European Journal of Obstetrics & Gynecology and Reproductive Biology 201 (2016) 151–155

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European Journal of Obstetrics & Gynecology and

Reproductive Biology
journal homepage: www.elsevier.com/locate/ejogrb

Mifepristone and misoprostol for cervical ripening in surgical abortion

between 12 and 14 weeks of gestation: a randomized controlled trial
Alexandra Ohannessian a, Karine Baumstarck b, Julia Maruani a, Emmanuelle Cohen-Solal a,
Pascal Auquier b, Aubert Agostini a,*
a
Department of Gynecology and Obstetrics, La Conception Hospital, 147 boulevard Baille, 13005 Marseille, France
b
Department of Public Health, Self-perceived Health Assessment Research Unit, Aix-Marseille University, 27 boulevard Jean Moulin, 13005 Marseille, France

A R T I C L E I N F O A B S T R A C T

Article history: Objective: Misoprostol and mifepristone are the two substances recommended for cervical preparation
Received 17 February 2016 during first-trimester surgical abortions to decrease intraoperative bleeding and complications. The
Received in revised form 29 March 2016 objective of the study was to evaluate whether the combination of mifepristone and misoprostol for
Accepted 2 April 2016
cervical preparation in an elective surgical abortion between 12 and 14 weeks of gestation can reduce
blood loss in comparison to misoprostol or mifepristone alone.
Keywords: Study design: A randomized controlled trial was performed in Marseille, France between May 2013 and
Abortion
May 2014. Women requesting a surgical abortion under general anesthesia between 12 and 14 weeks of
Cervical priming
Mifepristone
gestation were 198, randomized into three groups: one received 400 mg oral misoprostol 3 h before
Misoprostol surgery, one 200 mg oral mifepristone 36 h before surgery, and the other, both treatments. The main
Termination of pregnancy outcome was the quantity of intraoperative bleeding. The secondary outcomes were duration of
intervention, ease of dilatation, and complications.
Results: The quantity of intraoperative bleeding differed significantly between the groups (p = 0.001):
222  64 mL in the combination group, 329  129 mL in the misoprostol group, and 276  119 mL in the
mifepristone group. The combination was associated with a shorter operative duration (p = 0.001): 5  2 min
in the combination group, 7  5 min in the misoprostol group, and 7  3 min in the mifepristone group. A
hemorrhage was observed for 5 of 55 women (9%) in the combination group, 13 of 51 (25%) in the misoprostol
group, and 9 of 56 (16%) in the mifepristone group (p = 0.08). No cervical laceration or uterine perforation was
reported.
Conclusions: The combination of mifepristone and misoprostol in cervical preparation for elective
surgical abortions between 12 and 14 weeks of gestation significantly reduced blood loss in comparison
to misoprostol or mifepristone alone.
ß 2016 Elsevier Ireland Ltd. All rights reserved.

Introduction dilatation is the source of the principal complications of abortions:

Elective abortions are an international public health issue, with
one in five pregnancies worldwide resulting in the decision to
terminate [1]. In 2008, 43.8 million elective abortions were
performed worldwide, for a mean of 28 per 1000 women aged
15–44 years, with nearly 8.5 million complications [1]. These
complications can be life-threatening and are responsible for 13% of
the annual international maternal mortality [1]. Surgical abortion
requires mechanical dilatation of the uterine cervix. This cervical
* Corresponding author. Tel.: +33 610568052.
E-mail address: aubert.agostini@ap-hm.fr (A. Agostini).
cervical laceration (0.1–0.6%), uterine perforation (0.1–2.3%), includ-
ing the risk of wounding adjoining organs (bladder, vessels, or
rectum), severe hemorrhage (0.1–0.4%), and finally the long-term
risks of cervical incompetence, late miscarriage, and preterm delivery
[2–5]. On the other hand, inadequate cervical dilatation at the
moment of aspiration can cause other short-term complications:
ongoing pregnancy and infection that can affect fertility [2]. Cervical
preparation has shown benefits in terms of cervical dilatation and
reduction of intraoperative bleeding, as well as a reduction in the
incidence of complications [6–9]. Misoprostol and mifepristone are
the two substances recommended for cervical preparation during the
first trimester [6–13]. Nonetheless, the benefit of combining both
drugs during the first trimester has not been assessed.

http://dx.doi.org/10.1016/j.ejogrb.2016.04.007
0301-2115/ß 2016 Elsevier Ireland Ltd. All rights reserved.
152 A. Ohannessian et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 201 (2016) 151–155
The primary objective of this study was to compare the
effectiveness, assessed by intraoperative blood loss, of misoprostol,
mifepristone, and the combination of the two treatments, in
cervical preparation for elective surgical abortions between 12 and
14 weeks of gestation. The secondary objectives were to compare
the 3 treatment strategies in terms of duration of intervention, ease
of dilatation, satisfaction regarding the procedure, women’s
anxiety and perioperative experience, and complications.
Materials and methods
This study was a single-center randomized, controlled, single
(physician)-blinded trial conducted at the Conception University
Hospital Centre in Marseille in France, in 3 parallel groups: the
combination group, receiving a combination of mifepristone and
misoprostol, the misoprostol group, and the mifepristone group.
The inclusion criteria were: women aged 18 years or older,
requesting an elective abortion under general anesthesia for an
intrauterine singleton pregnancy between 12 and 14 weeks of
gestation (from last menstrual period) on the procedure date and
who provided written informed consent.
The exclusion criteria were women with a uterine malforma-
tion, coagulation disorders defined by laboratory indicators
(prothrombin time <70%, patient/control ratio for activated
clotting time >1.20), known allergy or hypersensitivity to one of
the active substances or excipients of either mifepristone or
misoprostol or a contraindication to its use, lack of health
insurance (in accordance with the French law), or refusal to
provide informed consent.
Secondary exclusion criteria were: failure to perform the
intervention (continuing the pregnancy, spontaneous abortion
before taking the medication), and inability to receive general
anesthesia the day of the abortion (not fasting, desire to change
anesthesia modality, and an intercurrent disease).
Pregnancies were dated by ultrasound measurement of the
craniocaudal length according to the French guidelines. It was
expected to range between 55 and 84 mm on the day of the
abortion [14].
Computer-generated randomized lists were drawn up before
the beginning of the study with a permuted randomization scheme
(block size: 6, randomization ratio [1:1:1]). After the written
consent was signed, women were randomly assigned to one of the
3 treatment groups. To ensure blinding, the treating medical staff
and investigators were unaware of the allocation. Only the
pharmacist delivering the treatments and the women knew the
allocation.
In the combination group, patients were given 200 mg of oral
mifepristone to take 36 h before the procedure, and 400 mg of oral
misoprostol to take 3 h before the procedure. Women in the
misoprostol group received 400 mg of oral misoprostol to take 3 h
before the procedure, and those in the mifepristone group 200 mg
of oral mifepristone to take 36 h before the procedure.
The abortion was performed under general anesthesia according
to standard clinical practice at this gestational age. After asepsis of
the vulva and vagina, the operator used a Pozzi tenaculum to grasp
the cervix and measure the spontaneous cervical dilatation.
Supplemental mechanical cervical dilatation was then performed
with Hegar dilators, with the size increasing in increments of
0.5 mm, up to dilator number 14 when possible. The amniotic sac
was systematically breakthrough with the last dilator, so as to let out
the amniotic fluid. The aspiration then took place, with a cannula of
the corresponding diameter. Five experienced surgeons performed
all abortions. Women were monitored for 6 h, first in the recovery
room and then in the department.
The primary endpoint was the quantity of intraoperative
bleeding. It is the quantity of blood collected during the
intrauterine aspiration, beginning after the mechanical cervical
dilatation and ending with the withdrawal of the cannula at the
end of the procedure. It was collected into a graduated (every
50 mL up to 1 L) aspiration collection box. At the end of each
procedure, the surgeon who performed it read and recorded the
quantity of blood in the box, expressed in mL.
The duration of the intervention was defined as the time from
the beginning of the supplemental mechanical cervical dilatation
to the end of the intrauterine aspiration. The spontaneous cervical
dilatation was assessed by the diameter of the Hegar dilator that
entered the cervix without force, before the supplemental
mechanical cervical dilatation began. The procedure was stan-
dardized by attempting to use the n814 Hegar dilator and
continuing with gradually decreasing dilators. The maximum
cervical dilatation was the largest diameter of Hegar dilator
introduced at the end of the mechanical dilatation, with a
maximum of 14 mm.
The ease of this supplemental mechanical cervical dilatation
was assessed by the operator with a visual analog scale (VAS)
ranging from 0 (very difficult) to 10 (very easy).
The satisfaction regarding the procedure was assessed sepa-
rately by a VAS by the physician and by the woman before
discharge (0–10, with a higher score corresponding to greater
satisfaction).
Anxiety was assessed with the State-Trait Anxiety Inventory
(STAI) before and after the intervention. The STAI is a self-
administered questionnaire, developed by Spielberger and vali-
dated in French; it comprises 20 questions that assess the subject’s
emotional state [15,16]. The scale range is 20–80, with higher
scores representing higher levels of anxiety.
Perioperative experience and satisfaction during the perioper-
ative period for general anesthesia was assessed with a well-
validated self-administered questionnaire, the EVAN-G, which
consists of 26 patient-generated items that yield a global index
(score range, 0–100, worst possible experience to best possible
experience) [17–19].
Tolerance of the treatments was assessed by questioning the
women about side effects before the procedure began.
The intraoperative complications reported were: cervical
lacerations (lesion of the cervix requiring a suture for hemostasis
or reconstruction of the cervical anatomy), uterine perforation
(diagnosis established by intraoperative ultrasound or instrumen-
tal assessment), hemorrhage between the end of aspiration and
hospital discharge (defined as of intermediate severity if it was
necessary to repeat the aspiration or inject oxytocin, and severe if a
blood transfusion or hemostatic surgical procedure was required —
either hysterectomy or artery ligation).
Assumptions for the sample-size calculation were based on an
analysis of the medical records of the study center (in 2012). The
sample size was determined to obtain 80% power and 5%
significance level to detect 30% difference (considered as the
minimal clinically significant difference) of quantity of blood loss
for pair-wise comparisons of groups. Considering a standard
deviation maximizing the sample size (i.e., 150 mL) and a 1:1:1
ratio, the calculation showed that 189 women were needed (63 per
group). Assuming a potential dropout rate of 5%, we planned to
include 198 women.
In compliance with the applicable legislation, the National
Agency of Drug Safety (ANSM) and the Patient Protection
Committee (CPP) of the South-Mediterranean region approved
this study in February 2013.
Data analysis
Results are reported according to the CONSORT statement
[20,21]. SPSS version 17.0 software was used for data analysis.
 A. Ohannessian et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 201 (2016) 151–155
Statistical significance was defined as p < 0.05. The analysis of
women’ characteristics was performed on the full analysis set,
defined as all women who received at least one or more allocated
study medication. The analysis of outcome measures was
performed on the population after exclusions. Descriptive statis-
tics characterized social, demographic, clinical, and outcome
variables at baseline and follow-up in each treatment group. To
verify that randomization resulted in comparable groups, baseline
between-group differences were assessed for relevant variables,
with ANOVA for the continuous variables and Chi-square tests for
the categorical variables. In accordance with the distribution of the
variables (Kolmogorov–Smirnov test), between-group differences
for the primary and secondary endpoints were assessed with the
one-way ANOVA or Kruskal–Wallis tests, followed by pairwise
comparisons (Bonferroni post hoc test) and Chi-square tests, as
appropriate.
Results
From May 2013 to May 2014, 198 women were randomized in
the study: 66 women in the combination group, 67 in the
misoprostol group, and 65 in the mifepristone group (Fig. 1),
respectively; 7, 13, and 7 did not receive their allocated treatment.
The full analysis set thus included 59 women in the combination
group, 54 women in the misoprostol group, and 58 in the
mifepristone group. The primary and secondary outcomes were
not available for 9 women due to contraindication to general
anesthesia on the day of abortion (4, 3, and 2, respectively). All
details are reported on the flow chart (Fig. 1). The 3 groups did not
differ for the baseline characteristics (Table 1).
Fig. 1. Flow diagram.
153
The quantity of intraoperative bleeding differed significantly
among the 3 groups (p = 0.001, Kruskal–Wallis test). It was lower in
the combination group than misoprostol group or mifepristone
group. Medians and interquartiles are presented in Fig. 2. In the
2  2 comparisons, the quantity of intraoperative bleeding was
significantly lower in the combination group compared to the
misoprostol group (p = 0.001) and compared to the mifepristone
group (p = 0.032). Moreover, the quantity of intraoperative
bleeding was significantly lower in the mifepristone group than
in the misoprostol group (p = 0.035).
The duration of the intervention, the spontaneous cervical
dilatation, and the ease of supplementary mechanical cervical
dilatation differed significantly between the 3 groups (all p-values
<0.001). In the combination group, the intervention was shorter,
the spontaneous dilatation was greater, and the mechanical
dilatation was easier. Physician satisfaction differed between the
3 groups and was highest for the combination group, while
women’s satisfaction did not differ.
None of pre- or post-procedure anxiety or the perioperative
experience differed significantly between the groups. These details
are reported in Table 2.
A hemorrhage of intermediate severity, defined by the need to
repeat the aspiration or inject oxytocin, was observed for 27 of
162 women (16.7%): 5 of 55 (9%) in the combination group, 13 of
51 (25%) in the misoprostol group, and 9 of 56 (16%) in the
mifepristone group (p = 0.08). Oxytocin injections alone resolved
23 of these situations, repeated aspiration 1, and the two
together 3.
There was no significant difference in side effects of these
pretreatments between the 3 groups and no serious adverse effect
was reported. In all, 23 women reported bleeding after they took
154 A. Ohannessian et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 201 (2016) 151–155

Table 1
Women characteristics.

Combination Misoprostol Mifepristone

group (N = 59) group (N = 54) group (N = 58)

Age (years) M  SD 25.9  5.7 26.2  6.0 26.6  6.3

BMI (kg/m2) M  SD 23.6  5.3 22.1  4.3 23.1  4.6
Previous pregnancies, n Med [IQR] 2.0 [1.0–4.0] 2.5 [2.0–4.0] 3.0 [2.0–5.0]
Parity, n Med [IQR] 0 [0–2.0] 0.5 [0–1.0] 0.5 [0–1.3]
Gestational age (weeks) M  SD 13.1  0.7 13.2  0.7 13.2  0.7

Combination group Misoprostol group Mifepristone group

n (%) n (%) n (%)

Smoker active 38 (64) 38 (70) 37 (64)

Vaginal delivery 1 24 (41) 23 (43) 22 (38)
Cesarean 1 7 (12) 5 (9) 10 (17)
Elective abortion 1 26 (44) 24 (44) 33 (57)
Early pregnancy loss 1 8 (14) 7 (13) 14 (24)
Therapeutic abortion 1 2 (3) 1 (2) 0
Ectopic pregnancy 1 0 0 1 (2)

BMI: body mass index; Med [IQR]: median [interquartile range]; M  SD: mean  standard deviation; combination group: group receiving mifepristone and
misoprostol.

No cervical laceration or uterine perforation was observed, and

no expulsion was observed before the abortion was performed.
All women left the hospital 6 h after the procedure. None stayed
longer than expected or returned within 48 h.

Comment

In our study, less intraoperative bleeding was observed in the

Fig. 2. Comparison of quantity of intraoperative bleeding between the groups.
the study drugs and before the abortion: 9 in the combination
group, 6 in the misoprostol group, and 8 in the mifepristone group
(Table 3).
combination group compared to the misoprostol group or the
mifepristone group. Moreover, the quantity of intraoperative
bleeding was also significantly lower in the mifepristone group
than in the misoprostol group.
Spontaneous dilatation was significantly greater and the
duration of the procedure significantly shorter in the combination
group.
The efficacy of this combination is probably due to their
different and synergistic action on the cervix. Mifepristone is a
selective modulator of the progesterone receptor. This synthetic
steroid has an antiprogestational activity through its competition
for progesterone receptors. It induces rupture of maternal
capillaries in the uterine decidua, causing decidual necrosis, and
uterine contractions that cause detachment of the gestational sac
and production of prostaglandins by the decidual glands. It also
sensitizes the myometrium to the prostaglandins. Finally, the

Table 2
Characteristics of the surgical procedure.

Combination Misoprostol Mifepristone p-values

group group group
M  SD M  SD M  SD Global Combination vs. Combination vs. Misoprostol vs.
misoprostol mifepristone mifepristone

Intraoperative bleeding (mL) 222  64 329  129 276  118 0.001 0.001 0.032 0.035

Duration of intervention (min) 52 75 73 0.001 0.001 0.012 0.98
Spontaneous dilatation (mm) 9.4  2.2 8.1  1.5 8.3  1.6 0.001 0.001 0.003 1.0
Dilatation maximum (mm) 12  0.9 12  1.0 12 + -1.1 0.1
Ease of mechanical dilatationa 8.8  1.6 6.8  2.5 7.7  2.3 0.001 0.001 0.029 0.09

Physician satisfactionb 8.8  1.3 6.8  2.1 7.7  1.9 0.001 0.001 0.004 0.03
Woman satisfactionb 7.6  1.7 7.9  1.6 7.5  2.3 0.6

Anxiety pre-intervention (STAI 20–80) 50  11 46  12 48  12 0.2

Anxiety post-intervention (STAI 20–80) 37  12 35  12 40  15 0.2
Perioperative satisfaction (EVAN-G 0–100) 70  15 70+/14 75  12 0.1

M  SD: mean  standard deviation; STAI: State-Trait Anxiety Inventory, 20–80, higher score corresponding to higher level of anxiety; EVAN-G: Anesthesia Experience questionnaire
for general anesthesia, 0–100, higher score corresponding to better experience; combination group: group receiving mifepristone and misoprostol.
a
Visual analog scale, 0–10, higher score corresponding to easier dilatation.
b
Visual analog scale, 0–10, higher score corresponding to higher satisfaction level.
 A. Ohannessian et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 201 (2016) 151–155 155

Table 3 The clinically significant difference in intraoperative bleeding,

Side effects before intervention.
which was 30% lower in combination group compared to misoprostol
Combination Misoprostol Mifepristone p-value group, shows the clinical interest of these findings. The difference
group (N = 55) group (N = 51) group (N = 56) between the mifepristone group and either misoprostol group or
n (%) n (%) n (%) combination group seems less clinically interesting.
Headaches 1 (2) 1 (2) 1 (2) 1.0
Nausea 0 4 (8) 2 (4) 0.1
Vomiting 1 (2) 1 (2) 3 (5) 0.5 References
Diarrhea 0 0 0 1.0
Abdominal pain 5 (9) 4 (8) 6 (11) 0.9 [1] World Health Organization. Safe and unsafe induced abortion. Global and
Cutaneous 0 0 0 1.0 regional levels in 2008 and trends during 1995–2008; 2012.
reaction [2] White K, Carroll E, Grossman D. Complications from first-trimester aspiration
Malaise 0 0 0 1.0 abortion: a systematic review of the literature. Contraception 2015;92(No-
(faintness, etc.) vember (5)):422–38.
Hot flushes 1 (2) 1 (2) 0 0.6 [3] Zhou W, Sorensen H, Olsen J. Induced abortion and low birthweight in the
Vertigo 0 1 (2) 0 0.3 following pregnancy. Int J Epidemiol 2000;29:100–6.
Shivering 0 1 (2) 1 (2) 0.6 [4] Klemetti R, Gissler M, Niinimäki M, Hemminki E. Birth outcomes after induced
Fever 0 0 0 1.0 abortion: a nationwide register-based study of first births in Finland. Hum
Reprod 2012;27(November (11)):3315–20.
Bleeding 9 (16) 6 (12) 8 (14) 0.8
[5] Saccone G, Perriera L, Berghella V. Prior uterine evacuation of pregnancy as
At least one 9 (16) 8 (16) 12 (21) 0.7
independent risk factor for preterm birth: a systematic review and meta-
Combination group: group receiving mifepristone and misoprostol. analysis. Am J Obstet Gynecol 2015. pii: S0002-9378(15)02596-X.
[6] HAS: French National Authority for Health. Support for the abortion up to
14 weeks. Clinical practice guidelines in March 2001, reviewed in 2010.
[7] RCOG: Royal College of Obstetricians and Gynaecologists. The care of women
requesting induced abortion (evidence-based clinical guideline number 7); 2011.
[8] World Health Organization. Safe abortion: technical and policy guidance for
effects of the prostaglandins on the cervix and the stimulation of health systems. 2nd ed. 2012.
substances such as cytokines, which modify collagen fibers, induce [9] Meirik O, My Huong NT, Piaggio G, Bergel E, von Hertzen H, WHO Research
cervical ripening [22,23]. Group on Postovulatory Methods of Fertility Regulation. Complications offirst-
trimester abortion by vacuum aspiration after cervical preparation with and
Misoprostol is a prostaglandin E1 analog that ripens the cervix without misoprostol: a multicentre randomised trial. Lancet 2012;379(9828):
by inducing myometrial contractions, reducing the cervical 1817–24.
concentration of collagens and increasing collagen solubility and [10] SOGC: The Society of Obstetricians and Gynaecologists of Canada. Clinical
practice guidelines. Induced abortion guidelines; 2006.
thus its degradation (collagenases and leukocyte elastase) [24].
[11] Allen RH, Goldberg AB, Board of Society of Family Planning. Cervical dilation
The choice of primary outcome should be discussed. The before first-trimester surgical abortion (<14 weeks’ gestation). SFP guideline
complication rate would be most pertinent for distinguishing the 20071. Contraception 2007;76(August):139–56.
most effective intervention. But the rarity of these events means [12] Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester-
surgical abortion. Cochrane Database Syst Rev 2010;17(February
that a much higher sample size would be needed. We can assume (2)):CD007207.
that the primary outcome, defined by the quantity of intraoper- [13] National Abortion Federation. Clinical policy guidelines; 2012.
ative bleeding, allows us to indirectly assess the risk of [14] CNGOF: National College of French Gynecologists and Obstetricians. Clinical
practice guidelines. Prolonged pregnancy; 2011.
complications, especially the risk of hemorrhage. This primary [15] Spielberger C. Manual for the state-trait anxiety inventory (form Y). Palo Alto,
outcome was chosen because it is easy to assess, reproducible, and CA: Consulting Psychologists; 1983.
objective, especially as it has been shown that cervical preparation [16] Gauthier J, Bouchard S. Adaptation canadienne-française de la forme révisée
du ‘‘State-Trait Anxiety Inventory’’ de Spielberger. Revue Canadienne des
reduces intraoperative bleeding [6–8]. Sciences du Comportement 1993;25(4):559–78.
We chose a homogenous group: all abortions were performed [17] Auquier P, Blache JL, Colavolpe C, et al. A scale of perioperative satisfaction for
at the end of the first trimester. As complications and deaths anesthesia. I. Construction and validation. Ann Fr Anesth Reanim 1999;18(8):
848–57.
increase with gestational age, it appears useful to determine the [18] Pernoud N, Colavolpe JC, Auquier P, et al. A scale of perioperative satisfaction for
best method for cervical ripening in late first-trimester surgical anesthesia. II. Preliminary results. Ann Fr Anesth Reanim 1999;18(8):858–65.
abortions [25–29]. [19] Auquier P, Pernoud N, Bruder N, et al. Development and validation of a
perioperative satisfaction questionnaire. Anesthesiology 2005;102(6):
For the treatments, we used a mifepristone dosage of one 200-
1116–23.
mg tablet orally 36 h before aspiration, as recommended in France [20] Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guide-
and by the World Health Organization [6,8]. The Cochrane lines for reporting parallel group randomized trials. Ann Intern Med
Database reports that it is one of the most effective methods for 2010;152:726–32.
[21] Moher D, Hopewell S, Schulz KF, et al. CONSORT 2010 explanation and
cervical preparation during the first trimester [12]. Similarly, the elaboration: updated guidelines for reporting parallel group randomised
misoprostol dose of 400 mg orally 3 h before the intervention trials. BMJ 2010;340:c869.
follows the current French recommendations, as well as the [22] Cadepond F, Ulmann A, Baulieu EE. RU486 (mifepristone): mechanisms of
action and clinical uses. Annu Rev Med 1997;48:129–56.
summary of product characteristics for Gymiso1, the only [23] Rådestad A, Thyberg J, Christensen NJ. Cervical ripening with mifepristone (RU
misoprostol drug authorized in France in this indication [6]. 486) in first trimester abortion. An electron microscope study. Hum Reprod
The study was performed on a single-blinded basis; the 1993;8:1136–42.
[24] Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles,
physician who performed the abortion did not know the treatment effects on the uterus and side-effects. Int J Gynaecol Obstet 2007;99(December
received. This knowledge therefore could not influence the (Suppl. 2)):S160–7.
performance of the procedure (dilatation, aspiration, quantity of [25] Ferris LE, McMain-Klein M, Colodny N, Fellows GF, Lamont J. Factors associated
with immediate abortion complications. CMAJ 1996;154:1677–85.
intraoperative bleeding, duration) or its assessment (difficulty of
[26] Bartlett LA, Berg CJ, Shulman HB, et al. Risk factors for legal induced abortion-
the dilatation, satisfaction with the procedure). Because no placebo related mortality in the United States. Obstet Gynecol 2004;103:729–37.
was available, the women obviously did know the treatment they [27] Bacle F, Boufassa F, Lambert J, Lefebvre P, Soulat C, Meyer L. Pregnancy
termination between 12 and 14 weeks gestation: practices and early compli-
received. It is improbable that this would have influenced the data
cations in comparison with termination between 8 and 12 weeks. J Gynecol
about the procedure, especially as the subjects received general Obstet Biol Reprod 2005;34:339–45.
anesthesia. But, it might have influenced the side effects reported, [28] Koskas M, Jerbi M, Boccara J, et al. Operative termination of pregnancy
and the assessments of anxiety and the perioperative experience. between 12 and 14 weeks’ gestation: influence of the operator’s experience.
J Gynecol Obstet Biol Reprod 2005;34:334–8.
Finally, it was a monocentric study. Thus, the results should be [29] Soulat C, Gelly M. Immediate complications of surgical abortion. J Gynecol
confirmed by a larger multicentric study. Obstet Biol Reprod 2006;35:157–62.