Medical methods: Advantages and disadvantages
Kristina Gemzell (Sweden)
Dept. of Obstetrics &.Gynecology, Karolinska University Hospital/Karolinska Institutet, Stockholm, Sweden
kristina.gemzell@ki.se
Delayed diagnosis of fetal anomalies, logistic and financial difficulties in obtaining abortion services, and failure to recognize an undesired pregnancy in the first trimester all contribute to the continuing need for late abortions. Second trimester abortion constitutes 10–15% of all induced abortions worldwide but is responsible for two-thirds of all major abortion-related complications. During the last decade, medical methods for second trimester induced abortion have shown a considerable development and have become safe and more accessible.
Today, in most cases, safe and efficient medical abortion services can be offered or improved by minor changes in existing health care facilities. The combination of mifepristone and misoprostol is now an established and highly effective method for termination of second trimester pregnancy. In some places medical abortion has become the recommended method for second trimester abortion leading to increased access. In countries where mifepristone is not available or affordable, misoprostol alone has also been shown to be effective, although a higher total dose is needed and efficacy is lower than for the combined regimen. Therefore, whenever possible the combined regimen should be used. Efforts should be done to reduce unnecessary surgical evacuation of the uterus after expulsion of the fetus and future studies should focus on improving pain management. More studies are also needed to explore the safety of medical abortion regimens in women with a previous caesarean section or uterine scar. Advantages and possible disadvantages with medically induced abortion in the second trimester will be discussed.
Medical treatment of abortion and missed miscarriage: what's the difference in results?
Silvio Viale San'Anna Hospital, Turin, Italy - silvioviale@libero.it
Objectives: We have compared the efficacy of medical treatment for abortions in women with missed miscarriages. The protocol was mifepristone 600 mg orally + gemeprost 1 mg vaginally two days after, eventually repeated once. Women didn't stay in hospital between mifepristone and gemeprost. Methods: Since April 2011, when mifepristone became available in Italy, until April 2014 we have performed 3545 medical abortions up to 7 weeks. Later we started to offer medical treatment also for blighted ovum and missed miscarriage up to eight weeks of development, regardless of the true gestational age. As at April 2014 we have performed 423 medical treatments of missed miscarriages and blighted ovum. Results: The overall success rate of medical management of abortion and missed miscarriage was 96.3%, with 147 surgical procedures out of 3968. For abortion the success rate was 96.5%, with 125 surgical procedures out of 3545. For missed miscarriage the success rate was 94.8%, a little less, with 22 surgical procedures out of 423. If we keep out the 32 cases in which the curettage occurred for failure in expulsion, 22 abortion and 10 missed miscarriage, the overall success rate rises from 96.3% to 97.1%. By doing the same for abortions and missed miscarriages we found that the success rate rise in both cases, from 96.5% to 97.1% for abortions and from 94.8% to 97.1% for missed miscarriage. Consequently, the rate of curettage drops from 3.5 to 2.9% for abortions and from 5.2 to 2.9% for missed miscarriages. Conclusions: The only significant difference is that medical treatment of missed miscarriage has a fourfold risk of failed expulsion compared to medical treatment of abortion, 2.4% versus 0.6%. With a success rate of 94.8% the medical regimen with mifepristone and gemeprost can be a routine alternative to surgical management of early fetal demise.
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.
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.
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.
Gunilla Kleiverda, MD, PhD, gynaecologist and Elles Garcia, MD, Flevoziekenhuis, Almere, Netherlands
Abortion clinics provide the vast majority (94%) of abortions in the Netherlands. Of the 11807 first-trimester abortions performed in 2008, 10% were medical abortions, the remaining 90% instrumental procedures.
In Almere, a vast-growing city close to Amsterdam, no traditional abortion clinic is present. The local Flevoziekenhuis started therefore an out-patient abortion clinic as a satellite in 2008. The clinic, not located in the hospital, offers possibilities of medical and instrumental abortion, and anonymous and non-anonymous care. Non-anonymous instrumental abortion up to 12-14 weeks is performed in the Flevoziekenhuis. For anonymous abortion and abortion after 12-14 weeks gestation, women are referred to abortion clinics in Amsterdam.
Women were referred either by their general practitioner or by self-referral. In the first year, 616 patients were seen. 127 did not have a termination of pregnancy, because a decision to keep the pregnancy, because of not being pregnant or a non-viable pregnancy. 56 women were referred to abortion clinics because of the wish to have an anonymous treatment or advanced gestational period.
Of the remaining 435 women, 239 (55 %) had a medical abortion, 196 (45%) had an instrumental first trimester abortion. The percentages of women who requested a medical abortion was high compared to national figures. However, rates of secondary aspiration were high as well, 35 (14.6%) in the medical abortion group, 5 (2.6%) in the primary aspiration group. Patient and health-care characteristics related to this high curettage risk will be presented and discussed.
New developments in medical abortion care at 9-13 weeks
Alan Templeton (Scotland)
University of Aberdeen, Scotland
allan.templeton@abdn.ac.uk
After considerable experience of a mifepristone-misoprostol regimen for induced abortion in the early first trimester, pilot studies indicated the feasibility of using a similar regimen in the late first trimester. A randomised study was then carried out which demonstrated efficacy and acceptability compared with surgical abortion, and indicated that medical regimen was an effective alternative, acceptable to the majority of women. Subsequent review of experience indicated that approximately half of women will opt for medical abortion at 9-13 weeks gestation, if offered the choice. However acceptability is less than surgery, and decreases with gestation. Similarly the ongoing pregnancy rate is higher at higher gestations. Further randomised study has indicated the efficacy and acceptability of sublingually administered misoprostol at all first trimester gestations, even though the frequency of prostaglandin related side affects is higher. Further developments using the regimen will be reported at the meeting.
Meri Khachikyan, “For Family and Health” Pan-Armenian Association, Yerevan, Armenia
Co-author: Ruzanna Abrahamyan
In Armenia, as in all former Soviet countries, induced abortion was the primary means of fertility control
for many years. The most frequently used methods for pregnancy termination are Dilatation and Curettage (D&C) and Electrical Vacuum Aspiration (EVA). More modern methods like medical abortion and Manual Vacuum Aspiration (MVA) are not commonly used. In 2002 the Parliament of Armenia adopted a new law on “Human Reproductive Rights and Reproductive Health” that legalizes induced abortion on request up to 12 weeks of gestation and legalizes induced abortion up to 22 weeks for medical or social reasons. According to official data from the Ministry of Health of Armenia, induced abortions before 22 weeks of gestation constituted 33 percent of all maternal deaths in 2002. In 2005 this had been reduced to 7% of all maternal deaths. Among women that have an abortion, the average number of abortions per lifetime is 2.6 (the survey reached 14-24 year old male and female respondents). Repeat abortions are common due to the lack of post-abortion contraception.
In the National Survey and Case Studies on Sexual and Reproductive Health Knowledge, Attitude, Behaviour and Experiences conducted among young people 16% of sexually active young women reported having had an unintended pregnancy in comparison with 19% of young men. The attempt to self-induce abortion is common. The rates of miscarriages and abortion-related complications are quite high. Most of young women were not happy with the quality of abortion care when having had a hospital-based abortion.
“For Family and Health” Pan-Armenian Association NGO (PAFHA), with support of the IPPF/IF and other donors has established its own clinic in Yerevan to provide sexual and reproductive health services, including comprehensive abortion care in response to the needs of young and poor women who cannot access high-quality care due to financial or social barriers. Since January 2009, the PAFHA has been involved in implementation of the IPPF Global Comprehensive Abortion Care Initiative in partnership with tertiary referral level health facility - Institute of Perinatology, Obstetrics and Gynaecology and a regional clinic that provides services for the town of Vayk and five neighbouring villages in Vayots Dzor region of Armenia. The purpose of the project is to reduce the incidence of abortion complications, and enable poor and young women in Armenia to access high-quality abortion services.
The project used different strategies like capacity building, community participation, and advocacy to improve abortion care and access to high quality abortion services. Within the framework of the project the PAFHA established an effective model of public-private partnership that involves introduction of the quality of care approach, improvement of the systems of clinical information management, improving the referral and follow-up systems. Support from decision makers, health professionals, journalists, community leaders, parents and peer-educators were essential in increasing access to comprehensive safe abortion care.
As an outcome of the initiative significant progress was revealed in the improvement of the quality of abortion care at the PAFHA clinic and its two partner clinics. Furthermore, the IPPF GCAC initiative gave a unique opportunity to PAFHA to introduce international approaches towards quality of abortion care nationally. In June 2010, the National guidelines and standards for providing safe abortion services in line with international recommendations were endorsed by the Ministry of Health. The implementation of a national program on monitoring and evaluating the quality of SRH services, including maternal and abortion care has been initiated.