Review of Literature Part2

7/26/2019 Review of Literature Part2

http://slidepdf.com/reader/full/review-of-literature-part2 1/22

Review of Literature

Pubmed, COCHRANE library and EMBASE searches were carried

out using the eywords miso!rostol, sublingual, labour, induction"

identi#ying studies !ublished in english between $%%$ to $%&'( )here

are a number o# studies which ha*e com!ared $'+g and '%+g

miso!rostol sublingually with other routes lie oral, *aginal and

buccal but to date no study has head to head com!ared $'+g

sublingual miso!rostol with '%+g sublingual miso!rostol #or induction o# labour at term( e ha*e analysed the studies in which

either $'+g or '%+g sublingual miso!rostol was com!ared with the

other routes and ha*e studied the e##icacy o# the sublingual

miso!rostol( )here are - studies com!aring '%+g sublingual and .

studies com!aring $'+g sublingual at / hour inter*als with the other

routes, there#ore we ha*e included only these studies( )he other

studies ha*e administered miso!rostol at 0 hourly inter*als( 1t has

been suggested that more trials should be conducted to test the

e##icacy o# lower dosages o# miso!rostol(

2ollowing studies com!ared '%+g sublingual miso!rostol

administered / hourly with the other routes(

Shetty et al (2002) com!ared the e##icacy, sa#ety and !atient

acce!tability o# miso!rostol administered sublingually with oral

administration #or cer*ical ri!ening at term in a randomised trial on

&%% women ha*ing similar demogra!hic !ro#ile with a !oor bisho!

score( )hey were the #irst one to study the sublingual route #or



induction o# labour( )here is no !re*ious re!ort( )hey di*ided the

!atients in two grou!s o# '% women each( One grou! was

administered '%+g by sublingual route and the other was gi*en the

same dose orally( )he dose was re!eated / hourly u! to a ma3imum o#

' doses or till the Bisho! score was - or more or till !atient

!rogressed into acti*e labour( 2ailed induction was considered i#

ade4uate cer*ical ri!ening was not achie*ed to allow arti#icial ru!ture

o# membranes and good uterine contractions were not established

e*en a#ter ' doses o# miso!rostol( )he !atient was then induced

#urther with !rostaglandin E$ gel at least / hours a#ter the last dose o#

miso!rostol or taen u! #or caesarean section( )he !rimary outcome

included number o# women deli*ering *aginally within $/ hours o#

initiation o# induction( Secondary outcome included induction5

deli*ery inter*al, total dose o# miso!rostol, need #or o3ytocinaugmentation, rate o# caesarean section, hy!erstimulation syndromes,

maternal side e##ects and neonatal outcomes including cord !H *alues

and N1C6 admissions( )here was no unsuccess#ul induction in the

sublingual grou! as &%%7 women had ade4uate cer*ical ri!ening and

good uterine contractions with ma3imum o# #i*e doses( A*erage dose

o# miso!rostol gi*en was &('8& and 9.(-7 o# the !atients deli*ered

#ollowing a single dose o# miso!rostol in the sublingual grou!(

Augmentation o# labour with o3ytocin was re4uired in ./7 o# the

!atients in the sublingual grou!( 1n the sublingual grou! 9.(-7

!atients deli*ered *aginally within $/ hours o# induction and the

mean induction to *aginal deli*ery inter*al was $% hours( )he mean



inter*al #rom induction to onset o# acti*e labour was &'8&$(9 hours

and the acti*e labour lasted #or /(:' hours( 1n the sublingual grou!

0$7 had normal *aginal deli*ery, $$7 had instrumental deli*ery and

&07 underwent caesarean section( Caesarean section in 07 o# the

cases was #or #oetal distress( One case ;$7< o# hy!erstimulation was

noted in the sublingual arm #or which caesarean section was done in

#oetal interest( Maternal side5e##ects in the #orm o# *omiting were

noted in &$7 o# the cases and there was no incidence o# diarrhoea in

the sublingual grou!( )he a*erage birth weight was .0%&8/.&(9gm(

)here were &%7 N1C6 admissions in the sublingual grou! although

none o# the neonates had an A!gar score=9 at ' minutes( -'(97

!atients in the sublingual grou! were satis#ied with their route o#

administration while &$7 o# the !atients re!orted un!leasant taste o#

the miso!rostol tablets( )he study concluded that sublingual route wasmore e##icacious and e4ually sa#e as the oral route( 1t seemed to be an

acce!table route #or the !atients enrolled in the study( Another

ad*antage is that sublingual miso!rostol could be administered

without re!eated *aginal e3amination(

Shetty et al (2002) conducted another non5blinded study to com!arethe e##icacy o# '%+g miso!rostol gi*en sublingually with &%%+g

administered by oral route #or cer*ical ri!ening and induction o#

labour at term along with a com!arison o# the !atient acce!tability o#

the two routes( )he $'% women included in the study were similar in

demogra!hic characteristics and were randomly allotted in the $

grou!s o# &$' each( )he dose was re!eated / hourly with assessment



o# !re5induction Bisho! score and a cardiotocogra!hic tracing !rior to

induction( 1# the !atient went in to acti*e labour or attained a Bisho!

score o# -, an arti#icial ru!ture o# membranes was !er#ormed( >abour

was augmented with o3ytocin i# re4uired at least / hours a#ter the last

dose o# miso!rostol had been gi*en( 2ailure o# induction was deemed

i# an arti#icial ru!ture o# membranes was not !ossible e*en a#ter

administration o# ' doses o# miso!rostol( 1n such cases the !atient was

either taen u! #or caesarean section or induced with !rostaglandin E$

gel at least 0 hours a#ter the administration o# last dose o# miso!rostol

as !er the !atient?s consent( )hey re!orted that 0$(-7 !atients in the

sublingual grou! deli*ered *aginally within $/ hours o# induction

with miso!rostol( 1n the sublingual grou!, the time taen #rom

induction to *aginal deli*ery was $&(-8&/(0 hours and the inter*al

#rom induction to acti*e labour was &'(08&$(. hours( )he duration o# acti*e labour was 0($8/(' hours( About hal# ;/-7< o# the !atients had

s!ontaneous *aginal deli*ery, $9($7 instrumental deli*ery and $/(-7

underwent caesarean section in the sublingual grou!( )he mean dose

o# miso!rostol administered was &('8%(-9 and 9/('7 re4uired @ust

one dose o# miso!rostol to deli*er( O3ytocin #or augmentation o#

labour was re4uired in /0(/7 o# the !atients( 6terine

hy!erstimulation was re!orted in &(07 o# the !atients( One !atient in

the sublingual grou! ;%(-7< had #ailure o# induction #ollowing which

she o!ted #or re5induction with PE$ gel but #inally had to undergo

caesarean section due to #ailed res!onse to the gel as well( )he

*arious indications #or caesarean section were &&($7 #or #oetal



distress, :(07 #or dystocic labour and .($7 had to undergo caesarean

in the second stage o# labour( 1n the sublingual grou! :$(07 women

#ound the sublingual route acce!table and -9(.7 were satis#ied with

their method o# induction( 1n the neonatal outcomes, the mean birth

weight re!orted was .'::8//. grams, :(07 were admitted to N1C6

and %(-7 had A!gar score =9 at ' minutes( Meconium stained li4uor

was re!orted in $&(07 o# the !atients( )hey concluded that '%+g

miso!rostol gi*en sublingually e*ery / hours has the same e##icacy

and sa#ety as &%%+g oral miso!rostol(

Wolf et al (2005) conducted a double5blinded randomised clinical

trial to study the e##icacy o# '%+g miso!rostol as com!ared to &%%+g

miso!rostol both gi*en sublingually #or induction o# labour( O# the

$%. !atients enrolled in the study #or medical or obstetric indications,

&%$ !atients were included in the '%+g miso!rostol grou! and &%&

!atients were gi*en &%%+g miso!rostol( )he !atients included in both

the grou!s had a similar demogra!hic !ro#ile( )he dose was re!eated

/ hourly till ade4uate uterine contractions o# at least . o*er a !eriod o#

&% minutes was established( Arti#icial ru!ture o# membranes was done

as soon as there was ade4uate cer*ical dilatation and head wasengaged( Ma3imum o# 0 doses o# miso!rostol was gi*en in each

grou!( 2ailure o# induction was deemed i# the !atient did not enter

acti*e !hase o# labour ;cer*ical dilatation /cm< within $/ hours o#

induction( Once in the acti*e !hase o# labour, augmentation with

o3ytocin was done i# necessary( Primary outcome included the time

taen #rom initiation o# induction o# labour to *aginal deli*ery(



Secondary outcomes included the rate o# *aginal deli*ery within &$

and $/ hours, mean dose o# miso!rostol administered in each grou!,

re4uirement o# o3ytocin #or augmentation o# labour, number o#

induction #ailures and neonatal outcomes( Preeclam!sia was the most

common indication #or induction( 1nduction to *aginal deli*ery

inter*al in the '%+g miso!rostol grou! was &'&.8:$0 minutes(

1nduction to total deli*eries ;*aginalo!erati*e< inter*al in the '%+g

grou! was &9'&8&$&& minutes( Percentage o# *aginal deli*eries

within &$ hours and $/ hours in the '%+g grou! was &'7 and .07,

res!ecti*ely( Need #or augmentation with o3ytocin was also lower in

the &%%+g grou! as com!ared to the '%+g sublingual grou!, 0&7 and

-&7, res!ecti*ely ;!D%(%%$<( )otal dose o# o3ytocin in the '%+g

miso!rostol grou! was ''$%;&:$95&&'9$< m6 whereas it was

..%%;:.%59:9.< m6 in the &%% +g miso!rostol grou!( )he !ercentageo# s!ontaneous *aginal deli*ery was almost same in both the grou!s5

097 in '%+g and 007 in &%%+g grou!( )he rate o# caesarean section

was $07 in '%+g and $&7 in &%%+g miso!rostol grou!s( accum and

#orce!s was a!!lied in $7 and '7 !atients in the '%+g grou!,

res!ecti*ely( )otal dose o# miso!rostol re4uired in the '%+g grou!

was &(98&(%0 and 0%7 deli*ered #ollowing a single dose o#

miso!rostol( Rate o# induction #ailure was signi#icantly lower in the

&%%+g grou! ;.97< as o!!osed to 0%7 !atients in the '%+g grou!

;!D%(%%$<( )achysystole was encountered more than double ;$.7< in

the &%%+g miso!rostol grou! as com!ared to &&7 in '%+g

miso!rostol ;!D%(%$<( Although tetanic contractions were more



#re4uently encountered in the '%+g miso!rostol grou! ;97< as

com!ared to the &%%+g grou! ;$7< but there was no statistically

signi#icant di##erence ;!D%(&9<( )here was also no statistically

signi#icant di##erence in the rate o# hy!erstimulation syndrome

obser*ed which was -7 in the '%+g grou! and &&7 in the &%%+g

grou! ;!D%(/0<( Maternal com!lications were obser*ed in $97 in the

'%+g sublingual grou! in the #orm o# nauseaF*omiting ;&07<,

bleeding ;$7< and endometritis ;&$7<( Abnormal #oetal heart tracing

was re!orted in -$7 in the '%+g sublingual miso!rostol grou! and

9.7 in the &%%+g grou! ;!D%(/0<( Perinatal outcomes in the '%+g

grou! in the #orm o# mean birth weight was $:0:89-% grams, N1C6

admissions were re!orted in &'7, A!gar score =9 at ' minutes was

seen in '7 and meconium staining o# li4uor was noted in &97( )hey

concluded that the higher dose o# &%%+g miso!rostol was moree##icacious #or cer*ical ri!ening and induction o# labour as com!ared

to '%+g miso!rostol, when both drugs are gi*en sublingually but is

associated with a higher incidence o# tachysytole and

hy!erstimulation syndrome(

Caliskan et al (2005) com!ared the e##icacy o# '%+g sublingualmiso!rostol with '%+g *aginal #or induction o# labour at term in a

randomised controlled trial on &0% women( Gose was re!eated /

hourly till a ma3imum o# 0 doses( 2urther dosing was withheld i# the

!atient had more than . contractions in &% minutes( 1# the !atient

entered acti*e labour or the Bisho! score was -, amniotomy was

!er#ormed and !atient was augmented with o3ytocin i# re4uired,



atleast / hours a#ter the last dose o# miso!rostol( 1n !atients who

#ailed to deli*er within $/ hours, o3ytocin was used as an alternate

induction method( )he !rimary outcome was the mode o# deli*ery(

Secondary outcomes included time taen #rom the induction to

*aginal deli*ery, rate o# deli*eries within $/ hours and &$ hours,

mean dose o# miso!rostol gi*en, need #or augmentation with

o3ytocin, uterine hy!erstimulation syndromes, rate o# emergency

caesarean sections #or #oetal distress and neonatal outcome( )he

number o# women deli*ering within $/ hours and &$ hours in the

sublingual grou! was :$('7 *s :&(.7 in the *aginal grou! ;!D%(9-<

and 0$('7 *s 0'7 ;!D%(9/<, res!ecti*ely( )he outcome o# sublingual

grou! was not statistically signi#icant when com!ared with the

*aginal grou!( )he induction to deli*ery inter*al was shorter in the

sublingual grou! ;9&&8/$' minutes< than the *aginal grou! ;9/-8.9:minutes, !D%('0< but this di##erence was not statistically signi#icant(

)he rate o# s!ontaneous *aginal deli*ery was 9-(-7 in the sublingual

grou! as com!ared to -&(.7 in the *aginal grou! ;!D%(0:< and $(''

had instrumental *aginal deli*ery *s &(.7 in the *aginal grou!

;!D%('9<( Caesarean section was done in &-(-7 women gi*en

sublingual miso!rostol, out o# which &$ women ;&'7< underwent

caesarean section #or #oetal distress( )he number o# doses re4uired

was signi#icantly more in the sublingual grou! ;&(:8 &($< as com!ared

to the *aginal grou! ;&(&8%(/, ! %(%%&<( aginal deli*ery #ollowing˂

single dose o# sublingual miso!rostol was '&(.7 while it was 9&($7

in *aginal route ;!D%(%&<( Rate o# tachysystole was signi#icantly



higher in the sublingual grou! ;&9('7< as com!ared to .(-7 in the

*aginal grou! ;!D%(%%'<( O3ytocin was needed #or augmentation o#

labour in '&(.7 in the sublingual grou! and /$('7 !atients in the

*aginal grou! ;!D%($0<( )ocolytic ;ritodrine< #or abnormal uterine

contractility was needed in .(-7 o# the !atients in the sublingual

grou! ;!D%(%-<( Neonatal outcomes in the #orm o# mean birth weight

was .$:-8'&/ grams in the sublingual grou!, N1C6 admission was

needed in .(-7 and meconium stained li4uor was obser*ed in &&(.7

o# the !atients in sublingual grou!( )hey concluded that '%+g

sublingual is as e##icacious as '%+g *aginal #or induction o# labour at

term although the incidence o# tachysystole in the sublingual grou! is

signi#icantly higher(

Bartusevicius et al ;2006< conducted a double5blinded, randomised

controlled study on &/% women #or induction o# labour at term to

com!are the e##icacy and sa#ety o# '%+g miso!rostol gi*en by

sublingual route with $'+g miso!rostol gi*en *aginally / hourly to a

ma3imum o# 0 doses( )he women enrolled were di*ided into two

e4ual grou!s, 9% in each grou!( 2urther dosing was withheld when

!atient entered acti*e labour ;cer*ical dilatation. cm<, Bisho! scorewas - or till good uterine contractions were established( Arti#icial

ru!ture o# membranes was !er#ormed as soon as ade4uate cer*ical

dilatation and #oetal head engagement was attained and augmentation

with o3ytocin was done i# re4uired, a#ter a ga! o# at least / hours

#rom the last dose o# miso!rostol administered( Monitoring was done

with continuous #oetal cardiotocogra!hy( )he !rimary outcome o# the



study was the number o# women deli*ering *aginally within $/ hours

o# initiation o# induction( Secondary outcome measures included

number o# women deli*ering within &$ hours o# induction, induction5

deli*ery inter*al, number doses o# miso!rostol administered, o3ytocin

augmentation, rate o# hy!erstimulation syndromes, neonatal outcomes

and maternal ad*erse e##ects( 1n the sublingual grou! -.7 !atients

deli*ered *aginally within $/ hours and &:7 deli*ered *aginally

within &$ hours as com!ared to 907 and &.7 in *aginal grou!( )his

di##erence was not statistically signi#icant ;&(& RR, C1 %(:5&(.< and

;&(/ RR, C1 %(95.($<, res!ecti*ely( 1nduction to *aginal deli*ery

inter*al was signi#icantly shorter in the sublingual grou! ;&'8.(9h< as

com!ared to *aginal grou! ;&0(98/(&h, !D%(%.<( )he a*erage dose o#

miso!rostol in the sublingual grou! was signi#icantly lower, &('8%('

*s &(-8%(0 in the *aginal grou! ;!D%(%%&<( S!ontaneous *aginaldeli*ery was re!orted in 907, instrumental deli*ery in 9(&7 and

caesarean section was done in &97 !atients in the sublingual grou!

which was 997, $(:7 and $%7 res!ecti*ely in the *aginal grou!(

)his di##erence was not statistically signi#icant( Caesarean section

was !er#ormed #or #oetal distress in &%7 in the sublingual grou! and

&&7 in the *aginal grou!, #or arrest o# labour in the #irst stage in /(.7

in the sublingual and $(-7 in the *aginal grou! and in the second

stage in $(:7 o# the !atients in the sublingual grou! *s /(.7 in the

*aginal grou!( Need o# o3ytocin was re!orted in /:7 o# the !atients

in both the grou!s( )achysystole was seen in &/7 !atients in the

sublingual grou! which was . times higher than the *aginal grou!



where it was /(.7( 1ncidence o# hy!ertonus and hy!erstimulation

syndrome was re!orted in $(:7 and 9(&7 o# the !atients in the

sublingual grou! *s /(.7 and 9(&7 in the *aginal grou!, res!ecti*ely(

Perinatal outcomes in the #orm o# mean neonatal birth weight was

.'0-(.8.9&(0 grams in the sublingual grou! and .'/:(/8.0&(: grams

in the *aginal grou!( N1C6 admissions and A!gar score =9 at '

minutes was similar in both grou!s ;$(:7<( Meconium !assage was

re!orted in $97 o# the !atients in both the grou!s( )hey concluded

that '%+g sublingual miso!rostol gi*en / hourly #or induction o#

labour at term has similar e##icacy as $'+g *aginal miso!rostol and

ha*e suggested to conduct #urther studies in larger number o# women(

Nassar et al (200) conducted a !ros!ecti*e randomised controlled

trial on &9% women at term gestation #or induction o# labour to

com!are !atient satis#action with sublingual and *aginal routes o#

administration o# miso!rostol( A#ter initial assessment o# Bisho! score

and C) monitoring, the women were di*ided into two grou!s( One

grou! recei*ed '%+g miso!rostol sublingually and in the other '%+g

miso!rostol was administered *aginally, both re!eated / hourly u! to

a ma3imum o# ' doses or till !atient either entered acti*e labour or aBisho! score - was attained( Arti#icial ru!ture o# membranes was

!er#ormed therea#ter( )he !atient was augmented with o3ytocin at

least / hours a#ter the last dose o# miso!rostol, i# re4uired( 2ailed

induction was deemed i# !atient did not enter the acti*e !hase o#

labour e*en a#ter ' doses o# miso!rostol( She was then o##ered a

caesarean section or #urther induction with o3ytocin in#usion( )he



!rimary outcome measure was the !ro!ortion o# !atients satis#ied

with the route o# administration o# miso!rostol which was de#ined as

the !atient !re#erence #or the same route in any subse4uent !regnancy(

Secondary outcome *ariables included *aginal deli*eries not achie*ed

within &$ and $/ hours, induction5deli*ery inter*al, mean doses o#

miso!rostol, need #or o3ytocin, #ailed inductions, emergency

caesarean sections, maternal side5e##ects and neonatal outcomes(

Patient satis#action rates were signi#icantly higher in the sublingual

grou!, 99(07 *s $'7 in the *aginal grou! and !atients had a more

!ositi*e a!!roach towards induction in the sublingual grou! in

subse4uent !regnancies ;.(& RR, :'7 C1 $($5/('<( )he number o#

!el*ic e3aminations done were also signi#icantly lower in the

sublingual grou! ;08$< as com!ared to *aginal grou! ;:8.,

! %(%%&<(aginal birth not achie*ed within &$ hours and $/ hours˂

were 0%7 and .'(.7, res!ecti*ely in the sublingual grou! *s '$(:7

and .&(-7 in the *aginal grou!( 1nduction to *aginal deli*ery inter*al

was &%(-8/(.hours in the sublingual grou! which was less than the

time taen in the *aginal grou! ;&&($8/(-h, !D%(0/<( 1nduction to the

total deli*eries inter*al was &&(08'(. hours in the sublingual grou! *s

&&('8'(& hours in the *aginal grou! ;!D%(:%<( 1n the sublingual grou!

'-(-7 had s!ontaneous *aginal deli*eries, '(:7 had instrumental

deli*eries and .'(.'7 underwent caesarean section as com!ared to

*aginal which was '9(97, &/(&7 and $-($7, res!ecti*ely( )he

*arious indications o# caesarean section were arrest o# dilatation in

&/(&7, arrest o# descent in .('7, NR2HR in &$(:7 and #ailed



induction in .('7 in the sublingual grou!( )here were no statistically

signi#icant di##erences between the two grou!s e3ce!t #or a higher

caesarean section rate #or arrest o# dilatation in the sublingual grou!

where it was &/(&7 *s /(97 in the *aginal grou! ;RR .(%, :'7 C1

&(&5-(9<( )he total number o# miso!rostol tablets re4uired were

&(08%(- in the sublingual grou! and &(08&(% in the *aginal grou!

;!D&(%%<( A#ter a single dose o# miso!rostol, '/(&7 !atients deli*ered

in the sublingual grou! as com!ared to //(97 in the *aginal grou!(

O3ytocin was re4uired in -&($7 o# the !atients and the ma3imum

dose re4uired was &$($8&&(0 m6 in the sublingual grou!(

)achysystole was re!orted in &%(0'7, hy!erstimulation in -($7 and

terbutaline was re4uired in &&(-7 o# the !atients in the sublingual

grou!( Maternal ad*erse e##ects o# the drug in the #orm o# headache

and #e*er occurred in $(.7 in the sublingual grou! and /(97 and.('7 in the *aginal grou!, res!ecti*ely( Nausea and *omiting were

re!orted in /(97 and .('7, res!ecti*ely in the sublingual grou! and

in .('7 and $(.7 in the *aginal grou!( )hey concluded that

sublingual route was !re#erred #or induction o# labour at term as

com!ared to the *aginal route but they stated that #urther studies need

to be conducted to ascertain the sa#ety o# sublingual route be#ore

ad*ocating it as the route o# choice #or induction o# labour with

miso!rostol(

!alik et al (20"0) com!ared the e##icacy and sa#ety o# '%+g

sublingual miso!rostol with &%%+g oral miso!rostol #or induction o#

labour at term in a randomised controlled trial which included &%%



!rimigra*ida with !re5labour ru!ture o# membranes( )he women were

induced at least 0 hours a#ter ru!ture o# membranes( All the women

had a similar demogra!hic !ro#ile( rou! A included '% women who

were administered &%%+g oral miso!rostol / hourly u! to $ doses and

grou! B included '% women who were gi*en '%+g sublingual

miso!rostol / hourly u! to $ doses( )he dose was re!eated i# Bisho!

score remained un#a*ourable and good uterine contractions were not

established( >abour was augmented with o3ytocin in case o# slow

!rogress( Outcome measures included were induction5deli*ery

inter*al, need #or o3ytocin administration, mode o# deli*ery, uterine

hy!erstimulation syndromes, side5e##ects o# miso!rostol and neonatal

outcome( 1n the sublingual grou!, :%7 women deli*ered *aginally

whereas 907 deli*ered in oral grou! ;!%(%'<, caesarean section was

!er#ormed in -7 women in sublingual grou! and $%7 in oral grou!and $7 had instrumental deli*ery in sublingual grou! as com!ared to

/7 in oral grou!( 2ollowing single dose o# sublingual '%+g

miso!rostol, 0/7 women deli*ered whereas only .$7 deli*ered in

the oral grou! ;! %(%'<( Only .07 women re4uired a second dose o# ˂

miso!rostol in the sublingual grou! as com!ared to 0-7 in the oral

grou!( 1n the sublingual grou!, .07 women re4uired augmentation

with o3ytocin which was signi#icantly less than the *aginal grou! in

which 9%7 women re4uired o3ytocin ;! %(%'<( )achysystole was˂

obser*ed in &%7 women gi*en sublingual miso!rostol as com!ared to

$7 in oral grou! ;!%(%'<( omiting was noted in &%7 o# the women

in both the grou!s ;!%(%'<( Occurrence o# meconium staining o#



li4uor was almost similar, -7 in sublingual grou! and &$7 in oral

grou!( N1C6 admission was also not signi#icantly di##erent, -7 in

sublingual and &$7 in oral grou! ;!%(%'<( )hey concluded that '%+g

sublingual miso!rostol has similar e##icacy and sa#ety as &%%+g oral

miso!rostol #or induction o# labour in women with !re5labour ru!ture

o# membranes(

#ayy$a et al (20"%) conducted a randomised controlled double5

blinded trial on &/% women at term gestation to com!are the e##icacy

and sa#ety o# '%+g sublingual miso!rostol with $'+g miso!rostol

administered *aginally #or induction o# labour( All the women

enrolled in the study had a similar demogra!hic !ro#ile( One grou!

;nD9$< was administered '%+g sublingual miso!rostol with a *aginal

!lacebo and the other grou! was gi*en $'+g *aginal miso!rostol with

a sublingual !lacebo ma3imum u! to 0 doses re!eated / hourly(

2urther doses were withheld i# at least . uterine contractions occurred

in &% minutes, !atient entered acti*e labour or cer*i3 was #a*ourable

#or amniotomy( Patient was augmented with o3ytocin / hours a#ter the

last dose o# miso!rostol i# needed( Primary outcome included the

number o# women deli*ering *aginally within $/ hours o# induction(Secondary outcomes included the number o# women deli*ering within

&$ hours o# induction, induction to *aginal deli*ery inter*al, mean

dose o# miso!rostol re4uired, mode o# deli*ery, need o# o3ytocin,

uterine hy!erstimulation, maternal side5e##ects and neonatal outcome(

)he !ercentage o# women deli*ering *aginally within $/ hours was

statistically not di##erent in the two grou!s, -.7 !atients in the



sublingual grou! and 907 in the *aginal grou! ;RR &(&, :'7 C1 %(:5

&(.<( Sublingual grou! had the ad*antage o# a shorter induction to

deli*ery inter*al ;&'8.(9h< as com!ared to the *aginal grou! where it

was &98/(& hours ;!D%(%%.<( )hey ha*e mentioned that the mean

number o# doses was also signi#icantly lower in the sublingual grou!

but ha*e not mentioned the absolute number( )achysystole was also

#ound three times more #re4uently in the sublingual grou! ;&/7 *s

/(.7< as com!ared to the *aginal grou!( Hy!erstimulation syndrome

was obser*ed in 9(&7 in both the grou!s( )hey ha*e concluded that

'%+g miso!rostol gi*en sublingually has similar e##icacy as $'+g

miso!rostol administered by *aginal route at term #or cer*ical

ri!ening and labour induction(

2ollowing studies com!ared $'+g miso!rostol administered

sublingually with the other routesI

Siwatch et al (20"2) conducted a randomiJed controlled trial on &0%

!atients to study the sa#ety and e##icacy o# $'+g miso!rostol gi*en by

the sublingual route as com!ared to the *aginal route #or cer*ical

ri!ening and induction o# labour at term( )he !atients were di*ided

into two grou!s with -% women in each grou!( )he grou!s were

similar in demogra!hic characteristics, !re5induction Bisho! score

and indications #or induction o# labour( rou! 1 recei*ed $'+g

miso!rostol *aginally and grou! 11 recei*ed the same dose by

sublingual route( )he dose was re!eated / hourly till regular uterine

contractions ;. contractions in &% minutes< were established or till



onset o# acti*e labour ;cer*ical dilatation.cm< or Bisho! score- or

till a ma3imum o# 0 doses( )he !rimary outcome included the total

!ercentage o# women deli*ering *aginally( Secondary outcomes

analysed were !ercentage o# women not deli*ered within $/ hours,

induction to deli*ery inter*al, number o# doses o# miso!rostol needed,

rate o# disorders o# uterine contractility, maternal side e##ects o#

miso!rostol, !ercentage o# #oetal distress and neonatal outcomes in

terms o# A!gar score and N1C6 admission( 1n both the grou!s $&7 o#

the !atients did not achie*e *aginal deli*ery within $/ hours o#

induction ;!D&(%<( Mean induction to deli*ery inter*al was also

similar in both the grou!s ;&'($'8'(%. hours in sublingual grou! and

&0(&98'(:0 hours in *aginal grou!<( 1n the sublingual grou! --(97

and :&($7 in the *aginal grou! ;!D%(0%< deli*ered *aginally( 1n

sublingual grou! &&(.7 and -(-7 in *aginal grou! underwentcaesarean section ;!D%(-.<( Caesarean section in sublingual grou!

was !er#ormed #or #oetal distress only in &&(&&7 *s /$(-'7 in *aginal

grou!, #or NPO> in ..(..7 in sublingual *s $-('97 in *aginal grou!

and #or meconium stained li4uor in ''(''7 *s $-('97 in *aginal

grou!( Mean dose o# miso!rostol re4uired was $(%'8%(:- in the

sublingual grou! and &(-&8%(-/ in *aginal grou! ;!D%(&%<( O3ytocin

was needed in .-(-7 in sublingual grou! and in $-(-7 in *aginal

grou! ;!D%(&-<( Mean dose o# o3ytocin re4uired was .'(0&8$&(: 16

in the sublingual grou! and /%(98$$(/ 16 in the *aginal grou!

;!D%(/%<( )achysystole, hy!ertonus and hy!erstimulation syndrome

and use o# terbutaline each was re!orted in %(%&7 o# the !atients in



both the grou!s( Maternal side e##ects in the #orm o# nausea, *omiting

was noted in .(9'7 in the sublingual grou! and $('7 in the *aginal

grou! ;!D&(%<( )here was no !ost!artum haemorrhage in the

sublingual grou! as com!ared to %(%&7 in the *aginal grou! ;!D&(%<(

Perinatal outcomes in the #orm o# mean neonatal weight was

$(0-8%(.. grams in the sublingual grou! and $(9:8%(.-: grams in the

*aginal grou! ;!D%(%'-<( A!gar score at & minute was -($%8%('/ and

at ' minute was :(&&8%(.0 in the sublingual grou! and -(%%8&(/% and

-(:.8%(-$ in the *aginal grou!, res!ecti*ely ;!D%($./, !D%(%0.<(

)hey concluded that miso!rostol in a dose o# $'+g was e4ually sa#e

and e##ecti*e by both *aginal and sublingual routes(

&yati et al (20"'< !er#ormed a clinical trial on &/% !regnant women

with similar demogra!hic characteristics to com!are the e##icacy and

sa#ety o# $'+g miso!rostol gi*en sublingually com!ared to *aginal

route #or induction o# labour at term( )he !atients, with a medical or

obstetric indication #or induction o# labour, were randomly di*ided

into two grou!s( One grou! had :% cases who were administered

$'+g miso!rostol sublingually and the other grou! included '% cases

who were gi*en $'+g miso!rostol *aginally at / hourly inter*als tillgood uterine contractions were established or u! to a ma3imum o# 0

doses( Patient was diagnosed as #ailed induction i# she did not enter

acti*e labour / hours a#ter the last dose o# miso!rostol administered

and o3ytocin in#usion was used to augment labour( )he !rimary

outcome measure included rate o# *aginal deli*ery within $/ hours

#rom the initial dose gi*en( Secondary outcomes analysed were rates



o# caesarean section #or #oetal distress, initial dose to acti*e labour

inter*al, induction to deli*ery inter*al, mean dose o# miso!rostol used

in the two grou!s, duration o# labour, need #or augmentation with

o3ytocin and neonatal outcomes( No signi#icant di##erence was

obser*ed in the outcomes studied in the $ grou!s( 1n the sublingual

grou!, -/(-7 !atients deli*ered *aginally as com!ared to :%7 in the

*aginal grou! ;PD%(0%<( Caesarean section was !er#ormed #or #oetal

distress in /(.7 in sublingual grou! and /7 in *aginal grou!, #or

absence o# acti*e labour in 0('7 in sublingual grou! *s $7 in *aginal

grou! and #or #ailure o# !rogression o# labour in .(.7 in sublingual as

com!ared to /7 in *aginal grou!( 1nduction to deli*ery inter*al was

&&(0$80(90 hours in sublingual grou! and &&(%-8.(/& hours in *aginal

grou! ;!D%(-$<, induction to onset o# acti*e labour inter*al was

-(-&80(%9 hours and the acti*e !hase o# labour lasted #or $(-:8&(:%hours in the sublingual grou! while it was -('-8'(&- hours and

$(-98&(9$ hours res!ecti*ely in *aginal grou!( 2ollowing a single

dose o# miso!rostol //(07 deli*ered, $9($7 deli*ered a#ter two

doses, &.7 a#ter three doses, -(97 a#ter / doses, $($7 a#ter #i*e doses

and /(.7 a#ter 0 doses, in the sublingual grou!( 1n the *aginal grou!

'%7 deli*ered a#ter single dose o# miso!rostol ;!D%($$<, ./7 a#ter $

doses ;!D%(/.<, 07 a#ter . doses ;!D%(&:<, -7 a#ter #our doses

;!D%(9:<, $7 a#ter ' doses ;!D%(:/<( Si3th dose was not re4uired in

the *aginal grou!( Maternal com!lications in the #orm o# abdominal

!ain ;'('7< and *omiting ;&$7< was more commonly seen in

sublingual grou! as com!ared to *aginal grou! where it was $7 and



&%7, res!ecti*ely( )his di##erence was not statistically signi#icant,

!D%($. and !D%(./, res!ecti*ely( )achysystole was noted in $($7 o#

the !atients in the sublingual grou! and $7 in the *aginal grou!

;!D%(0'<( Meconium staining o# li4uor was !resent in '7 o# the

!atients in sublingual and 07 in the *aginal grou! ;!D&<( )hey

concluded that $'+g sublingual miso!rostol is as e##ecti*e as $'+g

*aginal miso!rostol #or induction o# labour at term along with the

added ad*antage o# greater !atient acce!tability in terms o# ease o#

administration(

Sharai et al ;20"'< com!ared the sa#ety and e##icacy o# $'+g

sublingual miso!rostol with '%+g intra*aginal miso!rostol #or

cer*ical ri!ening in !rimi!arous #emales in a double5blinded !arallel

randomised controlled( )he 0. !atients included in grou! 1 were gi*en

'%+g miso!rostol *aginally with sublingual !lacebo and the 0.

!atients in grou! 11 were gi*en $'+g sublingual miso!rostol with

*aginal !lacebo( )he drug was gi*en / hourly u! to a ma3imum o# /

doses or till #re4uency o# . contractions in &% minutes was established

or till !atient went into acti*e labour( Arti#icial ru!ture o# membranes

was done in the acti*e !hase o# labour and labour was augmentedwith o3ytocin i# re4uired, atleast / hours a#ter last dose o#

miso!rostol( )he time inter*al #rom the initial dose o# miso!rostol to

*aginal deli*ery was the !rimary outcome( )he secondary outcomes

included #re4uency o# deli*eries within &$h and $/h o# induction,

mode o# deli*ery, total dose o# miso!rostol gi*en, bisho! score

#ollowing each dose, need #or augmentation with o3ytocin and uterine



hy!erstimulation syndromes along with neonatal outcomes lie birth

weight, & and ' min A!gar score, !assage o# meconium and N1C6

admissions( No signi#icant di##erence was seen in the inter*al #rom

the induction to *aginal deli*ery in either grou! ;&.(&8.(/0h in the

sublingual grou! and &.(&8.(&h in *aginal grou!, !D%(-0.<(

2ollowing induction o# labour there was mared im!ro*ement in

Bisho! score seen / hourly in both the grou!s( 1t was im!ro*ed to

.(98$(/ in sublingual and /(&8$(& in *aginal grou! ;!D%(.$&<

although the di##erence was not statistically signi#icant( )he mean

dose o# miso!rostol administered in the sublingual grou! was

.-('8&/+g which was #ound to be signi#icantly lower than the *aginal

grou! where it was -/(:8..+g ;!D%(%%&<( No signi#icant di##erence

was #ound in any o# the other !arameters studied lie time inter*al

#rom initial induction to the acti*e !hase o# labour ;9(08.($ hours insublingual grou! *s 9(.8. hours in *aginal< or rate o# *aginal deli*ery

be#ore &$ and $/ hours ;'$(-7 and &%%7, res!ecti*ely in sublingual

grou! as com!ared to '.(.7 and &%%7 in *aginal grou!<( )otal

*aginal deli*eries which was -/(&7 in sublingual grou! and 9&(/7 in

the *aginal grou! ;!D%(&..<( )otal caesarean deli*eries were &'(:7 in

the sublingual grou! and $-(07 in the *aginal grou! ;!D%(&..<(

Emergency caesarean section was re4uired in .($7 ;nD$< cases #or

#oetal distress in the sublingual grou! and in 9(:7 ;nD'< cases in

*aginal grou! ;!D%(//%<( )he other indications #or caesarean section

were NPO> in 0(.7 in sublingual grou! *s 9(:7 in *aginal grou!

;!D&< and MS> in 0(.7 in sublingual grou! *s &$(97 in *aginal



grou! ;!D%(.0.<( Rate o# hy!erstimulation syndrome was noted in

9(:7 in the sublingual grou! and in .($7 in *aginal grou! ;!D%(//%<(

Augmentation with o3ytocin was re4uired in $%(07 in the sublingual

grou! whereas only :('7 re4uired o3ytocin in *aginal grou!

;!D%(&.9<( Perinatal outcomes in the #orm o# mean birth weight was

.$.98.-: grams in the sublingual grou! and .$0-8.&/ grams in the

*aginal grou! ;!D%(0$.<( A!gar score at & minute was less than 9 in

&/(.'7 in the sublingual grou! and 0(.7 in the *aginal grou!

;!D%($/&<( )he !ercentage o# N1C6 admissions were &(07 in the

sublingual grou! and .($7 in the *aginal grou! ;!D&<( )he study

concluded that $'+g sublingual miso!rostol was as sa#e and

e##icacious as '%+g miso!rostol gi*en by *aginal route but #urther

studies are still needed to establish the sa#ety and e##icacy o#

sublingual route(

Documents

Review of Literature Part2