Contraception 70 (2004) 387 – 392

Original research article

Acceptability of home-use of misoprostol in medical abortion
Christian Fialaa, Beverly Winikoff b, Lotti Helstrfma,
Margareta Hellborga, Kristina Gemzell-Danielssona,*
a
Division for Obstetrics and Gynaecology, Department of Woman and Child Health, Karolinska Hospital / Institute, S-171 76 Stockholm, Sweden
b
Gynuity Health Projects, New York, NY 10010, USA
Received 10 May 2004; accepted 30 June 2004

Abstract
Introduction: Home-use of misoprostol would reduce the number of visits and improve access to medical abortion. We evaluated acceptance
of home-use of misoprostol among women and their partners.
Materials and Methods: One hundred women with up to 49 days of amenorrhea were given mifepristone, followed by misoprostol taken at
home.
Results: Women chose home-use of misoprostol because it felt more natural, private and allowed the presence of a partner/friend. Two
women had a vacuum aspiration due to incomplete abortion. Five unscheduled visits occurred. Ninety-six women were satisfied with their
choice of home-use. The male partners were generally satisfied with their partner’s choice of home-use and felt that their presence and
support had been valuable.
Discussion: Our study shows a high acceptability among women and their partners and confirms the safety and efficacy of home-use of
misoprostol. Women should be offered this choice to allow more flexibility and privacy in their abortions.
D 2004 Elsevier Inc. All rights reserved.
Keywords: Acceptability; Medical abortion; Misoprostol; Home use; Male partner

1. Introduction commonly used regimen of prostaglandin up to 49 days of

amenorrhea in continental Europe is 400 Ag misoprostol
Medical abortion using the antiprogestin mifepristone
administered orally as a single dose. This regimen is highly
(Exelgyn; Paris, France) combined with a prostaglandin has
effective to terminate a pregnancy up to 49 days of
been available in Europe since 1988. Several large
amenorrhea but less effective in more advanced pregnancy
multicenter studies have since confirmed the safety and
[5–8]. At a gestational duration beyond 49 days, vaginal
efficacy of this regimen with efficacy rates over 95%,
administration of a higher dose of misoprostol, 800 Ag
comparable to that of surgical abortion [1–3]. Several
instead of 400 Ag, has been shown to be more effective [9].
studies have examined women’s preferences for medical
In a few European countries, including Sweden, France
versus surgical abortion. When given the choice, 60 –80% of
and the UK, abortion can, according to the law, be
women chose the medical method (reviewed in Ref. 4).
performed only in hospital-affiliated facilities or facilities
The prostaglandin most widely used today is misoprostol
approved by the Department of Health. This requirement has
(Cytotec, Pfizer), a prostaglandin E1 analogue widely
also been applied to medical abortion, resulting in the
available for the prevention of gastric ulcers in patients
interpretation that all the drugs have to be given in an
taking nonsteroidal anti-inflammatory drugs. Mifepristone is
authorized facility followed by an obligatory observation
approved for medical abortion in almost all countries of the
period after misoprostol. Currently, three visits are required
European Union and the US with 600 mg mifepristone
for medical abortion: the first is for abortion counseling,
followed 36 –48 h later by a prostaglandin. The most
examination, contraceptive counseling and administration of
mifepristone; the second visit is for the administration of
misoprostol including a 3- to 4-h observation period. Finally,
* Corresponding author. Tel.: +46 8 517 721 28; fax: +46 8 517 743 14. a follow-up visit takes place 1– 4 weeks later. Although the
E-mail address: kristina.gemzell@kbh.ki.se (K. Gemzell-Danielsson). method has been shown to be very safe and effective, several
0010-7824/$ – see front matter D 2004 Elsevier Inc. All rights reserved.
doi:10.1016/j.contraception.2004.06.005
388 C. Fiala et al. / Contraception 70 (2004) 387–392
improvements have been suggested to increase accept-
ability and accessibility. A review of patient attitudes
towards medical abortion showed that most women prefer
oral administration of misoprostol, a shorter waiting time
until complete abortion is confirmed and fewer visits to the
clinic [4,10]. In several studies from the USA, home
administration of misoprostol has been shown to be
successful and safe [11,12]. It has also been shown to be
safe and preferred in Guadeloupe as well as in several
developing countries, including Tunisia and Vietnam
[13,14]. The practice of giving women the misoprostol to
take at home has been adopted as clinical routine in the US.
Home-use of misoprostol was accepted rapidly because of
the abundant experience with home-use of misoprostol
following methotrexate in medical abortion. In Europe,
there has been a very slow acceptance and frequently even
a resistance to giving misoprostol at home. The reluctance
to allow women more autonomy is surprising given the
huge amount of evidence showing the safety and efficacy
of home-use and the strong preference by many women for
this option.
A study on acceptability of home-use in the European
context was undertaken since this option is rarely available to
women in Europe. To our knowledge, the acceptability and
experience of the male partner has not been studied
previously.
The objective of the present study was to assess
acceptability of home-use of oral misoprostol for termina-
tion of pregnancies up to 49 days of gestation. In addition,
the experience of the male partner was investigated.
Acceptability of a shortened interval between mifepris-
tone and misoprostol to 1 day (day 1, day 2) followed by a
second dose of misoprostol on day 3 will be analyzed in a
separate paper.
2. Material and methods
The study was performed from December 2001 to
August 2003, at the Department of Obstetrics and Gyne-
cology, Karolinska University Hospital, Stockholm, Swe-
den. Women who presented at the abortion clinic and
fulfilled the inclusion criteria were given the option of
participating in the study. Women were not randomized but
could decide on their own where they wanted to take the
misoprostol. The objective of the study was to evaluate
acceptability of home-use. The patient’s preference was
therefore important. It was considered unethical and not
reasonable for the goal of the study to randomize patients to
home-use against their will.
No control group was analyzed. The goal of the study did
not include comparing home-use of misoprostol with the
standard regimen of hospital use. The objective was to show
whether home-use is an acceptable alternative to hospital-
use for those women who opt for it. It was irrelevant, in this
respect, whether a hospital group was more or less satisfied,
as long as there were numbers of women who preferred
home-use and found it acceptable.
Women with a pregnancy length up to 49 days of
amenorrhea, requesting medical abortion, were given the
choice between the standard protocol of administration of
misoprostol at the hospital and the possibility of taking it at
home. One hundred women who chose home-use of
misoprostol for their medical abortions were included in
the study consecutively. The gestational age was established
by menstrual history and confirmed by physical examina-
tion and endovaginal ultrasound examination (vaginal
probe, 7.5 MHz). The patients were accepted for the study
if they had no contraindication for medical abortion, were
above 18 years of age, lived within 1 h of the hospital and
were willing to cooperate with the requirements of the study.
Criteria for exclusion were abnormal pregnancy, a contra-
indication to mifepristone or misoprostol or signs of genital
infection. Women were counseled by the gynecologist in
charge, as well as by a trained and experienced nurse. They
saw the same nurse at all visits.
The patients received 600 mg mifepristone orally at the
hospital on day 1. The women were also given four tablets
of misoprostol (200 Ag per tablet) to take at home. They
were advised to take the first dose of two tablets of
misoprostol (400 Ag) orally the following day, 24 h after
mifepristone. A second dose of two tablets (400 Ag) of
misoprostol orally was taken 24 h after that, that is, 48 h after
mifepristone. All women received seven tablets of 500 mg
paracetamol and eight tablets of Citodon (500 mg para-
cetamol and 30 mg codeine) to use at home for pain relief at
their own discretion.
The first follow-up to assess the outcome of treatment
was performed on day 21 following the routine regimen used
for medical abortion. Outcome was evaluated using a urinary
hCG test with a cut-off value of 500 IU/ml. If necessary, an
ultrasound examination and serum hCG were performed. In
case of a continuing pregnancy or missed abortion, vacuum
aspiration was offered. Surgical intervention was performed
in case of heavy bleeding or if requested by the patient. A
further follow-up visit was scheduled when judged neces-
sary by the doctor. The treatment was regarded as successful
only if no surgical treatment was required until the first
subsequent menstruation. Women were advised to call the
clinic on a 24-h hotline for any problems or questions.
Women completed standardized questionnaires prior to
the beginning of treatment, at follow-up and at all
unscheduled visits or calls. These questionnaires covered
demographic characteristics, reasons for choosing home-use
of misoprostol, adherence to the regimen, side effects and
satisfaction with the treatment. Women also completed daily
symptom diaries during the study period. Intensity of pain
was rated on a visual analogue scale (VAS) ranging from 1
to 5. Use of any pain medication was recorded. Intensity of
bleeding was reported in relation to normal menstrual
bleeding. Women were also asked whether they believed
that the abortion was complete, and if so, when and on what
 C. Fiala et al. / Contraception 70 (2004) 387–392 389

basis (i.e., heavy bleeding, observed expulsion, disappear- Table 2

ance of pregnancy symptoms or other specified reasons). In Bleeding characteristics and other side effects
addition, women were asked whether someone had been Side effect (% of patients experiencing) Duration (days), Range
present with them at home when they took the first and/or mean (SD)
second dose of misoprostol. In cases where a partner, family Bleeding, any type (100%) 13.9 (5.3) 2–21
Heavy, greater than menses (93%) 3.3 (2.4) 1–11
member or a friend had been present at home in the hours
Normal, equal to menses 5.0 (3.4) 1–18
following misoprostol treatment, this person was also asked Spotting, less than menses 6.5 (3.9) 1–17
to answer a questionnaire concerning his or her experience Nausea (64%) 2.3 (1.8) 1–11
of the home-use if the woman agreed. Vomiting (16%) 1.7 (1.4) 1–6
Approval for the study was obtained from the Ethics Pain/cramps (91%) 3.5 (2.2) 1–15
Diarrhea (28%) 2.0 (2.1) 1–12
Committee, Karolinska Hospital, Stockholm. Approvals
Fever (28%) 1.5 (0.8) 1– 4
were also obtained from the Swedish Board of Health and
Welfare and the Swedish Medical Product Agency. The study related to the pregnancy, but unrelated to the treatment.
protocol was approved by the Population Council’s Institu- Sixty-nine women reported seeing the expelled gestational
tional Review Board. All women gave written informed sac. Among those who believed they had seen the expelled
consent. Data were recorded on standardized forms. sac, 66 self-judgments of complete abortion were made after
the first misoprostol dose. Two were made on day 3 and 1
3. Results on day 4.

3.1. Population characteristics, compliance, efficacy and 3.2. Misoprostol administration

side effects All participating women took both courses of misopros-
One hundred women were included in the study. All tol at home. Women had been advised to have a companion
women completed the study, used misoprostol at home present at home after administration of the first dose of
according to the study protocol and returned for follow-up. misoprostol. In most cases, a partner, a friend or a relative
Characteristics of the participating women are shown in such as a mother or sister was present (75% on day 2).
Table 1. No patient reversed her initial decision to choose Twenty-five women were alone. Seventy percent of the
home-use during further counseling. women who had a partner/friend present found the support
Women chose home-use of misoprostol because it felt to be very good and 10% described it as good (Table 3).
more natural, like a delayed menstruation or a spontaneous Five women were very dissatisfied with their partners
abortion (25%), easier (27%) and because they preferred to support and two were dissatisfied. Satisfaction with home
have the bleeding at home (9%). use did not differ between those women who had a partner
After treatment, there were no ongoing pregnancies. Two present and those who were alone.
women had a vacuum aspiration due to incomplete abortion No woman reported taking misoprostol too late or too
with an empty gestational sac still present in the uterine cavity early. In one case, an additional dose of 400 Ag of
at follow-up. Eight women had a concentration of h-hCG misoprostol was taken due to vomiting within 30 min of
above 500/mL at follow-up on day 21 after treatment and initial drug administration. This woman had to return to the
were therefore scheduled for a further follow-up. hospital to get an extra dose of misoprostol since no third
Bleeding characteristics and frequency of side effects are dose was given to keep just in case of vomiting.
shown in Table 2. No woman required a blood transfusion.
Table 3
Most women described the bleeding up to 24 h after Satisfaction with the method
misoprostol as heavier than their normal menstrual period,
Average score (n =100): min=1 (very
while 18 described it as equal and 18 as less. One serious unsatisfactory/untrue/much less), max=5
adverse event was reported in a patient who was diagnosed (very satisfactory/true/much stronger)
with a deep venous thrombosis. This was considered to be Decision to use at home 4.74
Feeling secure and calm 4.43
Impact on daily life 2.99
Table 1 The treatment day was 3.77
Characteristics of participants (n=100) as expected
Mean age, years (range) 33.2 (20 – 45) I got enough information 4.87
Mean gestational age, days since LMP (range) 42 (30–52) I got enough support from 4.5
Primigravid (n) 3 my partner/friend
Previous induced abortions (n) 59 Bleeding, compared to my 2.59
Previous medical abortion (n) 10 normal menstruation
Previous spontaneous abortion (n) 15 Pain, compared to 2.59
Previous delivery (n) 83 menstruation
Three women with a gestational length of more than 49 days were included The questionnaire was completed on day 3, 24 h after the first dose of
(50, 51 and 52 days, respectively). misoprostol.
390 C. Fiala et al. / Contraception 70 (2004) 387–392
3.3. Pain management and unscheduled consultations
Nine women recorded no pain at all while 91 reported
pain for an average of 3.5 (1–15) days (Table 2). Pain was
most frequently reported on the second day of the regimen,
after the first dose of misoprostol. Individual variation in the
experience of pain was large. After the procedure, some
women reported that pain had been less than their normal
menstrual period (16 on day 3, 21 on day 4), but most
women said it had been more pronounced (65 on day 3, 47
on day 2). Many women reported spontaneously that they
were happy to have experienced giving birth prior to
medical abortion. Most women had previously been
pregnant (97) and 83 had given birth (Table 1).
A total of 27 patients did not take any pain medication
(Table 4). Among women with a duration of amenorrhea of
less than 42 days, 37% did not take any medication for pain
relief as compared to only 19% of those with a gestation of
more than 42 days. Of those 67% who used pain
medication, the average dosage was 4.5 tablets, ranging
from 1 to 12 tablets.
Women were advised to call the clinic for any prob-
lems or questions. A substantial majority, 80 women,
made no calls to the 24-h hotline. Fourteen women called
once, four twice, one woman three times and one four
times (Table 5).
3.4. Acceptability and patient satisfaction
Most women (96%) were very satisfied (87%), or
satisfied (9%) with their choice to administer misoprostol
at home (Table 3). Three women were neutral and one was
very dissatisfied when asked on day 4. The reason given
for dissatisfaction was strong pain (n=1) (Table 3). Most
women (98%) stated that they would also make the same
choice in case of a new abortion in the future. All but five
women reported feeling secure and calm on the day of
misoprostol administration. On the day of the second
misoprostol administration, 74% of women reported
feeling very safe and 10% reported feeling safe and calm
while four women still felt worried. While a majority
stayed at home from work or took the treatment during a
weekend as a precaution, most women nevertheless
reported that the treatment had actually not affected their
daily life and routines (64% on day 3 and 74% on day 4).
For most women, the experience had been as expected. All
but three women found that they had received enough
information (Table 3).
Table 4
Pain management
Patients b42 days Patients z42 days
LMP (n = 43) LMP (n = 57)
No tablets taken 16 patients (37%) 11 patients (19%)
Mean number of tablets (SD) 2.8 (3.0)* 3.7 (3.2)*
Range 0 –12 0 –12
* p=.09 using Student’s test.
Table 5
Reasons for call to hotline
Day of Number of
treatment patients (n = 20)
Vomiting after mifepristone 1 1
Vomiting after misoprostol 2 5
Nausea, dizziness 5 1
Worried, not much effect 3, 5 4
Heavy bleeding 2, 5, 13 3
Prolonged bleeding 17 1
Pain 2, 2, 5 3
Assurance that everything is normal 4, 5 2
3.5. Partner satisfaction
Fifty-six male partners answered the questionnaire. The
partners were generally satisfied (85.7%) with their wife’s/
girlfriend’s choice to use misoprostol at home and 66.1%
were very satisfied. Only three partners reported being
dissatisfied with the home-use of misoprostol. Most
partners thought that they had been able to give good
support (72%). A few found it difficult to help and to know
what to do (11%).
4. Discussion
Misoprostol, especially when used orally, is not compli-
cated to administer, and there is no need for monitoring
immediately following administration. Most European pro-
tocols nevertheless require that women stay in the facility
for a 3- to 4-h period of observation after misoprostol
administration. However, the development of a standard
practice of home-use of misoprostol in the USA during the
last years has changed the practice in many countries, while
others remain more skeptical [11,13,15]. In France, the
guidelines recently changed to give the women a free choice
as to where they prefer to take the misoprostol [16]. An
important difference between France (Europe) and the US is
that while women in the US who chose medical abortion
take misoprostol at home according to the standard protocol,
women in France can now choose where they prefer to take
the treatment. Home-use has also proved to be safe and
effective and preferable to many women in countries like
Vietnam and Tunisia [14].
Previous studies have shown the importance to women of
making their own choice for abortion method and have
confirmed the impact of self-determination on acceptability
and satisfaction with the treatment. Therefore, only women
who chose to administer misoprostol at home were included
in the present study and no randomization was performed.
In addition, no comparison group was included as the
objective of the study was not to compare home-use with
clinic-use, but to show women can make the right choice for
themselves.
All women received detailed oral and written information
of what to expect after misoprostol administration. Despite
 C. Fiala et al. / Contraception 70 (2004) 387–392
this, some women used the availability of the telephone
hotline seemingly more often for support or to check the
hotline than for any real medical problems. Home-use
administration proved to be safe. No emergency visits were
made within the 4 h following misoprostol administration
when patients are usually requested to stay in the clinic for
observation. Overall, very few unscheduled visits occurred.
The efficacy rate was 98%, and no ongoing pregnancy
occurred.
Acute hemorrhage, the most serious problem that might
benefit from a 4-h observation period in the clinic, occurs in
less than 1/500 of subjects [17] (and Schaff, personal
communication). Rarely, heavy bleeding can occur due to
incomplete abortion or after a negative ultrasound exami-
nation several weeks after treatment, and therefore, women
should be informed about this possibility. An observation
period of 4 h after misoprostol administration obviously
does not reduce this risk. Although the emotional support
from the staff when misoprostol is administered in the clinic
may be of help for some women, it is not ideal for all
women and is usually not needed from a medical point
of view.
Being at home made most women feel comfortable,
whether they had the support of a partner or friend or
whether they were alone. Previous observations suggest that
women who feel more comfortable and relaxed have a
higher rate of successful medical abortions and could
possibly also reduce the need for pain medication [18]. In
a study in Vietnam and Tunisia, home administration of
misoprostol was compared to hospital administration. In
both countries, efficacy and acceptability were higher
among home users [14].
Obviously, women can make the right decision in a short
time, if they are provided qualified counseling. Only two
patients were negative about home-use of misoprostol, one
because of pain and the other because of heavy bleeding.
These two women reported that they would take misopros-
tol in the clinic in case of another medical abortion. Both
were immigrants from countries where abortion is illegal
(one from Iraq, one from Iran). Differences in cultural
attitudes about menstruation and abortion may have
contributed to the negative experience. The illegality of
abortion in the cultures of origin of these women may also
have been a factor in coping with the situation of having an
abortion at home.
Ninety-eight women said they would take the prosta-
glandin at home in case of a further abortion, and nearly all
of the women also wanted to take mifepristone at home,
since their experience was that mifepristone had practically
no side effects. Only one woman said she preferred to come
to the hospital for mifepristone administration. This had
helped her to make the decision to have an abortion.
Most women seemed to be prepared for the pain and
bleeding and felt calm and safe after treatment. Pain may
also increase with gestations z 50 days [12]. From our own
results, it seemed evident, although this did not reach
391
statistical significance, that women with a duration of
pregnancy less than 42 days required less pain medication.
Most women had previously experienced childbirth. Many
reported spontaneously that this helped in coping with the
pain and bleeding.
In conclusion, our study further confirms the safety,
efficacy and high acceptability of home-use of misoprostol
and suggests that it should become an option. Home-use of
misoprostol allows women more flexibility, privacy and
control in their abortions.
Complications are rare during the initial 4-h period after
misoprostol and do not appear to warrant requiring women
to stay under medical supervision. Detailed counseling and
information and the possibility of getting advice on the
telephone are likely to increase acceptability.
Most women were happy with the support of their
partners or friends. One interesting detail is the high rate of
satisfaction even among the 25% of women who were alone
at home when taking misoprostol. This suggests that being
alone is not necessarily a contraindication for home-use of
misoprostol.
In addition to the choice between medical and surgical
abortion, women who choose medical abortion should be
offered the choice of hospital or home administration of
misoprostol.
Acknowledgments
The authors are grateful to the staff at the SESAM clinic,
Karolinska Hospital, Stockholm, Sweden, for taking excel-
lent care of the patients. The study was supported by grants
from the Population Council and the Swedish Medical
Research Council (0855).
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