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 for
women right to the access to the fruits of modern science, could be listed.
Death after medical abortion not linked to mifepristone
Silvio Viale Sant'Anna Hospital, Turin, Italy - silvioviale@libero.it
The death of a woman of 36 years with no previous known medical condtions after a medical abortion in Turin last April 9 attracted great attention in the media, . The headlines were "death after RU486", but the first report of the medical examiner appointed by the coroner said that RU486 was not responsible for the death . The protocol was mifepristone 600 mg on the first day and gemeprost 1 mg on the third day. On the third day ketorolac 30 mg IM for pain was also administered together with methylergometrine maleate 0.2 mg IM to reduce blood loss. Shortly after the expulsion the woman developed shortness of breath and loss of consciousness followed by cardiac arrest. The first cardiac arrest occurred at around 12:30 and the woman died at 22:45 in the ICU. From the first evidence the autopsy did not reveal any relevant items. Unfortunately, this is not the only death that has occurred in Italy in 2014 after an abortion. Two other women died recently after an abortion. One woman died in Nocera Inferiore, near Salerno, from abdominal bleeding after surgical abortion in a woman with myomas and previous caesarean section. The other woman died in Turin from acute liver failure two days after a surgical procedure for missed miscarriage. In the first case the media interest was mostly local. In the second case the media didn't known about it. These three deaths remind us that there is no zero-risk in pregnancy and that, though rare, it is possible to die during an abortion procedure even in countries with advanced health care systems. Regarding the death after medical abortion that occurred in Turin, we can say that mifepristone is not responsible in any way.
Deciding on the method and location for induced abortion: a Flemish survey study
Joke Vandamme1, Ann Buysse1, Inge Tency2, Guy T'Sjoen1 1University of Ghent, Ghent, Belgium, 2KAHO Sint Lieven, Ghent, Belgium - jokel.vandamme@ugent.be
Introduction The Belgian health insurance system prescribes that women who opt for medical abortion should stay at the abortion centre when using mifepristone and misoprostol. A lot of women currently decide for the more rapid surgical method under local anaesthesia. In this study, we map the process of deciding for one of the abortion methods along the different stages of information provision. Method. During a four month study period in four Flemish abortion centres, all Dutch-speaking adult women with a gestational period of less than 8 weeks were asked to participate. During the first visit, they were questioned about the sources they had consulted to get information on the abortion methods and were asked for their initial preference. Afterwards, they were shown a standardized videotape with accurate information on both methods and were asked for their preferences again. In a second video, women learned about the possibility of performimg the misoprostol phase at home and were questioned about their final preferences. Results. Preliminary results show that, when entering the abortion centre, the majority of women (>70%) preferred medical above surgical abortion. Most of the women (>60%) sought information on the official abortion centre website. However, one in three had visited other websites and one in four got information from external professionals. After the provision of standardized information, the percentage that prefers medical abortion drops to 50%. If the misoprostol at home option were available, only one in five would still prefer medical abortion with use of misoprostol in the abortion centre. Conclusion. Flemish women may have an inaccurate idea about the current medical abortion process. The misoprostol at home possibility would be a good alternative for the ones who would otherwise decide for the surgical method as well as for those preferring medical abortion.
Mary Fjerstad, N.P., M.H.S., Senior Clinical Advisor, Medical Abortion Ipas, USA
Co-authors: James Trussell, Ph.D, Iriving Sivin, M.A., E. Steve Lichtenberg, M.D., M.P.H. and Vanessa
Cullins, M.D., M.P.H, M.B.A.
Background: From January 1, 2005 through June 30, 2008, we tracked 227,823 women having medical abortion at Planned Parenthood clinics in the U.S. In the first time period, January 1, 2005 through March 31, 2006, the medical abortion regimen used was mifepristone 200 mg followed 24-48 hours later by misoprostol 800 mcg vaginally. There was not a standardized practice for testing or treatment of infection. During this period, among the Planned Parenthood data, the rate of serious infection was 0.93 per thousand medical abortions. Serious infection was defined as those requiring IV antibiotics in the emergency department, hospitalization, surgery necessary to remove an infected organ, or death. In early 2006, Planned Parenthood changed the route of misoprostol administration from vaginal to buccal and required either routine provision of antibiotics or universal screening for chlamydia and treatment of positive cases. In July 2007, Planned Parenthood required routine antibiotics as part of the medical abortion regimen.
Methods: This was a retrospective analysis based on mandatory reports of number of medical abortions provided each quarter and reports of adverse events mandated by the Food and Drug Administration under Subpart H approval of mifepristone.
Results: Rates of serious infection dropped significantly after the joint change to buccal administration of misoprostol and to either: 1) testing for sexually transmitted infection or 2) routine antibiotics. There was a 73% decline seen by instituting these changes to a rate of serious infection from 0.93 per 1000 abortions to 0.25 per thousand. The subsequent change to routine provision of antibiotics led to a further significant reduction in the rate of serious infection- a 76% decline, from 0.25 per 1000 abortions to 0.06 per thousand.
Conclusions: The maximum contribution of the change to the buccal route of misoprostol could be as high as 67% (if screen-and-treat were completely ineffective), and as low as 0%. It seems unlikely that screen-and-treat was completely ineffective, because at least some who test positive would have been treated in time to prevent serious infection. The maximum contribution of routine use of antibiotics could be as high as 100% (if the switch to buccal administration of misoprostol were completely ineffective) and no lower than 33%.
The rate of serious infection after medical abortion declined by 93% after a change from vaginal to buccal administration of misoprostol combined with routine administration of antibiotics.
Although there have been 9 deaths in North America; 8 caused by Clostridium sordellii and one caused by Clostridium perfringens, there have not been reports elsewhere in the world of infection-related mortality following medical abortion.
De-medicalising contraception
Access to contraception is a reproductive health
right. While sex ‘just happens’, women need to
go through several hoops to obtain contraception.
Regulations, protocols and guidelines drive
service provision but do affect the perceptions
of both users and providers. Evidence-based
de-medicalisation of contraception may remove
personal and systematic barriers to effective use of
family planning methods. Emergency contraception
is a case study in this area. Other models of care
have emerged in the last decade. These include
over and under the counter oral contraception,
vending condoms and emergency contraception
and web based services. Themes emerging
from such models suggest that research, service
provision and advocacy schemes should aim to
push the boundaries of contraceptive regulation
towards user-friendly non-medicalised care.
Demographic characteristics of 400 women from Ireland and the Philippines who completed the online consultation form of the telemedical abortion service Women on Web
Rebecca Gomperts, Marlies Schellekens Women on Web, Amsterdam, The Netherlands - mschellek@zeelandnet.nl
The study analyzes the data of 200 women from the Philippines and 200 from Ireland who completed the online consultation form of Women on Web telemedical service in 2012. The study found that the geographical, cultural and political differences of Ireland and the Phillipines correspond to the demographic characteristics of women who completed the online consultation. For example average rates of contraceptive usage in the Philippines is 41% to 50% . On the other hand in Ireland contraceptives are widely available and accessible and 64.8% of people aged 18-49 use contraceptives. Our analyses found that more women from the Philippines reported that the unwanted pregnancy was caused because they did not use contraceptives compared to women from Ireland (70.5% vs 41.5%). Women in Ireland often already had children and reported failed contraception as a reason for their pregnancy (Table).
Ireland Philippines p-value
Total 200 200
Mean age 28 26
Reason for abortion:
I am too young 20 (10%) 50 (25%) 0.0008
Reason for abortion:
I am too old 10 (5%) 2 (1%) 0.012
Reason for abortion:
family is complete 51 (25.5%) 14 (7%) 0
Nulliparous 88 (44%) 106 (53%) 0.07
No contraceptive use 83 (41.5%) 141 (70.5%) 0
Monitoring the Abortion Process: Home Use Of Misoprostol in the United States
Eric Schaff, MD
Professor of Family Medicine and of Obstetrics and Gynecology
University of Rochester School of Medicine
New York, USA
The United States medical abortion experience has been unique. Frustrated with not having mifepristone, U.S. researchers explored the combination of methotrexate and misoprostol for medical abortion in the mid-1990s. The experience was mixed because the regimen often took several weeks to be successful. But, it provided abundant opportunity to explore different approaches to medical abortion.
Lessons from Methotrexate Medical Abortions
We learned early on with methotrexate abortions, that vaginal misoprostol was more effective than oral misoprostol. We also learned that repeating the misoprostol dose was necessary, safe and increased the effectiveness rates. We had to monitor the medical abortion with ultrasound because at two weeks, despite a history of bleeding, as many as 15-20% of pregnancies had not been expelled and the decision to perform an aspiration completion depended on the results of the viability of the pregnancy by ultrasound. And lastly, we learned that women could have a medical abortion safely at home as long as they had access to emergency medical care, if needed. Women also found home use of misoprostol highly acceptable.
Abortion Rights Mobilization Trials
In 1996, the Abortion Rights Mobilization (ARM), a non-profit advocacy group in New York City, contracted with the University of Rochester medical abortion researchers to coordinate trials with mifepristone. We applied the information learned from the U.S. experience with methotrexate, i.e., use of vaginal misoprostol, home administration of misoprostol, a repeat dose of misoprostol if needed, and routine ultrasound monitoring.
Over the following four-year period, the ARM trials have enrolled 7000 women in seven multicenter trials. These trials have recently come to a halt as the commercial product has come to market.
Summary of ARM Trials
In 1966, the first ARM trial used mifepristone 600 mg and vaginal misoprostol. It was an open label, non‑randomized, prospective trial at one site, up to 56 days gestation. The first follow up occurred within the first 7 days. There were 166 subjects with a 97% effectiveness up to 8 weeks. Four percent of subjects used a second misoprostol dose, 34% bled prior to misoprostol, and 11% did not require misoprostol. There were no transfusions, but there was 1 hospitalization related to bleeding.1
The second trial in 1997 used mifepristone 200 mg and vaginal misoprostol and was an open label, non‑randomized, prospective trial at 7 geographically diverse sites. There were 933 subjects with a 97% effectiveness up to 8 weeks pregnant. 2% used a second misoprostol dose and there were no transfusions and no hospitalizations.2
The third trial in 1998 extended the gestational age to 9 weeks pregnant using mifepristone 200 mg and vaginal misoprostol at 15 geographically diverse sites. Women used home misoprostol. There were 1137 subjects and 308 between 56‑63 days gestation. The regimen was 97% effective up to 8 weeks, 96% after 8 weeks, and 2% uses a second dose of misoprostol. There were one transfusion and two hospitalizations.3
The fourth ARM trial randomized misoprostol at 1, 2, or 3 days after mifepristone 200 mg. Again, it was an open label, prospective trial at 15 geographically diverse sites. There were 2255 women enrolled up to 8 weeks pregnant. The regimen was 98% effective at 1 and 2 days, and 97% effective at 3 days (2% used a second dose). There were no transfusions and 2 hospitalizations.4
We have had another trial completed comparing mifepristone 200 mg and Oral vs. Vaginal misoprostol at 24 hours. We used two doses of oral misoprostol 400 mcg two hours apart on day 2 up to 63 days pregnant. There were 1168 women enrolled. The effectiveness at first follow up was 89% in the oral group and 97% in vaginal group, ( p<0.001). In oral group, the regimen was 90% effective up to 7 weeks and 88% effective between 8‑9 weeks gestation. After a second vaginal dose of misoprostol was used, the overall effectiveness, 94% in oral group, 99% in vaginal group. There was more diarrhea with oral 33% v 18% vaginal misoprostol,( p<.001 ). There were no transfusions and no hospitalizations.
A sixth completed trial of 1000 women is still being analyzed to determine whether experienced US clinicians report that they need routine ultrasound.. Preliminary results show that about 57% of the time, clinicians report that ultrasound is not indicated. Ultrasound was reported to be indicated in about 22% of the time and “not indicated but desired” in the remaining 21%.
We have just finished our seventh trial which was a randomization of oral v vaginal misoprostol after mifepristone 200 mg at 48 hours up to 9 weeks pregnant. We used two doses of oral misoprostol 2 hours apart. There will be about 750 subjects enrolled. The results are pending. Low dose mifepristone and one dose of oral misoprostol 400 mcg after 49 days was not effective and the study was amended. There was 1 transfusion.
*********
In summary,
1. A 200 mg dose of mifepristone with vaginal misoprostol is as effective as the 600 mg standard mifepristone dose. Effectiveness rates with vaginal misoprostol have ranged from 96-98%.
2. With the use of vaginal misoprostol, we have demonstrated high effectiveness rates above 95% up to 9 weeks gestation.
3. A repeat dose of misoprostol in women with a persistent gestational sac at first follow up in the first week, was both safe and might improve effectiveness. A randomized trial of a repeat dose of misoprostol in initial non-responders would help to answer this question. Since there are few (5%) women who do not respond initially, it would require a large sample.
4. Vaginal misoprostol provided increased flexibility in the regimen and could be given 1, 2 or 3 days after mifepristone with effectiveness rates above 95%.
5. Home use of misoprostol is safe. Only 2 women out of 7,000 have needed an emergent aspiration curettage within 4 hours of using misoprostol, i.e., the time period when medical observation is required in France. Four transfusions occurred in these 7000 women (<0.1%). Of note, they all were delayed ranging from 1-3 weeks after using mifepristone.
6. Ultrasound dating of the pregnancy and confirming the abortion is highly accurate. It allows women to return earlier for evaluation, as soon as one day after using misoprostol, at a time when the serum hCG may still be elevated and the uterus has not fully involuted. It can also allow an early ectopic pregnancy to be detected. The French experience has demonstrated that ultrasound need not be routine.
From these studies, we conclude that the best regimen is mifepristone 200 mg in women up to 9 weeks pregnant (by ultrasound) followed 24-72 hours later by vaginal misoprostol at home, with a repeat dose of misoprostol in initial non-responders.
References
1. Schaff EA, Stadalius L, Eisinger SH, Franks P. Vaginal misoprostol administered at home
after mifepristone for abortion. J Fam Pract 1997;44:353‑360.2.
2. Schaff EA, Eisinger SH, Stadalius LS, Franks P, Gore BZ, Poppema S. Low‑dose mifepristone
200 mg and vaginal misoprostol for induced abortion. Contraception 1999; 59:1‑6.
3. Schaff EA, Fielding, SL, Eisinger SH, Stadalius LS, Fuller L. Low‑dose mifepristone
Followed by vaginal misoprostol at 48 hours for abortion up to 63 days. Contraception
2000; 61:41‑ 46.
4. Schaff EA, Fielding SL, Westhoff C, Ellerston C, Eisinger SH, Stadalius, LS, Fuller L.
Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion (< 56 days gestation): a randomized trial. JAMA 2000;284(15):1948‑1953.
Detection of violence against women via screening at the occasion of request for pregnancy termination
C.D. Liengme, F. Coquillat, M. Demierre, P. Hohlfeld, S.-C. Renteria (Switzerland)
Family Planning Center, Psycho-social Unit, Department for Obstetrics and Gynecology of University Hospital of Lausanne (CHUV), Switzerland
christiane.dufey-liengme@chuv.ch
Introduction. In Switzerland one out of five women is subject to interpersonal violence at least once in her life and 24 women die from such violence every year. Several surveys show that the problem of violence is generally underestimated as only about one case out of twenty is detected. Again surveys show that women would like to be questioned about violence when consulting a doctor.
In the summer of 2007 a new chapter concerning present and past violence was introduced into medical files. Doctors or midwives complete these files, while they are taking the medical history of women requesting a termination of pregnancy. The Family Planning Centre carried out a research to see what changes resulted from the introduction of this chapter and also to see which effects, if any, taking care of women after detection had on the spiral of violence.
Material and Methodology. This quantitative retrospective survey covered 2 four-month periods, the first extending from January to April 2007 and the second from January to April 2008. The data that were analyzed were collected from the medical files kept by doctors and midwives on women requesting a termination of pregnancy or re-considering the idea, and from the files of the Family Planning Centre advisors, who interview all the women concerned according to the protocol for termination of pregnancy at the Gynecology and Obstetric Department of the Lausanne University Hospital (CHUV)
Results. During these two periods a total of 451 women were taken care of. 82 of them admitted being or having been victims of violence, 21 out of 201 (10%) during the first period, and 61 out of 250 (25%) during the second period. These numbers show an increase of 150% in detected cases. A detailed analysis of the data collected concerning these 82 women will be presented: the type of violence, requests for help, legal and medical assistance provided.
Conclusion. Our study confirms the importance, for health professionals who take care of these women, of paying systematic attention to the fact that they may be or have been victims of violence. Women who are victims of violence are thus able to talk about it, to be listened to, informed and helped according to their specific needs. In the case of requests for a termination of pregnancy after a rape, the fact that the victim claims having been raped, allows the biological proof of sexual contact to be registered and kept on file.
Bojana Pinter, S.Baznik and T.Vovko, Department of Obstetrics and Gynecology,
University Medical Centre Ljubljana, Slovenia
Objectives: The aim of this study was to obtain a broader insight into social-economic, religious, and other characteristics of pregnant women having an induced abortion (IA), and into the reasons for induced abortion, use of contraception before and after IA, and to analyze women's attitude towards professional counselling before IA in the Ljubljana's region.
Design & methods: The study was based on two comparable questionnaires that were given to two groups of pregnant women: a study group of women that were having a first trimester IA at the Department of Obstetrics and Gynecology, University Medical Centre Ljubljana (323 subjects) and a control group of women in the first trimester of pregnancy that intended to give birth (60 subjects) and were attending out-patient clinics in the Ljubljana region. Participation in the study was voluntary and anonymous. The differences between the groups were analyzed using a chi-square test, and the correlations between individual characteristics were calculated using Pearson correlation coefficient. P values below 0.05 were regarded as significant.
Results: The average age was 28.8 ± 3.4 years in the study group, and 28.6 ± 7.0 years in the control group, the difference was not statistically significant (p=0.737). In the study group there were significantly more women that had finished primary school only than in the control group (17.9 %: 0.0 %; p<0.05), and fewer had achieved graduate (18.8 %; 6.7 %; p<0.05) or post-graduate education (2.2 %; 11.7 %; p<0.05). In the study group fewer women were employed (56.9 %; 80.4 %: p<0.05), and more of them unemployed (18.2 %; 5.4 %; p<0.05), and fewer lived with their spouses or family (55.5 %; 76.7 %; p<0.05). Women in the study group considered their socio-economic status significantly lower and fewer declared themselves as Roman-Catholics (66.3 %; 92.6 %; p<0.05). There was a significantly higher rate of barrier contraception use in the study group before the pregnancy. The main reasons for IA were current lack of wish for a child (48.7 %), financial and social reasons (35.3 %) and school or career (29.7 %). The majority (84.0 %) of women in the study group had professional counselling and 42.1 % of women in the study group would want such counselling.
Conclusions: Pregnant women who decided on an IA had poorer socio-economic status, fewer of them were Roman-Catholics, and they used less efficient contraception.
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.