Synopsis

For

FCPS (Obstetrics & Gynecology)

Comparison of Sublingual Misoprostol and per vaginal prostin

for induction of labour

By

Dr. Purnoor Abid

Supervisor

Dr. Nabia Tariq

Designation

Department of Obstetrics & Gynecology

Shifa International hospital, Islamabad

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INTRODUCTION

Induction of labour is the process of initiating contractions in pregnant persons who are

currently not in labour, to help them achieve vaginal delivery within 24 to 48 hours. 1, 2

Induction of labor is a common obstetric intervention that stimulates the onset of labor using

artificial methods.3 Cervical ripening is one of the methods used for labour induction; it is

“the use of pharmacological or other means to soften, efface, or dilate the cervix to increase

the likelihood of a vaginal delivery.”4

In the past 20 years prostaglandins have been used in a variety of formulations for labor

induction and cervical ripening. Prostaglandins were used intravenously in late 1960s but the

route of administration was associated with significant side effects. Literature supports the

use of two prostaglandin preparation for induction labor which includes dinoprostone

(prostaglandin E2) and misoprostol (prostaglandin E1). Misoprostol and dinoprostone are

equally efficacious in achieving spontaneous vaginal delivery, reduction in induction-delivery

interval and in reducing the need for oxytocin.5 Sublingual misoprostol is an effective way for

induction of labor at term. However, sublingual misoprostol has the advantage of easy

administration and may be more suitable than other routes.6

One trial reported that the induction to delivery interval was 4 hrs 2min with misoprostol

while 10 hrs 45 min with prostin, cesarean section rate was 6% with misoprostol while 26%

with prostin and meconium was passed in 4% cases with misoprostol while in 6% cases with

prostin (p<0.05).7 Another trial found that the induction to delivery interval was 14.42±7.182

hours with misoprostol while 14.73±7.022 hours with prostin, cesarean section rate was

26.3% with misoprostol while 35.1% with prostin, delivery within 12-24 hours in 88.8% vs.

90.2% and meconium was passed in 9.3% cases versus 8.8% cases, respectively (p>0.05).8

One more trial found that the induction to delivery interval was 1356±1033 min with

misoprostol while 1208±613 min with prostin, cesarean section rate was 32.9% with

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misoprostol while 27.3% with prostin, delivery within 12 hours in 13.8% vs. 15.1% and

meconium was passed in 22.2% cases versus 26.2% cases, respectively. The difference was

insignificant (p>0.05).9

The rationale of this study is to compare the outcome of Sublingual Misoprostol and per

vaginal prostin for induction of labour. Literature reported that the outcome of misoprostol

was good as compared to the prostin. However, controversial data has been retrieved from

literature. Moreover, the controversial data has been observed in Indian studies and also there

is no local study found in literature, which could help us to determine whether which drug is

more effective. So we want to conduct this study to find the more appropriate drug in order to

prevent complications of induction of labor. So that we may implement the results of this

study in local setting and update guidelines to implement more effective drug with less side

effects or without compromising the health of female and her neonate.

OBJECTIVE: To compare the outcome of Sublingual Misoprostol and per vaginal prostin

for induction of labour

OPERATIONAL DEFINITIONS:

Induction of labor: It is defined as the application of drugs to stimulate the uterine

contractions during pregnancy before labor begins on its own to achieve a vaginal birth

Outcome: It will be assessed in terms of following:

 Induction to delivery interval: it will be assessed in terms of minutes required from time

of induction till delivery of fetus

 Successful induction: It will be labeled if delivery occurs within 12 hours of induction

 Meconium passed: If thick yellowish green meconium observed in amniotic fluid during

labor

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 Mode of delivery: If there will be need to give incision in lower abdomen and delivery

the fetus due to reduced labor pains, failed induction, pathological cardiotocography, or

thick meconium stained liquor

 Need for second dose: It will be labeled if female will not deliver till 6-12 hours, then

second dose will be given

HYPOTHESIS: There is a difference in the outcome of Sublingual Misoprostol and per

vaginal prostin for induction of labour

MATERIAL AND METHODS

Study Design: Randomized controlled trial

Setting: Department of Obstetrics & Gynecology, Shifa International hospital, Islamabad

Duration: 6 months after approval of synopsis

Sample Size: Sample size of 90 females; 45 in each group is calculated with 80% power of

test, 5% level of significance and percentage of cesarean section i.e. 6% with sublingual

misoprostol and 26% with vaginal prostin for induction of labor

Sampling technique: Non probability purposive sampling

Sample selection

Inclusion criteria: Females of age 18-40 years, parity <5, presenting at gestational age >37

weeks (on LMP) undergoing induction of labor (as per operational definition)

Exclusion criteria

 Females with preeclampsia (BP≥140/90mmHg with proteinuria >+1 on dipstick method),

thyroid disorder (TSH>5mIU), liver disease (ALT & AST >40 IU), chronic or gestational

diabetes (BSR>200mg/dl), previous cesarean section(s)

 Abnormal placenta (previa, accreta, increta, abruption), amniotic fluid index <5cm or >21

cm (detected on ultrasound)

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 Multiple fetus, intrauterine growth restriction, congenital anomaly or macrosomia (fetal

weight >4kg) (detected on ultrasound), Ruptured membranes (on clinical examination)

Data Collection Procedure: After approval of synopsis, 90 females fulfilling selection

criteria will be enrolled in the study from OPD of Department of Obstetrics & Gynecology,

Shifa International hospital, Islamabad. After obtaining informed consent and demographic

information (name, age, parity, BMI, gestational age) will be recorded. Then females will be

randomly divided in two groups by using lottery method. In group A, 50mcg of misoprostol

sublingually will be given to all females. In group B, 3 mg of prostin gel will be given

intravaginally to all females. Then females will be followed-up in labor room till delivery.

The induction to delivery interval will be assessed in terms of minutes. Females will be

assessed 6 hourly for additional dose. If females will deliver within 12 hours, then successful

induction will be noted. Females will also be monitored continuously for meconium stained

liquor. Mode of delivery will also be noted (as per operational definition). All this

information will be recorded on a specially designed proforma (attached).

Data analysis: Data will be entered and analyzed through SPSS version 21. The quantitative

data like age, BMI, gestational age and induction to delivery interval will be presented as

mean ± SD. Qualitative variables like parity, delivery within 12 hours, need for additional

dose, meconium passed and mode of delivery will be presented as frequency and percentage.

Both groups will be compared for mean induction to delivery interval by using independent

samples t-test and for successful induction, meconium passed, need for additional dose and

mode of delivery by using chi-square test. P-value ≤ 0.05 will be taken as significant. Data

will be stratified for age, BMI, parity and gestational age. Post-stratification, both groups will

be compared for mean induction to delivery interval by using independent samples t-test and

for successful induction, meconium passed and mode of delivery by using chi-square test for

each strata. P-value ≤ 0.05 will be taken as significant.

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REFERENCES

1. Wing DA. Cervical ripening and induction of labor in women with a prior cesarean
delivery. UpToDate UpToDate 2015.
2. Grobman W. Cervical ripening and induction of labor in women with a prior cesarean
delivery. U: UpToDate, Post TW ur UpToDate [Internet] Waltham, MA: UpToDate 2019.
3. Tsakiridis I, Mamopoulos A, Athanasiadis A, Dagklis T. Induction of Labor: An
Overview of Guidelines. Obstetrical & Gynecological Survey 2020;75(1):61-72.
4. Chatsis V, Frey N. Misoprostol for Cervical Ripening and Induction of Labour: A
Review of Clinical Effectiveness, Cost-Effectiveness and Guidelines. Ottawa (ON): Canadian
Agency for Drugs and Technologies in Health; 2019. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK538944/.
5. Jha N, Sagili H, Jayalakshmi D, Lakshminarayanan S. Comparison of efficacy and
safety of sublingual misoprostol with intracervical dinoprostone gel for cervical ripening in
prelabour rupture of membranes after 34 weeks of gestation. Archives of gynecology and
obstetrics 2015 Jan;291(1):39-44.
6. Ayati S, Vahidroodsari F, Farshidi F, Shahabian M, Afzal Aghaee M. Vaginal versus
sublingual misoprostol for labor induction at term and post term: a randomized prospective
study. Iran J Pharm Res 2014 Winter;13(1):299-304.
7. Jahangir J, Mohd FZS. Sublingual misoprostol versus dinoprostone gel in labour
induction. New Indian J Obstet Gynecol 2020;6(2):127-30.
8. Raghavan JV, Pillai SK, Meera D. Intracervical dinoprostone versus sublingual
misoprostol for preinduction ripening of cervix. Indian Journal of Obstetrics and Gynecology
Research 2017;4(1):71-6.
9. Young DC, Delaney T, Armson BA, Fanning C. Oral misoprostol, low dose vaginal
misoprostol, and vaginal dinoprostone for labor induction: Randomized controlled trial. PloS
one 2020;15(1):e0227245.

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 PROFORMA

Comparison of Sublingual Misoprostol and per vaginal prostin for

induction of labour

Case No: Hospital No:

Name: w/o:

Age: BMI:

Gestational age: Parity:

Group: Misoprostol  Prostin 

Follow-up:

Induction to delivery interval: min

Delivery within 12 hours: Yes  No 

Need for additional dose: Yes  No 

Meconium passed: Yes  No 

Mode of delivery: Vaginal  Instrumental  Cesarean section 