International Journal of Gynecology and Obstetrics (2007) 98, 222–226

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

CLINICAL ARTICLE

Comparison of misoprostol and manual vacuum

aspiration for the treatment of incomplete abortion
C. Bique a , M. Ustá a , B. Debora a , E. Chong b,⁎,
E. Westheimer b , B. Winikoff b
a
José Macamo Hospital, Maputo, Mozambique
b
Gynuity Health Projects, New York, NY, USA

Received 19 March 2007; received in revised form 30 April 2007; accepted 2 May 2007

KEYWORDS Abstract
Misoprostol;
Incomplete abortion; Objective: To compare the safety, efficacy, and acceptability of misoprostol versus manual
Mozambique; vacuum aspiration (MVA) for treatment of incomplete abortion in Maputo, Mozambique. Methods:
Miscarriage A total of 270 women with clinically diagnosed incomplete abortions of up to 12 weeks of gestation
were randomized to either 600 μg oral misoprostol or MVA. Women were followed-up seven days
later to evaluate whether the abortion was complete. Results: Success was high for both MVA and
misoprostol groups (100% vs 91%, P = 0.002). Women in the MVA arm reported fewer side effects
but higher pain scores. Women who received misoprostol were significantly more likely to be
“very satisfied” with the treatment and willing to choose the method again. Conclusion: Although
oral misoprostol was less effective than MVA in this study, it was more acceptable to women.
Misoprostol is well-suited for use in low-resource settings, and should be promoted as an option for
the treatment of incomplete abortion.
© 2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.

1. Introduction abortion [1]. Nearly half of induced abortions (19 million)

Early pregnancy failure causes millions of women to seek
emergency medical services. Estimates based on figures for
the year 2000 indicate that of 210 million pregnancies
worldwide, approximately 32 million ended in miscarriage
and stillbirth, and another 46 million ended in induced
⁎ Corresponding author. 15 East 26th St., #1617, NY NY 10010, USA.
Tel.: +1 212 448 1230; fax: +1 212 448 1260.
E-mail address: echong@gynuity.org (E. Chong).
were considered to be unsafe (performed by unskilled
providers or under unhygienic conditions, or both) and
resulted in 67,900 deaths [2]. In Mozambique, abortion is
available only under restricted conditions, thus many women
attempt to terminate their pregnancies clandestinely with
traditional practitioners, and later present to health care
facilities with an incomplete abortion. Under a 1981 decree
from the Ministry of Health, abortion is permitted in
hospitals in cases of endangerment of health and contra-
ceptive failure, and requires a committee to confirm
whether legal grounds exist [3]. Although the decree has

0020-7292/$ – see front matter © 2007 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd.
All rights reserved.
doi:10.1016/j.ijgo.2007.05.003
Comparison of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion
been interpreted liberally in some hospitals (where abortion
services are provided to women who sign a written
statement), access is mostly limited to older, urban, higher
income women [4,5].
A 2002–2003 assessment of abortion-related services in 45
public health facilities across Mozambique found that nearly all
providers of uterine evacuation services used sharp curettage
(98%), and smaller percentages reported the use of manual
vacuum aspiration (51%) or electric vacuum aspiration (20%) in
their facilities [6]. The use of sharp curettage is discouraged by
the World Health Organization (WHO), as it is considerably
more painful for women than vacuum aspiration, and less safe
(rates of major complications are two to three times higher
than those of vacuum aspiration) [7,8]. A growing body of
research has shown that the prostaglandin E1 analogue,
misoprostol, offers a simple and noninvasive alternative to
surgical treatment for early pregnancy failure. In addition,
studies have found that treatment with misoprostol is
considerably more effective than expectant management
after one week [9,10].
Initially registered for the prevention of gastric ulcers
during long-term use of nonsteroidal anti-inflammatory
drugs, misoprostol is now used worldwide for numerous
obstetric or gynecologic indications including induction of
labor, preparation of the cervix for surgical procedures,
prevention or treatment of postpartum hemorrhage, and
pregnancy termination [11]. Previous studies of the effec-
tiveness of misoprostol in evacuating the uterus in cases of
early pregnancy failure have reported a wide range of
success rates, in part due to the type of pregnancy failure
being studied, the duration of the waiting period before the
outcome is assessed, and the criteria of success. Among
studies conducted since 2000 with sample sizes of 100 or
greater, misoprostol completed the abortion process in 46–
96% of participants [9,10,12–19]. The best regimen of
medical management is still under investigation, however
the highest success rates have been achieved using 400 μg
vaginal misoprostol [20], 600 μg vaginal misoprostol with
repeat dose if needed [21], and 600 μg oral misoprostol
[16,17]. Few studies testing the use of misoprostol for
incomplete abortion have been conducted in developing
countries, and even fewer have been carried out in sub-
Saharan Africa [9,17,21,22]. This study was designed to fill a
gap in the literature by testing oral administration of
misoprostol for incomplete abortion, in a hospital setting in
a low-income country with restrictive abortion policies.
2. Materials and methods
The study was conducted at José Macamo Hospital, a medium-
sized tertiary hospital located on the outskirts of Maputo,
Mozambique. A total of 270 women who presented with an
incomplete abortion, and gave their consent, were enrolled in
the study and randomized to receive either 600 μg oral
misoprostol or manual vacuum aspiration (MVA) (the current
surgical standard of care at the hospital). Since ultrasound is not
routinely used in Mozambique and pregnancy tests are not
widely available in government facilities, incomplete abortion
was diagnosed based on past or present history of vaginal
bleeding during pregnancy and an open cervical os. Women were
eligible for the study if they had a confirmed incomplete
223
abortion with uterine size equivalent to no more than 12 weeks
of gestation, were 18 years of age or older, lived or worked
within the hospital's geographic area of coverage, had no known
allergy to misoprostol, no signs of severe infection, and no
hemodynamic disturbance. Ethical approval for this study was
obtained from the Western Institutional Review Board and the
Maputo Health Directorate. The informed consent form was
provided in Portuguese; for those women who were illiterate,
the form was carefully read aloud and explained to the
participant by the nurse investigator. In a few cases the consent
form was explained in the participant's local language for better
understanding.
The randomization scheme was generated by computer and the
treatment allocations printed on cards and inserted into sequen-
tially numbered opaque envelopes. Once a woman's eligibility was
confirmed and the consent form signed, a member of the study
staff opened the next envelope in the sequence and assigned the
woman to the indicated treatment group. Women randomized to
the misoprostol group swallowed the pills in the presence of the
study investigator and remained in the clinic for approximately
one hour of observation. For women randomized to the MVA group,
a nurse-midwife with more than 5 years' experience with the
method performed the MVA approximately 10 min after randomi-
zation. In contrast to similar studies of incomplete abortion in
Uganda and South Africa (which used intramuscular pethidine and
general anesthesia, respectively), women undergoing surgical
evacuation received only verbal anesthesia (as well as kanamycin)
[17,21]. Verbal anesthesia is the current standard practice at the
hospital, as providers have found they are able to reduce women's
anxiety by explaining the procedure thoroughly and by providing
continuous reassurance during the surgery. Paracetamol was
provided as needed for pain management to women in both
groups. Follow-up visits were scheduled for seven days after the
initial visit, and women were given a telephone number at which
they could reach the study investigators with questions or in case
any complications should arise.
Women were asked to return to the hospital after one week
to confirm the status of the abortion. If the abortion was still
incomplete, women were given the option of waiting an
additional week to see if the abortion would complete
spontaneously, or immediately undergo a surgical evacuation.
For those who elected to wait, they were evaluated again seven
days later and, if there was still clinical evidence of substantial
retained products of conception in the uterus, they underwent a
surgical evacuation at that time. Prior to being discharged from
the study, all women answered a series of questions about the
acceptability of the treatment and its side effects. No monetary
compensation was provided to the women, but those who
attended the follow-up visit received a kapulana, a multi-
purpose cloth (worth approximately US $4) that is commonly
used by women in Mozambique.
The primary outcome of interest was the percentage of
women in each treatment arm who experienced a complete
abortion without recourse to additional surgical intervention.
Secondary outcomes of interest included experience of side
effects and acceptability of the treatment. This study was
designed to be a feasibility study as it employed a treatment for
incomplete abortion that was new to Mozambique. The sample
size of 270 was chosen to allow staff to gain expertise in the new
method and to allow comparisons to be drawn between the two
treatments. However, in the process of monitoring the first 20
cases, it was noted that the randomization scheme was not being
224 C. Bique et al.

appropriately followed. Therefore, the process of randomization Table 2 Clinical outcome

and how women were to be assigned to study arms was
Misoprostol MVA P
thoroughly reviewed and the study was re-started. The 23
(n = 123) (n = 124) value
women enrolled prior to the discovery of the randomization error
were excluded from the study analysis, although a review of Lost to follow-up 9.8 (12) 18.5 (23)
these data yielded success rates consistent with that of the full Returned for follow-up 90.2 (111) 81.5 (101) 0.067
study. Success 91.0 (101) 100.0 (101) 0.002
The sample (after excluding the 23 women who were not Failure 9.0 (10) 0.0
randomized) is large enough to detect a 6% or greater decrease in • medically necessary 3.6 (4) 0.0
efficacy with misoprostol, assuming a 99% success rate for MVA after initial treatment
procedures [23] (one-tailed, α = 0.05, β = 0.2). • surgical for patient's 4.5 (5) 0.0
The study forms were completed by staff at the study site and preference
reviewed by the principal investigator for completeness and data • surgical for provider's 0.9 (1) 0.0
quality. Forms were sent to New York, USA and data were entered preference
into SPSS 14.0 (SPSS, Chicago, IL, USA), and all discrepancies were Abbreviations: MVA, manual vacuum aspiration.
resolved by referral to the original study forms. Chi-square tests Values are given as percentage (number) unless otherwise
were used to analyze categorical data, and t tests were used for indicated.
continuous data (also using SPSS).

3. Results completions in the misoprostol group, 5 were at the women's

request, 4 were deemed medically necessary (due to
Between December 2004 and January 2006, 270 women were infection), and 1 was conducted for the provider's conve-
enrolled in the study. As discussed above, 23 women were not nience. Of the 5 women who requested surgical completion,
randomized and were not included in the analysis. A total of 3 decided not to wait an additional week and requested
123 women were randomized to the misoprostol group, and completion at their scheduled follow-up visit once the
124 to the MVA group. Participant characteristics are shown provider determined that their abortion was still incom-
in Table 1. The two groups did not differ significantly on plete. The other two women returned to the clinic 1–2 days
background characteristics; participants had a mean age of after misoprostol administration (before their scheduled
25 years, were predominantly unmarried, and about one out follow-up visit) presenting with heavy bleeding and cramping
of five reported previously having an induced abortion. and requested a surgical completion.
Approximately half of participants told the provider that At the follow-up visit, the provider completed with each
their current abortion was induced, which coincided with woman a table recording the side effects she experienced and
providers' estimates of the proportion of pregnancies that what days she experienced them. Women in the misoprostol
were interfered with.
Thirty-five women were lost to follow-up after the initial
visit, 12 from the misoprostol group and 23 from the MVA
group. Success rates for the misoprostol and MVA groups were Table 3 Side effects reported
91.0% and 100%, respectively (Table 2). Of the 10 surgical
Misoprostol MVA P
(n = 111) (n = 101) value
Side effects reported:
a Heavy bleeding 35.1 (39) 2.0 (2) b 0.001
Table 1 Participant characteristics
Normal bleeding 95.5 (106) 35.6 (36) b 0.001
Misoprostol MVA Spotting 82.9 (92) 93.1 (94) 0.035
(n = 123) (n = 124) Nausea 11.7 (13) 2.0 (2) 0.006
Age, year 25.8 ± 6.0 25.4 ± 6.0 Vomiting 4.5 (5) 0.0 0.061
Education, year 8.0 ± 2.4 7.6 ± 2.7 Pain/cramps 99.1 (110) 100.0 (101) 1.000
Parity 1.5 ± 1.5 1.5 ± 1.5 Fever 25.2 (28) 0.0 b 0.001
Married 21.5 (26) 19.7 (24) Chills 84.7 (94) 0.0 b 0.001
Had previous induced abortion 19.5 (24) 21.0 (26) Woman given 84.4 (92) 98.0 (99) b 0.001
Had previous spontaneous 13.0 (16) 9.7 (12) additional drugs
abortion following procedure
As reported by woman, current 50.4 (62) 49.2 (61) Mean pain score 2.63 4.21 b 0.001
abortion was induced Overall side effects b 0.001
In provider's opinion, woman's 50.4 (62) 53.7 (66) characterized as:
abortion was induced Easily tolerable 85.5 (94) 38.8 (38)
Tolerable 10.0 (11) 61.2 (60)
Abbreviations: MVA, manual vacuum aspiration.
Values are given as mean ± SD or percentage (number) unless
Bad 3.6 (4) 0.0
otherwise indicated. Abbreviations: MVA, manual vacuum aspiration.
a
There are no statistically significant differences between Values are given as percentage (number) unless otherwise
participants in the two groups. indicated.
Comparison of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion 225

Table 4 Satisfaction with treatment method representing no pain at all and the largest representing the
worst pain imaginable. Women were asked to select the circle
Misoprostol MVA P
that best represented the level of pain they felt from the
(n = 111) (n = 101) value
treatment.
Satisfaction with b 0.001 Women were more than twice as likely to express being
treatment: “very satisfied” with misoprostol than with MVA (86.5% vs
Very satisfactory 86.5 (96) 36.6 (37) 36.6%, P b 0.001) (Table 4). More than 90% of women
Satisfactory 9.9 (11) 63.4 (64) receiving misoprostol would choose the method again or
Unsatisfactory 3.6 (4) 0.0 recommend the method to a friend, whereas approximately
Would choose method b 0.001 one-fourth of women in the MVA group were not sure they
again would take either of those actions. When asked to name up
Yes 93.7 (104) 68.0 (68) to two best and worst features of the treatment, most
Not sure 4.5 (5) 24.0 (24) women in the misoprostol group were happy to have avoided
No 1.8 (2) 8.0 (8) surgery (82.0%); common worst features included fever/
Would recommend b 0.001 chills (71.2%) and cramps (64.0%). Women who underwent
method to a friend MVA appreciated the small amount of bleeding involved post-
Yes 93.7 (104) 69.3 (70) procedure (93.1%) and the rapidity of the treatment (98.0%),
Not sure 4.5 (5) 26.7 (27) but disliked most the pain (99.0%) and cramps (64.4%) they
No 1.8 (2) 4.0 (4) experienced.
Best features (asked for
up to 2)
Avoided surgery 82.0 (91) 0.0 4. Discussion
Little pain 12.6 (14) 0.0
Small amount of 36.9 (41) 93.1 (94) This study demonstrates that 600 μg oral misoprostol, while
bleeding slightly less effective than MVA, is nonetheless a highly
Quick treatment 5.4 (6) 98.0 (99) effective treatment for incomplete abortion in a low-
Worst features (asked resource setting. The high success rate of the misoprostol
for up to 2) group is consistent with other studies in low-resource
Pain (related to the 4.5 (5) a 99.0 (100) countries using a 600 μg dose [9,16,17,21]. Despite experi-
MVA procedure) encing more side effects, women receiving misoprostol
Other pain 16.2 (18) 2.0 (2) reported feeling less pain and expressed a higher satisfaction
(abdominal, stomach, with the procedure than those in the MVA group. This
pelvic) sizeable difference in satisfaction between the two groups is
Cramps 64.0 (71) 64.4 (65) not typically found in the literature and it is possible that the
Fever/chills 71.2 (79) 0.0 providers in the study, pleased with the success of this new
Bleeding 27.0 (30) 0.0 technology, may have over-reported women's satisfaction
Nausea/vomiting 4.5 (5) 0.0 with misoprostol.
Abbreviations: MVA, manual vacuum aspiration. Women in the misoprostol group reported experiencing
Values given as percentage (number) unless otherwise indicated. fever and chills at a higher rate than that found in similar
a
These women had a surgical completion after taking studies. This may reflect provider bias — since providers filled
misoprostol. out the table of side effects with the women at the follow-up
visit, perhaps they were more likely to prompt women in the
misoprostol group to recall these symptoms than those in the
group were significantly more likely than women in the MVA MVA group. On the other hand, fever and chills were the most
group to experience the majority of side effects reported, commonly mentioned worst features by women receiving
especially heavy bleeding (35.1% vs 2.0%, P b 0.001), fever misoprostol, so this may not be a spurious finding.
(25.2% vs 0%, P b 0.001), and chills (84.7% vs 0%, P b 0.001) One particularly notable aspect of this study is the
(Table 3). These side effects, in addition to cramping, nausea, extremely limited use of ultrasound. As is the standard
and vomiting, are all known and expected effects of practice in Mozambique, clinical examination is the primary
misoprostol and women are counseled about them. Interest- method of diagnosis, and ultrasound is reserved for cases
ingly, although women in the misoprostol group experienced where there is doubt on the success of the treatment or
a greater number of side effects than the MVA group, they complications that need to be confirmed. While perhaps some
were more likely to characterize these side effects as easily women were incorrectly diagnosed as having an incomplete
tolerable (85.5% vs 38.8%, P b 0.001).While they experienced abortion that required treatment or had a surgical completion
fewer side effects, women in the MVA group experienced that was not necessary, the high success rate in the misoprostol
a greater degree of pain: their reported mean pain score group and the lack of adverse outcomes suggests that the use
was significantly higher (4.2 vs 2.6, P b 0.001), and a higher of misoprostol for treatment of incomplete abortion can be
percentage of women were given additional pain medication safe and effective without use of ultrasound, which is often
following the procedure (98.0% vs 84.4%, P b 0.001). Pain less available in low-resource settings and requires skilled
level was measured with a seven-point Likert scale; a visual providers to conduct the examination.
analog scale was developed by the study team containing The main weakness of the study is the 14% of women who
seven circles of increasing size, with the smallest circle did not return for their follow-up visit. This is somewhat to be
226
expected as the study site was a tertiary-level hospital, and
cultural norms dictate that one visits the hospital only in an
emergency. We can surmise that women did not return because
their treatment was successful, although it is also possible that
they may have sought care elsewhere. There was greater
attrition from the MVA group than the misoprostol group; this
may be attributable to women's assumptions regarding the
effectiveness of surgery, or may reflect women's discomfort
during the treatment and their subsequent reluctance to
return for follow-up care.
From this study it is clear that oral misoprostol offers a
safe and simple alternative to surgical treatment of
incomplete abortion, and is well-suited for use in a country
such as Mozambique. The health system is comprised of many
small primary care facilities dispersed throughout the rural
areas, where more than 70% of the country's population lives.
These small units do not have the capacity or the equipment
to offer manual vacuum aspiration, but with proper training,
could potentially treat incomplete abortions with misopros-
tol. Making this simple and effective treatment widely
available could avert numerous complications and adverse
outcomes experienced by women in these settings who are
often left to seek medical care outside the formal healthcare
system.
As an added incentive, recent analyses indicate that
misoprostol is a less costly option than surgical evacuation
for women presenting with early pregnancy failure [24,25].
Future work should include lobbying the government to
include misoprostol in its essential medicines list, and to
ensure an adequate supply is available across the country.
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