prostaglandin E1 analogue, is commonly used for medical abortion, cervical priming, the management of miscarriage, induction of labor and the management of postpartum hemorrhage. Thus, misoprostol is a very versatile drug in obstetrics and gynecology. Knowledge of the pharmacokinetic profiles is important for designing regimens for various applications. Misoprostol can be given orally, vaginally, sublingually, buccally or rectally. Studies of misoprostol’s pharmacokinetics and effects on uterine activity have demonstrated the properties of the drug after various routes of administration. These studies can help to design the optimal dose and route of administration of misoprostol for the management of missed and incomplete abortion.