 Medical and Service Delivery Guidelines
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Contents
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Introduction
Medabon® is a combination therapy for medical abortion in pregnancies through nine weeks, or up to and including 63 days since a woman’s last menstrual period (LMP). Medical abortion refers to the process of ending a pregnancy by taking medication, rather than through surgical intervention.* It may also be referred to as medication abortion, the abortion pill, non-aspiration abortion, or non-surgical abortion. The term “medical abortion” does not mean that a physician needs to be involved or that the procedure is performed out of medical necessity.
Medical abortion has been used by millions of women throughout the world. In 2006, the World Health Organization (WHO) released updated recommendations on medical abortion based on available evidence.1 According to these recommendations, medical abortion through nine weeks’ gestation is safe and effective. The most effective and safest medical abortion regimen requires the use of two drugs, mifepristone and misoprostol. Medabon® packages contain mifepristone and misoprostol together.
This document on Medabon® has four sections that roughly correspond to the medical abortion process
from a health worker’s perspective: background information, screening, administration, and followup.
The protocol on page 9 provides an overview of the medical abortion process using Medabon®. This document was developed for an audience with a moderate amount of medical expertise. The level of technical detail and language may be adapted for the health providers who will be implementing services in a specific setting.
* The term “surgical abortion” is often used to refer to procedures such as vacuum aspiration (electric or manual) and sharp curettage, also known as dilatation & curettage (D&C).
1. Background information on Medabon®
Mifepristone and misoprostol are licensed separately in many countries. Medabon® offers the benefit of the drugs being licensed and packaged together in one medical abortion product.

Mifepristone acts by blocking progesterone receptors,
leading to changes in the endometrial lining so that it
ceases to support pregnancy, softening and dilation
of the cervix, and increased uterine sensitivity to
prostaglandins (such as misoprostol).2
Misoprostol is the preferred prostaglandin analog for
use with mifepristone because of its efficacy, safety,
low cost, and wide availability.3 Misoprostol softens
the cervix and increases uterine contractility, and the
contractions expel the pregnancy
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Misoprostol administration |
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Women have options in terms of when and how they can take misoprostol.* Providers should discuss these options with each woman taking Medabon® so that she can choose the regimen most optimal to her needs and preferences.
MISOPROSTOL administration
(Day 1 is mifepristone day)
| Route |
Timing |
| Vaginal (800 μg) |
Day 2 or 3
(24–48 hours after
mifepristone) |
| Sublingual (800 μg) |
Medabon® is registered for vaginal and sublingual use of misoprostol. See page 8 for complete instructions regarding administration of misoprostol, including through vaginal and sublingual routes. There is additional evidence that buccal use of misoprostol (i. e., inserting pills between the cheek and the gum) is also effective and is widely used in some countries,8–10 but Medabon® is not currently labeled for this route.
* The initial registrations and labeling for Medabon® recommended that misoprostol be used vaginally 36–48 hours after mifepristone. Since then, Concept Foundation has gained access to data showing that misoprostol can be administered safely and effectively by the sublingual route,4,5 and misoprostol can be administered by both the vaginal and sublingual routes 24–48 hours post-mifepristone.6,7 These changes are being made to regulatory submissions and eventually to packaging materials. Despite
this original labeling, providers may wish to comply with the new evidence-based regimens stated in these guidelines. |
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Dosing and regimen
The Medabon® regimen consists of one 200-mg tablet
of mifepristone given orally, followed one to two
days (24 to 48 hours) later by four 200-μg tablets of
misoprostol. This is the regimen recommended by WHO
as a safe and effective method for medical abortion.1
Medical abortion with Medabon® generally requires
three steps:
1. Administration of mifepristone.
2. Administration of misoprostol one to two days later.
3. A follow-up assessment one to two weeks (generally
10–14 days) after mifepristone administration to
confirm completion of abortion.
Effectiveness
An effective medical abortion is generally defined as
a pregnancy terminated without need for another
uterine evacuation method, such as vacuum aspiration
or curettage. The Medabon® regimen has been shown
to achieve complete abortion in about 98 percent of
cases, and less than 1 percent of women using this
regimen experience ongoing, viable pregnancies.5,11
The rate of complete abortion for the Medabon®
regimen can vary by provider. As provider experience
increases, they are likely to be more comfortable with
the method and less likely to perform unnecessary
interventions. Following the regimen outlined in
these guidelines will help ensure the highest rates
of success. For example, adhering to the suggested
interval between administration of misoprostol and
a follow-up visit will help ensure that a woman’s
abortion has had time to complete and will make
unnecessary intervention less common. Of course,
women should seek follow-up care sooner if they have
problems or concerns.
Expected effects
Vaginal bleeding and cramping are normal and
expected. The medical abortion process may feel like an
intense, crampy, and long menstrual period, or similar
to a spontaneous miscarriage.
Vaginal bleeding, often accompanied by the passage
of clots, is usually heavier than a menstrual period.
Bleeding sometimes begins after taking mifepristone,
but most often starts one to three hours after
misoprostol is taken. The amount and duration of
bleeding varies: bleeding is generally heaviest for a few
hours during the actual abortion and has the general
pattern of diminishing over time, often lasting up to
two to three weeks. Cramping is typically strongest in
the hours after misoprostol is taken, then eases off after
the pregnancy is expelled.12
After the pregnancy passes, which the woman may
not be able to differentiate from other blood and/or
clots, she will likely experience a persistent decrease of
bleeding and cramps until the bleeding ends.
Side effects
Uterine contractions can be painful, and some women
will experience side effects—including nausea,
vomiting, diarrhea, headache, chills, shivering, and
transient fever lasting less than a day. There are no
long-term health effects of Medabon®, nor will the
medication impact any future pregnancies.13
| Medabon® key facts |
- Medabon® consists of two medicines: mifepristone and misoprostol.
- The Medabon® regimen is in line with current (as of June 2009) WHO recommendations for medical abortion1: one 200-mg tablet of mifepristone given orally, followed 24–48 hours later by four 200-μg tablets of misoprostol. The four misoprostol tablets can be administered vaginally or sublingually.
- Medabon® is registered for use in pregnancies through nine weeks (63 days) since a woman’s LMP.
- Medical abortion with mifepristone and misoprostol has been shown to be 98 percent effective when used through nine weeks (63 days) since LMP.5
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2. Screening for Medabon®
Contraindications
There are very few situations that absolutely exclude a
woman from taking Medabon®.
Women cannot take Medabon® if they:
• Are allergic to any of the drugs involved
(mifepristone, misoprostol, or another prostaglandin).
• Have inherited porphyria, a rare blood disorder.14
• Have a hemorrhagic disorder or are on concurrent
anticoagulant therapy, unless transfusion services are
available (there is very limited evidence describing
provision of medical abortion in such cases).
• Have a known or suspected ectopic pregnancy.
Precautions
Women with these conditions should be treated
with caution specific to their situation:
• Currently taking long-term systemic corticosteroid
therapy for asthma or other conditions.15,16 By contrast,
the medicines in asthma inhalers are not systemically
absorbed and women taking these medicines may
use Medabon®.
• Chronic adrenal failure. It is possible that women
with chronic adrenal failure may acutely develop
dehydration, low blood pressure, or shock after taking
mifepristone. Women with chronic adrenal failure
should take an increased dose of glucocorticoids
when using mifepristone and should be carefully
monitored for signs and symptoms of shock.15,16
Note: Women with multiple gestation17 and obese
women18 may be given Medabon® in the same doses
as other women. Additionally, women who have
used Medabon® in the past may use it again with no
decrease in efficacy.
Special considerations
There is little evidence on the use of medical abortion
in women with the following conditions: severe anemia
(hemoglobin level < 9 g/dL), clinical illness or unstable
health problems, or sepsis. Whether to administer
medical abortion to women with these conditions will
depend on the available options for safe abortion care,
referrals, and clinical judgment.
The following women can take Medabon®, but may
require additional information or clinical care:
-
Women who are breastfeeding. Misoprostol enters
breast milk soon after administration, and it is likely
that mifepristone does as well. There is no evidence
to suggest that either medication is harmful to
infants. Women who are concerned about the effects
of misoprostol on infants can take the medication
immediately after nursing.19
- Women with an intrauterine device (IUD). Women
with an IUD can be treated with Medabon® as long
as the IUD is removed beforehand. See page 11 for
information on reinitiating contraception after taking
Medabon®.
- Women with sexually transmitted infections
(STIs). Women with a confirmed STI should be
treated concurrently with the initiation of medical
abortion. Women with a suspected STI should be
evaluated or referred and treated as appropriate
for the health care setting; however, treatment of
suspected STIs should not delay the abortion.
Given that Medabon® is only licensed for pregnancies
through nine weeks, the likelihood of Rh-sensitization
is very low. There is currently not enough evidence to
recommend for or against Rh screening through nine
weeks since LMP.20 Depending on the prevalence of
RhD-negative blood in the population and the ability to
offer Rh-immune globulin, the country standard should
be followed.
Confirming pregnancy and timing
Medabon® is licensed for women with pregnancies
through nine weeks: in other words, a woman can
take Medabon® through 63 days after the first day of
her LMP.
Duration of pregnancy can generally be confirmed
by taking the woman’s history and with a physical
examination. If signs of pregnancy are not clearly
present, a blood or urine test confirming pregnancy
may be required. Ultrasound is not necessary and
should not be a prerequisite for abortion in settings
where it is unavailable or makes the procedure
overly expensive.1,21 Where ultrasound is available,
it may help to determine the length of pregnancy
in cases of a discrepancy in dating, or to confirm an
intrauterine pregnancy.
| Undiagnosed ectopic pregnancy |
An ectopic pregnancy is a pregnancy located outside
the uterine cavity. Medabon® does not treat ectopic
pregnancy, a preexisting condition rather than a
complication of the abortion procedure. Therefore,
ectopic pregnancy may be diagnosed when a
woman seeking a medical abortion undergoes
clinical assessment before the procedure. However,
ectopic pregnancy can go undetected during clinical
assessment and even remain undetected after a
medical abortion is performed. A woman may still
experience bleeding and cramping after taking
Medabon®, even if she has an ectopic pregnancy, and
a provider is unlikely to examine the expelled tissue
to confirm termination of pregnancy. Therefore,
diagnosis and treatment of ectopic pregnancy may
take place in the course of follow-up.
Typical symptoms of ectopic pregnancy are
abdominal or pelvic pain—often one-sided—
and vaginal bleeding. Pain and bleeding may be
persistent or erratic and variable and, in some cases,
absent.28 High-risk factors for ectopic pregnancy are
tubal surgery, tubal sterilization, previous ectopic
pregnancy, in utero exposure to diethylstilbestrol,
use of intrauterine device (IUD)*, and documented
tubal disease.30
Ectopic pregnancy can sometimes be confirmed
with an ultrasound, but often an ultrasound can only
confirm the absence of an intrauterine pregnancy.
With serial β-hCG measurements and ultrasound
showing an empty uterine cavity in an asymptomatic
patient, ectopic pregnancy can be strongly suspected.
It is rare to actually see the ectopic pregnancy on
ultrasound, unless a very good unit, a transvaginal
probe, or a highly skilled sonographer is available
and the patient’s pelvic anatomy and location of the
ectopic pregnancy permit visualization. If ultrasound
is not available and ectopic pregnancy is suspected,
or if the woman is symptomatic for ectopic
pregnancy, she should be referred to an appropriate
gynecology service for urgent treatment.
* Women with an IUD in place and those who have had tubal ligation are more likely to have an ectopic than intrauterine pregnancy if conception does occur,
but their baseline risk of pregnancy is far lower than that of women not using contraception.29
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Choosing medical abortion or vacuum aspiration
Both medical abortion and vacuum aspiration have
been found to be acceptable methods to women.22,23,24
Women are more likely to find a method acceptable if
they have chosen it themselves.25,26
Women choose medical abortion or vacuum aspiration
for a variety of reasons that reflect a woman’s specific
circumstances and cultural context. Factors women
consider in choosing between available methods
include the length of gestation, the duration of the
abortion process, where the abortion will occur, and
what they are likely to experience.23
Both medical abortion and vacuum aspiration are safe
and effective methods with low complication rates.11,27
There are, therefore, very few situations where a clear
medical preference for either method exists.
Possible reasons to recommend medical abortion:
• Severe obesity. A surgical procedure may be more
technically challenging.1
• Uterine malformations, a fibroid uterus, or previous
cervical stenosis.
• A wish to avoid an invasive procedure.
Possible reasons to recommend surgical abortion (usually vacuum aspiration):
• Contraindications to medical abortion.
• Time or geographical constraints preclude follow-up
to confirm that medical abortion is complete.
• A woman has made the free and informed choice
that she would like to be sterilized or have an IUD
inserted, and the procedures can be carried out at
the same time.
• Suspected ectopic pregnancy (so tissue can be
examined to verify complete abortion).
Each woman who chooses medical abortion should be
clearly informed:
• What will be done at each visit and what she will
experience or do at home.
• What the medical abortion may feel like.
• What the common side effects are.
• How long the process may take.
• What the potential risks and complications are.
• What pain medications are available and how to use
them.
• That she must plan to complete the abortion process
once she starts it.
• When she will be able to resume her normal
activities, including sexual intercourse.
• When she needs to seek medical attention.
• What contraceptive methods are available and how
to get/start them.
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3. Prescribing and administering Medabon®
Scheduling medical abortion
with Medabon®
The full medical abortion process should be taken
into consideration when health providers and women
schedule clinic visits. For most women, expulsion will
happen within four to six hours of taking misoprostol.31
Bleeding and cramping will likely be heaviest at this
time. If misoprostol is administered in a clinic setting,
it is advisable that a woman stays in the clinic until she
feels comfortable and able to return home. Women
should be informed of this in advance so that they can
plan for misoprostol administration around travel time,
work and family needs, and the ability to have someone
there with her if she chooses.
Women should have access to emergency care during
the medical abortion process. Providers and women
should make a plan for where to seek emergency care
in the rare event of a serious complication.
Medabon® administration
Step 1. Woman swallows one mifepristone pill.
If a woman vomits within 30 minutes of taking
mifepristone, she will need to take another
mifepristone pill.
Step 2. Four 200-μg misoprostol tablets are
administered one or two days (24–48 hours)
later (see box “Misoprostol administration,”
page 3).
Vaginal administration: The woman or health worker
should use their finger to push the four tablets one at a
time into the vagina as far as they are able.
Health workers who administer misoprostol vaginally
should follow the instructions on the package insert
and wear clean gloves. If women administer misoprostol
vaginally themselves, either at home or in the clinic,
they should be advised to wash their hands first.
Sublingual administration: Women should place two
tablets of misoprostol under their tongue and wait
for them to dissolve. As soon as they have dissolved,
two more tablets can be taken in the same way. If the
first two tablets have not dissolved after 20 minutes,
women can swallow any remaining fragments and take
the final two tablets.
Some women may prefer to take all four tablets at once.
In that case, women should place all four tablets under
the tongue and wait for them to dissolve. If they have
not dissolved after 20 minutes, women can swallow any
remaining fragments.
Swallowing the tablets whole (oral administration) is
less effective than placing them under the tongue until
they dissolve or for 20 minutes.5
More information on Step 3, the follow-up visit, is
provided on page 12.
Resuming normal activities
Women should have clear expectations regarding when
they will or can resume normal activities. For example:
• Showering and bathing are fine at any time in the
medical abortion process. Vaginal douching is not
recommended.32
• Women may ask when they are able to resume sexual
activity. There is no evidence base to suggest ideal
timing, but women should be encouraged to wait
until they feel comfortable and ready (see below).
• Women can ovulate, and therefore get pregnant,
before menstruation returns to normal. Women who
want to prevent pregnancy should use a contraceptive
method during sexual relations after taking Medabon®.
Women have been found to ovulate as early as
ten days following abortion. See page 11 for more
information about contraceptive options.
• The return of menses following medical abortion will
generally occur after about five weeks.33
Medabon® Clinic Visits and Protocol
| STEP 1. Initial clinic visit and mifepristone administration |
- Confirm pregnancy and length of pregnancy.
- Counsel woman on pregnancy/abortion options.
- Complete physical exam and medical history.
- Screen for contraindications and risk factors.
- Rule out ectopic pregnancy.
- if the woman chooses Medabon® she may want to take misoprostol in the clinic or at home.
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For women who decide to take misoprostol in the clinic:
• Counsel woman on what to expect.
• Create schedule of Medabon® visits.
• Create plan for emergency follow-up care.
• Provide suggestions for dealing with side effects.
• Woman takes mifepristone orally. |
For women who decide to take misoprostol at home:
• Counsel woman on how to administer misoprostol
vaginally or sublingually, using visual aids as
appropriate.
• Review signs of serious complications and confirm
woman has printed materials.
• Create plan for emergency follow-up care.
• Provide suggestions for dealing with side effects
and make pain medication available.
• Schedule follow-up visit.
• Provide misoprostol tablets to take home.
• Woman takes mifepristone orally. |
| STEP 2. Misoprostol administration (24–48 hours later) |
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In the clinic:
• Administer misoprostol vaginally or sublingually.
• Make pain medication available.
• Review signs of serious complications and confirm woman has printed materials.
• Review plans for follow-up visit.
• Review side effects and management |
At home:
• Woman administers misoprostol vaginally or sublingually. |
| STEP 3. Follow-up visit (10–14 days after mifepristone administration)
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- Confirm that abortion is successful (most women will be in this category).
- If the woman is experiencing problematic bleeding (see page 12 for more detail), treatment options include:
- Waiting longer for bleeding to stop.
- An additional dose of misoprostol.
- Uterine evacuation.
- In the case of continuing pregnancy, uterine evacuation is recommended.
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Managing effects of the abortion
Bleeding
Bleeding can be managed similarly to a very heavy
menstrual period or a spontaneous miscarriage (e.g.,
with sanitary pads or cotton wool). It will be heaviest
after taking misoprostol—often during expulsion of the
products of conception—and light bleeding may last
two weeks or longer. It is not uncommon for bleeding
to stop and then start again. Some women, up to 20
percent in one study, may continue to have bleeding
or spotting 35–42 days after the initiation of a medical
abortion.34 If bleeding is heavy, prolonged, or causes
anemia (or symptoms of anemia, such as dizziness,
faintness, or significant loss of energy), then vacuum
aspiration, fluid replacement, or transfusion might be
required. The risk of bleeding requiring intervention
(transfusion and/or aspiration) ranges from 0.02 to
1.8 percent.35–37
Cramping and pain
Women are most likely to feel pain in the first few hours
after administration of misoprostol.1 Women should
receive medicines (or where they are unavailable,
prescriptions or recommendations for medicines)
to manage pain and have the pain medicine
available when taking the misoprostol. Nonsteroidal
anti‑inflammatory drugs (NSAIDs) like ibuprofen
(400–800 mg) have been shown to be more effective
than paracetamol (500–1,000 mg)38 and can be taken at
the same time as misoprostol, but not before. If possible,
women should have access to or at least a prescription
for a narcotic pain medicine in the event they need
it; codeine 30–40 mg may be added to either NSAIDs
or paracetamol. Women should be advised of other
comfort measures, such as use of hot water bottles.
Seeking care for possible complications
When educating women about the use of Medabon®,
it is important to stress that serious complications are
rare, but that they should be on the look-out for the
following signs and symptoms, and seek help (ideally
from their original provider) if they experience:
• Persistent, heavy bleeding to the point where they
feel sick or weak, or if they soak more than two pads
per hour for more than two consecutive hours.
• Fever of 38°C/100.4°F or higher continuing for more
than the day following misoprostol use.
• Persistent vomiting or diarrhea for more than the day
on which misoprostol was administered.
• Very severe, continuous, or increasing abdominal
pain that is unrelieved by medication, rest, a hot
water bottle, or a heating pad.
Little to no bleeding 24–48 hours following misoprostol
is not an emergency, but is cause for seeking follow-up
care as it may be a sign of continued pregnancy.
Infection after medical abortion procedures is rare.
Women should, however, be informed of the symptoms
of infection and encouraged to seek follow-up care
should symptoms of infection occur. The severity of the
infection should determine what treatment is provided;
oral antibiotics are used for most treatment of infection
or presumed infection.39
Women should always be given printed information
on signs of complications to take home (see the
sample patient brochure in these materials). As noted
previously, providers and women should discuss
a plan for emergency care prior to the medical
abortion process. Ideally, women should seek care
for complications from their original providers. If
the original provider is not available, accessible, or
cannot provide the necessary follow-up, providers
should work with women to identify an alternative
in advance. Women should be encouraged to take
their informational materials with them if they seek
emergency care elsewhere, in case the facility is
unfamiliar with medical abortion and associated
complications.
Most back-up care is similar to that needed by
women having a spontaneous abortion, and many
communities have a health care facility already in
place to provide such care. In rare cases, serious
complications do occur that require emergency
follow-up (see the “Medical Guidelines for Providers of
Emergency Care” included in this packet).
Contraceptive counseling and services
Women taking Medabon® should be offered
contraception. Women can become pregnant within
ten days of the abortion if they are not using an
effective method of contraception.40 Evidence supports
the use of any modern contraceptive method after an
uncomplicated
abortion.41,42
Women can begin taking hormonal methods, whether
combined (estrogen and progestin) or progestin-only,
on the same day as misoprostol administration, when
expulsion of the products of conception generally
occurs.43 These methods include oral contraceptives,44–46
injectable methods, implants, and the contraceptive
patch. For women taking the misoprostol at home, they
can be given any patient-initiated hormonal methods
and told to start them on the day they take misoprostol.
They may see a provider for injectable contraception or
implants. The vaginal contraceptive ring can be started
when bleeding slows down after expulsion of the
pregnancy.
Condoms, spermicides, the cervical cap, and the
diaphragm can be used as soon as women start
having sex again.1 If a woman would like to have an
IUD inserted or undergo sterilization, these procedures
should be performed after an assessment confirms that
the woman is no longer pregnant and the products of
conception have been expelled.
Natural family planning or fertility-awareness methods
cannot be initiated until a woman’s regular cycles have
resumed, and she may need to use a barrier method—
like a condom or a diaphragm—in the meantime.
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4. Following up
A follow-up visit is desirable approximately two weeks
(10–14 days) after taking Medabon®. During this visit, the
clinician confirms that the woman is no longer pregnant
and that bleeding patterns are within the expected range,
ensures contraception is provided if desired, and answers
her questions. Confirmation that the pregnancy has been
terminated is possible by pelvic examination, bleeding and
symptom history, or by ultrasound, if necessary.
The following scenarios represent the most likely situations
encountered at the follow-up visit:
Successful medical abortion
The woman reports she no longer feels pregnant, has
taken the medications as instructed, and had bleeding and
cramping consistent with a successful medical abortion.
This is the most common outcome.
Problematic bleeding
Problematic bleeding encompasses a range of bleeding
patterns that may be tiresome or problematic for the
woman, or, in rare cases, are true emergencies. In the case
of problematic bleeding, the pregnancy is not growing, but
the woman’s bleeding pattern is not gradually diminishing.
The pelvic exam is consistent with a small or non-pregnant
uterus. Treatment options, unless indicated otherwise
below, are:
1) waiting longer for bleeding to stop; 2) an
additional dose of misoprostol, which may help the uterus
contract and expel residual tissue or a persistent empty sac;
or 3) uterine evacuation.
Various patterns of problematic bleeding requiring specific
interventions are:
Persistently heavy bleeding
The woman may have
been bleeding continuously—like during a heavy
menstrual period—since she took misoprostol. If the
woman feels weak from bleeding, a uterine aspiration
is recommended. If she is clinically stable and feels well,
a repeat dose of misoprostol may be offered as long
as the woman is willing and able to return two days to
one week later, depending on the duration and amount
of problematic bleeding, to assess whether bleeding
is diminishing.45 Although providing a second dose of
misoprostol is a practice used by some providers to
increase uterine contractility and expel residual tissue,
its use has been studied for expulsion of a persistent
sac or unexpelled embryo47; providing a repeat dose
of misoprostol has not been studied for alleviation of
problematic bleeding.
Erratic bleeding
Some women have days of very
little bleeding, no bleeding, or spotting, and erratically
experience very heavy, gushing bleeding. If a woman is
symptomatic for anemia, perform uterine aspiration.
Hemorrhage
Hemorrhage causing hemodynamic
instability is an emergency and is treated with an
immediate uterine evacuation to empty the uterus.
If the hemorrhage has been very serious, blood or fluid
transfusion should be considered. If transfusion services
are not available, the woman should be transported to
the nearest facility providing these services.
Continued pregnancy
The woman reports continued pregnancy symptoms
and the uterus is larger than on previous exam. Uterine
evacuation is recommended at this time.
Possible birth defects if pregnancy continues
Evidence on birth defects associated with mifepristone
or misoprostol are inconclusive. From an estimated two
million procedures performed between 1987 and 2008
in countries where Exelgyn Laboratories holds marketing
authorization for a mifepristone product—Mifegyne®—a
total of 26 malformations have been reported in cases
where the combined treatment failed or the woman
changed her mind about the procedure after taking
the mifepristone.48 Six cases of malformation have been
reported after use of mifepristone alone, and twenty other
cases have been reported after use of mifepristone and
a prostaglandin. According to these authors, none of the
events have been conclusively related to the treatment.
Women who choose to carry a pregnancy to term should be
counseled on the possibility of birth defects and encouraged
to seek active follow-up care throughout pregnancy.
References
- World Health Organization (WHO). Frequently Asked Questions
about Medical Abortion: Conclusions of an International
Consensus Conference on Medical Abortion in Early First Trimester,
Bellagio, Italy. Geneva: WHO; 2006. Available at: www.who.int/
reproductive-health/publications/medical_abortion/.
- Creinin M. Medical abortion regimens: historical context
and overview. American Journal of Obstetrics & Gynecology.
2000;(2Suppl):S3–S9.
- Foster A. Medication Abortion: A Guide for Health Professionals.
Cambridge: Ibis Reproductive Health; 2005. Available at:
www.ibisreproductivehealth.org/downloads/Medication_
abortion_A_guide_for_health_professionals_English.pdf.
- Tang OS, Chan C, Ng E, Lee S, Ho P. A prospective,
randomized, placebo-controlled trial on the use of
mifepristone with sublingual or vaginal misoprostol for
medical abortions of less than 9 weeks gestation. Human
Reproduction. 2003;18(11):2315–2318.
- Raghavan S, Comendant R, Digol I, et al. Two-pill regimens
of misoprostol after mifepristone medical abortion through
63 days’ gestational age: a randomized controlled trial of
sublingual and oral misoprostol. Contraception. 2009;
79(2):84–90.
- Hamoda H, Ashok PW, Dow J, Flett GM, Templeton A. A pilot
study of mifepristone in combination with sublingual or
vaginal misoprostol for medical termination of pregnancy up
to 63 days gestation. Contraception. 2003;68(5):335–338.
- Jvon Hertzen H, Piaggio G, Wojdyla D, et al. Two mifepristone
doses and two intervals of misoprostol administration for
termination of early pregnancy: a randomized factorial
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Related resources
Castleman L, Winikoff B, Blumenthal P. Providing abortion
in low-resource settings. In: Paul M, Lichtenberg S, Borgatta L,
Grimes D, Stubblefield P, Creinin M, eds. Management of
Unintended and Abnormal Pregnancy: Comprehensive Abortion
Care. Wiley-Blackwell; 2009.
Creinin MD and Gemzell Danielsson K. Medical abortion
in early pregnancy. In: Paul M, Lichtenberg S, Borgatta L,
Grimes D, Stubblefield P, Creinin M, eds. Management of
Unintended and Abnormal Pregnancy: Comprehensive Abortion
Care. Wiley-Blackwell; 2009.
Gynuity Health Projects and Reproductive Health
Technologies Project (RHTP). Frequently asked questions
about fatal infection and mifepristone medical abortion:
technical version [fact sheet]. New York: Gynuity Health
Projects and RHTP; 2006. Available at: www.gynuity.org/
resources/info/faqs-on-fatal-infection-and-medical-abortiontechnical-
version/. Also available in Spanish and Turkish.
Hyman AG, Castleman LD. Woman-centered abortion care:
Reference manual. Chapel Hill, NC: Ipas; 2005. Available at: www.ipas.org/Publications/Woman-centered_abortion_
care_Reference_manual.aspx. Also available in French,
Portuguese, and Spanish.
Hyman AG, McInerny T, Turner K. Woman-centered abortion
care: Trainer’s manual. Chapel Hill, NC: Ipas; 2005. Available
at: www.ipas.org/Publications/Woman-centered_abortion_
care_Trainers_manual.aspx. Also available in French,
Portuguese, and Spanish.
Ibis Reproductive Health. Medication Abortion:
A Training Module for Health Professionals. Cambridge,
MA: Ibis Reproductive Health; 2003. Available at: www.ibisreproductivehealth.org/downloads/Medication_
Abortion_Training_Module.ppt. Also available in Arabic.
International Consortium for Medical Abortion (ICMA). The ICMA Information Package on Medical Abortion:
Information for Health Care Providers. Available at: www.medicalabortionconsortium.org/articles/for-healthcare-
providers/. Also available in Arabic, French, Hindi,
Portuguese, Romanian, Russian, and Spanish.
Ipas. Best practices in medical abortion: starting
contraception after first-trimester abortion [fact sheet].
Chapel Hill, NC: Ipas; 2007. Available at: www.ipas.org/
Publications/asset_upload_file685_2890.pdf. Also available in German, Russian, and Spanish.
McInerny T, Baird TL, Hyman AG, Huber AB. A Guide to
Providing Abortion Care. Chapel Hill, NC: Ipas; 2001. Available at: www.ipas.org/Publications/asset_upload_file207_2447.pdf. Also available in Romanian and Russian.
Paul M, Stewart FH, Weitz TA, Wilcox N, Tracey JM. Early
Abortion Training Workbook. San Francisco, CA: University
of California, San Francisco Center for Reproductive Health
Research & Policy; 2003. Available at: www.teachtraining.org/
Workbook.html.
Philip NM, Shannon C, Winikoff B, eds. Misoprostol and
Teratogenicity: Reviewing the Evidence. New York: Gynuity
Health Projects and Population Council; 2003. Available at: www.gynuityorg/resources/info/misoprostol-andteratogenicity-
reviewing-the-evidence/. Also available
in Spanish.
Talluri-Rao S, Baird TL. Information and Training Guide for
Medication-Abortion Counseling. Chapel Hill, NC: Ipas; 2003.
Available at: www.ipas.org/Publications/asset_upload_
file24_2449.pdf. Also available in Portuguese and Russian.
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