International Journal of Gynecology and Obstetrics (2007) 99, S172–S177
a v a i l a b l e a t w w w . s c i e n c e d i r e c t . c o m
w w w . e l s e v i e r. c o m / l o c a t e / i j g o
Misoprostol for the termination of pregnancy up to 12completed weeks of pregnancy
A. Faúndes a,⁎, C. Fiala b, O.S. Tang c, A. Velasco d
a Department of Gynecology and Obstetrics, State University of Campinas (UNICAMP), Campinas, SP, Brazilb Gynmed Clinic, Vienna, Austriac Department of Obstetrics and Gynecology, University of Hong Kong, Hong Kong SAR, Chinad Department of Gynecology and Obstetrics. Hospital Eusebio Hernández (Maternidad Obrera), Havana, Cuba
The aim was to review the current knowledge about the use of misoprostol alone for abortioninduction during the first 12 weeks of pregnancy. Publications reporting experiences withmisoprostol alone for pregnancy termination within the first 12 weeks of pregnancy were included
in the analysis. Vaginal administration of 800 μg repeated up to three times at 6, 12 or 24 h intervals
has an 85% to 90% effectiveness, defined as complete abortion, in most studies. Oral administration
is less effective, but sublingual administration at 3-hour interval has the same effectiveness, with
more frequent side effects. The oral and sublingual routes appear to be better accepted thanvaginal administration. Most studies are limited to the first 9 weeks of pregnancy. The experience onpregnancy termination between 10 and 12 weeks is not yet sufficient for a recommendation.
2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
The regimen of mifepristone followed by a suitableprostaglandin analogue (usually misoprostol) has become
It is estimated that 46 million pregnancies are terminated
increasingly available and is now the gold standard for
voluntarily each year, 27 million carried out under safe
conditions and 19 million falling into the category of “unsafeabortions” Until the second half of the twentieth century,
Mifepristone is an antiprogestin that blocks most proges-
dilatation and curettage (D & C) was the most common and
terone receptors. When a prostaglandin is administered 24 to
virtually only method used for safe termination of early
48 h after mifepristone, uterine contractions expel the
pregnancy. Abortion by vacuum aspiration gained greater
products of conception and the effectiveness of the
acceptance in the 1960s and has become the standard of care.
combination is greatly enhanced. This medical abortion
First trimester pregnancy can also be terminated safely
regimen is highly effective and well accepted and
pharmacologically (medical abortion).
women who wish to avoid invasive procedures regardmedical abortion as a more natural and preferable option. The combination of metrotrexate and misoprostol hasalso been used, but this combination has not proven
⁎ Corresponding author. Tel.: +55 19 3289 2856; fax: +55 19 3289 2440.
0020-7292/$ - see front matter 2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
Misoprostol for the termination of pregnancy up to 12 completed weeks of pregnancy
Where mifepristone is not accessible, various misoprostol-
Recently, the buccal route of administration has also
only regimens are being used, and dozens of reports have
been investigated, but not yet for this indication
been published on the outcomes of various treatments. The
Intervals between doses vary from 3 to 48 h .
comparison of the results of the published data on the use of
According to pharmacokinetics and clinical experience, the
misoprostol is not possible due to a lack of uniformity in many
interval between vaginal doses may not need to be shorter
variables: intervals between doses vary from 3 to 48 h, the
than 5–6 h and probably no longer than 24 h.
time point for assessing this outcome varies from a few daysto several weeks (), and the gestational age of women
There is experience on the use of these regimens up to
differs between reports. These factors make it difficult to
63 days (9 weeks) pregnancy , but too few
conclude what regimen might be the most effective.
reports on the use of misoprostol between 9–13 weeks
Most publications report vaginal administration of multiple
to affirm that these regimens are equally effective
doses of 800 μg of misoprostol (4 tablets of 200 μg) up
to three doses. The available information suggests that effec-tiveness is dose related with doses up to 800 μg if administered
The misoprostol-only regimen has been approved for the
termination of early pregnancy in only one country (Brazil) at thetime of writing (February 2007). However, its widespread use in
When misoprostol is used alone, the oral route is less
countries with restricted abortion laws appears to be associated
effective than vaginal . Vaginal administration
with reduction in maternal morbidity and mortality .
should therefore be chosen unless there are reasons toavoid it. The sublingual route is a reasonable alternative
Alternative routes may be sought as some acceptability
• Suspected ectopic pregnancy or non-diagnosed adnexal mass.
studies, have shown that women prefer a non-vaginal route
Moreover, when given vaginally, fragments of thetablets may remain visible for many hours.
The sublingual route is a reasonable alternative
Although the sublingual route is significantly less effective thanthe vaginal route if misoprostol is administered every 12 h, the
• If molar pregnancy is diagnosed, intrauterine aspiration
effectiveness is similar if administered with a 3-h interval
between doses . The main drawback of the sublingual route
• If there is an intrauterine device (IUD) in place, this should
is that it may cause more frequent gastrointestinal side-effects
be removed before administering misoprostol.
(such as nausea, vomiting, shivering and hyperthermia) than
• Coagulation disorders/currently taking anticoagulants.
vaginal administration . These side effects are dose
• Women should be advised that the treatment can fail and
dependent and last only for a short time.
they should be prepared to terminate the pregnancy by
Summary of studies with vaginal administration of misoprostol alone for first trimester abortion
surgical method, because there have been reports of con-
genital malformations in newborn infants of mothers givenmisoprostol during the first trimester of pregnancy .
Despite the wide range of results from different studies and
• Breastfeeding: Small amounts of misoprostol or its active
different regimens, the success rate, defined as a complete
metabolite may appear in breast milk . There is no in-
abortion, is around 90% during the first trimester of pregnancy
formation on the effects on nursing infants. It is recom-
Success depends on the length of the time interval
mended therefore that breast milk is not given to the infant
between treatment and the assessment of the outcome.
for 4 h after oral administration or 6 h after vaginal miso-prostol administration.
Depending on the regimen used, pregnancy continues in
• Anemia detected at the time of abortion should be treated
4% to 8% of women with gestational age of up to 63 days
without delaying the procedure. The average blood loss
when vaginal misoprostol is used alone ().
during medical abortions may be more than in surgicalabortions .
• Previous cesarean section: there is evidence from one study
that the safety and efficacy of early abortion (up to seven
In the majority of cases, expulsion of the products of
weeks) is unaffected by previous cesarean section .
conception occurs hours after administration: close to 70%
Although extremely rare, uterine rupture in early pregnancy
within the first 12 h around 80% during the first
24 h, 95% within 48 h and further increases until at least 72 hafter the initial dose However there may be a
large variability depending on route, dose and time intervalbetween misoprostol doses.
The first choice is 800 μg administered by the vaginal routeevery 6, 12 or 24 h for a maximum of three doses. Three doses
Prolonged or serious side effects are rare.
of 800 μg at 3-hourly intervals can also be used sublinguallyMoistening the tablets appears to slightly increase plasma
levels but no improvement in the clinical effects has beendemonstrated Doses higher than 800 μg are not
Vaginal bleeding during abortion induced with misoprostol
recommended due to increased side effects .
is generally more intense than regular menstrual bleedingand is usually no different from that which occurs with a
spontaneous abortion Although there may be greatvariations, there is typically menstrual-like or heavier
Several studies carried out in developed and developing coun-
bleeding for the first week and then spotting for an
tries have shown that home administration of misoprostol is ef-
additional week. The mean pre- to post-abortion fall in
fective and safe up to 9 weeks since the last menstrual period.
hemoglobin varies between 0.2 and 1.0 g/dL (
Most of those studies have been done using the combination of
Prolonged and intensive bleeding affects between 1% and
mifepristone and misoprostol and only a few with
10% of women and may necessitate emergency surgical
uterine evacuation, preferably with manual vacuum as-piration. The need for transfusion has been rarely reported
• Voluntary termination of the pregnancy and informed
consent of the woman about her choices and the nature of
• Backup arrangements for surgical abortion.
Cramping usually starts within the first few hours and may
• Dating of gestational age and ruling out ectopic pregnancy
begin as early as 30 min after misoprostol administration. The
pain may be stronger than that experienced during a regular
• If required by national guidelines, blood group and Rhesus
period and can be present in 80%–90% of women Non-
factor should be determined and in cases where women are
steroidal anti-inflammatory drugs (NSAIDs) or other analgesia
Rhesus negative, a dose of anti-D serum should be admin-
can be used for pain relief without affecting the success of the
istered prior to treatment. However, there is currently little
evidence to support that Rhesus factor isoimmunizationoccurs for pregnancies up to 63 days gestation
Where resources are available, and depending on the
Chills are a common side effect of misoprostol but are
clinical situation, the following tests may be useful:
transient. Hyperthermia can be very severe and morecommon with higher doses when the interval between
• Hemoglobin, hematocrit and screening for STDs may also
doses is shorter or with oral or sublingual administration
be provided depending on local prevalence and guidelines.
. Fever does not necessarily indicate infection.
In addition, serological tests to diagnose for syphilis, HIV
An antipyretic can be used for relief of fever, if needed. If
and hepatitis B and C surface antigen may also be used.
fever or chills persist beyond 24 h after taking misoprostol,
Misoprostol for the termination of pregnancy up to 12 completed weeks of pregnancy
Indicators of bleeding in clinical studies of misoprostol alone for first trimester abortion
the woman may have an infection and should seek medical
include excessive bleeding, fever of more than 1 day and
abdominal pain. Antibiotic treatment should be begunimmediately if there is any suspicion of infection, although
it is less frequent after medical than after surgical methodof abortion .
Women should return for follow-up one or two weeks after
About 20% of women report pregnancy-related nausea and
the initial administration of the drug or earlier if they feel the
vomiting before treatment. These symptoms may
need. A good clinical history and bi-manual exam should
increase after misoprostol administration. An anti-emetic
enable the provider to determine the absence of symptoms
can be used if needed, but symptoms will usually resolve
and that the uterus is firm and well involuted. In case of
uncertainty a pregnancy test and ultrasound examination
may be needed to confirm a complete expulsion. The usualurinary pregnancy tests may be positive for up to 4 weeksfollowing the abortion as the pregnancy hormone hCG is
Diarrhea may also occur following administration of misoprostol
Those women who have not aborted within 72 h after the
last dose should be given the option of a second course of
misoprostol treatment or surgical abortion; they should beinformed that their chances of success of the second course
The risk of fetal abnormalities after misoprostol used early in
is around one in three If there is an urgent need to
pregnancy is probably very low but women who do
evacuate the uterus or if the woman is not prepared to
not abort after misoprostol, should have access to surgical
accept a new attempt of treatment with misoprostol, she
abortion, if that is the woman's informed choice. Vacuum
should be offered the alternative surgical abortion. There is
aspiration is the recommended option.
clear evidence that vacuum aspiration is the preferredtechnique: both electric or manual vacuum aspirations are
Women with incomplete abortion should be offered the
Women should be given simple instructions on how to
choice of aspiration evacuation or misoprostol treatment with
recognize any complications that might require medical
600 μg of oral misoprostol if eligible .
Once administration of misoprostol has begun, women must
have easy access to a health professional capable of answeringtheir questions and providing them with assistance or hospital
Women should be informed about immediate return to
care. During the early first trimester, the possibility of ectopic
fertility, contraceptive methods, their characteristics, effec-
tiveness and side effects, including their capacity to protect
Women must be informed that they will have bleeding
against sexually transmitted infections (STIs). After selection
and cramping as described above, and that they can use
of the most appropriate method, that method should be
NSAIDs as required. The symptoms calling for clinical care
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SPS NOTIFICATION TO BE CONSIDERED BY INDONESIAThis Draft Technical Regulation shall apply to quick frozen peaches of the species Prunus Persica L. as defined below and offered for direct consumption without further processing, except repacking, if required. It does not apply to the product when indicated as intended for further processing or for other industrial purposes. Definitions, requiremen
Antabus® 1. NOMBRE DEL MEDICAMENTO Forma de administración Antabus se administra por vía oral. Añadir los comprimidos prescritos en un vaso de agua o zumo de frutas hasta su completa disolución y beber inmediatamente. 2. COMPOSICIÓN CUALITATIVA Y CUANTITATIVA Preferiblemente, Antabus debe tomarse al levantarse, aunque en pacientes que presentan efectos sedante puede tomarse Cada