Vaginal Misoprostol efficacy for labour induction

ORIGINAL ARTICLE
Tablet misoprostol for induction of labour by vaginal route
Sumant R.Shah1*, Kritika Poddar2, Shikha Poddar3, Shubhda Gupta4
1
Professor, Department of Obstetrics and Gynaecology , Civil Hospital, B.J.Medical College, Ahmedabad
2
Resident, Department of Obstetrics and Gynaecology, Civil Hospital, B.J.Medical College, Ahmedabad
3
Consultant Obstetrics and Gynaecology
4
Resident, Department of Obstetrics and Gynaecology, Civil Hospital, B.J.Medical College, Ahmedabad
o Maternal outcomes
ABSTRACT (i)
BACKGROUND: Aim of the study is to evaluate the efficacy of dose of Misoprostol for labour induction by
(ii)
vaginal route and to decide the safe dose of Misoprostol in terms of maternal and fetal outcome. MATERIALS
AND METHODS: It is a prospective study which was conducted (iii)in Civil Hospital, Ahmedabad. Total numbers of
women taken for the study were 100. Out of them 50 were induced (iv)with 50 µg (Group A) and 50 were induced with
25 µg of Misoprostol (Group B). The study period was from July (v) 2003 to October 2005. Patient with pregnancy
more than 28 weeks were induced. Total numbers of patients with previous history of caesarean section were 15.
(vi)
RESULTS: We found that the most common indication for induction of labour is premature rupture of membranes
(vii)
followed by postdatism and than hypertensive disorders .Success of induction relies on better Bishop Score.
Misoprostol does not have any significant side effects. It seems(viii)
that 50 µg vaginal Misoprostol gives better results
(ix)the complications of Misoprostol in higher dose
as compared to 25 µg but the result is statistically insignificant and
of 50 µg are much more significant than that in low dose of 25(x) µg. CONCLUSION: 25 µg vaginal Misoprostol
gives equivalent results of labour induction as 50 µg vaginal Misoprostol
(xi) and the added advantage is that it is much
safer than 50 µg vaginal Misoprostol especially in previous caesarean section patients.
(xii)
(xiii)section
Key words: Misoprostol, Vaginal route, Labour induction, Caesarean
(xiv)
(xv)
INTRODUCTION Vaginal delivery rates within a specified
Induction of labour is a common practice in time.
clinical obstetrics. Induction is defined as an Operative delivery rates (caesarean section
intervention designed to artificially initiate and instrumental delivery).
uterine contractions leading to progressive Length of labour/incidence of prolonged
dilation and effacement of cervix and birth of the labour.
baby. This includes both women with intact Measures of effectiveness (oxytocin
membranes and women with spontaneous augmentation rates, epidural usage, cervix
rupture of the membranes but who are not in unfavourable /unchanged at 12-24 hours).
labour. Maternal morbidity or mortality.
Induction and augmentation are different entity. Patient satisfaction.
Augmentation is basically an intervention Vaginal delivery achieved or not within in 24
designed to increase the rate of progress of hours.
labour in women who are already in labour. The
Uterine hypo or hypercontractility with or
basic aim for doing induction of labour is the
without FHR changes.
initiation and parturition in a manner which is in
Fetal outcomes
the best interest of mother and fetus. Induction of
A healthy neonates with normal APGAR score.
labour requires continuous maternal and fetal
Adverse perinatal outcomes (meconium stained
surveillance keeping following outcomes in
liquor, five minutes APGAR score of less than
mind:
* seven, NICU admissions).
Corresponding Author:
Care during induction:
Sumant R.Shah
17,Ambica Society
Fetal surveillance: The use of electronic fetal
Near Garden monitoring, the use and interpretation of
Usmanpura, Ahmedabad cardiotocography in intrapartum fetal
Email: drsrshah@gmail.com surveillance.

43 Int J Int Med Res. 2016; 3(3):43-48 e ISSN: 2393-9869 p ISSN: 2350-0360
 Vaginal Misoprostol efficacy for labour induction

Maternal surveillance: Consent should be taken. and maternal and neonatal outcomes were
The process of labour induction should be studied. The results of the study were as follows:
considered when vaginal delivery is felt to be the Table 1: Parity
appropriate route of delivery. GROUP A (n=50) GROUP B (n=50)
PARITY No. of No. of
Aims of study % %
patients patients
(A) To evaluate the efficacy of dose of Nulliparous 27 54 27 54
Parous 23 46 23 46
Misoprostol for labour induction by vaginal
Pattern of parity distribution is same in both the
route.
groups. 54% were nulliparous and 46% were
(B) To study the safety of Misoprostol in terms
multiparous.
of fetal outcome and maternal complications.
Table 2: Distribution of patients with history
(C) To decide the safe dose of Misoprostol with
of previous caesarean section
least complications especially in patients GROUP A (n=50) GROUP B (n=50)
with previous caesarean section. No. of patients % No. of patients %
6 12 9 18
MATERIALS AND METHODS
My study is prospective study to judge the Total number of patients with previous caesarean
efficacy of dose of Misoprostol for labour section were 15 out of 100. Out of 15, 6 patients
induction by vaginal route and to know the safe (12%) were induced with 50 microgram of
and effective dose to minimise or omit its vaginal Misoprostol and 9 patients (18%) were
complications. The study was conducted in Civil induced with 25 microgram of vaginal
Hospital, Ahmedabad. Total numbers of women Misoprostol.
taken for the study were 100. Out of them 50 Table 3: Indications of induction
GROUP A
were induced with 50 microgram (Group A) and GROUP B (n=50)
(n=50)
Indications
50 were induced with 25 microgram of No. of
%
No. of
%
patients patients
Misoprostol (Group B). The study period was PROM 19 38 18 36
from July 2003 to October 2005. Patient with Postdate 13 26 12 24
PIH 5 10 5 10
pregnancy more than 28 weeks were induced. Early rupture of
4 8 5 10
Total numbers of patients with previous history membranes
Abruption placentae 1 2 3 6
of caesarean section were 15. Eclampsia 1 2 3 6
Cases that were excluded from study are: IUD 4 8 3 6
Those with history of previous two caesarean Oligohydrominos - - 1 2
Chorioamnionitis 1 2 - -
sections, Cephalopelvic disproportions, Fetal Congenital anomaly 1 2 - -
distress, Placenta praevia, Cord prolapsed, Premature rupture of membranes at term or pre-
Cardiac disease, Carcinoma cervix, Pelvic term was the main indication for induction
tumors, Hypersensitivity to prostaglandins, i.e.46% in both the groups. Second most
Those who require caesarean section. common indication was postdatism. In Group A,
RESULTS 13 patients (26%) and in Group B (24%) were
This study was carried out in Civil Hospital, induced for postmaturity. For hypertension, 5
Ahmedabad from July 2003 to October 2005. patients (10%) were induced in Group A and 5
Total 100 patients were included. This was patients (10%) were induced in Group B.
randomised prospective trial. Out of 100 Eclampsia was the indication for induction of
patients, 50 were included in group A who were labour in 1 patient (2%) in Group A and in 3
induced with 50 microgram of vaginal patients (6%) in Group B.For Abruptio
misoprostol and 50 were included in group B, placentae,1 patient (2%) in Group A and 3
who were induced with 25 microgram of vaginal patients (6%) in Group B were induced.
misoprostol. Induction for intrauterine death was done in 4
After induction, the patients were closely patients (8%) in Group A and in 3 patients in
monitored for maternal and fetal well being and Group B. The common causes of intrauterine
they were followed up till the date of discharge death were severe PIH, hypertension,
postmaturity and idiopathic.
44 Int J Int Med Res. 2016; 3(3):43-48 e ISSN: 2393-9869 p ISSN: 2350-0360
 Vaginal Misoprostol efficacy for labour induction

One patient each was induced for congenital Table 5: Total dose requirement for induction
anomaly, chorioamnionitis and peripartum Doses GROUP A (n=50) GROUP B (n=50)
No. 1 2 3 4 1 2 3 4 5
cardiomyopathy in Group A i.e. 2% each.1 Dosage
patient was induced for oligohydrominos in (micro- 50 100 150 200 25 50 75 100 125
gram)
Group B. Patients 25 14 9 2 23 13 10 3 1
Table 4: Preinduction Bishop score and rate (n)
% 50 28 18 4 46 26 20 6 2
of successful outcome
Pre- GROUP A (n=50) GROUP B (n=50) Tablet Misoprostol was repeated in patients
induction every 4 hourly depending on maternal and fetal
Bishop NP P SI % NP P SI %
score well being and progress of labour. In Group A,
0-3 6 5 10 90.9 14 10 20 83.3 maximum number of patients i.e. 25 (50%)
4-6 18 18 36 100 10 11 21 100
>6 3 - 3 100 3 2 5 100
required no more than one dose of 50 microgram
NP=Nulliparous, P=Parous, SI=Successful vaginal Misoprostol, 14 patients (28%) required
induction 2 doses or 100 microgram vaginal Misoprostol, 9
Successful outcome was defined in terms of patients (18%) required 3 doses or 150
effective uterine contractions. microgram vaginal Misoprostol, 2 patients (4%)
In Group A, out of 11 cases with Bishop Score required 4 doses or 200 microgram vaginal
between 0-3, 10 cases had successful induction Misoprostol for labour induction. In Group B, 23
i.e 90.91%. The one case who had induction (46%) required one dose of 25 microgram
failure was a nulliparous patient induced for IUD vaginal Misoprostol, 13 patients (26%) required
with Bishop Score 0. In patients with Bishop 2 doses or 50 microgram vaginal Misoprostol, 10
Score between 4-6, all 36 patients had successful patients (20%) required 3 doses or 75 microgram
induction (100%). In patients with Bishop Score vaginal Misoprostol, 3 patients (6%) required 4
>6, all the 3 cases had successful induction i.e. doses or 100 microgram vaginal Misoprostol and
100%. 1 patient (2%) required 5 doses or 125
In group B, 20 out of 24 cases with Bishop Score microgram vaginal Misoprostol for labour
0-3 (83.3%) had successful induction. 4 cases induction. Therefore, at the end of 12 hours in
had induction failure, out of which 2 patients Group A only 2 patients (4%) and in Group B 4
(4%) were nulliparous while 2 patients (4%) patients (8%) required 4th dose of vaginal
were parous. Both the parous patients were Misoprostol for labour induction. But the
second gravid patients with history of previous maximum dose used in Group A was 200
caesarean section who were as good as microgram while in Group B was 125
nulliparous patients with additional risk of scar microgram. So if more number of doses were
dehiscence. kept in Group B, better induction results could
With Bishop Score between 4-6 and more than 6, be accepted.
100% women had successful induction. Table 6: Parity distribution and rate of
Therefore all the patients who had induction successful outcome
GROUP A (n=50) GROUP B (n=50)
failure had Bishop Score between 0-3, both in No. of No. of
Parity
Group A and Group B. In Group A, 1 case and in n successful % n successful %
induction induction
Group B 4 cases had induction failure. The z Nulli-
27 26 96.3 27 25 92.5
value comes out to be 0.66 (less than 2, the parous
Parous 23 23 100 23 21 91
critical level of significance) which is
In Group A, in nulliparous patients, 26 out of 27
insignificant at 95% confidence limits.Therefore,
cases had successful induction i.e. 96.3% while
success of induction was better with 50
all the parous patients had successful induction
microgram vaginal misoprostol, but that is
i.e. (10 0%).While in Group B, in nulliparous
statiscally insignificant. The failure of induction
patients, 25 out of 27 cases had successful
was more related to Bishop score than the dose
induction i.e. 92.5% while the 21 out of 23
of Misoprostol.
parous patients had successful induction i.e.

45 Int J Int Med Res. 2016; 3(3):43-48 e ISSN: 2393-9869 p ISSN: 2350-0360
 Vaginal Misoprostol efficacy for labour induction

(91%). Therefore, Group A had higher incidence In Group A, 9 patients i.e. 18% patients had
of successful outcome than group B. Nulliparous undergone caesarean section for fetal distress
patients and those who have never had any and one patient (2%) had undergone caesarean
vaginal delivery had higher incidence of section for other indications.
induction failure. Table 10: Complications of labour and
Table 7: Outcome of induction delivery
GROUP A (n=50) GROUP B (N=50) GROUP A (n=50) GROUP B (N=50)
OUTCOME No. of No. of Complications No. of No. of
% % % %
patients patients patients patients
Success 49 98 46 92 Meconium stained
9 18 6 12
Failure 1 2 4 8 liquor
In Group A, 49 out of 50 patients (98%) had Hyperstimulation
7 14 1 2
syndrome
successful induction and 1 out of 50 cases had Tachysystole 3 6 2 4
(2%) had induction failure. In group B, 46 out of Precipitate labour 2 4 1 2
Cervical tear 2 4 1 2
50 patients (92%) had successful induction and 4 Traumatic PPH 1 2 - -
out of 50 cases had (8%) had induction failure. Rupture uterus 1 2 - -
There is no significant induction failure in Group In Group B, only 5 patients(10%) patients had
B in comparison to Group A (Z=1.4, P>0.05). undergone caesarean section for fetal distress
Table 8: Mode of delivery and 3 patients (6%) had undergone caesarean
Mode of
GROUP A (n=50) GROUP B (N=50) section for failed induction.4 patients (8%) had
No. of No. of
delivery
patients
%
patients
% undergone caesarean section for other indications
Spontaneous
38 76 36 72
like CPD, eclampsia and cervical dystocia.
vaginal
Instrumental 2 4 2 4
Therefore, the incidence of fetal distress was
LSCS 10 20 12 24 higher in Group A i.e. 18% as compared to
In Group A, 38 patients (76%) had spontaneous Group B i.e. 10%. The cause could be iatrogenic.
vaginal delivery, 2 patients (4%) delivered by However on applying the statistical formulae, the
operative vaginal delivery and 10 patients (20%) values were found to be statistically insignificant
had undergone caesarean section for various in 95% confidence limits.
indications. In Group B, 36 patients (72%) had Total number of cases of meconium stained
spontaneous vaginal delivery, 2 patients (4%) liquor were 9 (18%) in Group A and 6 (12%) in
delivered by operative vaginal delivery and 12 Group B. However it is not known whether
patients (24%) had undergone caesarean section meconium stained liquor is iatrogenic or due to
for various indications. Therefore, patients effect of Misoprostol on fetal gastrointestinal
induced with 50 microgram of vaginal tract.
Misoprostol for induction had greater number of In Group A, 3 patients (6%) had tachysystole
total vaginal deliveries than in Group B. But the while in Group B, 2 patients (4%) had
Z value obtained is <2, which is insignificant. tachysystole. Hyperstimulation syndrome was
Therefore, statistically there is no significant seen in 7 patients (14%) in Group A and in 1
difference between vaginal deliveries in Group A patient (2%) in Group B.
and in Group B. Cervical tear was present in Group A in 2
Table 9: Indications of caesarean section patients (4%) and in 1 patient (2%) in Group B.
GROUP A (n=50) GROUP B (N=50) There was 1 case of rupture uterus (2%) in
Indication No. of No. of
patients
%
patients
% Group A. The patient was a case of previous
Failed
- - 3 6 caesarean section induced for severe PIH with 50
induction(NPOL)
Fetal distress 9 18 5 10 microgram of vaginal Misoprostol. This resulted
Others 1 2 4 8 in traumatic PPH (2%) for which 4 blood
NPOL: Non progress of labour transfusions were given and 5 units of PRC were
The indication for caesarean section was 20% in given. Exploratory laprotomy was done and
Group A and 24% in Group B. rupture was repaired. No such case was recorded
in Group B.

46 Int J Int Med Res. 2016; 3(3):43-48 e ISSN: 2393-9869 p ISSN: 2350-0360

Precipitate labour was present in 2 patients (4%)
in Group A and in 1 patient (2%) in Group B.
Therefore, the incidence of complications was
greater in group A in comparison to group B.
This was found to be statistically significant as
the Z or normal deviate calculates is 4.05 (i.e.
>2) which is highly significant.
Therefore 25 microgram of vaginal Misoprostol
is much safer compared to 50 microgram.
Table 11: Neonatal outcome
GROUP A (n=50) GROUP B (N=50)
Neonatal
No. of No. of
outcome
patients
%
patients
% 12% of patients in Group A and 18% of patients
Total live birth 44 88 43 86
Total still birth 6 12 7 14
a)fresh 3 6 3 6
b)macerated 3 6 4 8
c)antepartum 4 8 7 14
d)intrapartum 2 4 - -
Early neonatal
3 6 2 4
death
In Group A 44 patients (88%) had live births and
6 (12%) had still births. 3 out of 6 births had
macerated baby in whom induction was done for
intrauterine fetal death. There were 3 fresh still
births (6%), out of which 2 were intrapartum:
one was a case of eclampsia with extreme
prematurity with baby weight 1.6 kg and another
was a case of congenitally anomalous child (Non
Immune Hydrops Fetalis). Third was a case of
abruptio placenta with FHS absent at the time of
admission. There were no still births due to
harmful effects of inducing agent. One case (2%)
had early neonatal death due to moderate birth
asphyxia. The induction was done in this patient
for PIH and the baby was IUGR. So the cause of
birth asphyxia could be PIH and IUGR and not
the inducing agent. 2 of the early neonatal death
were due to Hyaline Membrane Disease in
preterm.
In Group B, 43 out of 50 (86%) were live births.
There were 7 cases (14%) of still births. In which
4 cases (8%) were of macerated still birth
induced for intrauterine death and 3 cases (6%)
were of fresh still births. All the cases were
antepartum still births. 2 of the cases (4%) were
of early neonatal death. One was due to
prematurity with IUGR with abruptio placentae.
Other was due to severe birth asphyxia with milk
aspiration syndrome with respiratory failure with
shock.
47 Int J Int Med Res. 2016; 3(3):43-48
Vaginal Misoprostol efficacy for labour induction
DISCUSSION
A total of 100 patients were included in this
randomised prospective trial comparing 50
micrograms vaginal Misoprostol i.e. Group A
with 25 micrograms vaginal Misoprostol i.e.
Group B in order to find out a safe and effective
dose of Misoprostol for labour induction. 50
patients were included in each group.
The parity distribution was similar in each group
i.e. 54% nulliparous patients and 46% parous
patients, so the two groups were comparable.
in Group B had history of previous caesarean
section. The most common indication for labour
indication was premature rupture of membranes
and early rupture of membranes i.e. 46% in each
group. Second most common indication was
postdatism with 26% patients in Group A and
24% in Group B. At Bishop score 0-3, the rate of
successful induction in Group A was 90.91%
while in Group B, the rate was 83.3%. In patients
with Bishop score 4 or more than 4, whether in
Group A or Group B, all had successful
induction, that is 100%. Group B patients
required more number of doses for successful
induction and delivery than Group A. At the end
of 12 hours, only 4% patients in Group A require
subsequent dose, while in Group B 8% patients
require subsequent doses. Total amount of dose
administered in Group A was much more than
Group B i.e. maximum amount given after 4
doses in Group A was 200 microgram while in
Group B, even after 5 doses, the maximum
dosage was 125 microgram.
Nulliparous patients and patient who had
previous caesarean section who never had
vaginal delivery had higher chances of induction
failure. Overall outcome was 98% successful
induction in Group A and 92% successful
induction in Group B. Group A had higher
success rate than Group B. But this difference in
rate of successful induction is statistically
insignificant within 95% confidence limits.
The rate of caesarean section was higher in
Group B, but it was found to be statistically
insignificant. Misoprostol does not have any
significant side effects.
Mean induction delivery in patient with Bishop
Score between 0-3 was longer in Group B in
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both nulliparous and parous patient by 4.5 hours
and 2.9 hours respectively as compared to Group
A. In cases with Bishop Score >4, all the patients
had almost comparable induction delivery
interval irrespective of dose and parity.The need
for augmentation is similar in both groups i.e.
8%.
Overall rate of complication in Group A was
50% while in Group B was 22% which is
statistically significant within 95% confidence
limit. The most common complication was
meconium stained liquor which was 18% in
Group A and 12% in Group B; followed by post
partum bleeding and traumatic PPH which was
8% in Group A and 2% in Group B. This
suggests that 25microgram dose of vaginal
Misoprostol is safer. The inducing agent has no
impact on neonatal outcome.
CONCLUSION
From the study, it seems 50 micrograms vaginal
Misoprostol gives better results as compared to
25 micrograms, but statistically insignificant
within 95% confidence limits. Large number of
patients in both the study groups can give better
conclusions.
The data suggests that the most common
indication for induction of labour is premature
rupture of membranes followed by postdatism
and than hypertensive disorders.
Bishop score had greater bearing on success of
induction rather than the dose of Misoprostol.
The patient with Bishop score between 0-3 had
90-91% and 83.3% successful induction in
Group A and Group B respectively. While all
patients having Bishop score 4 or more than 4
had successful induction in both the groups.
The total number of doses required were more
with 25 micrograms Misoprostol than 50
micrograms Misoprostol, however the total
amount of Misoprostol used was more with 50
micrograms Misoprostol.
The rate of LSCS was similar in both the groups
i.e. 20% in Group A and 24% in Group B, this
difference was found to be statistically
insignificant.
The incidence of LSCS for fetal distress was
higher with 50 micrograms Misoprostol than
with 25 micrograms, but it was also found to be
statistically insignificant.
48 Int J Int Med Res. 2016; 3(3):43-48
Vaginal Misoprostol efficacy for labour induction
Mean induction delivery interval and duration of
first stage of labour was shorter with 50
micrograms of vaginal Misoprostol than 25
micrograms.
The requirement of augmentation in the form of
oxytocin, artificial rupture of membranes and
PGE2 is similar in both the groups.
Misoprostol does not have any significant side
effects.
The complications of Misoprostol in higher dose
of 50 micrograms are much more significant than
that in low dose of 25 micrograms.
As there was one case of rupture uterus in
previous caesarean patient so 50 micrograms for
labour induction should be used very cautiously
and judiciously in patients with previous
caesarean section.
In short, 25 micrograms vaginal Misoprostol
gives equivalent results of labour induction as 50
micrograms vaginal Misoprostol and the added
advantage is that it is much safer than 50
micrograms vaginal Misoprostol specially in
previous caesarean patients.
REFERENCES
1. Michael A. Freidman; Manufacturer’s
Warning regarding Unapproved Uses of
Misoprostol ; N Engl J Med 2001;344:61.
2. House committee on Government Reform
and Oversight. Off label drug use and FDA
review of supplemental drug applications :
hearing before the Subcommittee on Human
resources and Intergovernmental Relations.
104th congress, 2nd session, September 12th,
1996; 53-94.
3. Rayburn WF. A Physician’s prerogative to
prescribe drugs for off-lable uses during
pregnancy. Obst gynecol 1993; 81:1052-5.
4. Goldberg AB, Greenburg MB, DarneyPD.
Misoprostol and pregnancy. N Engl J Med
2001; 344:34-47.
5. Hale RW, Zinberg S. Use of Misoprostol in
pregnancy. N Engl J med 2001; 345-59.
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