The goal of NAF’s clinical trainings is to assist health care professionals in different countries and sites in building their capacity to improve the quality of abortion care they provide women. These programs are directly funded by grants or by the sites themselves.
NAF is working in collaboration with the Open Society Institute and Ipas to establish the use of Manual Vacuum Aspiration (MVA) for first trimester abortion in Eastern Europe, Central Asia, and former Soviet Union countries. These comprehensive trainings on abortion care and MVA have been conducted in Moscow and St. Petersburg, Russia; Moldova; Macedonia; Albania; Kyrgyzstan; and Georgia.
With significant expertise in training medical abortion providers, NAF is working with Gynuity Health Projects to develop and provide training on mifepristone in conjunction with the launch of an operations research study in South Africa. This study will provide the National Department of Health with the data on how acceptable mifepristone is to both providers and patients in the public health system. Our goal is to demonstrate the feasibility of integrating medical abortion into termination of pregnancy services in South Africa’s public health sector.
Moldova has a 50-year history of legal abortion. Now that abortion providers have access to more training and education opportunities, their former techniques are being replaced with safer methods. NAF training has afforded health care professionals in Moldova the opportunity to learn a new and safer method of abortion and significantly improve the quality of care women receive.
In May 2002, a team of NAF faculty worked with colleagues to train physicians in Manual Vacuum Aspiration (MVA) using local anesthesia at a hospital in Chisinau, Moldova. By November 2002, the number of Moldovan physicians trained in MVA increased to 25. MVA has become the principal method of abortion at the hospital, and counseling and local anesthesia have become a routine practice in care.
We understood that the MVA project offered us the opportunity to not only change the abortion technique, but to improve all abortion practice and to improve the general quality of abortion services, to better meet women’s rights and needs. This approach was very important — to consider MVA not only as a new abortion method, but as a new abortion policy.
In December 2001, the initial site assessment took place at the largest clinic – Ob-Gyn Clinic #1 – in Chisinau, the capital of Moldova. Based on the assessment, training goals were established to:
- implement patient education and preference for general or local anesthesia;
- implement MVA technique in first trimester abortion care;
- implement tissue examination for confirmation of procedure completion; and
- provide models of patient centered abortion care.
In May 2002, three NAF faculty went to Chisinau to conduct a 10-day training course in comprehensive abortion care. The training involved didactic, interactive, and clinical components to present and implement the abortion care models. The process was rigorous and energizing for the participants and faculty. Physicians in Moldova were extremely skilled in ob-gyn practices and had no difficulty in learning the new concepts.
As of December 2003, the hospital reports that sharp curettage has been replaced with MVA and that 86% of procedures are done with local anesthesia. The original participants who were trained using MVA have trained others and as a result there are currently 60 physicians in Moldova trained in MVA technique and comprehensive abortion care. Trainers from Moldova are now participating as faculty in other NAF training programs in Eastern Europe and Central Asia.
Example of MVA Training Curriculum
Introduction to MVA
Safety, Efficacy, and Service Delivery Implications of MVA
Infection Prevention Practices
Pregnancy Verification and Estimation of Gestational Age
Patient Selection and Medical Screening
Counseling, Patient Preparation, and Informed Consent
MVA Abortion Technique
Pain Management in First Trimester Abortion
Post-Abortion Care and Follow-Up
Review of Abortion Complications
Quality Management of MVA Services
In 1997, South Africa became the only country in the world to legislate access to abortion services. The Choice on Termination of Pregnancy Act not only affirmed the right of women to choose abortion, it also encouraged the development and integration of abortion as part of reproductive health services at the primary health care level.
Mifepristone (RU-486) was approved for use in abortion procedures by the South African Medicines Control Council in August 2001. With significant expertise in training medical abortion providers, NAF began working with South African and international colleagues to develop and provide training on mifepristone for use in the public sector.
In March 2002, the first medical abortion training for South Africans was convened in Paris by the Population Council and the Center for Training in Reproductive Health Technologies (France). During 2003, NAF worked with Ibis Reproductive Health and Gynuity Health Projects to plan a training program in conjunction with the launch of an operations research study to determine the feasibility of offering medical abortion in the public health sector. In November 2003, NAF and a coalition of colleagues conducted a medical abortion training in Johannesburg for teams of nurses, physicians, and researchers in two provinces, Guatang and Western Cape.
The goals of the South Africa training program were to:
- provide training and resources on mifepristone, and
- provide participants with the survey instruments and information needed to conduct the operations research study on provider and patient acceptability.
In November 2003, NAF and Gynuity faculty conducted a three-day medical abortion training course for 15 participants in Johannesburg, South Africa. The training involved:
- Didactic and interactive components of medical abortion care models,
- A problem-solving approach to clinical case studies, and
- Development of strategies for overcoming barriers to service delivery.
Participants agreed that including medical abortion in termination of pregnancy (TOP) services:
- Offers women increased access to abortion care.
- Offers the health system the potential to serve more women earlier in their pregnancies.
- Has the potentioal to reduce the demand for later abortions, thereby increasing the health system’s capacity to provide those services
Medical Abortion Training Curriculum
NAF’s training program included the following:
- overview of global medical abortion;
- pharmacology and mechanism of action of mifepristone and misoprostol;
- medical abortion regimens;
- indications and contraindications;
- blood tests and ultrasound for gestational dating;
- side effects and complications of medical abortion;
- patient management;
- post-medical abortion management;
- post-medical abortion contraception;
- review of study methods and instruments; and
- discussion of challenges and how to overcome barriers.
NAF’s training and technical assistance in South Africa are designed to help introduce and build a strong foundation for high-quality medical abortion services. The South African medical community and policy officials at local, provincial and national levels have reviewed the favorable results of the initial feasibility, costing, and operations research studies.
Further deliberations are being carried out regarding practical aspects of integrating medical abortion into current termination of pregnancy (TOP) curricula and services for the Republic of South Africa.
NAF will continue to provide technical assistance in the development of up-to-date educational materials and curricula for health care providers and trainers. NAF also provides faculty for national and regional meetings and Training of Trainers workshops
We also provide information for policymakers and advocates: short user-friendly documents that provide a basic overview of medical abortion. All of these documents include both South African and international research and experience in the field of medical abortion. See for example the fact sheets South Africa/Medical Abortion: History and Overview and South Africa/Mifepristone and Misoprostol for Medical Abortion: A Brief Background.
Early Clinical Studies
Clinical testing of mifepristone as a means of inducing medical abortion began in France in 1982. Results from these trials showed that when used as a single agent, mifepristone induced a complete abortion in up to 80% of women up to 49 days’ gestation.1 By adding small doses of a prostaglandin analogue a few days later to stimulate uterine contractions, investigators discovered that the paired medication regimen could effect a complete medical abortion in nearly 100 percent of women.2,3,4
In 1988, France and China became the first countries to license the combination of mifepristone and a prostaglandin analogue for abortion during early pregnancy. Since then, this medical abortion regimen has been approved in over thirty-five countries worldwide including Austria, Belgium, Denmark, Great Britain, Greece, India, Israel, Russia, South Africa, Sweden, Tunisia, Taiwan, the USA and Vietnam. Millions of women worldwide have used mifepristone and a prostaglandin analogue to terminate pregnancy with impressive safety and efficacy.
The South African Experience
In the Guidelines for Termination of Pregnancy (TOP) Implementation issued by the Maternal, Child and Women’s Health Directorate in April of 1997, among the Principles of Introduction was a statement anticipating the introduction of medical abortion to South Africa: “Once medical abortifacients become available in South Africa they should be introduced into the health services to farther decentralise services in a safe and effective manner.”5 In 2001, the Medicines Control Council (MCC) of the Republic of South Africa approved mifepristone. The Department of Health and other key organizations working towards the enhancement of Sexual and Reproductive Health services in the RSA have continued to evaluate international and national safety, efficacy and acceptability data6,7 since that time, but a formal policy which would allow for provision of medical abortion as described by the 1997 Guidelines has yet to be finalized.
Mechanism of Action
Mifepristone blocks the progesterone receptor, leading to profound changes in the endometrium. Mifepristone also softens the cervix to facilitate expulsion of the pregnancy.8,9 The prostaglandin analogue misoprostol accelerates the process of expulsion by stimulating uterine contractions as well as softening the cervix.10
Eligibility for Medical Abortion with Mifepristone and Misoprostol
The original regimen tested and approved for medical abortion included a single oral dose of 600 mg of mifepristone followed 48 hours later by a 400-µg oral dose of misoprostol. Using this regimen, the highest rates of complete abortion (about 95%) have been seen in women up to 49 days’ gestation, with a small, progressive decrease in efficacy when extending the gestational age to 63 days. 3,11 More recent research has established that a 200 mg dose is equally as effective as a 600 mg dose of mifepristone.12 Different routes of administration and corresponding dosage variations of misoprostol have also been evaluated, and studies have demonstrated that misoprostol can be safely administered at home.13,14 Several evidence-based alternative regimens are widely accepted clinical practice, and are included in the practice protocols of many professional organizations.15,16
The MCC-approved regimen includes the 600 mg dose and a limit of 56 days’ gestation (calculated from onset of the last menstrual period) for eligibility for mifepristone medical abortion. Contraindications to medical abortion with mifepristone and misoprostol include allergy to either of these medications, chronic systemic use of corticosteroids, chronic adrenal failure, hemorrhagic disorder or current therapy with anticoagulants, confirmed or suspected ectopic pregnancy, porphyrias, severe uncontrolled asthma, and the presence of an intrauterine device (removal of the IUD eliminates this contraindication).
Side Effects and Complications
Side effects are expected with medical abortion. Some side effects, such as pain and bleeding, result from the abortion process itself. Side effects of the medications include nausea, vomiting, diarrhea, fever, and chills. In most cases, side effects can be managed with appropriate counseling and symptomatic treatments, such as oral analgesics for pain. Complications of medical abortion are rare; vaginal bleeding requiring transfusion occurs in approximately 1 in 2000 cases.17 Uterine infection (endometritis) is also rare because medical abortion does not require insertion of an instrument into the uterus. Approximately 2%-5% of women undergoing medical abortion will require vacuum aspiration to complete the abortion or to control bleeding.17,18 Serious complications, including death, are extremely rare occurrences following either spontaneous, surgical, or medical abortion.
The Future of Medical Abortion in the Republic of South Africa
A wealth of international research and experience, and a growing body of national data on medical abortion supports the safety, effectiveness and acceptability of this alternative to early surgical abortion for the women of South Africa.
- Grimes DA, Mishell DR Jr, Shoupe D, Lacarra M. Early abortion with a singler dose of the antiprogestin RU-486. Am J Obstet Gynecol 1988;158:1307-12.
- Ulmann A, Silvestre L, Chemama L, et al. Medical termination of early pregnancy with mifepristone (RU 486) followed by a prostaglandin analogue: study in 16, 369 women. Acta Obstet Gynecol Scand 1992;71:278-83.
- Spitz IM, Bardin CW, Benton L et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Engl J Med 1998; 338:1241-47.
- Peyron R, Aubény E, Targosz V, et al. Early termination of pregnancy with mifepristone (RU 486) and the orally active prostaglandin misoprostol. N Engl J Med 1993;328:1509-1513.
- Guidelines for Termination of Pregnancy for Health Workers – April 1997. Maternal, Child and Women’s Health Directorate, Department of Health, Republic of South Africa; April 1997.
- Cooper D, Dickson K, Blanchard K, Cullingworth L, Brown H, Mavimbela N, von Mollendorf C, van Bogaert LJ and Winikoff B. Medical abortion eligibility and its acceptability in South Africa. Reproductive Health Matters 2005; 13(26):75-83.
- Cullingworth L, de Pinho H. A cost analysis of service provision of medical abortions in the public health sector at primary and secondary level. Women’s Health Research Unit, Department of Public Health, University of Cape Town. 2002
- Spitz IM, Bardin CW. Mifepristone (RU 486) – A modulator of progestin and glucocorticoid action. N Engl J Med 1993; 329:404-12.
- Schindler AM, Zanon P, Obradovic D, Wyss R, Graff P, Herrmann WL. Early ultrastructural changes in RU-486-exposed decidua. Gynecol Obstet Invest 1985;20:62-67.
- Koopersmith TB, Mishell DR Jr. The use of misoprostol for termination of early pregnancy.Contraception 1996;53:238-242.
- Aubény E, Peyron R, Turpin CL, et al. Termination of early pregnancy (up to 63 days of amenorrhea) with mifepristone and increasing doses of misoprostol. Int J Fertil Menopausal Stud 1995;40(suppl 2):85-91.
- World Health Organization Task Force on Post-Ovulatory Methods of Fertility Regulation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: a randomised trial. Br J Obstet Gynaecol 2000;107:524-530.
- von Hertzen H, Honkanen H, Piaggio G, et al. WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy. Br J Obstet Gynaecol2003; 110; 808-818.
- Schaff EA, Eisinger SH, Stadalius LS et al. Low-dose mifepristone 200 mg and vaginal misoprostol for abortion. Contraception 1999;59:1-6.
- ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists Number 67, October 2005. Medical Management of Abortion. Obstet Gynecol 2005; 106(4): 871-882.
- National Abortion Federation. Clinical Policy Guidelines 2005. Early Medical Abortion 2005; 7-9.
- Henderson JT, Hwang AC, Harper CC, et al. Safety of mifepristone abortions in clinical use.Contraception 2005; 72(3):175-178.
- Kruse B, Poppema S, Creinin MD, Paul M. Management of side effects and complications in medical abortion. Am J Obstet Gynecol 2000; 183: S65-S75.
Prepared by NAF, Ibis, WHRU, Gynuity Health Projects, and Ipas-South Africa
6 February 2006
Feasibility, acceptability, costing, and operations-research studies have been successfully conducted in the public health services in South Africa, and indicate that women and providers are interested in this alternative to surgical abortion in early pregnancy. In addition, these studies have shown that mifepristone misoprostol can be successfully integrated into existing public sector termination of pregnancy (TOP) services.
Frequently asked questions about Medical Abortion:
What is medical abortion?
The term medical abortion refers to pregnancy termination with abortion-inducing medications in lieu of surgical intervention. The most common regimen includes two medications: mifepristone, followed in 1-2 days by misoprostol.
What is mifepristone?
Mifepristone, once known as RU 486, is a medication that blocks the action of the hormone progesterone. Progesterone is needed to sustain embryonic growth. In order to be most effective in terminating pregnancy, mifepristone is followed by another medication; in most countries, this will be a prostaglandin analogue called misoprostol. These medicines are more than 90% effective when used up to 63 days from the onset of the last menstrual period. They are still effective, only less so, beyond 63 days of gestation.
What is misoprostol?
Misoprostol is a medication commonly used to prevent gastric ulcers in individuals who need to take aspirin, ibuprofen or other medications on a continuous basis. In medical abortion, it causes the uterus to contract, and helps to expel the pregnancy.
How safe is medical abortion?
International research has shown that major complications associated with medical abortion are extremely rare. Well over one million women worldwide (excluding China where at least an additional 22 million medical abortions have occurred) have used mifepristone safely since it was first licensed in France in the late 1980’s. In large multicenter trials, <0.5% of women required emergency medical intervention. Serious infections and hemorrhage occur rarely following safe and legal medical or surgical abortions. Since medical abortion is not an invasive procedure, there may be less risk for complications related to instrument and operator techniques.
Who will provide medical abortion?
In South Africa, professional nurses who have undergone certified abortion training provide the majority of abortions before 12 weeks of gestation, and, with the appropriate additional training, are eminently well-suited to integrate this method of pregnancy termination into their practices. International evidence has indicated that abortion care procedures conducted by mid-level providers are safe and effective, with low complication rates.
How effective is the mifepristone-misoprostol regimen?
International clinical trials have reported that various mifepristone regimens are between 90-99% effective (when successful medical abortion is defined as the avoidance of a vacuum aspiration for any reason, including continuing pregnancy [generally <1%], incomplete abortion, bleeding, and patient preference). This has been confirmed in the South African study evaluating integration of medical abortion into TOP services in 3 provinces, where 93% of women had a complete abortion without need for further intervention for any reason.
How do South African women feel about having a medical abortion?
In the acceptability and feasibility study, 82% of the 653 women presenting for an abortion felt that they would be interested in having a medical abortion if it were available. In the subsequent operations research study that evaluated integration of medical abortion into current TOP services, 96% of the 289 women who chose medical abortion stated that their experience was either satisfactory or very satisfactory, and 89% deemed it “not at all difficult.” Medical abortion was also well accepted by providers.
Why are there different regimens for medical abortion, and which is best?
International research has proven the safety and effectiveness of a variety of simplified medical abortion regimens. Multiple large-scale trials have shown that 200 mg of mifepristone is as effective as (and 1/3 the cost of) the approved 600 mg regimen, and pharmacokinetic studies have even shown that serum levels of mifepristone do not actually increase beyond the first 100 mg dose. In addition, research has shown that mifepristone and misoprostol regimens are effective up to 63 days from the last menstrual period (the current regimen in South Africa is labeled for use up to 56 days). A number of studies have confirmed that vaginal misoprostol doses of 800 µg are very effective, and that home use of misoprostol is safe and preferred by many women. In fact, some of these simplified regimens have been shown to be more cost-effective than the standard regimen.
A multitude of international and professional health care entities have incorporated evidence-based regimens into their clinical policies, technical bulletins, and practice guidelines. (See Selected References.)
Is home use of the second medication safe and acceptable to women?
Many women prefer to experience their medical abortions in their own homes, so that they can rest comfortably or go about their daily routine, as it suits them. Home use reduces the number of routine visits to the health service from 3 to 2, which is often more convenient for the woman, and also reduces the burden on the health service providers. In the South African operations research, 80% of women who chose medical abortion also chose to use their misoprostol at home, and 96% of women found their experiences either “satisfactory” or “very satisfactory.”
How do women experience this process?
Some women are quite uncomfortable during the most intense part of the process, some women find that cramping and bleeding are similar to a heavy, but normal, menstrual flow, and others notice very little disruption. There may be brief episodes of nausea, fever and chills, diarrhea, or vomiting as the misoprostol begins to take effect, but these side effects are generally mild and self-limiting, and women tolerate them quite well. Most abortions will be completed within 24 hours of misoprostol use.
What about products of conception?
At the stage of pregnancy when these medications are used, the products of conception are miniscule and generally indistinguishable from the menstrual-type flow that accompanies their passage. There is no identifiable placenta at this stage of pregnancy. Infrequently, the sac or the embryo may be distinguishable to the woman who is looking for it as a delicate structure no larger than 1-2 cm. Women who are not actively interested in looking for the products of conception will rarely see them.
Do women in South Africa attend for TOP early enough for medical abortion, and are they interested in the method?
In a study of feasibility and acceptability of medical abortion in South Africa, 22% of 673 women attending a termination of pregnancy service were ≤56 days gestation, and thus (had the option been available) would have been eligible for MTOP according to the MCC regimen eligibility guidelines. In addition, more than 82% of these women felt that they or other women would be interested in medical abortion as an option.
Will women return to the services for the follow up visit?
In the operations research study 91% of women returned for follow-up. International studies have shown that the loss to follow-up is low, and that high-quality counseling, a crucial component in the provision of medical abortion, results in excellent follow-up.
Is ultrasound required to establish duration of pregnancy to determine eligibility for medical abortion?
Although ultrasound is a convenient tool, it is by no means essential to providing safe medical abortion. International and national clinical trials comparing clinical exams to ultrasound evaluations show that providers can accurately assess gestational age by clinical examination, and international experience has shown that providing medical abortion without ultrasound is safe and effective.
Where can I find more information about mifepristone and misoprostol?
South African Resources:
Ipas South Africa
P.O Box 2155 Parklands 2121 South Africa
Tel: + 27 (11) 880 4104
Fax +27 (11) 447 8599
See Medication Abortion – Frequently Asked Questions
Reproductive Health and HIV Research Unit
Department of Obstetrics and Gynaecology
University of the Witwatersrand
P O Bertsham, 2013
Johannesburg, South Africa
Tel: (+27) (0) 11 989 9200
Fax: (+27) (0) 11 933 1227
Women’s Health Research Unit
School of Public Heath and Family Medicine, Univerity of Cape Town,
Observatory, Cape Town, South Africa
Tel: +27 21 406 6818
Fax: +27 21 448 8151
National Abortion Federation:
See Professional Education – Educational Resources – Medical Abortion
ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists; Number 67, October 2005. “Medical Management of Abortion.” Obstet Gynecol 2005; 106 (4): 871-882.
Cooper D, Dickson K, Blanchard K, Cullingworth L, Brown H, Mavimbela N, von Mollendorf C, van Bogaert LJ and Winikoff B. Medical abortion eligibility and its acceptability in South Africa.Reproductive Health Matters 2005; 13 (26):75-83.
Cullingworth L, de Pinho H. A cost analysis of service provision of medical abortions in the public health sector at primary and secondary level. 2002;Women’s Health Research Unit, Department of Public Health, University of Cape Town.
El-Refaey H, Rajasekar D, Abdalla M, Calder L, Templeton A. Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol. New Engl J Med 1995;332:983-7.
Elul B, Hajri S, Ngoc NN, et al. Can women in less-developed countries use a simplified medical abortion regimen? Lancet 2001; 357:1402-1405
Henderson J T, Hwang A C, Harper C C, Stewart F H. Safety of mifepristone abortions in clinical use. Contraception 2005; 72: 175-178.
National Abortion Federation Clinical Policy Guidelines 2005. Early Medical Abortion. 2005; National Abortion Federation; 7-9.
Newhall E P, Winikoff B. Abortion with mifepristone and misoprostol: regimens, efficacy, acceptability and future directions. Am J Obstet Gynecol 2000; 183: S44-S53.
Ngoc N T, Winikoff B, Clark S, Ellertson C, Am Kn, et al. Safety, efficacy and acceptability of mifepristone-misoprostol abortion in Vietnam. Int Fam Plann Perspect 1999; 25: 10-14.
Schaff EA, Fielding SL, Eisenger 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.
Schaff EA, Fielding SL, Westhoff C. Randomized trial of oral versus vaginal misoprostol at one day after mifepristone for early medical abortion. Contraception 2001; 64: 81-85.
Schaff EA, Fielding SL, Westhoff C, Ellertson C, Eisinger SH, Stadalius LS, Fuller L. Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: A randomized trial. JAMA 2000;284: 1984-1953.
Von Herttzen H, Honkanen H, Piaggio G, et al. WHO multinational study of three misoprostol regimens after mifepristone for early medical abortion. I: Efficacy. Br J Obstet Gynaecol2003;110:808-818.
World Health Organization Task Force on Post-Ovulatory Methods of Fertility Regulation. Comparison of two doses of mifepristone in combination with misoprostol for early medical abortion: A randomized trial. Br J Obstet Gynaecol 2000; 107: 524-530.
Prepared by NAF, Ibis, WHRU, Gynuity Health Projects, and Ipas-South Africa
27 February 2006