Cervical lacerations in planned versus labor cerclage removal: A systematic review

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Review

Cervical

lacerations

in

planned

versus

labor

cerclage

removal:

a

systematic

review

Giuliana

Simonazzi

a

,

Alessandra

Curti

a

,

Maria

Bisulli

a

,

Viola

Seravalli

b

,

Gabriele

Saccone

c

_,

_Vincenzo

_Berghella

d,

_*

a

DepartmentofMedicalSurgicalSciences,DivisionofObstetricsandPrenatalMedicine,St.OrsolaMalpighiHospital,UniversityofBologna,Bologna,Italy

b

DepartmentofGynecologyandObstetrics,TheJohnsHopkinsHospital,Baltimore,MD,USA

c

DepartmentofNeuroscience,ReproductiveSciencesandDentistry,SchoolofMedicine,UniversityofNaplesFedericoII,Naples,Italy

d_Division_of_{Maternal-Fetal}_Medicine,_Department_of_Obstetrics_and_Gynecology,_Sidney_Kimmel_Medical_College_of_Thomas_Jefferson_University,_{Philadelphia,}

PA,USA

Contents

Introduction... 19

Materialsandmethods... 20

Results... 20 Comment... 21 Conﬂictsofinterest... 22 Fundingstatement ... 22 References... 22 Introduction

Evidencesuggeststhatcervicalcerclageiseffectiveinreducing theincidenceofpretermbirthinsingletonpregnanciesatriskof recurrent preterm birth [1,2]. Although it is a relatively easy proceduretoperform,it isassociatedwithpregnancy

complica-tions. In particular, women with a cerclage in place can have

EuropeanJournalofObstetrics&GynecologyandReproductiveBiology193(2015)19–22

ARTICLE INFO

Articlehistory:

Received18March2015

Receivedinrevisedform21May2015 Accepted30June2015 Keywords: Pretermbirth Pretermlabor Labor Cervicallacerations ABSTRACT

Objective:Theaimofthisstudywastoevaluatetheincidence ofcervicallacerations withcerclage

removalplannedbeforelaborcomparedtoaftertheonsetoflaborbyasystematicreviewofpublished

studies.

Studydesign: Searcheswereperformedinelectronic databasesfrominceptionof eachdatabaseto

November2014. Weidentiﬁedallstudiesreportingtherateofcervicallacerationsandthetimingof

cerclageremoval(eitherbeforeoraftertheonsetoflabor).Theprimaryoutcomewastheincidenceof

spontaneous and clinically signiﬁcant intrapartum cervical lacerations (i.e. lacerations requiring

suturing).

Results:Sixstudies,whichmettheinclusioncriteria,wereincludedintheanalysis.Theoverallincidence

ofcervicallacerationswas8.9%(32/359).Therewere23/280(6.4%)cervicallacerationsintheplanned

removalgroup,and9/79(11.4%)intheremovalafterlaborgroup(oddsratio0.70,95%conﬁdence

interval0.31–1.57).

Conclusions: Insummary,plannedremovalofcerclagebeforelaborwasnotshowntobeassociatedwith

statisticallysigniﬁcantreductionintheincidenceofcervicallacerations.However,sincethatourdata

probablydidnotreachstatisticalsigniﬁcancebecauseofatypeIIerror,furtherstudiesareneeded.

ß2015ElsevierIrelandLtd.Allrightsreserved.

* Correspondingauthorat:DivisionofMaternal-FetalMedicine,Departmentof Obstetricsand Gynecology,Thomas JeffersonUniversity, 833Chestnut Street, Philadelphia,PA19107,USA.Tel.:+12159557996;fax:+12159555041.

E-mailaddress:Vincenzo.berghella@jefferson.edu(V.Berghella).

ContentslistsavailableatScienceDirect

European

Journal

of

Obstetrics

&

Gynecology

and

Reproductive

Biology

j o urn a l hom e pa ge : ww w. e l s e v i e r. c om/ l o ca t e / e j ogr b

http://dx.doi.org/10.1016/j.ejogrb.2015.06.032

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cervicalinjuriesduringlabor[3].Thesuturemaytearthroughthe

cervix during the shortening and dilatation which occur in

particularwithuterinecontractions.

Because of this concern, cerclage removal has been

recom-mendedbymany as a planned out-patientprocedure once the

patientreaches36–37weeks[4–6].Othershaveinsteadreported favorableoutcomeswhenallowingwomentoretaincerclageuntil theonsetoflaborevenatterm[7].Moreover,themeaninterval betweenelectivecerclageremovalandspontaneousdeliveryis14

daysandwomenwithcerclagewhoachieved36–37weekshada

chanceofspontaneousdeliverywithin48hofonly11%[8].

There are no randomized studies and limited literature

comparing cerclage removal before (planned) versus after the

onsetoflabor.

Theaimofthisstudywastoevaluatetheincidenceofcervical lacerationswithcerclageremovalplannedbeforelaborcompared toaftertheonsetoflaborbyreviewofpublishedstudies.

Materialsandmethods

SearcheswereperformedinMEDLINE,OVID,Scopus, Clinical-Trials.gov, the PROSPERO International Prospective Register of

SystematicReviews, EMBASE,ScienceDirect.com,MEDSCAPEand

theCochraneCentralRegisterofControlledTrialswiththeuseofa combinationoftextwords relatedto‘‘cerclage,’’‘‘pretermbirth’’ and ‘‘cervical lacerations’’ from inception of each database to November2014.Norestrictionsforlanguageorgeographiclocation wereapplied.Inaddition,thereferencesofalltheincludedstudies werescreenedforanypotentiallyrelevantstudies.

We identiﬁed observationalstudies (eithercohort andcase– controlstudies)reportingtherateofcervicallacerationsandthe timingof cerclage removal (eitherbefore or afterthe onset of labor).Allstudiesevaluatingpatientswithcervicalcerclagewho deliveredvaginallyandreportingoncervicallacerationsand on

timing of cerclage removal were included in the review. Only

womenwhoreached36weeksofgestationalageandcouldhave

cerclageremovaleitherplannedat36–37weeksorinlaborwere

included. We compared the incidence of cervical laceration in

cerclageremovalplannedbeforelaborwithcerclageremovalafter theonsetoflabor.

Thefollowing criteriawereusedtoexcludestudies:(1) case reports, reviews, guidelines, letters to the editor and reports

without a comparison group; (2) studies which reported the

outcomeofinterestforcerclageinmultiplegestations;(3)studies

which reported the outcome of interest for Lash or Mann

procedures;(4) studieswhich reportedtheoutcome ofinterest

for open or laparoscopic transabdominal cerclage; (5) studies

whichreportedcervicalocclusionasanoutcomeofinterest. Tworeviewers(AC,GS)independentlyassessedthequalityof

the included studies via the Methodological Index for

Non-RandomizedStudies(MINORS)[9].

Theprimary outcomewastheincidenceofspontaneousand

clinicallysigniﬁcantintrapartumcervicallacerations(i.e. lacera-tionsrequiringsuturing).Thesecervicallacerationsweredeﬁned aslacerationsassociatedwithbleedingorthatrequiredcervical suturing.Authorswerecontactedformissingdata.

Before data extraction, the review was registered with the

PROSPERO International Prospective Register of Systematic

Reviews (registration No.: CRD42014015201). The review was

reported following thePreferred Reporting Itemfor Systematic

ReviewsandMeta-analyses(PRISMA)statement.

Thedataanalysiswascompletedindependentlybyauthors(GS,

AC)usingReviewManager5.3(Copenhagen:TheNordicCochrane

Centre,Cochrane Collaboration, 2014). The analyseswere then

compared,and any difference wasresolved withreview of the

entiredata.Statisticalheterogeneitybetweenstudieswasassessed

usingHigginsI2_statistics._The_summary_measures_were_reported asoddsratio(OR)with95%conﬁdenceinterval(CI).

Results

Sixstudies,whichmettheinclusioncriteria,wereincludedin theanalysis (Fig. 1)[4–7,10–13] Allincludedstudies had good methodological quality (Fig.2). Original database of one study wereobtainedfromtheprimaryauthors[13].

The characteristics and results of each study are shown in

Table1.Allincludedstudieswereretrospectivecohortstudies.A

total of 427 cerclages were included, withthe majority being

McDonald.Ofthe359womenwhohadvaginaldelivery,280(78%) hadplannedremovalat36–37weeks,while79(22%)hadremoval aftertheonsetofspontaneouslaborat36 weeksorafter.Three studies included only history-indicated cerclage [4,7,12]; one study includedboth ultrasound-indicatedand history-indicated

cerclage [13], while the other two included ultrasound- and

history-andphysicalexam-indicatedcerclage[10,11].

Fig.1.Flowdiagramofstudiesidentiﬁedinthesystematicreview. G.Simonazzietal./EuropeanJournalofObstetrics&GynecologyandReproductiveBiology193(2015)19–22

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Theoverallincidenceofcervicallacerationswas8.9%(32/359) (Table 1). There were 23/280 (6.4%) cervical lacerations in the plannedremovalgroup,and9/79(11.4%)intheremovalafterlabor group(OR0.70,95%CI0.31–1.57).

Comment

Based on the present review, planned removal of cervical

cerclage before the onset of labor was not associated with

statistically signiﬁcant reduction in the incidence of cervical

lacerations. However, while non-signiﬁcant there were 11.4%

lacerationsinafterlaborgroup,and6.4%intheplannedremoval

group (30% non-signiﬁcant reduction). Based on these data,

probably limited by a type II error, we continue to remove

cerclagearound36weeks,beforetheonsetoflabor.

Oneofthestrengthsofourstudyistheinclusionofallpublished studiesevaluatingpatientswithcervicalcerclagewhodelivered vaginallyandreportingdataaboutcervicallacerationsandabout

timing of cerclage removal. All the included studies had good

methodologicalquality[9].Sofar,thereisnopriormeta-analysis onthissubject.Nosimilarsystematicreviewswerefoundduring thesearchprocess.Originaldatabaseofonestudywereobtained

[13].

Limitationsofourstudyareinherenttothelimitationsofthe includedstudies.Noneofthestudiesincludedwereclinicaltrials andnoneofthemwereprospective.ItisnotknownifShirodkar cerclageshaveadifferentriskforlacerationthanMcDonald.The

individual studies included reported a wide range of cervical

lacerationrate(1%to39%).Noneoftheincludedstudiesaimed primarilyatcomparingremovalofthecerclagebeforeorafterthe onsetoflabor,andonlytwostudieshadcervicallacerationasthe primaryoutcome,whichindicatesthatthetopicisnotproperly studied [10,13]. For this reason, an adjusted analysis was not feasibleandassessingtheresultsinaforestplotwasnotpossible. Whileauthorswerecontactedformissingdata,onlyoneprovided additional data [13]. Moreover, it is still unclearwhen cervical lacerationsassociatedwithcerclageoccur,e.g.attimeofremoval,

and/or duringlabor. Thedifferences between data obtained by

Fig.2.Assessmentofriskofbias.OverallMINORSscoring[9].

Table1

Dataofincludedstudies.

Jongen[4] Abdelhak[7] Melamed[10] Fox[11] Shin[12] Seravalli[13] Total

Suture(N) 20 96 18 69 127 97 427

Typeofcerclage N/R ModiﬁedShirodkar N/R Shirodkar McDonald McDonald –

Vaginaldelivery 16 62 18 55 111 97 359/427

Plannedremoval 5/16(31%) 0/62 18/18(100%) 55/55(100%) 111/111(100%) 91/97(94%) 280/359(78%) Laborremoval 11/16(69%) 62/62(100%) 0/18 0/55 0/111 6/97(6%) 79/359(22%) GAatplannedremoval(weeks) 36(360

–366 ) N/R N/R 36.02.2 35(360 –386 ) 36.5(360 –376 ) 36 GAatdelivery(weeks) N/R 37.24.0 N/R 37.33.2 37.63.3 36.55.5 37

Totalcervicallaceration 4/16(25%) 5/62(8%) 7/18(39%) 3/55(5%) 12/111(11%) 1/97(1%) 32/359(8.9%) Cervicallacerationinplanned

removalgroup

0/5 0/0 7/18(39%) 3/55(5%) 12/111(11%) 1/91(1%) 23/280(6.4%)

Cervicallacerationinlabor removalgroup

4/11(36%) 5/62(8%) 0/0 0/0 0/0 0/6 9/79(11.4%)

N/R:notreported;GA:gestationalage.DataaboutGAarepresentedasmeansstandarddeviationorasmedian(range).

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differentstudiesshowedthatprobablytherewereotherfactors thatarenotcontrolledinnon-prospectivestudies.Sincethatour dataprobablydidnotreach statisticalsigniﬁcance becauseof a

type II error, further studies are needed. A power analysis

suggesteda totalsamplesizeof 716womentoachieve 80% to

power(with an

a

of0.05) todetecta 28%decreaseof cervical laceration.Largeandwell-designedrandomizedtrialsareneeded. Conﬂictsofinterest

Theauthorsreportnoconﬂictofinterest.

Fundingstatement

Noﬁnancialsupportwasreceivedforthisstudy. References

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[2]BerghellaV.Cerclagedecreasespretermbirth:ﬁnallythelevelIevidenceis here.AmJObstetGynecol2011;205:89–90.

[3]HargerJH.Comparisonofsuccessandmorbidityincervicalcerclage proce-dures.ObstetGynecol1980;56:543–8.

[4]JongenVH,vanRoosmalenJ.Complicationsofcervicalcerclageinruralareas. IntJGynaecolObstet1997;57:23–6.

[5]KuhnRJO,PepperellRJ.Cervicalligation:areviewof242pregnancies.AustNZ JObstetGynaecol1977;17:79.

[6]LashAF.Theincompetentinternalosofthecervix,complicationsafterrepair. AmJObstetGynecol1961;81:465.

[7]AbdelhakYE,AronovR,RogueH,YoungBK.Managementofcervicalcerclageat term:removethestructureinlabor?JPerinatMed2000;28:453–7. [8]BisulliM,SuhagA,ArvonR,Seibel-SeamonJ,VisintineJ,BerghellaV.Intervalto

spontaneousdeliveryafterelectiveremovalofcerclage.AmJObstetGynecol 2009;201:163.

[9]SlimK,NiniE,ForestierD,KwiatkowskiF,PanisY,ChipponiJ.Methodological indexfornon-randomizedstudies(MINORS):developmentandvalidationofa newinstrument.ANZJSurg2003;73:712–6.

[10]MelamedN,Ben-HaroushA,ChenR,KaplanB,YogevY.Intrapartumcervical lacerations:characteristics,riskfactor,andeffectsonsubsequentpregnancies. AmJObstetGynecol2009;200:388.

[11]FoxNS,RebarberA,BenderS,SaltzmanDH.LaboroutcomesafterShirodkar cerclage.JReprodMed2009;54:361–5.

[12]ShinJE,ShinJC,KimSJ,LeeY.Effectofcerclageonlaborcourseandobstetric outcome:acase–controlstudy.JMaternFetalNeonatalMed2012;25:1179–82. [13]SeravalliV,PottiS,BerghellaV.Riskofintrapartumcervicallacerationsin

womenwithcerclage.JMaternFetalNeonatalMed2013;26:294–8. G.Simonazzietal./EuropeanJournalofObstetrics&GynecologyandReproductiveBiology193(2015)19–22