International Journal of Gynecology and Obstetrics 123 (2013) 207–212

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International Journal of Gynecology and Obstetrics

journal homepage: www.elsevier.com/locate/ijgo

CLINICAL ARTICLE

Titrated oral misoprostol solution versus vaginal misoprostol for

labor induction
Alex S.R. Souza a,b,c,d,e,⁎, Francisco E.L. Feitosa f, Aurélio A.R. Costa a,e, Ana P.R. Pereira a, Andreza S. Carvalho a,
Renata M. Paixão a, Leila Katz a,d, Melania M.R. Amorim a,d,g
a
Department of Maternal and Child Health, Instituto de Medicina Integral Prof. Fernando Figueira, Recife, Brazil
b
Emergency Obstetric Care, Policlínica e Maternidade Prof. Arnaldo Marques, Recife, Brazil
c
Department of Maternal and Child Health, Universidade Federal de Pernambuco, Recife, Brazil
d
Research Department, Instituto de Pesquisa Prof. Joaquim Amorim Neto, Campina Grande, Brazil
e
Emergency Obstetric Care, Hospital Barão de Lucena, Recife, Brazil
f
Department of Obstetrics, Universidade Federal do Ceará, Fortaleza, Brazil
g
Department of Obstetrics, Universidade Federal de Campina Grande, Campina Grande, Brazil

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

Article history: Objective: To determine the efficacy and safety of a titrated oral misoprostol solution compared with vaginal mi-
Received 20 March 2013 soprostol tablets for labor induction. Methods: A randomized, triple-blind, multicenter clinical trial was con-
Received in revised form 13 June 2013 ducted between March 2010 and June 2011. Women with a single gestation (n = 200) were randomized to
Accepted 28 August 2013 receive a titrated oral misoprostol solution (initial misoprostol dose 20 μg/hour; dose increased by 20 μg/hour
every 6 hours up to 80 μg/hour for a maximum of 48 doses) or vaginal misoprostol tablets (25 μg of misoprostol
Keywords:
every 6 hours for a maximum of 8 doses). Risk ratios (RR) and 95% confidence intervals (CIs) were calculated for
Clinical trial
Induced labor
maternal and perinatal outcomes. Results: The frequencies of vaginal delivery not achieved within 12 hours (RR
Misoprostol 0.87; 95% CI, 0.62–1.22) and within 24 hours (RR 1.11; 95% CI, 0.83–1.49) were similar in the 2 groups. No differ-
ences were found in terms of uterine hyperstimulation, unfavorable cervix at 12 and 24 hours, oxytocin augmen-
tation, tachysystole, epidural analgesia, adverse effects, and perinatal outcome. Approximately 70% of the women
preferred the oral solution. Conclusion: A titrated oral misoprostol solution was as effective and safe for labor in-
duction as vaginal misoprostol tablets.
ClinicalTrial.gov: NCT00 992524
© 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

1. Introduction
Misoprostol is one of the most common methods used to induce
labor and can be administered by various routes and using several treat-
ment regimens. The frequency of induced births depends on the country
and region, with an estimated average of 20% of births [1–8]. The effec-
tiveness of misoprostol is no longer questioned, although the ideal dose
and route of administration remain to be defined [3–10]. The WHO [1]
recommends 25 μg of oral misoprostol every 2 hours or 25 μg of vaginal
misoprostol every 6 hours (strong recommendation).
In an open randomized clinical trial [8], a titrated oral misoprostol
solution was shown to be of exceptional benefit, with a lower rate of
uterine hyperstimulation and higher rates of nausea and vaginal de-
livery in the oral solution group compared with vaginal misoprostol.
⁎ Corresponding author at: Avenida Rui Barbosa 579, Ap. 406, Graças, 52 011–040
Recife, Pernambuco, Brazil. Tel./fax: +55 81 2122 4122.
E-mail address: alexrolland@uol.com.br (A.S.R. Souza).
However, other studies [11–15] have failed to confirm the superiority
of this regimen.
A lower-dose regimen with shorter dosing intervals seems to be in
accordance with the pharmacokinetics of oral compared with vaginal
misoprostol [8–10]. Although previous studies [8,11,12,14] have evalu-
ated the use of a titrated misoprostol solution, none used a homoge-
nized oral solution. The present study was conducted to determine
the effectiveness and safety of a titrated oral homogenized misoprostol
solution compared with vaginal misoprostol tablets for the induction of
labor in full-term live pregnancies.
2. Materials and methods
A multicenter randomized, triple-blind clinical trial was carried out
at Instituto de Medicina Integral Professor Fernando Figueira (IMIP),
Policlínica e Maternidade Professor Arnaldo Marques, and Hospital
Barão de Lucena, all in the city of Recife, Pernambuco, in northeastern
Brazil, between March 1, 2010, and June 30, 2011. The study was

0020-7292/$ – see front matter © 2013 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.ijgo.2013.06.028

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208 A.S.R. Souza et al. / International Journal of Gynecology and Obstetrics 123 (2013) 207–212
approved by the Institutional Review Board at IMIP. All participants
voluntarily agreed to take part in the trial and gave their written
informed consent.
The sample size was calculated using OpenEpi version 2.3 (OpenEpi;
Atlanta, GA, USA). In a pilot study [16] of the titrated oral solution, 52%
of women did not have a vaginal delivery within 12 hours of misopros-
tol administration, and the respective rate with vaginal misoprostol was
73% in another study conducted at IMIP [17]. Assuming these rates, a
sample of 184 women would be needed to achieve a significance level
of 5% and a statistical power of 80%. This number was increased to 200
to allow for loss of follow-up.
The inclusion criteria were single live pregnancy, pregnancy dura-
tion of 37 weeks or more, indication for labor induction (hypertension,
premature rupture of membranes, diabetes, or pregnancy duration of
41 weeks or more), vertex presentation, estimated fetal weight of less
than 4000 g according to ultrasonography, amniotic fluid index of
more than 5 cm, and modified Bishop score of 6 or less.
Patients with uterine scar, abnormal fetal well-being test, fetal
abnormalities, restricted fetal growth, genital bleeding related to pla-
cental abnormalities, or contraindications to vaginal delivery were
excluded. Fetal well-being was evaluated by Doppler flow velocimetry,
cardiotocography, and/or biophysical profile scoring, depending on the
routine at each hospital.
All women included in the study were accompanied according to
standard routine for their clinical condition, and fetal well-being was
evaluated by intermittent fetal auscultation or intrapartum cardio-
tocography [19].
The randomization procedure was performed using Random Alloca-
tion version 1.0 (Isfahan University of Medical Sciences; Isfahan, Iran).
Numbers from 1 to 200 were randomly allocated to 2 groups designated
A and B, and the resulting lists were sent to the pharmaceutical compa-
ny in charge of the drug preparation.
The medication used in the study (oral misoprostol solution, vaginal
misoprostol tablets, and the respective placebos) was purchased by
IMIP from Hebron S/A Indústrias Químicas e Farmacêuticas (Caruaru,
Pernambuco, Brazil). The quality of the medication was controlled by
the batch number, according to protocols of the Brazilian pharmaceuti-
cal industry [18]. Vaginal tablets of misoprostol are commercially avail-
able in Brazil at a dose of 25 μg. The oral solution was prepared in
100 mL bottles (2 μg/mL of misoprostol). The placebo and misoprostol
formulations for each route of administration contained the same ingre-
dients, except for the presence of the active substance, and were identi-
cal in appearance, color, taste, and shape.
The study medications and placebos were packaged by the pharma-
ceutical company in identical boxes numbered sequentially from 1 to
200 in accordance with the randomization list. Each box contained a
set of 8 vaginal tablets (placebo or 25 μg of misoprostol) and 16 bottles
containing 100 mL of the oral solution (placebo or 2 μg/mL of misopros-
tol), in the following combinations: oral misoprostol solution with pla-
cebo tablets, and misoprostol tablets with oral placebo solution.
The initial dose of the oral solution was 20 μg/hour (10 mL/hour) of
misoprostol or 10 mL/hour of placebo for the first 6 hours, which was
increased by 20 μg/hour (10 mL/hour) every 6 hours by the attending
nurse with a calibrated medicine cup if labor was not induced (maxi-
mum dose 80 μg/hour or until the 48th dose). The vaginal tablet
(25 μg misoprostol or placebo) was placed into the posterior fornix
by the attending physician every 6 hours (maximum dose 200 μg or
8 tablets).
The primary outcome was vaginal delivery not achieved within
12 hours. Secondary outcomes were vaginal delivery not achieved
within 24 hours, uterine hyperstimulation, cesarean delivery, severe
neonatal morbidity (neonatal seizures and/or asphyxia) or perinatal
death, and severe maternal morbidity (uterine rupture, sepsis, and/or
admission to the intensive care unit) or maternal death. Other outcomes
evaluated were unfavorable cervix after 12–24 hours, need for oxytocin
augmentation, hypertonia/hypersystole, tachysystole, uterine rupture,
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epidural analgesia, instrumental vaginal delivery, and adverse effects
(headache, nausea, vomiting, diarrhea, and postpartum hemorrhage).
Neonatal outcomes were meconium-stained amniotic fluid, 1-minute
and 5-minute Apgar scores of less than 7, admission to the neonatal
intensive care unit, neonatal encephalopathy, and perinatal death [20].
On discharge from the hospital, the woman’s preference for the oral
or vaginal misoprostol formulation was evaluated by asking which for-
mulation she would prefer should labor induction be required in a
future delivery.
The indication for cesarean delivery and the times between the be-
ginning of induction and the beginning of labor, between the beginning
of induction and vaginal delivery, and between the beginning of labor
and vaginal delivery were evaluated.
A non-reassuring fetal heart rate (FHR) pattern, evaluated using
cardiotocography or intermittent fetal auscultation, was defined as the
persistence of a baseline FHR of less than 110 bpm, presence of late FHR
decelerations (reduction in FHR following uterine contractions), or pres-
ence of fetal tachycardia (persistent FHR of more than 160 bpm) [19].
Hypertonia/hypersystole was defined as uterine contractions for
at least 2 minutes, tachysystole as 6 or more uterine contractions
during 2 consecutive 10-minute periods, and uterine hyperstimulation
as tachysystole or hypersystole/hypertonia associated with a non-
reassuring FHR pattern [21]. If tachysystole was detected, the woman
was advised to lie on her left side and treated with intravenous hydra-
tion (1000 mL). If the pattern persisted, tocolysis was performed using
0.25 mg of subcutaneous terbutaline [1]. In cases of uterine hyper-
stimulation, a cesarean delivery was performed as soon as possible.
Labor was defined as the presence of 3 uterine contractions in
10 minutes with cervical changes [2]. Induction was considered to
have failed when labor failed to begin and/or the Bishop score remained
at 6 or less following administration of 8 vaginal tablets or 1 hour after
the 48th dose of the oral solution.
The statistical analysis was performed with Epi Info version 7
(Centers for Disease Control and Prevention, Atlanta, GA, USA), using
the intention-to-treat principle. For data collection and analysis, the
groups were initially identified as A or B, and both the statistician and
the investigators were blinded with respect to the allocated group
until the analysis was concluded.
Categorical variables were compared in contingency tables using the
χ2 test of association and the Fisher exact test, as appropriate. Continu-
ous variables with normal distribution were compared using t test. For
discrete variables and those without normal distribution, the Mann–
Whitney U test was used. To determine the normality of numeric vari-
ables, the Kolmogorov–Smirnov test was used. Risk ratios (RR) and
95% confidence intervals (CIs) were calculated. The P values for all
tests were 2-tailed; P b 0.05 was considered statistically significant.
A Kaplan–Meier survival analysis was performed to assess the time
from the beginning of induction until delivery, with the log rank test
used to compare the areas under the curve for the 2 routes of adminis-
tration. Women delivering by cesarean delivery were considered cen-
sored at the time of the cesarean delivery.
3. Results
During the study period, 450 women were referred to the participat-
ing hospitals for labor induction (Fig. 1). Of these, 203 met the inclusion
criteria; however, 3 declined participation. Therefore, 200 women re-
mained in the study, 100 of whom were randomly assigned to the oral
misoprostol solution group and 100 to the vaginal misoprostol group.
There were no protocol violations.
There were no significant differences in the baseline characteristics
of the 2 treatment groups (Table 1).
The 2 groups were not significantly different in terms of vaginal de-
livery not achieved within 12 hours (P = 0.45) (Table 2). The same was
true for vaginal delivery not achieved within 24 hours, uterine hyper-
stimulation, and cesarean delivery. The main reasons for performing a
 A.S.R. Souza et al. / International Journal of Gynecology and Obstetrics 123 (2013) 207–212 209

Excluded (n=250):
Assessed for eligibility (n=450) Did not meet inclusion criteria
(n=186)
Enrollment Previous uterine scar (n=18)
Fetal anomalies (n=15)
Suspected or confirmed fetal growth
restriction (n=18)
Compromised fetal well-being (n=10)
Randomized (n=200) Declined participation (n=3)

Allocated to titrated oral suspension (n=100) Allocated to vaginal misoprostol (n=100)

Allocation
Received allocated intervention (n=100) Received allocated intervention (n=100)

Lost to follow-up (n=0) Lost to follow-up (n=0)

Discontinued intervention (n=0) Follow-up Discontinued intervention (n=0)

Analyzed (n=100) Analysis Analyzed (n=100)

Fig. 1. Procedures for the selection and follow-up of participants.

Table 1
Baseline characteristics in the 2 study groups.a

Characteristics Oral misoprostol solution Vaginal misoprostol

(n = 100) (n = 100)

Age, y 23.0 ± 6.1 (14–39) 23.5 ± 6.7 (14–41)

Estimated fetal weight, g 3156.4 ± 282.9 (2753.0–3950.0) 3192.0 ± 364.8 (2300.0–3970.0)
Weight at birth, g 3181.2 ± 365.1 (2425.0–4685.0) 3189.9 ± 463.2 (2235.0–4355.0)
Number of previous deliveries 0 (0–1) 0 (0–1)
Nulliparity 73 (73.0) 64 (64.0)
Pregnancy duration, w 39.3 ± 1.3 (37–42) 39.5 ± 1.4 (37–42)
Bishop score 4 (3–6) 4 (3–5)
Bishop score b4 41 (41.0) 39 (39.0)
Indications for inductionb
Hypertensive syndromes 64 (64.0) 50 (50.0)
Pregnancy duration ≥41 weeks 33 (33.0) 33 (33.0)
PROM 13 (13.0) 18 (18.0)
Low AFI (5–8)c 7 (7.0) 15 (15.0)
Diabetes 4 (4.0) 4 (4.0)

Abbreviations: AFI, low amniotic fluid index; PROM, premature rupture of membranes; SD, standard deviation.
a
Values are given as mean ± SD (range), median (interquartile range), or number (percentage).
b
Patients may have had more than 1 indication for labor induction.
c
Excluding patients with PROM.

cesarean delivery were protracted active phase, induction failure, non- The 2 groups did not differ with respect to having an unfavorable
reassuring FHR, and uterine hyperstimulation, with no significant differ- cervix after 12 and 24 hours, induction failure, and requirement for oxy-
ences between the groups (Table 3). tocin augmentation (Table 2). Of the 92 women who required oxytocin,

Table 2
Maternal outcomes according to route of administration of misoprostol for labor induction.

Maternal outcome Oral misoprostol solutiona Vaginal misoprostola RR (95% CI) P value
(n = 100) (n = 100)

Primary outcome
Vaginal delivery not achieved within 12 hours 81 (81.0) 85 (85.0) 0.87 (0.62–1.22) 0.45b
Secondary outcomes
Vaginal delivery not achieved within 24 hours 63 (63.0) 58 (58.0) 1.11 (0.83–1.49) 0.47b
Uterine hyperstimulation 2 (2.0) 2 (2.0) 1.00 (0.37–2.69) N0.99c
Cesarean delivery 41 (41.0) 37 (37.0) 1.09 (0.82–1.44) 0.56b
Unfavorable cervix after 12 hours 59 (59.0) 46 (46.0) 1.30 (0.98–1.73) 0.06b
Unfavorable cervix after 24 hours 34 (34.0) 25 (25.0) 1.23 (0.93–1.63) 0.16b
Induction failure 12 (12.0) 6 (6.0) 1.38 (0.96–1.97) 0.14b
Need for oxytocin augmentation 47 (47.0) 45 (45.0) 1.04 (0.79–1.37) 0.78b
Tachysystole 3 (3.0) 0 (0.0) ND 0.25c
Epidural analgesia 1 (1.0) 0 (0.0) ND N0.99c
Forceps delivery 2 (2.0) 2 (2.0) 1.00 (0.37–2.69) N0.99c
Vaginal delivery 57 (57.0) 61 (61.0) 0.92 (0.70–1.22) 0.56b

Abbreviations: CI, confidence interval; ND, not defined; RR, relative risk.
a
Values are given as number (percentage).
b
χ2 test.
c
Fisher exact test (2-tailed).

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210 A.S.R. Souza et al. / International Journal of Gynecology and Obstetrics 123 (2013) 207–212

Table 3
Principal indications for cesarean delivery according to route of administration of misoprostol for labor induction.a

Indications for cesarean delivery Oral misoprostol solutionb Vaginal misoprostolb RR (95% CI) P value
(n = 41) (n = 37)

Protracted active phase 16 (39.0) 15 (40.5) 0.97 (0.63–1.50) 0.89c

Induction failure 12 (29.3) 6 (16.2) 1.38 (0.91–2.10) 0.17c
Nonreassuring FHR 6 (14.6) 11 (29.7) 0.62 (0.31–1.21) 0.11c
Uterine hyperstimulation syndrome 2 (4.9) 2 (5.4) 0.95 (0.35–2.59) N0.99d
Persistent tachysystole 1 (2.4) 0 (0.0) ND N0.99d
Other 7 (17.1) 6 (16.2) 1.03 (0.59–1.79) 0.92c

Abbreviations: CI, confidence interval; FHR, fetal heart rate; ND, not defined; RR, relative risk.
a
Patients may have more than 1 indication for cesarean delivery.
b
Values are given as number (percentage).
c
χ2 test.
d
Fisher exact test (2-tailed).

Fig. 2. Time (hours) from induction to delivery according to the route of administration of misoprostol (Kaplan–Meier survival curve).

44 (47.8%) delivered within 24 hours in the oral group and 48 (52.2%) in The frequency of adverse effects was similar in the 2 groups
the vaginal group (P = 0.69). (Table 4). There were no episodes of shivering or diarrhea. Perinatal
Tachysystole was only found in the oral misoprostol group (Table 2). outcomes were also similar in the 2 groups (Table 5). There were no
Epidural analgesia was required for delivery in 1 patient in the oral cases of neonatal encephalopathy or death.
misoprostol solution group only. There were no differences between
the group in terms of vaginal delivery and forceps delivery. No woman
died, no cases of severe maternal or perinatal morbidity or perinatal Table 4
death occurred, and there was no hypertonia or uterine rupture. Adverse effects according to route of administration of misoprostol for labor induction.
No significant difference was found between the 2 groups with Adverse effects Oral misoprostol Vaginal RR (95% CI) P value
respect to the mean time from the beginning of induction to the onset solutiona misoprostola
of labor (oral misoprostol [n = 83], 16.4 ± 12.9 hours; vaginal miso- (n = 100) (n = 100)
prostol [n = 88], 14.5 ± 11.3 hours; P = 0.31). Likewise, there was Nausea 28 (28.0) 18 (18.0) 1.30 (0.98–1.73) 0.09b
no significant difference in the mean time from the beginning of induc- Vomiting 13 (13.0) 8 (8.0) 1.27 (0.88 - 1.84) 0.25b
tion to vaginal delivery (oral misoprostol [n = 59], 22.9 ± 14.9 hours; Headache 6 (6.0) 6 (6.0) 1.00 (0.56–1.79) N0.99b
Hyperthermia 5 (5.0) 5 (5.0) 1.00 (0.53–1.89) N0.99b
vaginal misoprostol [n = 63], 22.3 ± 13.0 hours; P = 0.81) and in
Postpartum 0 (0.0) 2 (2.0) 0.0 (0.00–∞) 0.50c
the mean time between the onset of labor and vaginal delivery hemorrhage
(oral misoprostol [n = 59], 7.05 ± 4.65 hours; vaginal misoprostol
Abbreviations: CI, confidence interval; RR, relative risk.
[n = 63], 6.98 ±3.83 hours; P = 0.93). The Kaplan–Meier survival a
Values are given as number (percentage).
curves for the time from induction to delivery did not differ between b
χ2 test.
c
the groups (Fig. 2). Fisher exact test (2-tailed).

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 A.S.R. Souza et al. / International Journal of Gynecology and Obstetrics 123 (2013) 207–212
Table 5
Perinatal outcomes according to route of administration of misoprostol for labor induction.
Perinatal outcomes Oral misoprostol solutiona
(n = 100)
Meconium-stained amniotic fluid 17 (17.0)
1-minute Apgar score b7 7 (7.0)
5-minute Apgar score b7 1 (1.0)
Neonatal resuscitation 7 (7.0)
Admission to neonatal ICU 5 (5.0)
Perinatal infection 1 (1.0)
Abbreviations: CI, confidence interval; ICU, intensive care unit; RR, relative risk.
a
Values are given as number (percentage).
b
χ2 test.
c
Fisher exact test (2-tailed).
With respect to the mother’s preference regarding the route of ad-
ministration, 69.5% (95% CI, 62.6–75.8%) of the women reported that
they would prefer the oral solution to the vaginal tablets should they
need to use the drug to induce labor in a subsequent pregnancy.
4. Discussion
In the present study, no significant differences in the evaluated out-
comes were found when an oral misoprostol solution was compared
with vaginal misoprostol tablets.
Several studies [8,17,22,23] have evaluated the frequency of vaginal
delivery not achieved within 12 hours among women who received
oral titrated versus vaginal misoprostol for labor induction. In previous
reports [8,17,23], 68–74% of women exposed to vaginal misoprostol
had not given birth at 12 hours compared with 85% in the present
study. By contrast, with oral misoprostol, the frequency of vaginal deliv-
ery not achieved within 12 hours was only 26% in the first randomized
clinical trial assessing this route of administration [8]. This finding
differs drastically from the results of the present study, where the fre-
quency of vaginal delivery not achieved within 12 hours was 81% in
the group receiving misoprostol via the oral route.
In the present study, similar rates of vaginal delivery not achieved
within 24 hours were found for the oral solution (63%) and the
vaginal tablets (58%) of misoprostol, a result that is consistent with
the findings from most other studies [3,7,12,17,24]. However, in
the randomized controlled trial [8], the frequency of vaginal delivery
not achieved within 24 hours was 5.9% for the oral solution and 46%
for the vaginal tablets.
The frequency of uterine hyperstimulation was low in the present
study, with no significant difference between the groups. This finding is
consistent with other reports [3,7,9,11,12,17,23,25]. The rate of cesarean
deliveries was similar in the 2 groups, in concordance with a Cochrane
review [3]. No difference was found between the groups with respect
to the indications for cesarean delivery.
There were no cases of severe neonatal morbidity, neonatal death,
severe maternal morbidity, or maternal death in the present study,
which is consistent with the results of other studies [3].
Likewise, no difference between the 2 groups was found in the need
for oxytocin augmentation. The Cochrane review [3] reported a greater
need for oxytocin in women using oral misoprostol (57%) than in those
with vaginal administration (51%), a finding that is in agreement with
the results from another randomized controlled trial [13].
With reference to uterine hyperactivity, no statistically significant
differences in the rate of tachysystole were found in the present study.
No cases of uterine hypertonia occurred. The Cochrane review [3]
found lower rates of uterine hyperstimulation with no change in the
FHR with the use of oral misoprostol compared with vaginal tablets.
With respect to the remaining outcomes (epidural analgesia and in-
strumental vaginal delivery), no significant differences were found, in
agreement with the results of the Cochrane review [3].
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211
Vaginal misoprostola RR (95% CI) P value
(n = 100)
17 (17.0) 1.00 (0.69–1.45) N0.99b
9 (9.0) 0.86 (0.49–1.54) 0.60b
3 (3.0) 0.49 (0.09–2.72) 0.62c
6 (6.0) 1.08 (0.64–1.83) 0.77b
4 (4.0) 1.12 (0.61–2.04) N0.99c
3 (3.0) 0.49 (0.09–2.72) 0.62c
The mean time from the beginning of induction to the onset of labor,
from the beginning of induction to vaginal delivery, and from the onset
of labor to vaginal delivery did not differ between the 2 groups. The
respective values in the present study are similar to those reported pre-
viously [9,17,24], with the exception of the findings from the first pub-
lished randomized controlled trial [8] comparing an oral misoprostol
solution with vaginal misoprostol and those from another study [16]
that investigated the oral solution alone.
Approximately 70% of the women reported that they would prefer
the oral misoprostol solution over the vaginal tablets, should labor
have to be induced in a future pregnancy. Another study [24] reported
a satisfaction rate of approximately 85% with a sublingual solution.
The present results show that the efficacy and safety of a titrated oral
misoprostol solution are similar to those found with vaginal administra-
tion of a 25-μg dose every 6 hours. Further studies should be conducted
before use of the oral misoprostol solution can be recommended in rou-
tine practice; future studies should also specifically address the issue of
patient preference and satisfaction.
Acknowledgments
The Instituto de Medicina Integral Professor Fernando Figueira, where
the study was carried out, is a private, nonprofit healthcare organization
based in Recife, Pernambuco, Brazil. The Institute did not interfere with
the study design or analysis but covered all the costs involved in con-
ducting the study, including the purchase of medication.
Conflict of interest
The authors have no conflicts of interest.
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