JAMA Episiotomy

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  CLINICIAN’S CORNER CLINICAL REVIEW Outcomes of Routine Episiotomy A Systematic Review Katherine Hartmann, MD, PhDMeera Viswanathan, PhDRachel Palmieri, BSGerald Gartlehner, MD, MPHJohn Thorp, Jr, MDKathleen N. Lohr, PhD E PISIOTOMY IS AMONG THE MOST common surgical proceduresexperienced by women in theUnitedStates. 1 Thirtypercentto35% of vaginal births include episi-otomy. 2,3 Episiotomy became routinepractice well before emphasis on us-ingoutcomesresearchtoinformprac-tice. In seeking to establish an evi-dencebasetosupportorrefutetheuseofepisiotomy,randomizedclinicaltrialsin the mid and late 1980s found thatroutine episiotomy compared with re-strictiveusewasassociatedwithhigherrisk of anal sphincter and rectal inju-ries and precluded a woman from giv-ing birth with an intact or minimallydamaged perineum. 4-7 Larger trials inmorevariedpopulationsfollowedinthe1990s, with similar results. Investiga-tors also began to assess longer-termoutcomes such as persistent pain, pel-vicfloordefects,urinaryandrectalcon-tinence, and sexual function and sat-isfaction.Despite decades of research, whichmany interpret as definitive evidenceagainstroutineuseofepisiotomy,littleprofessional consensus has developedabout the appropriateness of routineuse.Lackofconsensusisillustratedbyvariationinuse.At18Philadelphiahos-pitalsstudiedinthemid1990s,42%of women overall had an episiotomy,while hospital averages ranged from20%to73%. 8 From1987to1992,Lowandcolleagues 9 documentedclinician-level variation from 13.3% to 84.6%,with an average of 51% among spon-taneous term births in a prospectivelyenrolled population of uncomplicatedbirths. Wide variation existed amongboth midwives and physicians. Varia-tion has also been reported by time of day 10 and by facility type, size, and lo-cation. 11 Obstetric health care practi-tioners who view episiotomy favor-ablyendorsesurveyitemsthatstatethatepisiotomy should be used to “pre-ventperinealtraumaandtopreventpel-vic floor relaxation and the conse- See also Patient Page.CME available online atwww.jama.com Author Affiliations:  Center for Women’s Health Re-search (Drs Hartmann and Thorp and Ms Palmieri),DepartmentofEpidemiology,SchoolofPublicHealth(Dr Hartmann and Ms Palmieri), Department of Ob-stetricsandGynecology,SchoolofMedicine(DrsHart-mannandThorp),andCecilG.ShepsCenterforHealthServicesResearch(DrsHartmannandGartlehner),Uni-versityofNorthCarolinaatChapelHill;ResearchTri-angle Institute, Research Triangle Park, NC (DrsViswanathan and Lohr). Corresponding Author:  Katherine Hartmann, MD,PhD, Center for Women’s Health Research, Univer-sity of North Carolina, Campus Box 7521, 725 Air-portRd,ChapelHill,NC27599-7521(khartman@med.unc.edu). ClinicalReviewSectionEditor: MichaelS.Lauer,MD.We encourage authors to submit papers for consid-eration as a “Clinical Review.” Please contact Mi-chael S. Lauer, MD, at lauerm@ccf.org. Context  Episiotomyatthetimeofvaginalbirthiscommon.Practicepatternsvarywidely,asdoprofessionalopinionsaboutmaternalrisksandbenefitsassociatedwithroutineuse. Objective  Tosystematicallyreviewthebestevidenceavailableaboutmaternalout-comes of routine vs restrictive use of episiotomy. Evidence Acquisition  We searched MEDLINE, Cumulative Index to Nursing andAlliedHealthLiterature,andCochraneCollaborationresourcesandperformedahandsearchforEnglish-languagearticlesfrom1950to2004.Weincludedrandomizedcon-trolled trials of routine episiotomy or type of episiotomy that assessed outcomes inthe first 3 postpartum months, along with trials and prospective studies that assessedlonger-term outcomes. Twenty-six of 986 screened articles provided relevant data.We entered data into abstraction forms and conducted a second review for accuracy.Each article was also scored for research quality. Evidence Synthesis  Fair to good evidence from clinical trials suggests that immedi-ate maternal outcomes of routine episiotomy, including severity of perineal laceration,pain, and pain medication use, are not better than those with restrictive use. Evidence isinsufficient to provide guidance on choice of midline vs mediolateral episiotomy. Evi-dence regarding long-term sequelae is fair to poor. Incontinence and pelvic floor out-comeshavenotbeenfollowedupintotheagerangeinwhichwomenaremostlikelytohavesequelae.Withthiscaveat,relevantstudiesareconsistentindemonstratingnoben-efit from episiotomy for prevention of fecal and urinary incontinence or pelvic floor re-laxation.Likewise,noevidencesuggeststhatepisiotomyreducesimpairedsexualfunction—pain with intercourse was more common among women with episiotomy. Conclusions  Evidencedoesnotsupportmaternalbenefitstraditionallyascribedtorou-tine episiotomy. In fact, outcomes with episiotomy can be considered worse since someproportion of women who would have had lesser injury instead had a surgical incision.  JAMA. 2005;293:2141-2148  www.jama.com ©2005 American Medical Association. All rights reserved.  (Reprinted) JAMA,  May 4, 2005—Vol 293, No. 17  2141  at J H Quillen College, on July 24, 2005 www.jama.comDownloaded from   quencesofpelvicfloorrelaxation,suchasbladderprolapseandurinaryincon-tinence.”Furthermore,theyagreewiththe statement that they “prefer to em-ploy episiotomy frequently because itis easier to repair than the lacerationthat results when episiotomy is notused.” 12 Simultaneousbeliefinpreven-tion of future sequelae and ease of re-pair creates potential for misattrib-uted motivations.National data on use of episiotomyshowaconsistentdeclineovertheprior2decades. 1,2 However,persistentwidepractice variation suggests that episi-otomyuseisheavilydrivenbylocalpro-fessional norms, experiences in train-ing, and individual practitionerpreference rather than variation in theneedsofindividualwomenatthetimeof vaginal birth. Our goal was to refo-cusattentiononroutineepisiotomybysystematically reviewing the best evi-denceavailableaboutthematernalout-comes of routine vs restrictive use of episiotomy, including type of episi-otomy. Specifically, we sought to de-scribe maternal outcomes such as de-gree of perineal injury and pain closeto the time of birth, as well as longer-termoutcomessuchasurinaryandfe-cal incontinence, pelvic floor defects,and sexual dysfunction. EVIDENCE ACQUISITION  Wesoughtstudiesthat(1)reportedout-comes related to episiotomy and peri-neal injury at the time of vaginal birth;(2) were published in English; (3) hadmore than 40 participants; and (4) re-ported srcinal research. 13 For sum-mary of short-term maternal outcomesof routine vs restrictive use of episi-otomy or of episiotomy type, we lim-ited searches to randomized clinicaltrials. For longer-term outcomes, suchasincontinence,pelvicfloordefects,andsexualfunction,weincludedbothtrialsand prospective cohorts.In collaboration with a research li-brarian,wesearchedMEDLINE,Coch-rane Collaboration resources, and theCumulative Index to Nursing and Al-liedHealthLiteratureusingthesearchterms  episiotomy  and  labor stage, sec-ond . We then hand-searched refer-ence lists of research articles, reviews,and texts and consulted with our ad-visory group to ensure full identifica-tion of relevant articles from 1950throughMay2004.Weconducteddualindependent reviews of abstracts anda single review of full articles to applythe inclusion criteria. Initial data ab-stractionwasdonebyK.H.,M.V.,R.P.,G.G.,andJ.T.andasecondteammem-ber assessed initial entries for accu-racy, completeness, and consistency.The2abstractors,withthefullteamasneeded, reconciled discrepancies.To rate quality of individual ar-ticles, 2 authors independently ratedeach article. A third author reviewedscoresandflaggeddifferences.Werec-onciled any differences in componentoroverallqualityclassificationbycon-sensus.Togradetheglobalstrengthof evidence relevant to specific out-comes, we used the approach de-scribedbyWestandcolleagues. 14 Thatsystem encompasses 3 domains: (1)quality of the individual studies as as-sessedbyexaminationofachecklistof specific elements of study design andconduct;(2)quantityofrelevantstud-ies identified (including number of studies and adequacy of the samplesize); and (3) consistency of findings.Gradesforstrengthofevidencewereas-signed by consensus. 13 Althoughmeta-analysiswasnottheprimary goal, we calculated summarymeasureswhenpossible.Variationbe-tween studies was assessed using testsof homogeneity, including exact testsas required. Scarcity of studies withsimilar exposure categories, outcomemeasures,andtimingofmeasurementoften prohibited calculation of sum-mary measures and examination of sources of heterogeneity. For sum-mary estimates, we required similarmeasuresinthesametimeframe.Whenheterogeneity was observed ( P  .10),we used DerSimonian and Laird ran-dom-effects models to generate sum-marymeasures. 15 Ifnomeaningfulhet-erogeneity was found, we appliedMantel-Haenszel fixed-effects modelsto estimate summary measures. EVIDENCE SYNTHESIS Oursearchidentified986articles;659were excluded after reviewing the ab-stract. We reviewed the full texts of 327 articles. Twenty-six met inclu-sion criteria. Maternal Postpartum Outcomes Sevenrandomizedtrials,withatotalof 5001 participants, compared restric-tivevsroutineuseofepisiotomy. 16-22 Sixof the 7 trials used mediolateral episi-otomy. The only North American trial,conductedinCanada,usedmidlineepi-siotomy,whichismoreconventionalinthe United States. 19 Each trial com-pared2groups:agroupinwhichtheob-stetrichealthcarepractitionerwastore-strictuseofepisiotomyandagroupwitha liberal use policy that endorsed rou-tine use. The strictest definition of re-strictiveusewastoavoidepisiotomyun-less indicated for fetal well-being. 16,22 Other definitions pivoted on instruc-tions to “avoid episiotomy,” use onlywhen“medicallynecessary,”ornotper-form episiotomy for the purpose of avoiding a laceration. 17-19,21 The largesttrial defined restrictive use as only forfetal indications or to avoid severe lac-erations. 20 Routineusegroupswerede-fined in terms such as “routinely con-ducted,”“usualcare,”and“elective.” 17-21 Twostudiesdescribedroutineasusetopreempt a tear. 16,22 Overall, inclusion criteria for thesestudies were poorly specified. Gener-ally, participants had term births of singletons with vertex presentation.Three studies enrolled only womenhavingafirstbirth,whicheliminatesin-fluenceofpriorperinealtraumaontrialoutcomes. 17,21,22 Instudieswithoutpar-ity restrictions, the proportion of women who were primiparous rangedfrom 40% to 68%, with good balancebetween study groups. 16,18-20 In 1 ex-ception, multiparous women weresomewhat more likely to be in the re-strictive use group. 18 Eachstudyfocusedonnormalspon-taneous vaginal births. To reduce thenumber of operative vaginal deliveriesorcesareanbirths,mosttrialsallocatedwomenasclosetobirthasfeasible.The OUTCOMES OF ROUTINE EPISIOTOMY 2142  JAMA,  May 4, 2005—Vol 293, No. 17  (Reprinted)  ©2005 American Medical Association. All rights reserved.  at J H Quillen College, on July 24, 2005 www.jama.comDownloaded from   proportion of assisted vaginal birthsranged from 0 to 5% 16,19-21 up to15%. 17,18,22 In2cases,authorsnotedthenumber of cesarean births and exclu-sion from further analyses. 19,22 Both of these studies enrolled women duringprenatal care, an approach that im-provedrepresentativenessofthepopu-lation, making exclusion from analysislogical. Perineal Outcomes . The strongesttrial (good quality) was the first con-ducted, 16 which achieved a wide gra-dient of episiotomy use: 10.2% in therestrictive use group and 51.4% in theroutine use group. Women in the re-strictiveusegroupweremorelikelytohave an intact perineum; 33.9% in therestrictive use group had neither pos-terior perineal lacerations nor episi-otomycomparedwith24.3%intherou-tine use group. Third- and fourth-degree lacerations were rare (0.5%overall) and did not differ by group.Amongnulliparouswomen,74%oftherestrictive use group compared with89% of the routine use group requiredanysuturing,includingforanteriororlabial lacerations. For multiparouswomen,66%oftherestrictiveusegroupand 69% of the routine use group re-quired sutures. 16 The largest trial was a multisiteArgentine study of fair quality, with2606 participants. 20 This study docu-menteddecreasedriskofposteriorperi-nealsurgicalrepair(relativerisk[RR],0.72; 95% confidence interval [CI],0.68-0.75)anda2.4-foldincreaseinriskof anterior tears among women in therestrictive use group (95% CI, 1.89-2.94)comparedwithroutineuse.Sixty-three percent of women in the restric-tive use group had a surgical repaircompared with 88% in the routine usegroup. Pain and healing complica-tions were less frequent in the restric-tive use group.Results of the remaining trials werecompatible with these findings( T ABLE  1 ): intact perineum was uni-formlylesscommonintheroutinecom-paredwiththerestrictiveusegroup(RR,0.46;95%CI,0.30-0.70). 16,18,19,21,22  With2exceptions, 16,19 studiesreportedmorethird- and fourth-degree lacerations inthe routine use group. All trials wereunderpowered to distinguish differ-ences,withatotalof105rectalinjuriesamong 5001 participants (RR for rou-tinevsrestrictiveuse,1.13;95%CI,0.78-1.65). 16-22 Anterior lacerations, includ-inganteriorlabiallacerations,weremorecommonintherestrictiveusegroupsin4 studies 16,19,20,22 and in the routine usegroup in 1 study. 21 Anterior lacerationsdidnotcontributetooverallhigheruseof suturing, suggesting that these tearswere less severe than posterior tears.Need for any suturing was 26% higherintheroutineusegroups(RR,1.26;95%CI, 1.08-1.48). 16,20,21 Pain Outcomes . Five studies as-sessedpainoutcomes( T ABLE 2 ). 16,18-20,22 Sleep and colleagues used midwivesmasked to group to assess pain at 10postpartum days. 16 Participants re-portedtheirpainseverityintheprior24hours.Severitywasvirtuallyidenticalbe-tweengroups:intheroutineusegroup,14.6%hadmildpain,7.8%hadmoder-ate pain, and 0.2% had severe pain; re-spective proportions for the restrictiveusegroupwere14.1%,7.5%,and0.9%.Useoforalanalgesicsbypostpartumday10 was rare and comparable at 2% and3%, respectively. Pain outcomes werealso comparable at 3 months.House and colleagues reported thatlevel of pain was more severe on thethirdpostpartumdayintheroutineusegroup. 18 Theyassessedpainusingavi-sual analog scale during an interviewconducted by an author (masking wasnotnoted).Onday3intheroutineusegroup, 11% had severe pain, 34% hadmoderatepain,and55%hadmildpain;respective categories for the restric-tiveusegroupwere10%,22%,and68%.The restrictive use group had less ten-derness on examination on the thirdpostpartumday:79%hadmildormini-malpain,18%hadmoderatepain,and3%hadseverepaincomparedwith51%,39%,and10%intheroutineusegroup, Table 1.  Perineal Injury Outcomes of Clinical Trials of Routine vs Restrictive Episiotomy Use SourceTotal No. ofParticipants Group No.IntactPerineum, %EpisiotomyPerformed, %Third- or Fourth-DegreeTear, % Anterior Tears, % Any Use ofSuturing, % Sleep et al, 16 1984 1000 Routine 502 24.3 51.4 0.2 17.3 78.0Restrictive 498 33.9 10.2 0.8 26.3 69.0Harrison et al, 17 1984 181 Routine 89 . . . 44.9 5.6 . . . . . .Restrictive 92 20.6 7.6 0.0 . . . . . .House et al, 18 1986 165 Routine 71 11.3 69.0 1.4 . . . . . .Restrictive 94 42.6 18.1 0.0 . . . . . .Klein et al, 19 1992 703 Routine 350 12.6 93.7 7.4 10.6 . . .Restrictive 353 19.2 43.8 7.7 14.9 . . . Argentine Episiotomy Trial 2606 Routine 1298 . . . 82.6 1.5 8.1 88.1Collaborative Group, 20 1993Restrictive 1308 . . . 30.1 1.1 19.2 63.0Eltorkey and Nuaim, 21 1994 200 Routine 100 7.0 83.0 0.0 18.0 85.0Restrictive 100 28.0 53.0 0.0 12.0 67.0Dannecker et al, 22 2004 146 Routine 76 10.0 76.7 8.3 41.7 . . .Restrictive 70 28.6 40.8 4.1 55.1 . . .  Abbreviation: Ellipses indicate data not reported. OUTCOMES OF ROUTINE EPISIOTOMY ©2005 American Medical Association. All rights reserved.  (Reprinted) JAMA,  May 4, 2005—Vol 293, No. 17  2143  at J H Quillen College, on July 24, 2005 www.jama.comDownloaded from   respectively.Thesedifferencesweresta-tistically significant and likely to beclinically relevant. Differences in painbygroupwereresolvedby6weeksand3 months.The only trial using midline episi-otomy found no difference in McGillPain Scale scores for perineal pain orpain with urination on days 1, 2, and10. 19 TheArgentinestudy 20 didnotad-equatelydefinehowtheymeasuredpainand reported “pain on the day of dis-charge.”Theroutineusegroupwasde-scribed as 42.5% with pain and the re-strictiveusegroupas30.7%withpain.The most recent study provided themostnuancedapproachtopainassess-ment. 22 Theinvestigatorsuseda100-mmvisual analog scale to assess pain with4 activities. During bed rest, women inthe routine use group reported meanscores of 39 mm (SD, 28 mm) com-pared with 22 mm (SD, 21 mm) in therestrictiveusegroup;duringsitting,69mm(SD,23mm)comparedwith51mm(SD, 25 mm); during walking, 56 mm(SD, 24 mm) vs 37 mm (SD, 24 mm);and during defecation, 36 mm (SD, 30mm)vs21mm(SD,21mm).Acrossallactivities the restrictive use group ex-perienced less perineal pain ( P =.005-.048),withdifferenceslikelytobeclini-cally significant.None of the 5 studies found pain tobe lessened by routine episiotomy. Nosummary measures were appropriategiven the variety of methods and tim-ing of pain measurement. Healing Outcomes . Two trials re-portedphysicalexaminations.TheAr-gentinetrialreportednodifferencesinhematoma prior to discharge and, at 7days, infection, healing complica-tions, or dehiscence. Only 44% of thewomen were evaluated at 7 postpar-tumdays. 20 Houseandcolleagues 18 ex-amined participants at 3 days and at 6weeks. Risk of infection was assessedfor all participants on day 3. Poorwoundappositionandgranulationtis-sue,indicatingsecondaryhealing,wereassessed at the later visit, which in-cluded 53% of participants. Each ad-verse outcome was equivalent. Other Outcomes . Two studies esti-matedmaternalbloodloss.Onefoundnodifferenceinchangeinmaternalhe-moglobin. 22 The other found that esti-mated blood loss (method not de-fined)was58mLgreaterintheroutineuse group, a statistically but not clini-cally relevant difference. 18 Incision Type Only 1 trial and no prospective co-hortscomparedmidlineandmediolat-eral episiotomy. 23 The trial allocatedwomen having a first birth to midlineepisiotomy(“incisionsdivided2cmto3 cm of the perineal tissue in the mid-line”)ormediolateralincisions(“madefromthemidlineandcarriedtotherightof the anal sphincter for about 3 cm to4 cm”). 23 This study received a poorquality rating. We noted an inad-equate randomization method, lack of allocation concealment, and failure tomask outcome assessors as potentialsources of bias.Morecomplicationsoccurredinthemidline group ( P  .001). Twenty-four percent of the midline group hadan extension of the episiotomy into orthrough the sphincter compared with9%ofthemediolateralgroup.Themid-linegrouphadlessbruisingoftheperi-neum( P  .001).Theinvestigatorsdidnotfinddifferencesinpain.Ofpartici-pants, 76% attended 3-month follow-up. Women in the midline group be-gansexualintercourseearlier( P  .01)and had a better cosmetic appearanceofthescar( P  .02)thanthemediolat-eralgroup.Nodifferencesinpainorsat-isfactionfromsexualintercoursewereidentified. Urinary Incontinence,Fecal Incontinence,and Pelvic Floor Defects Sixteenpublicationsprospectivelycol-lected data about continence or pelvicfloormusclefunction( T ABLE 3 ).Thesepublications include 4 reports from 2trials of restrictive vs routine episi- Table 2.  Perineal Pain Outcomes of Clinical Trials of Routine vs Restrictive Episiotomy Use SourceNo./TotalParticipants AssessmentTiming of AssessmentOutcomeGroupStudy GroupRoutine Restrictive Sleep et al, 16 1984 885/1000 Pain severity in prior 24 h, % 10 d Mild 14.6 14.1Moderate 7.8 7.5Severe 0.2 0.9House et al, 18 1986 165/165 Pain severity using VAS (1-3,minimal; 4-6, moderate;7-10, severe), %3 d Minimal 54.9 68.1Moderate 33.8 22.3Severe 11.3 9.6Klein et al, 19 1992 703/703 Mean perineal pain severity scoreusing 6-point McGill PainScale * 1 d 1.56 1.502 d 1.10 1.1610 d 0.40 0.40 Argentine Episiotomy Trial CollaborativeGroup, 20 19932422/2606 Any perineal pain (not defined), % Discharge 42.5 30.7Dannecker et al, 22 2004 53/146 Mean (SD) maximum pain scoreusing 100-mm VAS scale(0 = “not at all”; 100 = “verymuch”)1-5 d Bed rest 39 (28) 22 (21)Sitting 69 (23) 51 (25)Walking 56 (24) 37 (24)Defecation 36 (30) 21 (21)  Abbreviation: VAS, visual analog scale. * Mean perineal pain scores were calculated from stratified numbers in the srcinal article and weighted by parity (primiparous = 359; multiparous = 344). OUTCOMES OF ROUTINE EPISIOTOMY 2144  JAMA,  May 4, 2005—Vol 293, No. 17  (Reprinted)  ©2005 American Medical Association. All rights reserved.  at J H Quillen College, on July 24, 2005 www.jama.comDownloaded from 
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