International Journal of Gynecology and Obstetrics 111 (2010) 131–135

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International Journal of Gynecology and Obstetrics

j o u r n a l h o m e p a g e : w w w. e l s ev i e r. c o m / l o c a t e / i j g o

CLINICAL ARTICLE

A randomized controlled trial of 400-μg sublingual misoprostol versus manual

vacuum aspiration for the treatment of incomplete abortion in two Egyptian hospitals☆
Rasha Dabash a,⁎, Mohamed Cherine Ramadan b, Emad Darwish c, Nevine Hassanein d,
Jennifer Blum a, Beverly Winikoff a
a
Gynuity Health Projects, New York, USA
b
El Galaa Teaching Hospital, Cairo, Egypt
c
Alexandria University Faculty of Medicine/Shatby Maternity Hospital, Alexandria, Egypt
d
Public Health Consultant, Cairo, Egypt

a r t i c l e i n f o a b s t r a c t

Article history: Objective: To compare the safety, efficacy, and acceptability of 400-μg sublingual misoprostol with that of
Received 15 March 2010 manual vacuum aspiration (MVA) in 2 Egyptian hospitals. Methods: Participating women were randomized
Received in revised form 2 June 2010 to either MVA or misoprostol treatment for incomplete abortion. The primary outcome, complete uterine
Accepted 20 July 2010 evacuation, was determined 1 week later, as were adverse effects, change in hemoglobin, acceptability, and
satisfaction. Results: Complete uterine evacuation was achieved in 98.3% of women who received misoprostol
Keywords:
and 99.7% who underwent MVA (relative risk [RR] 0.99; 95% confidence interval [CI], 0.97–1.00). A decrease
Hemoglobin
Incomplete abortion
in hemoglobin of 2 g/dL or more was comparably rare in the 2 groups (0.3% misoprostol vs 0.9% MVA;
Manual vacuum aspiration RR 0.34 [95% CI, 0.04–3.21]). Mean change in hemoglobin was also clinically similar (–0.5 g/dL misoprostol
Misoprostol vs –0.4 g/dL MVA; P b 0.01). Heavy bleeding was rare (2.4% misoprostol vs 1.6% MVA; RR 1.55 [95% CI, 0.51–
Post-abortion care 4.68]) following treatment. Nearly all women (96.8% misoprostol vs 98.3% MVA) were satisfied with their
treatment but those who received misoprostol were significantly more likely to prefer that method in the
future (81.9% vs 62.8%; RR 1.30 [95% CI, 1.19–1.43]). Conclusion: The high efficacy, safety, and acceptability of
400-μg sublingual misoprostol indicate that it is analogous to surgery as a first-line treatment for incomplete
abortion. Misoprostol might improve post-abortion care when resources are limited and surgical treatment
is unavailable.
© 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction
The prostaglandin E1 analog misoprostol is inexpensive, widely
available, and easy to store and use. Its strong uterotonic and cervical-
ripening qualities have made it an accepted and widely used treat-
ment for several reproductive health indications, including cervical
ripening, labor induction, and incomplete abortion/failed pregnancy
[1,2]. Misoprostol is an effective alternative to surgical evacuation for
incomplete abortion [3–18], which is one of the most common clinical
presentations of failed pregnancy in low-income countries.
A single dose of 600-μg oral misoprostol effectively evacuates the
uterus following incomplete abortion in 91%–99% of cases [14–18].
One study also showed that a dose of 400 μg administered sublingually
is as effective and is associated with comparable adverse effects [19]. In
2009, after reviewing data regarding its use for incomplete and
☆ Clinicaltrial.gov registration number: NCT00466999.
⁎ Corresponding author. 15 East 26th Street, No. 801, New York, NY 10010, USA.
Tel.: + 1 212 448 1230.
E-mail address: rdabash@gynuity.org (R. Dabash).
spontaneous abortion, the WHO added misoprostol to its Model List of
Essential Medicines for this indication—noting that, in addition to
being as effective as surgery, misoprostol “in some settings may be
safer as well as cheaper” [20].
In 1995, a study of Egyptian hospitals showed that post-abortion
cases comprised one-fifth of hospital admissions and consumed sub-
stantial resources [21]. Egypt subsequently became one of the first
countries in the region to introduce manual vacuum aspiration (MVA)
as an outpatient service in lieu of dilatation and curettage under general
anesthesia. Manual vacuum aspiration was piloted in selected tertiary
hospitals and later expanded to additional hospitals throughout the
country. Its introduction was an important step toward making post-
abortion care safer, more accessible, and potentially more cost-effective.
Nonetheless, more than a decade after its introduction, access to MVA
and post-abortion care services remains highly centralized and limited
to select hospital sites.
The aim of the present introductory study was to examine the
safety, efficacy, and acceptability of 400-μg sublingual misoprostol
compared with MVA in 2 hospitals to understand the potential role of
misoprostol as a first-line treatment for incomplete abortion in Egypt.

0020-7292/$ – see front matter © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
doi:10.1016/j.ijgo.2010.06.021
132 R. Dabash et al. / International Journal of Gynecology and Obstetrics 111 (2010) 131–135
2. Materials and methods
Between February 7, 2007, and October 28, 2008, women pre-
senting with an incomplete abortion and a maximum uterine size of
12 weeks of gestation were screened for eligibility at 2 large tertiary
hospitals in Egypt: El Galaa Teaching Hospital, Cairo; and Shatby
Maternity Hospital, Alexandria. Incomplete abortion was defined by
an open cervical os confirmed by clinical examination, with either
past or present history of vaginal bleeding, or evidence of retained
products of conception if ultrasound was performed. Women were
included if they were at least 21 years of age, lived or worked within
1 hour of the hospital, and agreed to provide contact information
and return for follow-up. Exclusion criteria were as follows: known
allergy to prostaglandins; symptoms of possible ectopic pregnancy;
signs of hemodynamic instability; and signs of infection requiring
immediate intervention.
Women consented via signature or thumbprint after information
was provided verbally and in writing by study staff. Women's baseline
hemoglobin (Hb) was measured instantly, using a Hemocue device
(Hemocue, Ängelholm, Sweden). Participants were then randomly
assigned to either MVA or 400-μg sublingual misoprostol. Randomi-
zation was based on a computer-generated sequence in blocks of
10; the sequence was prepared by Gynuity staff in New York using
sequentially numbered envelopes, which were opened by providers
following enrollment.
Participants randomized to the misoprostol group received 2 200-μg
misoprostol tablets (Misotac, Sigma Pharmaceuticals, Egypt) to hold
under the tongue for 20 minutes, after which they were instructed to
swallow any remnants. Those in the surgery group underwent MVA—
the standard surgical treatment in both hospitals. Pain management
practices with MVA depended on provider preference, ranging from
verbal anesthesia only to general anesthesia. Women in both groups
were also provided with 500-mg paracetamol tablets to take, as needed,
for pain and cramping. Following treatment administration, women in
the misoprostol group were discharged at the provider's discretion,
usually within 1 hour. Discharge following MVA treatment was variable
and largely dependent on standard hospital procedure. Antibiotics were
prescribed only if there were signs of potential infection. Information,
including what should be expected following treatment and signs of
possible complications requiring immediate hospital care, was given to
all women. Before discharge, family-planning options were discussed,
and all women were scheduled for a 1-week follow-up visit and given a
study card to record adverse effects experienced at home.
The primary outcome was complete evacuation of the uterus
without recourse to surgical intervention for any reason following
initial study treatment. Secondary outcomes were a clinically sig-
nificant change (at least 2 g/dL) in Hb following treatment, adverse
effects, satisfaction, and acceptability. A sample of 668 women was
required to detect a 1-sided difference (α = 0.05, β = 0.2) of 4% or
more, assuming a 98% efficacy with MVA. The sample was increased
by approximately 5% to account for possible loss to follow-up.
Treatment outcomes were determined at follow-up. Abortion
status was assessed from clinical history and examination, in addition
to vaginal ultrasound when necessary. Women with a closed cervical
os and no signs of an incomplete abortion were deemed to have
undergone successful treatment and were discharged from the study
after a brief interview and a follow-up Hb measurement. Women with
signs of retained products of conception and no signs of complication
were given the option of waiting an additional week before surgical
evacuation. If the abortion was still not complete 1 week later, women
underwent immediate surgical completion.
Women were encouraged to call the study hotline or return to the
hospital if they experienced any signs of complication, as discussed in
counseling. Those who failed to return for follow-up were contacted
via telephone to reschedule their appointments. Women who were
reachable by telephone but not willing or able to return to the hospital
provided most of their follow-up data by telephone. To offset the
cost of travel for the additional study visit, women received 20 LE
(approximately US $4) at their follow-up visit.
Data were collected via study forms by trained physicians, nurses,
and social workers and were reviewed on-site by site investigators and
study coordinators before entry into SPSS version 14.0 (SPSS, Chicago,
IL, USA). Data were periodically queried by Gynuity staff, who also
conducted periodic monitoring visits to assess study progress and
protocol compliance. The research protocol was approved by the
appropriate ethics committees at both sites. Data from study sites were
merged, cleaned, and analyzed on an intention-to-treat basis. χ2 tests
or t tests were used, as appropriate, to compare outcome measures.
P b 0.05 was considered to be statistically significant.
3. Results
In total, 700 eligible women were assessed, of whom 697 were
enrolled and randomized to a treatment group (Fig. 1). The 2 groups
did not differ statistically with regard to background characteristics
(Table 1). Few women were suspected to have interfered with their
current pregnancy: 2.0% in the misoprostol group and 2.3% in the MVA
group (relative risk [RR] 0.8; 95% confidence interval [CI], 0.32–2.38).
Ultrasound was used before randomization to confirm the diagnosis
of incomplete abortion in approximately one-third of women (30.4%
misoprostol vs 27.6% MVA; RR 1.10 [95% CI, 0.87–1.39]). All women
received treatment as allocated, with no reports of problems in
randomization or treatment administration. Outcome data were noted
and analyzed for all participants, with the exception of 2 women (1 in
each study group) who were lost to follow-up. Treatment outcomes
were assessed via telephone for 13 women in the misoprostol group and
10 in the MVA group.
Both methods were highly effective at treating incomplete abor-
tion (98.3% misoprostol vs 99.7% MVA; RR 0.99 [95% CI, 0.97–1.00])
(Table 2). Treatment success was determined 1 week after treatment,
except for 11 (3.2%) women who opted for an extended follow-up
visit after presenting with signs of continued incomplete abortion.
Providers opted for ultrasound use in approximately one-fifth of
cases, with recourse to ultrasound slightly more likely in women
treated with misoprostol (21.6% misoprostol vs 15.2% MVA; RR 1.42
[95% CI, 1.03–1.97]).
One woman allocated to the MVA group underwent a second
surgical evacuation at a private clinic following persistent pain and
bleeding. The 6 failures in the misoprostol group comprised 2 women
who underwent surgical evacuation following persistent heavy bleed-
ing, 3 women with evidence of retained products of conception at
follow-up, and 1 woman who underwent surgical evacuation within a
few hours of misoprostol administration (owing to light–moderate
bleeding) by a provider unfamiliar with the method and study protocol.
Treatment for incomplete abortion rarely resulted in a clinically
significant decrease in Hb. One (0.3%) of the participants in the
misoprostol group and 3 (0.9%) in the MVA group experienced a
decrease of at least 2 g/dL. The mean change in Hb following
treatment was significantly higher in the misoprostol group (–0.50
vs –0.39 g/dL; P b 0.01), although it was clinically negligible. Heavy
bleeding (compared with normal menses) was infrequently reported
and transient (Table 3). Women treated with misoprostol were more
likely to report normal (menses-like) bleeding following treatment
(62.7% misoprostol vs 48.4% MVA; RR 1.29 [95% CI, 1.12–1.49]) and for
slightly longer (2.26 days misoprostol vs 1.52 days MVA; P b 0.01).
Approximately 90% of women in both groups reported light bleeding
(RR 0.96 [95% CI, 0.91–1.01]), which was slightly more persistent in
the misoprostol group (3.23 vs 2.73 days; P b 0.01).
Pain and/or cramps lasting approximately 2.5 days were reported
by most women (87.8% misoprostol vs 75.9% MVA; RR 1.16 [95% CI,
1.07–1.24]). The medication provided during and after treatment was
viewed as adequate by 89.4% in the misoprostol group and 84.4% in
 R. Dabash et al. / International Journal of Gynecology and Obstetrics 111 (2010) 131–135 133

Fig. 1. Flow of study participants.

the MVA group (P = 0.06). Women treated with misoprostol and
given only paracetamol were almost twice as likely to report that their
pain was less than expected (83.0% misoprostol vs 42.4% MVA;
RR 1.96 [95% CI, 1.72–2.24]). Based on provider preference, various
pain control measures were used in the MVA group. The majority of
women (67%) received only a sedative (diazepam) before the
procedure, whereas 26% received verbal or no anesthesia. General
anesthesia was used for 7% of women in the MVA group, and only 1
woman received local anesthesia.
Fever and chills were experienced by 28.4% and 21.4% of women,
respectively, in the misoprostol group, compared with 5.1% and 2.2%,
respectively, in the MVA group. Other adverse effects such as vomiting/
nausea were also significantly more common in the misoprostol
group (Table 3). All reported adverse effects were transient and well
tolerated by the vast majority of women (approximately 98% of women
in each group). Despite the greater likelihood of some adverse effects,
women in the misoprostol group were more than twice as likely as
women in the MVA group to describe the adverse effects experienced
as easily tolerable (27.3% vs 11.0%; RR 2.49 [95% CI, 1.76–3.51]).
Satisfaction was high in both groups (Table 4); however,
significantly more women in the misoprostol group stated that they
would opt for the same treatment again and would recommend it to a
friend. In terms of the best features of the treatment received, women
in the misoprostol group listed the avoidance of surgery, hospitali-
zation, and anesthesia; commonly cited worst features included

Table 1
Participant characteristics.a,b Table 2
Efficacy and change in hemoglobin.a
Misoprostol Manual vacuum aspiration
(n = 349) (n = 348) Misoprostol Manual vacuum Relative risk P value
aspiration (95% confidence
Age, y 28 ± 6 28 ± 6
interval)
Married 348 (99.7) 347 (99.7)
Education, y 7.7 ± 4.4 8.1 ± 3.9 Efficacy n = 348 n = 347
Parity 1.5 ± 1.6 1.6 ± 1.6 Success 342 (98.3) 346 (99.7) 0.99 (0.97–1.00)
Previous spontaneous abortion 131 (37.5) 108 (31.0) Hemoglobin n = 335 n = 337
Previous induced abortion 7 (2.0) 7 (2.0) Post-treatment 10.4 (7.8–13.4) 10.4 (6.7–14.0) – 0.99
Provider suspicion that woman 7 (2.0) 8 (2.3) Hemoglobin
interfered with pregnancy Change, g/dL –0.5 (0.0–2.3) –0.4 (0.0–3.0) – b 0.01
Pre-treatment hemoglobin 10.9 (7.8–14.0) 10.8 (7.0–14.3) Decrease ≥2 g/dL 1 (0.3) 3 (0.9) 0.34 (0.04–3.21)
a a
Values are given as mean ± SD, number (percentage), or mean (range). Values are given as number (percentage) or mean (range) unless otherwise
b
None of the characteristics were significantly different. indicated.
134 R. Dabash et al. / International Journal of Gynecology and Obstetrics 111 (2010) 131–135

Table 3 bleeding and adverse effects. Many women who underwent MVA
Adverse effects following treatment.a appreciated that it was a quick outpatient procedure; the potential
Misoprostol Manual vacuum Relative risk (95% P value assurance of a full “cleaning” or evacuation with MVA was also
aspiration confidence interval) frequently cited. However, the predominant worst features in this
Adverse effect n = 327 n = 316 group were the invasive nature of the treatment and the perceived
Heavy bleedingb 8 (2.4) 5 (1.6) 1.55 (0.51–4.68) potential for complications.
Mean days 1.13 1.40 – 0.54
Normal bleedingb 205 (62.7) 153 (48.4) 1.29 (1.12–1.49)
Mean days 2.26 1.52 – b0.01
4. Discussion
Light bleeding b 292 (89.3) 294 (93.0) 0.96 (0.91–1.01)
Mean days 3.23 2.73 – b0.01
Pain/cramps 287 (87.8) 240 (75.9) 1.16 (1.07–1.24) The present study demonstrated that 400-μg sublingual miso-
Mean days 2.63 2.63 – 0.98 prostol is as safe, effective, and acceptable as MVA as a first-line
Nausea 132 (40.4) 83 (26.3) 1.54 (1.22–1.93) treatment for incomplete abortion, which is consistent with results
Mean days 1.21 1.18 – 0.60
from a study showing this lower dose regimen to be comparable to
Fever 93 (28.4) 16 (5.1) 5.62 (3.38–9.33)
Mean days 1.25 1.44 – 0.18 600-μg oral misoprostol [19]. Apart from the small percentage (1.7%
Chills 70 (21.4) 7 (2.2) 9.66 (4.51–20.69) misoprostol/0.3% MVA) of women who underwent surgical evacua-
Mean days 1.24 1.00 – b0.01 tion for persistent incomplete abortion, no additional interventions
Vomiting 32 (9.8) 17 (5.4) 1.82 (1.03–3.21)
were needed following either initial treatment.
Mean days 1.13 1.06 – 0.43
The adverse effects noted by women were transient, well tolerated,
Pain experienced n = 346 n = 335 and easily managed—regardless of treatment group—which mirrors
More than 7 (2.0) 5 (1.5) 1.37 (0.44–4.28) findings from other comparative studies of misoprostol and surgical
expected evacuation for incomplete abortion [14–17]. Similar studies com-
Same as expected 50 (14.5) 183 (54.6) 0.26 (0.20–0.35)
paring medical and surgical treatment for incomplete abortion
Less than 289 (83.5) 147 (43.9) 1.90 (1.67–2.17)
expected documented that bleeding was generally more persistent and
pronounced following misoprostol use [18]. In the present study,
Pain management n = 348 n = 347 “normal” bleeding and spotting lasted longer in the misoprostol group,
Pain control/ 311 (89.4) 293 (84.4) 0.06
but heavy bleeding was rarely reported.
medication
adequate
In a study of bleeding after a range of early-pregnancy failures
among women in the USA, misoprostol treatment—compared with
Tolerability n = 343 n = 341 curettage—was associated with a greater decrease in Hb concentration
Very difficult 0 (0.0) 1 (0.3) – 0.50 and more chance of a clinically significant change (at least 2 g/dL),
Difficult 6 (1.7) 5 (1.4) 1.19 (0.37–3.87)
although women rarely required additional intervention [22]. One
Tolerable 242 (70.6) 297 (87.1) 0.81 (0.75–0.88)
Easily tolerable 95 (27.7) 38 (11.2) 2.49 (1.76–3.51) of the limitations of that study was that few women with incomplete
a
abortion were included, making the assessment of bleeding outcome
Values are given as number (percentage) unless otherwise indicated.
b
Compared with normal menses.
in this specific group more difficult. In the present study of women
with incomplete abortion in a general population in which anemia is

Table 4
Acceptability and satisfaction.a

Misoprostol Manual vacuum aspiration Relative risk P value

(95% confidence interval)

Overall satisfaction with method n = 348 n = 347

Satisfied/very satisfied 337 (96.8) 341 (98.3) 0.99 (0.96–1.01)
Unsatisfied/very unsatisfied 11 (3.2) 6 (1.7) 1.83 (0.68–4.89)
Would choose the same method again in future 285 (81.9) 218 (62.8) 1.30 (1.19–1.43)
Would recommend to a friend 283 (81.3) 212 (61.1) 1.33 (1.21–1.47)
Best featuresb n = 347 n = 345
Avoids surgery/hospitalization 314 (90.5) 104 (30.1) 3.00 (2.55–3.54)
Avoids anesthesia 126 (36.3) 8 (2.3) 15.66 (7.78–31.50)
Good “cleaning” 0 (0.0) 94 (27.2) – b0.01
Few adverse effects 76 (21.9) 90 (26.1) 0.84 (0.64–1.10)
Fast 91 (26.3) 175 (50.7) 0.52 (0.42–0.63)
Safe, simple, easy 39 (11.2) 33 (9.6) 1.18 (0.76–1.82)
Effective method 1 (0.3) 81 (23.5) 0.01 (0.00–0.09)
Other 0 (0.0) 6 (1.7)c – 0.02
Worst featuresb n = 345 n = 346
Invasive/complicated 1 (0.3) 242 (69.9) 0.00 (0.00–0.03)
Pain 117 (33.9) 55 (15.9) 2.13 (1.61–2.83)
Bleeding 66 (19.1) 16 (4.6) 4.14 (2.42–7.00)
Other adverse effects 72 (20.9) 48 (13.9) 1.50 (1.08–2.10)
Uncertainty/fear of method failure 49 (14.2) 2 (0.6) 24.57 (6.02–100.24)
Other 1 (0.3)d 4 (1.2)e 0.25 (0.03–2.23)
a
Values are given as number (percentage) unless otherwise indicated.
b
Women were asked to note the 2 best and 2 worst features.
c
Relief from pain; no follow-up needed; familiar treatment.
d
Too fast.
e
Fear/anxiety; loss of pregnancy.
 R. Dabash et al. / International Journal of Gynecology and Obstetrics 111 (2010) 131–135
prevalent [23], the likelihood of a clinically significant decrease in
Hb (at least 2 g/dL) following either treatment was extremely low
(less than 1%). Moreover, despite the ease of access to blood products
in both of the tertiary facilities in the present study, no blood trans-
fusions were required.
Because the present study was conducted in 2 facilities with
significant experience of providing post-abortion care, the findings
are limited in their generalizability to other settings, particularly
lower-level facilities—where currently access to postabortion care
services is limited or non-existent. In these settings misoprostol
would probably have its greatest impact. Future operations research
will be crucial for assessing both the programmatic feasibility of
providing this simple technology at lower levels of the healthcare
system and its role in expanding access to care.
The cost-effectiveness of misoprostol for post-abortion care is
likely to be an important component in limited-resource settings.
From the perspective of cost and practicality, the administration of
a 2-pill sublingual regimen may be preferable to an equally effective
3-pill oral regimen in some settings: for example, where misoprostol
is expensive or inaccessible. In Egypt, where there are several com-
mercially available misoprostol products [24], the drug is widely
available and inexpensive (2 pills cost approximately US $0.37). In
this context, the cost of either a 600-μg oral regimen or a 400-μg
sublingual regimen of misoprostol seems negligible compared with
the costs associated with surgery, including both specialized equip-
ment and trained providers.
Finally, innovations to simplify treatment services further should
be explored. For example, as is common in standard clinical practice,
some women in the present study did not return for follow-up visits,
opting instead to provide the necessary information to providers
by telephone. Future research should explore the feasibility of
alternatives to routine clinic visits for follow-up, including the use
of clinical algorithms of essential data obtained via telephone or
text messaging. Such innovations could reduce the number of visits
required by most women, and may further reduce cost and improve
women's satisfaction.
Acknowledgment
The study was funded by a grant from the David and Lucille
Packard Foundation.
Conflict of interest
The authors have no conflicts of interest.
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