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:

cervical laceration (0.1–0.6%), uterine perforation (0.1–2.3%), includ-
Elective abortions are an international public health issue, with ing the risk of wounding adjoining organs (bladder, vessels, or
one in five pregnancies worldwide resulting in the decision to rectum), severe hemorrhage (0.1–0.4%), and finally the long-term
terminate [1]. In 2008, 43.8 million elective abortions were risks of cervical incompetence, late miscarriage, and preterm delivery
performed worldwide, for a mean of 28 per 1000 women aged [2–5]. On the other hand, inadequate cervical dilatation at the
15–44 years, with nearly 8.5 million complications [1]. These moment of aspiration can cause other short-term complications:
complications can be life-threatening and are responsible for 13% of ongoing pregnancy and infection that can affect fertility [2]. Cervical
the annual international maternal mortality [1]. Surgical abortion preparation has shown benefits in terms of cervical dilatation and
requires mechanical dilatation of the uterine cervix. This cervical 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
* Corresponding author. Tel.: +33 610568052. first trimester [6–13]. Nonetheless, the benefit of combining both
E-mail address: [email protected] (A. Agostini). 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 intrauterine aspiration, beginning after the mechanical cervical
effectiveness, assessed by intraoperative blood loss, of misoprostol, dilatation and ending with the withdrawal of the cannula at the
mifepristone, and the combination of the two treatments, in end of the procedure. It was collected into a graduated (every
cervical preparation for elective surgical abortions between 12 and 50 mL up to 1 L) aspiration collection box. At the end of each
14 weeks of gestation. The secondary objectives were to compare procedure, the surgeon who performed it read and recorded the
the 3 treatment strategies in terms of duration of intervention, ease quantity of blood in the box, expressed in mL.
of dilatation, satisfaction regarding the procedure, women’s The duration of the intervention was defined as the time from
anxiety and perioperative experience, and complications. the beginning of the supplemental mechanical cervical dilatation
to the end of the intrauterine aspiration. The spontaneous cervical
Materials and methods dilatation was assessed by the diameter of the Hegar dilator that
entered the cervix without force, before the supplemental
This study was a single-center randomized, controlled, single mechanical cervical dilatation began. The procedure was stan-
(physician)-blinded trial conducted at the Conception University dardized by attempting to use the n814 Hegar dilator and
Hospital Centre in Marseille in France, in 3 parallel groups: the continuing with gradually decreasing dilators. The maximum
combination group, receiving a combination of mifepristone and cervical dilatation was the largest diameter of Hegar dilator
misoprostol, the misoprostol group, and the mifepristone group. introduced at the end of the mechanical dilatation, with a
The inclusion criteria were: women aged 18 years or older, maximum of 14 mm.
requesting an elective abortion under general anesthesia for an The ease of this supplemental mechanical cervical dilatation
intrauterine singleton pregnancy between 12 and 14 weeks of was assessed by the operator with a visual analog scale (VAS)
gestation (from last menstrual period) on the procedure date and ranging from 0 (very difficult) to 10 (very easy).
who provided written informed consent. The satisfaction regarding the procedure was assessed sepa-
The exclusion criteria were women with a uterine malforma- rately by a VAS by the physician and by the woman before
tion, coagulation disorders defined by laboratory indicators discharge (0–10, with a higher score corresponding to greater
(prothrombin time <70%, patient/control ratio for activated satisfaction).
clotting time >1.20), known allergy or hypersensitivity to one of Anxiety was assessed with the State-Trait Anxiety Inventory
the active substances or excipients of either mifepristone or (STAI) before and after the intervention. The STAI is a self-
misoprostol or a contraindication to its use, lack of health administered questionnaire, developed by Spielberger and vali-
insurance (in accordance with the French law), or refusal to dated in French; it comprises 20 questions that assess the subject’s
provide informed consent. emotional state [15,16]. The scale range is 20–80, with higher
Secondary exclusion criteria were: failure to perform the scores representing higher levels of anxiety.
intervention (continuing the pregnancy, spontaneous abortion Perioperative experience and satisfaction during the perioper-
before taking the medication), and inability to receive general ative period for general anesthesia was assessed with a well-
anesthesia the day of the abortion (not fasting, desire to change validated self-administered questionnaire, the EVAN-G, which
anesthesia modality, and an intercurrent disease). consists of 26 patient-generated items that yield a global index
Pregnancies were dated by ultrasound measurement of the (score range, 0–100, worst possible experience to best possible
craniocaudal length according to the French guidelines. It was experience) [17–19].
expected to range between 55 and 84 mm on the day of the Tolerance of the treatments was assessed by questioning the
abortion [14]. women about side effects before the procedure began.
Computer-generated randomized lists were drawn up before The intraoperative complications reported were: cervical
the beginning of the study with a permuted randomization scheme lacerations (lesion of the cervix requiring a suture for hemostasis
(block size: 6, randomization ratio [1:1:1]). After the written or reconstruction of the cervical anatomy), uterine perforation
consent was signed, women were randomly assigned to one of the (diagnosis established by intraoperative ultrasound or instrumen-
3 treatment groups. To ensure blinding, the treating medical staff tal assessment), hemorrhage between the end of aspiration and
and investigators were unaware of the allocation. Only the hospital discharge (defined as of intermediate severity if it was
pharmacist delivering the treatments and the women knew the necessary to repeat the aspiration or inject oxytocin, and severe if a
allocation. blood transfusion or hemostatic surgical procedure was required —
In the combination group, patients were given 200 mg of oral either hysterectomy or artery ligation).
mifepristone to take 36 h before the procedure, and 400 mg of oral Assumptions for the sample-size calculation were based on an
misoprostol to take 3 h before the procedure. Women in the analysis of the medical records of the study center (in 2012). The
misoprostol group received 400 mg of oral misoprostol to take 3 h sample size was determined to obtain 80% power and 5%
before the procedure, and those in the mifepristone group 200 mg significance level to detect 30% difference (considered as the
of oral mifepristone to take 36 h before the procedure. minimal clinically significant difference) of quantity of blood loss
The abortion was performed under general anesthesia according for pair-wise comparisons of groups. Considering a standard
to standard clinical practice at this gestational age. After asepsis of deviation maximizing the sample size (i.e., 150 mL) and a 1:1:1
the vulva and vagina, the operator used a Pozzi tenaculum to grasp ratio, the calculation showed that 189 women were needed (63 per
the cervix and measure the spontaneous cervical dilatation. group). Assuming a potential dropout rate of 5%, we planned to
Supplemental mechanical cervical dilatation was then performed include 198 women.
with Hegar dilators, with the size increasing in increments of In compliance with the applicable legislation, the National
0.5 mm, up to dilator number 14 when possible. The amniotic sac Agency of Drug Safety (ANSM) and the Patient Protection
was systematically breakthrough with the last dilator, so as to let out Committee (CPP) of the South-Mediterranean region approved
the amniotic fluid. The aspiration then took place, with a cannula of this study in February 2013.
the corresponding diameter. Five experienced surgeons performed
all abortions. Women were monitored for 6 h, first in the recovery Data analysis
room and then in the department.
The primary endpoint was the quantity of intraoperative Results are reported according to the CONSORT statement
bleeding. It is the quantity of blood collected during the [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) 151–155 153

Statistical significance was defined as p < 0.05. The analysis of The quantity of intraoperative bleeding differed significantly
women’ characteristics was performed on the full analysis set, among the 3 groups (p = 0.001, Kruskal–Wallis test). It was lower in
defined as all women who received at least one or more allocated the combination group than misoprostol group or mifepristone
study medication. The analysis of outcome measures was group. Medians and interquartiles are presented in Fig. 2. In the
performed on the population after exclusions. Descriptive statis- 2  2 comparisons, the quantity of intraoperative bleeding was
tics characterized social, demographic, clinical, and outcome significantly lower in the combination group compared to the
variables at baseline and follow-up in each treatment group. To misoprostol group (p = 0.001) and compared to the mifepristone
verify that randomization resulted in comparable groups, baseline group (p = 0.032). Moreover, the quantity of intraoperative
between-group differences were assessed for relevant variables, bleeding was significantly lower in the mifepristone group than
with ANOVA for the continuous variables and Chi-square tests for in the misoprostol group (p = 0.035).
the categorical variables. In accordance with the distribution of the The duration of the intervention, the spontaneous cervical
variables (Kolmogorov–Smirnov test), between-group differences dilatation, and the ease of supplementary mechanical cervical
for the primary and secondary endpoints were assessed with the dilatation differed significantly between the 3 groups (all p-values
one-way ANOVA or Kruskal–Wallis tests, followed by pairwise <0.001). In the combination group, the intervention was shorter,
comparisons (Bonferroni post hoc test) and Chi-square tests, as the spontaneous dilatation was greater, and the mechanical
appropriate. dilatation was easier. Physician satisfaction differed between the
3 groups and was highest for the combination group, while
women’s satisfaction did not differ.
Results None of pre- or post-procedure anxiety or the perioperative
experience differed significantly between the groups. These details
From May 2013 to May 2014, 198 women were randomized in are reported in Table 2.
the study: 66 women in the combination group, 67 in the A hemorrhage of intermediate severity, defined by the need to
misoprostol group, and 65 in the mifepristone group (Fig. 1), repeat the aspiration or inject oxytocin, was observed for 27 of
respectively; 7, 13, and 7 did not receive their allocated treatment. 162 women (16.7%): 5 of 55 (9%) in the combination group, 13 of
The full analysis set thus included 59 women in the combination 51 (25%) in the misoprostol group, and 9 of 56 (16%) in the
group, 54 women in the misoprostol group, and 58 in the mifepristone group (p = 0.08). Oxytocin injections alone resolved
mifepristone group. The primary and secondary outcomes were 23 of these situations, repeated aspiration 1, and the two
not available for 9 women due to contraindication to general together 3.
anesthesia on the day of abortion (4, 3, and 2, respectively). All There was no significant difference in side effects of these
details are reported on the flow chart (Fig. 1). The 3 groups did not pretreatments between the 3 groups and no serious adverse effect
differ for the baseline characteristics (Table 1). was reported. In all, 23 women reported bleeding after they took

Fig. 1. Flow diagram.

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

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
Fig. 2. Comparison of quantity of intraoperative bleeding between the groups. for progesterone receptors. It induces rupture of maternal
capillaries in the uterine decidua, causing decidual necrosis, and
the study drugs and before the abortion: 9 in the combination uterine contractions that cause detachment of the gestational sac
group, 6 in the misoprostol group, and 8 in the mifepristone group and production of prostaglandins by the decidual glands. It also
(Table 3). 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
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