In 2001 the Medicines Control Council (MCC) of the Republic
of South Africa approved mifepristone as a safe and effective
agent when used in conjunction with misoprostol for the termination
of early pregnancy. This step represented a milestone for South
African women, who now have access to an additional method
of very early abortion that millions of women worldwide have
used safely and effectively since it was first introduced in
France and China in the late 1980's.
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.
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
Website: www.ipas.org
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
www.rhru.co.za
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
www.whru.uct.ac.za
Internationally-based Resources:
Gynuity Health Projects
www.gynuity.org
See Working
Papers and Documents
Ibis
www.ibisreproductivehealth.org
www.medicationabortion.org
National Abortion Federation:
www.prochoice.org
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 Gynaecol 2003;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
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