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Int J Biol Med Res.2015;6(3):5140-5142
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Volume 6, Issue 2, April 2015
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BIOLOGICAL AND MEDICAL RESEARCH
Original Article
A COMPARATIVE STUDY OF INTRAVAGINAL MISOPROSTOL VS INTRA CERVICAL
DINOPROSTONE GEL FOR INDUCTION OF LABOUR.
Archana a, Bhawna Sharma b, Nidhi chauhan c
a
Assistant Professor, Deptt. of gyne and obstetrics, HIHT , Dehradun
Assistant Professor, Deptt. of gyne and obstetrics , HIHT, Dehradun
c
Assistant Professor, Deptt. of gyne and obstetrics , HIHT, Dehradun
b
ARTICLE INFO
ABSTRACT
Keywords:
Abstract : Induction of labour is a common need in obstetrics ward. There are various
complications and drug side effects associated with it. This study has been designed to compare
the safety and efficacy of 50μg intra-vaginal misoprostol (PGE1 analogue)with 0.5mg intracervical dinoprostone gel (PGE2). . 40 pregnant women with different indications of induction
of labour participated in the study. They were randomized to receive either 50 μg vaginal
misoprostol 6-hourly or 0.5 mg of intracervical dinoprostone gel 12 hourly. The maternal and
foetal outcome were judged in terms of Bishop's score, induction to delivery interval, need for
oxytocin for augmentation of labour, mode of delivery, maternal and foetal side effects. The
results show induction-Delivery intervals were significantly shorter and the requirement of
oxytocin was less for augmentation of the labour in the tab. misoprostol group than
dinoprostone gel group. Intra vaginal misoprostol is an effective agent for induction of labour
than intra cervical gel. Intravaginal misoprost is an effective agent for induction of labour than
intracervical gel. All these result were statistically significant. Very few maternal and foetal
side-effects noted. There was no significant difference in foetal outcome seen. Therefore, it can
be concluded that misoprostol is easy to administer and is cheap, stable at room temperature,
effective drug for induction of labour.
Misoprostol
Dinoprostone
Prostaglandins
c
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1. Introduction
Induction of labour is defined as artificial initiation of uterine
contractions before spontaneous onset of labour, with or without
ruptured membrane. There are medical ,surgical and combined
method for this. Augmentation is the purpose of stimulation of
uterine contractions that are already present but found to be
inadequate. Overall induction rate is 20% and augmentation with
oxytocin is 35% so total 55%of total deliveries .It is indicated when
there is risk in continuation of pregnancy either to mother or
foetus.
Cervical ripening is an essential prerequisite for induction and
is assessed with Bishops scoring system. A favourable cervix is
with a modified Bishop score of more than 8 and unfavourable
cervix with a Bishop score of < 4.2. In order to improve cervical
score and induce myometrial contractility, prostaglandins in
various forms and preparations have been used.(1) Karim (2)
introduced the use of prostaglandins (PG's) to induce labour. PGE2
and PGE2V have been commonly used for induction of labour, but
they are expensive and have some limitations Recently an
alternative prostaglandin PGE1 analogue misoprostol has been
used for cervical ripening and to induce labour (3).Misoprostol, a
synthetic PGE1 analogue, was commercialized in 1987 for
antiulcer,antisecretory and cytoprotective effects. Misoprostol
* Corresponding Author : Archana
c Copyright
2010 BioMedSciDirect Publications. All rights reserved.
was also effective as cervical priming agent (4). It is now being
tried orally,intravaginally and intracervically for induction of
labour (5,6).
Prostaglandins are used to induce labour. Dinoprostone (PgE2)
are used intracervically and it is deposited just below the internal
os .It can be repeated 6 hrly maximum 3 doses .It provides slower
release of 0.3mg/hr. But this one is inconvenient method and the
drug is expensive too.
The present study was designed to assess the effect of
intravaginal misoprostol and intracervical dinoprostone for
induction and progress of labour and to assess maternal and foetal
outcome.
MATERIAL AND METHODS
The present study was conducted in the department of
Obstetrics and gynaecology in HIHT DEHRADUN.A complete
history was taken from the patients and informed about the
favourable and unfavourable outcome of this study. General per
abdominal and per vaginal examination with routine
investigations of each woman, was done.
Archana et al. Int J Biol Med Res. 2015; 6(3): 5140-5142
5141
Inclusion criteria
Medical indication for labour induction.
Gestation age greater than 36 weeks
Vertex presentation, intact membranes, Bisop score <6.
Normal foetal heart rate.
Primigravida and Multigravida women were included.
Table 2: Case distribution in accordance to indication of
induction of labor
Exclusion criteria
Cephalopelvic disproportion
Placenta previa or any unexplained vaginal bleeding;
parity > 4
Previous caesarean section or any other scar on uterus
There were definite indication for induction of
labour-pre-eclampsia B.P.>140/90, POSTDATED
PREGNANCY,Intra uterine growth retardation,
Study design
A total of 40 women were randomly selected for the
prospective study and were divided into two groups of 20 each.
Group I : Control group- Dinoprostone gel was administered
intracervically (0.5 mg) and repeated after 12hours, if required.
Group II : Study group- Misoprostol tablet was administered
intravaginal (50 μg). The tablet was repeated every 6 hours for a
maximum of 4 doses or until active labour starts, that is 3-4 or
more contractions in first 10 minutes and cervical ripening,
dilatation of at least 4cm.
The mean time period between application of drug and onset
of satisfactory uterine contraction in Misoprostol group was 2.08
±1.46 and Dinoprostone group was 2.21±1.20 and was
statistically insignificant. (Table 3)
Table 3: Distribution of patients according to induction
initiation labor interval
During drug therapy, maternal status, foetal status and
progress of labour were observed carefully. To assess the efficacy
of drug, the induction- delivery interval, duration of 1st, 2nd and
3rd stage of labour and mode of delivery were recorded.
Efficacy and safety of misoprostol as a method of cervical
ripening and labour induction as compared to dinoprostone was
assessed. Therapy was discontinued if woman developed severe
diarrhoea, vomiting, signs of foetal or maternal distress, uterine
hypercontractility,tachycardia, fever or rigors
Foetal outcome was evaluated by Agar score at 1 min and 5
min of life and their birth weights according to the gestational
age. Maternal outcome was evaluated by any complication and
side effects.
The mean induction to delivery interval in our study was
shorter in Misoprostol 6.92±2.03 as compared to Dinoprostone
group 12.54±6.63 which is statistically significant. (Table 4)
Table 4: Induction to delivery interval
Statistical analysis was performed by Student 't' test.
Results
In our study we have observed that majority of the women
were in age group of 22 to 30 years with Gravida 1 to 3, whose
period of gestation was between 37 to 41 weeks and Bishop
score was between 0 and 10. (Table 1)
It has been seen that the most common indication in both the
group was post-dated pregnancy followed by PPROM and IUD.
(Table 2).
OBSERVATIONS
Table 1 : Subjects profile in both groups
As far as mode of delivery is concerned it has been seen that
93.3% and 83.3% of the subject delivered vaginally in
Misoprostol and Dinoprostone group respectively and 7.7%
among those 83.3% delivered vaginally in Dinoprostone group
required instrument (Forceps) whereas none required
instrumentation in Misoprostol group. Whereas LSCS was
conducted in 6.6% and 16.6% in Misoprostol and Dinoprostone
group respectively, indication being failed induction in 6.6% in
misoprostol group and 13.3% in Dinoprostone group, whereas
foetal distress in 3.4% in dinoprostone group. It has also been
observed that LSCS performed in Dinoprostone group was
significantly higher than in Misoprostol group. (Table 5).
Archana et al. Int J Biol Med Res. 2015; 6(3): 5140-5142
5142
Table 5: Mode of Delivery
There was no statistical difference in maternal and fetal
complication, 30% of all the patients developed maternal
complication where as 10% developed fetal complications , in
both misoprostol and dinoprostone group . (Table 6)
REFERENCES
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Fletcher HM, Mitchell S, Simeon FJ. Intravaginal misoprostol as a
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Nunes f, Rodrigues R, Manuel Meirinho. Randomized comparison
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Table 6: Maternal and fetal complications
As observed there was no difference in APGAR score at 1 minute
and 5 minute in both Misoprostol and Dinoprostone group.
(Table 7)
Table 7: Neonatal outcome (Apgar score at 1 minute)
DISCUSSION
Induction of labour is a common obstetrical procedure done
in labour room to ensure benefits or minimize risks to mother
and or foetus. . Oxytocin was the commonest inducing agent but
with introduction of prostaglandins it was found that
prostaglandins are better agents when cervix is unripe .Labour
induction with prostaglandins is an emerging technology The
usual agent, dinoprostone and misoprostol is now well
established. Unlike dinoprostone, misoprostol is cheap, and does
not require refrigeration for its storage, as it is stable at room
temperature.
In our study both the groups did not differ significantly with
age, parity , gravidity, gestational age and indication of
induction(table 1 &2).
The induction- initiation of labor interval was shorter in
Misoprostol group 2.08±1.46 as compared to Dinoprostone
group 2.21±1.20. (Table 3) which is in accordance with the study
conducted by Beltrage et al, Nunes et al, Buser et al and
Rosenberg et al. The mean induction to delivery interval in our
study was shorter in Misoprostol 6.92±2.03 as compared to
c Copyright 2010 BioMedSciDirect Publications IJBMR - ISSN: 0976:6685.
All rights reserved.