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Middle East Fertility Society Journal (2014) 19, 96101

Middle East Fertility Society

Middle East Fertility Society Journal


www.mefsjournal.org
www.sciencedirect.com

ORIGINAL ARTICLE

Vaginal misoprostol versus vaginal surgical


evacuation of rst trimester incomplete abortion:
Comparative study
Mahmoud Shokry
a
b

a,*

, Mohamed Fathalla a, Mostafa Hussien a, Ashraf A. Eissa

Department of Obstetrics and Gynecology, Womens Health Centre, Faculty of Medicine, Assiut University, Egypt
Department of Radiology, Faculty of Medicine, Bani Sweef University, Egypt

Received 30 October 2012; accepted 9 May 2013


Available online 14 June 2013

KEYWORDS
Incomplete abortion;
Misoprostol;
Surgical vaginal evacuation;
Vaginal bleeding

Abstract Objectives: The aim of this study is to assess the effectiveness and acceptability of using
vaginal misoprostol for management of rst trimester spontaneous incomplete abortion as an alternative to direct vaginal surgical evacuation in our setting.
Methods: This is a prospective comparative study performed on 147 patients with rst trimester
incomplete abortion between 8 and 12 weeks requesting medical management. They were divided
into two groups according to patients choice; group (I) received misoprostol tablet 400 mcg (Cytotec, Serono) every 4 h for a maximum of three doses while group (II) underwent surgical vaginal
evacuation directly under general anesthesia. Only 54 patients in group I and 51 patients in group
II completed their follow up and included in the analysis.
Results: Although vaginal surgical evacuation was successful in solving the problem in 100% of
cases, misoprostol was successful in 79.6% (p = 0.0006). The overall satisfaction was slightly higher
in the surgical group but almost equal percentage of both groups mentioned that they will recommend the method to a friend. No serious side effects or complications were reported in the misoprostol group. The incidence of excessive post-abortive bleeding was more in the misoprostol
group than in the surgical evacuation group (p = 0.0336). Also endometrium using transvaginal
ultrasonography was signicantly thicker in the misoprostol group than in group II (p = 0.0071)
but with no clinical importance as it was not associated with severe vaginal bleeding necessitating
medical or surgical interventions.

* Corresponding author. Address: Department of Obstetrics and


Gynecology, Assiut University, Assiut 71515, Egypt. Tel.: +20 966
501 243 291/114 116 3619.
E-mail address: mshromih@yahoo.com (M. Shokry).
Peer review under responsibility of Middle East Fertility Society.

Production and hosting by Elsevier


1110-5690 2013 Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society.
http://dx.doi.org/10.1016/j.mefs.2013.05.007

Vaginal misoprostol and incomplete abortion

97

Conclusion: Although vaginal surgical evacuation is more effective than misoprostol in solving
the problem still medical treatment is effective and acceptable especially when surgical management
is not available or risky or patients refuse to do surgical management.
2013 Production and hosting by Elsevier B.V. on behalf of Middle East Fertility Society.

1. Introduction
Approximately 1115% of pregnancies end in spontaneous
rst-trimester miscarriage (1). Vaginal surgical evacuation of
retained products of conception (RPOC) was the main stay
of treatment for a long time to reduce complications such as
infection and unscheduled hemorrhage. However, surgical
management may be complicated with infection, uterine perforation or bowel damage (2). This paved way to more recourse
to medical and expectant management. Expectant management for incomplete abortion in the rst trimester after use
of misoprostol or after spontaneous abortion may be practical
and feasible, although it may increase anxiety associated with
the impending abortion (3,4). The available Cochrane systematic review evidence suggests that expectant care as well as
medical treatment with misoprostol are acceptable alternatives
to routine vaginal surgical evacuation (5).
Misoprostol as a thermostable prostaglandin E1 analogue
has been previously tested in the management of incomplete
miscarriage in different regimens and settings (68). Overall results indicate efcacy, effectiveness and acceptability in most
of these studies. Some other studies used the sublingual route
instead of the oral or vaginal route for uterine evacuation after
early pregnancy failure (912).
The aim of this study is to assess the effectiveness and
acceptability of using vaginal misoprostol for management of
rst trimester spontaneous incomplete abortion as an alternative to direct vaginal surgical evacuation in our setting.
2. Patients and methods
2.1. Inclusion and exclusion criteria
This is a prospective comparative study performed in a private
practice with a University afliation during the period from
April 2009 to October 2011. This study included 147 pregnant
women between 8 and 12 week cases requesting medical management for spontaneous rst trimester incomplete abortion.
Patients who are hemodynamically unstable, septic abortion,
fever, bronchial asthma or known hypersensitivity to misoprostol were excluded. All patients signed a written informed
consent before recruitment into the study.
The diagnosis of incomplete abortion was conrmed by
transvaginal ultrasonography examination using a Sono
ACE 9900 Prime Multi-beam 3-D Ultrasound System (Medison, Korea) check for the presence or absence of retained
products of conception. The eligible patients were divided into
two groups according to patients choice; group (I) received
misoprostol tablet 400 mcg (Cytotec, Serono) every 4 h for a
maximum of three doses while group (II) did not receive any
uterotonics and directly underwent vaginal surgical evacuation
under general anesthesia by the standard technique of the hospital. All patients were followed up for the rst 24 h for
abdominal pain scores, vital signs; presence of excessive vagi-

nal bleeding dened as the presence of vaginal bleeding more


than menstrual blood with or without presence of blood clots.
Abdominal pain was treated when necessary by oral ibuprofen,
400 mgm, single oral dose and repeated when needed every 6 h
for a maximum of 2 days.
Patients were observed for the severity of pain and passage
of products of conception per vagina as well as for severity of
vaginal bleeding. Any of the patients who had vaginal bleeding
more than usual was checked by transvaginal ultrasonography. If intrauterine contents other than blood clots were seen,
vaginal evacuation of retained products of conception, under
general anesthesia was performed. If only blood clots and
thickened endometrium >15 mm were noted, oral methylergonovine (methergin tablets, Sandoz Pharmaceuticals) 0.2 mg
was prescribed at a dose of two tablets per day for three successive days. Patients with no excessive bleeding were discharged home 12 h after vaginal surgical evacuation in group
II or after conrming complete uterine emptying using transvaginal ultrasonography in the misoprostol group.
All participants were requested to come for a follow-up visit after one week. The patients were asked about the amount
and duration of vaginal bleeding, fever, pelvic pain (using visual analogue score), or passage of eshy parts per vagina.
They were asked also about their satisfaction for the method
they chose for the management of their condition, whether
they will recommend this method to a friend as well as about
any experienced side effects. Transvaginal ultrasonography
examination was performed to all patients who came for the
follow up visit, to measure the endometrial thickness at the
maximum anteroposterior diameter on the long-axis view of
the uterus. An incomplete abortion is associated with a prominent endometrial echo (thickness greater than 5 mm) round or
oval echogenic intra-cavitary lesion, high-intensity echogenic
foci associated with acoustic shadowing, uid in the uterine
cavity, and is stippled echo pattern (Fig. 1).
Endometrial cavity after complete abortion showed no content with normal thickness (Fig. 2).
2.2. Pain scoring
Pain was assessed during the hospital stay four hourly and
during the follow up visit, visual analogue scoring (VAS)
was used by means of a 10-cm line with verbal anchors saying
no pain at one end and excruciating pain at the other end.
The primary outcome measure was the effectiveness of
misoprostol for completion of evacuation in cases of incomplete abortion. Secondary outcomes included the proportion
of patients reporting severe pain or bleeding within and after
10 days, and the presence of any adverse effects or major complications and patient satisfaction with the method.
2.3. Statistical analysis
Data were statistically described in terms of mean and standard
deviation (SD). Comparison of the studied groups was done

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M. Shokry et al.

Figure 1 An incomplete abortion is associated with a prominent endometrial echo (thickness greater than 5 mm) round or oval
echogenic intra-cavitary lesion, high-intensity echogenic foci associated with acoustic shadowing, uid in the uterine cavity, and is stippled
echo pattern (Fig. 1).

Figure 2

Endometrial cavity after complete abortion showing no content with normal thickness (Fig. 2).

using students t test. Chi square test was used to compare categorical variables. A p-value less than 0.05 was considered statistically signicant. All statistical calculations were performed using
computer programs Microsoft Excel version 7 (Microsoft Corporation, NY, USA) and SPSS version 13 (Statistical Package for
the Social Science; SPSS Inc., Chicago, IL, USA) statistical program. Fig. 3 shows a owchart of study procedure including patients enrollment, allocation, follow up and analysis.
3. Results
Demographic characteristics of both groups were comparable
as regards age (years), height (cms), weight (kgs) body mass in-

dex (BMI, in kg/m2) gestational age at the time of pregnancy


termination in weeks, gravidity, parity as well as number of
primiparous patients. No statistically signicant differences
were recorded between both groups as regards history of previous abortions as shown in (Table 1).
Success of the method of treatment in completely solving
the medical problem was different between the two study
groups (Table 2). Despite that the vaginal surgical evacuation method was successful in solving the medical problem
in 100% of cases, the medical management using misoprostol was successful in 79.6% (p = 0.0006), so it was needed
to have vaginal surgical evacuation in 11 cases of the misoprostol group.

Vaginal misoprostol and incomplete abortion

Figure 3

Table 1

99

A owchart of study procedure including patients enrollment, allocation, follow up and analysis.

Demographic characteristics of the study population.


Misoprostol group (N = 54)

ERPC group (N = 51)

P-value

Age (years)
Height (cm)
Weight (kg)
Body mass index
Gestational age (weeks)
Range (weeks)

26.9 4.6
159.4 5.4
66.4 11.3
25.9 3.6
8.4 1.3
712

27.1 5.4
160.7 4.5
64.8 11.8
25.4 3.2
8.2 1.2
711

0.8938
0.1968
0.4845
0.3623
0.3986

Parity
Primiparous {No. (%)]
Multiparous {No. (%)]
History of previous abortion {No. (%)}

11 (20.4%)
43 (79.6%)
8 (14.8%)

12 (23.5%)
39 (76.5%)
6 (11.8%)

0.6956
0.6956
0.6458

ERPC = Evacuation of retained products of conception.

Patient satisfaction was signicantly higher in the surgical


evacuation group (Table 2). However, almost the same percent
of patients in each group reported they will recommend the

method to a friend. In the meantime the incidence of side effects and tolerability of the method of treatment were comparable in both of the study groups (Table 2).

100
Table 2

M. Shokry et al.
Clinical outcomes of the study groups.

Success of the treatment method


Patient method satisfaction
Patient recommendation to a friend of the treatment method
Incidence of side eects
Tolerability of the method of treatment
Incidence of signicant lower abdominal cramps (within 7 days)
Incidence of excessive post-abortive bleeding
Endometrial thickness (mm) (within 7 days) [Mean (SD)]

Misoprostol group
(N = 54) {No. (%)}

ERPC group
(N = 51) {No. (%)}

p-value

43 (79.6%)
46 (85.2%)
42 (77.8%)
11 (20.4%)
46 (85.2%)
5 (9.3%)
7 (12.96%)
8.43 0.49

51 (100%)
47 (92.2%)
43 (84.3%)
6 (11.8%)
45 (88.2%)
3 (5.9%)
1 (1.96%)
6.03 0.39

0.0006
0.2617
0.3939
0.2315
0.6458
0.5144
0.0336
0.0071

ERPC = Evacuation of retained products of conception.

The incidence of excessive post-abortive bleeding dened as


bleeding anytime more than menstrual bleeding was more in
the misoprostol group than in the surgical evacuation group
(p = 0.0336). Also endometrial thickness using transvaginal
ultrasonography was signicantly thick in the misoprostol
group than in group II (p = 0.0071).
Regarding pain scores, both groups were comparable
regarding pain score at their rst presentation to the clinic.
Both groups were comparable regarding their complaint of signicant painful lower abdominal cramps (VAS score >4) during their follow up visit one week after discharge (p = 0.514)
(Table 2).
4. Discussion
In this study, we compared the effectiveness of vaginal misoprostol 400 mcg (Cytotec, Serono) every 4 h for a maximum
of three doses versus direct vaginal surgical evacuation of
spontaneous rst trimester incomplete abortion in a population that is more familiar with surgical evacuation. Misoprostol was comparable regarding effectiveness. The overall
satisfaction was slightly higher in the surgical group but equal
percentage of both groups mentioned that they will recommend the method to a friend. No serious side effects or complications were reported in the misoprostol group. Also, there
was no difference in post abortive endometrial thickness or
prolonged bleeding but more women in the misoprostol group
reported heavy bleeding.
We tested the effectiveness of misoprostol to ensure complete evacuation of the uterine contents and to lessen the need
for vaginal surgical evacuation in cases of incomplete abortion.
The use of misoprostol to facilitate complete uterine expulsion
of products of conception was mentioned repeatedly in the literature either to ripen the cervix facilitating manual vacuum
aspiration (13) or to help complete expulsion of the retained
intrauterine conception products.
Home self-administration of doses as small as 400 mcg sublingually was feasible and acceptable for medical abortion up
to 56 days gestation (14). The high efcacy, safety, and acceptability of 400-lg sublingual misoprostol indicate that it is an
alternative to surgery for incomplete abortion. Hence, misoprostol might improve post-abortion care when surgical treatment is unavailable (15).
The side effects reported in our study were transient and
tolerable, which agrees with ndings of other studies. It was reported that cramping usually starts within the rst few hours

after misoprostol administration (16). Pain scores, 6 and 24 h


after evacuation, were signicantly higher among misoprostol
patients compared to controls. Severe abdominal pain was recorded when administering misoprostol for pregnancy termination in the late rst and early second trimesters (17,18)
and consequently signicantly higher analgesia requirement
in women who require increased number of misoprostol doses.
Our results are also in agreement with the results of Neilson
and colleagues 2010; who reported that the administration of
misoprostol to women with incomplete abortion appears to
be safe and can avoid vaginal surgical evacuation in 80% of
cases. It was also considered as an acceptable choice by a subset of women. However, women should be given proper analgesia and advice about possible occurrence of more than
average bleeding. Given the availability of health service resources to support all expectant, medical and surgical management of spontaneous rst trimester incomplete abortions,
women experiencing miscarriage at less than 13 weeks should
be offered these three choices (5).
5. Conclusion
Although vaginal surgical evacuation is more effective than
misoprostol in solving the problem still medical treatment is
effective and acceptable especially when surgical management
is not available or risky or patients refuse to undergo surgical
management.
6. Conicts of interest
None.
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