Speeches
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Oct. 22, 2010, 02:00
Decline in rates of serious infection following medical abortion regimen changes
American practice and overwiew of the Clostridium infections
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.
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Oct. 2, 2014, 12:00
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
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Nov. 24, 2000, 02:00
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.
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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.
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Oct. 14, 2006, 02:00
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. -
Oct. 14, 2006, 11:00
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. -
Oct. 22, 2010, 08:00
Does a previous abortion modify womens’ contraceptive choice?
Pascale Roblin, Lisa Tichane, Sylvie Camil, Aubert Agostini and Raha Shojai, France
Objective: Care givers often expect that women with a previous abortion are more likely to use highly effective contraceptive devices to prevent further unwanted pregnancies. We assessed the failed contraceptive method used before an abortion between women with and without a previous abortion.
Methods:In a series of 450 women requesting a medical abortion at home before 7 weeks in a community care center in Marseille, France, there were 157 (35%) patients who had a history of at least one previous abortion. We realized a case –control study to compare the failed contraceptive method leading to an unwanted pregnancy between 157 women with a previous abortion and 293 women without a previous abortion. Chi-2 test was performed and considered significant for p<0.05.
Results: The rate of women using no contraception, natural methods or condoms were similar in both groups. The rate of COC users was 16% in the group of patients with a previous abortion vs 14,7% in the control group (p=0,8). None of the patients used IUD or implants in both groups.
Conclusion:The contraceptive profile of women with an unwanted pregnancy is similar between women with and without a previous abortion. In our population, a history of abortion did not modify womens’ contraceptive choice towards more effective methods.
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Oct. 15, 2016, 09:00
PS04.1
Early and very early medical abortion
Philippe Faucher
Hôpital Trousseau, Paris, FranceEarly medical abortion will be defined in this presentation by termination of pregnancies with Mifepristone/Misoprostol when no visible gestational sac is visible on ultrasound. Very early medical abortion will be defined by termination of pregnancies before the date of expected menstruation. Providers are reluctant to provide medical abortion so early mainly because of the fear of a missed diagnosis of ectopic pregnancy. Consequences for women are not negligible: repeated consultations, repeated ultrasound, repeated HCG could delay the termination of the pregnancy and induce problems of costs, confidentiality or emotional distress. Arguments will be presented to reassure providers about the possibility to provide early medical abortion safely. A protocol for follow up of early medical abortion will be presented based on correct information given to the women (especially symptoms that must induce a visit to the emergency service) and serum HCG testing seven days after the medical abortion. The second argument is the possibility of a reduced efficacy of medical abortion in the early period of pregnancy which was suggested in one study. Published data on this fact will be presented. Finally very early medical abortion will also be considered in this presentation on the basis of recent studies.
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Oct. 2, 2014, 12:00
Early, liberal provision of intrauterine contraception after first trimester abortion is not associated with an increased risk of postabortal adverse events or complications
Elina Pohjoranta, Maarit Mentula, Satu Suhonen, Oskari Heikinheimo Helsinki University Central Hospital, Helsinki, Finland - elina.kuronen@helsinki.fi
Objectives: We carried out a randomized prospective study to assess the effects of early provision of intrauterine contraception (either LNG-IUS or Cu-IUD) vs. routine practice of starting contraception following first trimester induced abortion. This is a secondary analysis comparing early (i.e. within 3 months) adverse events/complications in the two groups. Method: Altogether 756 women undergoing an induced abortion were randomized into two groups (378 in the intervention and 372 in the control group). In the intervention group, 70 (19%) women chose surgical abortion; 68 (97%) of them received an IUS/IUD at the time of abortion. Of the 308 women choosing medical abortion, 290 (83%) received the IUS/IUD at the follow-up visit 2-3 weeks after abortion, the remaining 61 (17%) later. The women in the intervention group had an appointment with the study nurse at 3 months after the abortion. For the control group, a follow-up and future contraceptive counselling was scheduled in primary health care, which is the normal practice. All women were advised to contact the hospital should complications arise. The hospital charts were reviewed for postabortal complications (i.e. bleeding, residual tissue, ongoing pregnancy or infection requiring treatment) within 3 months. Results: 58 (15%) women in the intervention group and 45 (12%) women in the control group were treated for an adverse event (p=0.196). The rate of complications among all women choosing medical abortion was 82 (13%) and 21 (15%) among those choosing surgical abortion. In the intervention group, 24 (41%) patients' complications were detected before the follow-up, 31 (53%) at the follow-up visit, and 3 (5%) at 3 months. Altogether 20 (5.3%) IUS/IUD expulsions occurred by 3 months, 7 (35%) of which were before 2-3 weeks. Conclusions: The early insertion of an IUD after first trimester abortion does not increase the overall risk of adverse events/complications nor cause extra visits to the clinic.
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Oct. 22, 2010, 08:00
Early medical abortion as the first choice method at the University Department of Obstetrics and Gynaelacogy in Ljubljana, Slovenia
Andreja Štolfa Gruntar and Bojana Pinter, Department of Obstetrics and Gynecology, University Medical
Centre Ljubljana, Slovenia
Medical abortion was introduced as a method of first trimester induced abortion 20 years ago, when as one of WHO collaborating centres in the area of reproductive health our Department of obstetrics and gynecology was offered the possibility to carry out the studies investigating the efficacy and safety of abortion inducing drugs, although the drugs had not been registered in Slovenia.
Until 7 years ago medical abortion was performed only in women enrolled in various WHO studies. However, when the direct import of the needed drugs (mifepristone and misoprostol) became possible, we started to perform early medical abortions on a regular basis in women who decided on this method for early abortion of an unwanted pregnancy. Knowing the method well we wanted it to become the predominant method of early abortion. But since there was no agreement among gynecologists that it should be the method of choice for an early abortion, women still choose the method they prefer. Dilatation and curettage under general anesthesia is still the most frequently used method, although some women decide on endometrial aspiration without anesthesia, too.
The reasons why women decide on a surgical abortion under general anesthesia are: not being aware of what is being done, fear of pain, gynecologist's advice. Many gynecologists still advise their patients the abortion done under general anesthesia, because it has been done successfully for years, and as they are still sceptical about medical methods due to the lack of knowledge and personal experience.
Our intention is to increase the percentage of medical abortions among the eligible women wanting to end an unwanted pregnancy. Due to the aforementioned reasons our aim has not been achieved yet. There are around 1500 early abortions to end an unwanted pregnancy at the Department per year (e.g. 1546 in 2006, 1334 in 2008). Of these there are 13,5% endometrial aspirations without anesthesia, 55,6% surgical abortions under general anesthesia, and only 30,9% medical abortions. Obtaining good results with medical abortion and spreading the knowledge among patients and gynecologists, and with efficient motivation for medical instead of surgical procedure, the rates of early medical abortion to end an unwanted pregnancy have been slightly increasing, but the rates could be further improved. So in March 2010 we organized a seminar to promote medical abortion as the first choice method and to exchange experience with other abortion-care practitioners in the rest of Slovenia.
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Sept. 15, 2018, 02:00
Medical abortion in Bulgaria is available in unusual circumstances. Abortion in Bulgaria is allowed up to 12 weeks upon wish, up to 20 weeks - for medical conditions or foetal anomalies, and after that - in extreme circumstances.
The legislation regarding abortion has been made in 1990 and last reviewed in 2000. Medical abortion doesn’t exist in it. It is written envisaging surgical procedures only. It requires blood tests (FBC, MSU, clotting, blood group, Rh) and vaginal swab prior to every abortion. It also requires the abortion to start and end in a medical facility. It otherwise classifies the act as a criminal offence and envisages imprisonment of up to 5 years and if repeated - up to 8 years.
Medical abortion, however, has been performed in the country over the past 10 years or so. Prior to the official availability of registered drugs, Cytotec was in wide circulation. It still is, regardless of the lack of registration in the country.
Mifepristone and Misoprostol have been first registered in 2012, reaching the market in the end of 2014. Their registration is for distribution in pharmacies, by prescription. The obs&gynae society, however, is largely against the wide availability of the medications, being afraid women will self medicate, and are reluctant to prescribe them, seeing it as illegal to participate in abortion outside medical facility. Very few hospitals offer MTOP or medical management of miscarriage as an inpatient procedure. Professional knowledge on medical abortion is limited. It is widely believed that every pregnancy must end with delivery or curettage.
A few hospitals and doctors do provide medical abortion, albeit in variation of regimens, and more and more women request it.
It is because of women’s increasing interest and the few doctors fighting for the cause, that medical abortion is surviving in Bulgaria.