Misoprostol for treatment of incomplete abortion

Table of Contents
I. Introduction 1
II. Overview of misoprostol for incomplete abortion 3
What misoprostol is and how it works
•
Formulation
•
Efficacy in treating incomplete abortion
•
Safety
•
Acceptability
•
Comparison to other treatment methods
•
Misoprostol is an important new treatment for incomplete abortion
•
III. Treatment of incomplete abortion using misoprostol 8
Who can receive misoprostol for treatment of incomplete abortion?
•
Who can provide misoprostol for treatment of incomplete abortion?
•
Dose and timing
•
Route of administration
•
Safety of misoprostol for treatment of incomplete abortion
•
IV. Service design, visit schedule and managing complications 14
Ultrasonography
•
Provider experience
•
Schedule of clinic visits
•
Managing side effects and complications
•
Follow-up
•
V. Counseling, information provision and service delivery 20
Choosing a method
•
Establishing eligibility
•
Preparing women for what to expect
•
Family planning and contraceptive services
•
Reproductive and other health services
•
Provider and staff training
•
Community and service provider partnerships
•
Desirable (but not required) facilities and supplies
•
VI. Integrating misoprostol into existing postabortion care services 29
VII. Missed abortion 30
VIII. Looking forward 32
IX. Appendix 34
Frequently Asked Questions
•
X. References 38
1
I. Introduction
The launch of this guidebook follows closely the inclusion of misoprostol for
the management of incomplete abortion and miscarriage in the World Health
Organization’s Model List of Essential Medicines in April, 2009.
1
The Expert
Committee on the Selection and Use of Essential Medicines decided that
misoprostol is as effective as surgery and perhaps safer and cheaper in some
settings. This new status marks a turning point in the role of misoprostol from
a promising technology to an established, internationally recognized essential
medicine for the treatment of incomplete abortion.
Approximately one in five recognized pregnancies are spontaneously miscarried in
the first trimester
2
and an additional 22% end in induced abortion.
3
An incomplete
abortion can result from either spontaneous or induced pregnancy loss and occurs
when products of conception are not completely expelled from the uterus.
Incomplete abortion is closely related to unsafe abortion in many parts of the world.
Where abortion services are restricted, women may seek pregnancy terminations
from unskilled providers, have procedures performed in environments lacking
minimal medical standards, or both.
4
Some women may resort to self-induction.
These conditions increase the likelihood that women will experience abortion
complications and will seek treatment for incomplete terminations.
5
Safe and
effective treatment for incomplete abortion is an important way to reduce
abortion-related morbidity and mortality, particularly in settings where legal
abortion is restricted.
Incomplete abortion can be treated with expectant management, which allows
for spontaneous evacuation of the uterus, or active management, using surgical
or medical methods. Expectant management is not preferred by many providers
due to its relatively low efficacy and the fact that the time interval to spontaneous
expulsion is unpredictable.
6
The standard of care for active management varies by
setting but has traditionally been surgery with general or local anesthesia. Surgical
methods are highly effective for treatment of incomplete abortion. However, these
treatments require trained providers, special equipment, sterile conditions and
often anesthesia, all of which are limited in many settings.
6
2
Medical methods for treatment of incomplete abortion require few resources and
can be administered by low- and mid-level providers.
7
Such technologies could
increase access to services for women far from surgical care facilities. Misoprostol
is the most common and thoroughly studied form of medical management and
offers a highly effective alternative treatment for women wishing to avoid invasive
surgery and anesthesia.
8
In environments with few resources and limited access to
surgical methods, such as primary and secondary care centers, misoprostol allows
for the vast majority of cases to be treated without needing referral to higher level
facilities.
8
Additionally, misoprostol is widely available, easy to administer, stable
at room temperature, accessible, and inexpensive in most countries. Misoprostol
offers women and providers a safe, effective, and non-invasive treatment option
for incomplete abortion that is particularly useful where supplies are limited and
skilled providers are few. In settings where special postabortion care (PAC) services
have been introduced to address morbidity and mortality associated with unsafe
abortion, misoprostol can be integrated easily within existing services.
Information about this Guidebook
This guidebook was created for providers and policymakers who are interested
in learning about misoprostol to treat incomplete abortion, whether arising from
spontaneous or induced pregnancy loss. The goal of this guidebook is to synthesize
the available literature to provide appropriate, effective and safe clinical guidelines
for use of misoprostol in treatment of incomplete abortion. Chapter II focuses on
the efficacy, safety, and acceptability of misoprostol for treatment of incomplete
abortion, while Chapters III through V outline who can be offered the method,
recommended regimens, schedule of clinic visits, management of side effects,
counseling, and service delivery. Chapter VI addresses how misoprostol can be
integrated into existing PAC services and Chapter VII provides brief information on
missed abortion.
3
II. Overview of misoprostol for incomplete abortion
A. What misoprostol is and how it works
Misoprostol (with a variety of trade names, the most common being Cytotec
®
) is
registered in over 80 countries, mostly for prevention of gastric ulcers secondary
to long-term use of non-steroidal anti-inflammatory drugs (NSAIDs). Misoprostol
is a prostaglandin E1 analog which, like natural prostaglandins, affects more than
one type of tissue, including the stomach lining and the smooth muscle of the
uterus and cervix.
6, 9, 10
Over the last two decades, research on use of misoprostol
in reproductive health has burgeoned due to its very effective uterotonic and
cervical ripening properties.
6, 10
At present, misoprostol is an accepted and widely
used treatment for cervical ripening, induction of abortion in the first and second
trimester, prevention and treatment of postpartum hemorrhage, and incomplete
abortion. At the same time, few misoprostol products have been registered for
reproductive health uses.
B. Formulation
Misoprostol is most commonly manufactured as a 200 mcg tablet intended for
oral administration, although 100 mcg pills also exist in some countries.
10
Vaginal
formulations are also available in some places, mostly as a 25 mcg suppository,
but also in larger doses. Misoprostol has several important advantages over other
agents with uterotonic properties. For example, it is stable at ambient temperature
11

while other products require refrigeration or freezing. Some other products are only
administered by injection.
9
Misoprostol is less expensive and more widely available
than other treatments.
11
With new misoprostol products and generics appearing
each year, its price can be expected to decrease as availability increases.
C. Efficacy in treating incomplete abortion
Misoprostol is effective in emptying the uterus because of its ability to induce
uterine contractions and to soften the cervix. Misoprostol for treatment of
incomplete abortion has been well documented in women presenting with uterine
size less than or equal to a pregnancy at 12 weeks since last menstrual period
(LMP).
12
Successful use of misoprostol implies complete evacuation of the uterus
without recourse to surgical intervention. Infrequently, surgical completion may be
needed for retained products of conception, heavy bleeding, or at the request of the
woman. The efficacy rates found in the literature are inconsistent due to differences
in regimens, time to determination of success, and inclusion and exclusion criteria.
However, recent studies have attempted to standardize these variables and have
achieved high efficacy. Overall, in studies that each enrolled more than 100 women
and used misoprostol in at least one treatment arm (600 mcg oral or 400 mcg
sublingual misoprostol) with at least 7 days before follow-up, efficacy averaged 95%
(see Table 1), with success rates as high as 99%.
13

4
Table 1: Misoprostol and Manual Vacuum Aspiration (MVA)
for treatment of incomplete abortion
Year Author N Treatment Time to
Success
Success
2009
Diop A, et al.
14
150;
150
600 mcg oral misoprostol;
400 mcg sublingual
misoprostol
Days 7 & 14 94.6%;
94.5%
2007
Bique C, et al.
15
123 600 mcg oral misoprostol;
MVA
Days 7 & 14 91%;
100%
2007
Dao B, et al.
16
227 600 mcg oral misoprostol;
MVA
Days 7 & 14 94.5%;
99.1%
2007
Shwekerela B, et al.
13
150 600 oral misoprostol;
MVA
Days 7 & 14 99%;
100%
2005
Ngoc NTN, et al.
17
150;
150
600 oral single or
double dose*
Day 7 95.3%;
93.8%
2005
Weeks A, et al.
18
160 600 mcg oral misoprostol;
MVA
Days 7 to 14 96.3%;
91.5%
* 150 women received an additional 600 mcg oral misoprostol dose at 4 hrs (Ngoc NTN, et al.)
5
D. Safety
Misoprostol has been used by millions of men and women worldwide since its
approval in 1988 for prevention of gastric ulcers associated with chronic NSAID
use. Importantly, misoprostol has been used safely for incomplete abortion in many
countries. Misoprostol has not been associated with long-term effects on women’s
health, and prolonged or serious side effects are virtually nonexistent.
E. Acceptability
Women and providers find misoprostol for treatment of incomplete abortion to be
highly acceptable. Many women report that they would choose misoprostol again if
they were to need treatment for incomplete abortion in the future. Research in low-
resource settings in several countries has indicated that over 90% of women were
“very satisfied” or “satisfied” with misoprostol treatment.
13, 16, 17, 18
F. Comparison to other treatment methods
Incomplete abortion can be treated with expectant, surgical, or medical management.
Expectant management involves allowing the uterus to evacuate the products
of conception spontaneously without provider intervention. Generally, expectant
management results in lower success rates compared to active (surgical or
medical) management.
19
Surgical evacuation procedures include dilatation and
curettage (D&C), electric vacuum aspiration (EVA), and manual vacuum aspiration
(MVA). These methods achieve a high success rate (91.5-100%) but carry a small
risk of serious complications including infection, cervical laceration and uterine
perforation. Most important, in many settings, surgical management may not be
feasible. Misoprostol provides an effective, safe, and acceptable treatment option
for women who do not have access to surgical treatment or who wish to avoid
invasive procedures. Rates of gynecological infection after expectant, surgical, and
medical management of incomplete abortion are low (2-3%) and do not differ
by method of treatment.
20
Additionally, experience has shown that women find
misoprostol to be as acceptable as MVA; in fact, in some studies, more women
have reported being “very satisfied” with misoprostol treatment than MVA
treatment.
13, 16, 18
Refer to Table 2 for a comparison of methods of management of
incomplete abortion.
G. Misoprostol is an important new treatment for incomplete
abortion
In countries where legal abortion is restricted, the PAC model provides a framework
for care of women experiencing complications from unsafe abortion (see page 7).
Treatment of incomplete abortion is an essential component of PAC services, and
misoprostol can serve as an effective treatment option. Misoprostol treatment
can be readily integrated into existing PAC services with basic provider training.
Importantly, misoprostol is a safe and effective treatment option for PAC where there
are no other treatment options or where there are few skilled providers.
6
Table 2: Comparing expectant, medical and surgical management
of incomplete abortion
Who can offer the
treatment?
What is needed to
offer the treatment?
What are the risks?
Expectant Mid-level and
skilled providers
Ability to diagnose the
problem
Failure; need for
medical or surgical
completion
Medical Mid-level and
skilled providers
Above plus drug
supplies
Failure; need for
surgical completion;
side effects
Surgical Skilled providers All of the above plus
sterilized equipment,
surgical supplies, and
a special room
Cervical laceration;
uterine perforation;
infrequent failure
7
Essential elements of postabortion care where abortion services
are restricted
21
1. Community and service provider partnerships
• Preventunwantedpregnanciesandunsafeabortion
• Mobilizeresourcestohelpwomenreceiveappropriateand
timely care for complications from abortion
• Ensurethathealthservicesreectandmeetcommunity
expectations and needs
2. Counseling
• Identifyandrespondtowomen’semotionalandphysicalhealth
needs and other concerns
3. Treatment
• Treatincompleteandunsafeabortionandpotentiallylife-
threatening complications
4. Contraceptive and family planning services
• Helpwomenpreventanunwantedpregnancyorpracticebirth
spacing
5. Reproductive and other health services
• Preferablyprovidedon-site,orviareferralstootheraccessible
facilities in providers’ networks
8
III. Treatment of incomplete abortion using
misoprostol
A. Who can receive misoprostol for treatment of incomplete
abortion?
Eligibility criteria
Misoprostol can be used for early, uncomplicated incomplete abortion.

Eligible women have the following:
 Open cervical os
 Vaginal bleeding or history of vaginal bleeding during this pregnancy
 Uterine size of less than or equal to 12 weeks’ LMP

Women who are NOT eligible have the following:
 Known allergy to misoprostol or other prostaglandin
 Suspected ectopic pregnancy
 Signs of pelvic infection and/or sepsis
 Hemodynamic instability or shock
Assessment of uterine size
Providers should assess a woman’s uterine size prior to misoprostol
administration. A woman with a uterus 12 weeks’ LMP or smaller is
eligible for treatment with misoprostol. Uterine size can be estimated by
conducting a physical exam. Precise dating of the initial gestational age
is unnecessary as long as the uterine size at presentation for treatment is
equivalent to a pregnancy of 12 weeks’ LMP or less.

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