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Uso de la episiotomía selectiva versus sistemática para el parto vaginal

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References

Referencias de los estudios incluidos en esta revisión

Ali 2004 {published data only}

Ali SS, Malik M, Iqbal J, Faruqi NJ. Routine episiotomy versus selective episiotomy in primigravidae. Annals of King Edward Medical College 2004;10(4):482‐4. CENTRAL

Belizan 1993 {published data only}

Belizan J, Campodonica L, Carroli G, Gonzalez L, Lede R, Palermo M, et al. Routine vs selective episiotomy: a randomised controlled trial. Argentine Episiotomy Trial Collaborative Group. Lancet 1993;342(8886‐8887):1517‐8. CENTRAL

Dannecker 2004 {published data only}

Dannecker C, Hillemanns P, Strauss A, Hasbargen U, Hepp H, Anthuber C. Episiotomy and perineal tears presumed to be imminent: randomized controlled trial. Acta Obstetricia et Gynecologica Scandinavica 2004;83(4):364‐8. CENTRAL
Dannecker C, Hillemanns P, Strauss A, Hasbargen U, Hepp H, Anthuber C. Episiotomy and perineal tears presumed to be imminent: the influence on the urethral pressure profile, analmanometric and other pelvic floor findings ‐ follow‐up study of a randomized controlled trial. Acta Obstetricia et Gynecologica Scandinavica 2005;84:65‐71. CENTRAL

Eltorkey 1994 {published data only}

Eltorkey MM, Al Nuaim MA, Kurdi AM, Sabagh TO, Clarke F. Episiotomy, elective or selective: a report of random allocation trial. Journal of Obstetrics and Gynaecology 1994;14:317‐20. CENTRAL

Harrison 1984 {published data only}

Harrison RF, Brennan M, North PM, Reed JV, Wickham EA. Is routine episiotomy necessary?. British Medical Journal 1984;288:1971‐5. CENTRAL

House 1986 {published data only}

House MJ, Cario G, Jones MH. Episiotomy and the perineum: a random controlled trial. Journal of Obstetrics and Gynaecology 1986;7:107‐10. CENTRAL

Juste‐Pina 2007 {published data only}

Juste‐Pina A, Luque‐Carro R, Sabater‐Adan B, Sanz‐De Miguel E, Vinerta‐Serrano E, Cruz‐Guerreiro E. Selective episiotomy versus routine episiotomy in nuliparous women with vaginal delivery performed by midwives [Episiotomia selectiva frente a episiotomia rutinaria en nuliparas con parto vaginal realizado por matronas]. Matronas Profesion 2007;8(3‐4):5‐11. CENTRAL
Luque‐Carro R, Subiron‐Valera AB, Sabater‐Adan B, Sanz De Miguel E, Juste‐Pina A, Cruz‐Guerreiro E. Selective episiotomy versus routine episiotomy. Assessment three years after (2007‐2008). Matronas Profesion 2011;12(2):41‐8. CENTRAL

Klein 1992 {published data only}

Klein M, Gauthier R, Jorgensen S, North B, Robbins J, Kacrorowski J, et al. McGill/University of Montreal multicentre episiotomy trial. Innovations in Perinatal Care. Proceedings of the 9th Birth Conference; 1990 Nov 11‐13; San Francisco, USA. 1990:45‐55. CENTRAL
Klein MC, Gauthier RJ, Jorgensen SH, Robbins JM, Kaczorowski J, Johnson B, et al. Does episiotomy prevent perineal trauma and pelvic floor relaxation? [Forebygger episiotomi perineal trauma och forsvagning av backenbotten?]. Jordemodern 1993;106(10):375‐7. CENTRAL
Klein MC, Gauthier RJ, Jorgensen SH, Robbins JM, Kaczorowski J, Johnson B, et al. Does episiotomy prevent perineal trauma and pelvic floor relaxation?. Online Journal of Current Clinical Trials 1992;Doc 10:0‐29. Accessed 17.12.2009. CENTRAL
Klein MC, Gauthier RJ, Robbins JM, Kaczorowski J, Jorgensen SH, Franco ED, et al. Relationship of episiotomy to perineal trauma and morbidity, sexual dysfunction, and pelvic floor relaxation. American Journal of Obstetrics and Gynecology 1994;171:591‐8. CENTRAL
Klein MC, Kaczorowski J, Robbins JM, Gauthier RJ, Jorgensen SH, Joshi AK. Physicians' beliefs and behaviour during a randomized controlled trial of episiotomy: consequences for women in their care. Canadian Medical Association Journal 1995;153:769‐79. CENTRAL

Murphy 2008b {published data only}

Macleod M, Goyder K, Howarth L, Bahl R, Strachan B, Murphy D. Morbidity experienced by women before and after operative vaginal delivery: prospective cohort study nested within a two‐centre randomised controlled trial of restrictive versus routine use of episiotomy. BJOG: an International Journal of Obstetrics and Gynaecology 2013;120(8):1020‐7. CENTRAL
Murphy DJ. Randomised controlled trial of restrictive versus routine use of episiotomy for instrumental vaginal delivery ‐ a multi‐centre pilot study (ongoing trial). National Research Register (www.nrr.nhs.uk) (accessed 6 July 2006). CENTRAL
Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study. BJOG: an international journal of obstetrics and gynaecology 2008;115(13):1695‐703. CENTRAL

Rodriguez 2008 {published data only}

Rodriguez A, Arenas EA, Osorio AL, Mendez O, Zuleta JJ. Selective vs routine midline episiotomy for the prevention of third‐ or fourth‐degree lacerations in nulliparous women. American Journal of Obstetrics and Gynecology 2008;198(3):285.e1‐4. CENTRAL

Sleep 1984 {published data only}

Sleep J, Grant AM. West Berkshire perineal management trial: three year follow up. BMJ 1987;295:749‐51. CENTRAL
Sleep J, Grant AM, Garcia J, Elbourne D, Spencer J, Chalmers I. The Reading episiotomy trial ‐ a randomised trial comparing two policies for managing the perineum during spontaneous vaginal delivery. Proceedings of 23rd British Congress of Obstetrics and Gynaecology; 1983 July 12‐15; Birmingham, UK. 1983:24. CENTRAL
Sleep J, Grant AM, Garcia J, Elbourne DR, Spencer JAD, Chalmers I. West Berkshire perineal management trial. British Medical Journal 1984;289:587‐90. CENTRAL

Sulaiman 2013 {published data only}

Sulaiman AS, Ahmad S, Ismail NA, Rahman RA, Jamil MA, Mohd Dali AZ. A randomized control trial evaluating the prevalence of obstetrical anal sphincter injuries in primigravida in routine versus selective mediolateral episiotomy. Saudi Medical Journal2013; Vol. 34, issue 8:819‐23. CENTRAL

Referencias de los estudios excluidos de esta revisión

Amorim 2015 {published data only}

Amorim MMR, Neto AHF, Katz L, Coutinho I, Melo I, Leal NV. Selective episiotomy compared with implementation of a nonepisiotomy protocol. A randomized clinical trial. Obstetrics & Gynecology 2015;125(5 Suppl):41S‐42S. CENTRAL
Melo I, Katz L, Coutinho I, Amorim MM. Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial. Reproductive Health 2014;11(1):66. CENTRAL

Coats 1980 {published data only}

Coats PM, Chan KK, Wilkins M, Beard RJ. A comparison between midline and mediolateral episiotomies. British Journal of Obstetrics and Gynaecology 1980;87:408‐12. CENTRAL

Detlefsen 1980 {published data only}

Detlefsen GU, Vinther S, Larsen P, Schroeder E. Median and mediolateral episiotomy [Median og mediolateral episiotomi]. Ugeskrift for Laeger 1980;142(47):3114‐6. CENTRAL

Dong 2004 {published data only}

Dong LQ, Li HL, Song ZL. Clinical study and application of the improved episiotomy incision and anesthesia method in the vaginal deliveries. Journal of Qilu Nursing 2004;10(1):1‐3. CENTRAL

El‐Din 2014 {published data only}

El‐Din AS, Kamal MM, Amin MA. Comparison between two incision angles of mediolateral episiotomy in primiparous women: a randomized controlled trial. Journal of Obstetrics and Gynaecology Research 2014;40(7):1877‐82. CENTRAL

Golmakani 2011 {published data only}

Golmakani N, Saeidi SR, Mazloum R, Soltani B. Evaluation of perineal trauma in primiparous women with routine and selective episiotomy. Iranian Journal of Obstetrics, Gynecology and Infertility 2011;13(6):32‐8. CENTRAL

Henriksen 1992 {published data only}

Henriksen TB, Bek KM, Hedegaard M, Secher NJ. Episiotomy and perineal lesions in spontaneous vaginal deliveries. British Journal of Obstetrics and Gynaecology 1992;99:950‐4. CENTRAL
Henriksen TB, Bek KM, Hedegaard M, Secher NJ. Episiotomy and perineal lesions in spontaneous vaginal delivery [Episiotomi og perineale laesioner ved spontane vaginale fodsler]. Ugeskrift for Laeger 1994;156:3176‐9. CENTRAL

Islam 2013 {published data only}

Islam A, Hanif A, Ehsan A, Arif S, Niazi SK, Niazi AK. Morbidity from episiotomy. JPMA. The Journal of the Pakistan Medical Association 2013;63(6):696‐701. CENTRAL

Javed 2007 {published data only}

Javed I, Shoaib T, Bhutta S. Liberal versus restricted use of episiotomy in primigravida. Journal of Surgery Pakistan 2007;12(3):106‐9. CENTRAL

Karbanova 2013 {published data only}

Karbanova J, Rusavy Z, Betincova L, Jansova M, Necesalova P, Kalis V. Clinical evaluation of early postpartum pain and healing outcomes after mediolateral versus lateral episiotomy. International Journal of Gynecology and Obstetrics 2014;127(2):152‐7. CENTRAL
Karbanova J, Rusavy Z, Betincova L, Jansova M, Parizek A, Kalis V. Clinical evaluation of peripartum outcomes of mediolateral versus lateral episiotomy. International Journal of Gynecology and Obstetrics 2014;124(1):72‐6. CENTRAL
Karbanova J, Rusavy Z, Betincova L, Jansova M, Parizek A, Kalis V. Mediolateral vs. lateral episiotomy and associated intrapartal complications in primiparous women. International Urogynecology Journal and Pelvic Floor Dysfunction2013; Vol. 24:S66‐S67. CENTRAL
Karbonava J, Rusavy Z, Betincova L, Jansova M, Necesalova P, Kalis V. Clinical evaluation of early postpartum pain and the healing outcomes of mediolateral versus lateral episiotomy. Journal of Maternal‐Fetal & Neonatal Medicine 2014;27(Suppl 1):83. CENTRAL
Necesalova P, Karbanova J, Rusavy Z, Pastor Z, Jansova M, Kalis V. Mediolateral versus lateral episiotomy and their effect on postpartum coital activity and dyspareunia rate 3 and 6 months postpartum. Sexual & Reproductive Healthcare 2016;8:25‐30. CENTRAL
Rusavy Z, Karbanova J, Betincova L, Kalis V. Timing of episiotomy and delivery outcome. International Urogynecology Journal and Pelvic Floor Dysfunction 2014;25(1 Suppl 1):S136‐S137. CENTRAL
Rusavy Z, Karbanova J, Jansova M, Kalis V. Anal incontinence and sexuality after mediolateral and lateral episiotomy: a randomized controlled trial. International Urogynecology Journal and Pelvic Floor Dysfunction 2015;26(1 Suppl 1):S39‐S40. CENTRAL

Moini 2009 {published data only}

Moini A, Yari RE, Eslami B. Episiotomy and third‐ and fourth‐degree perineal tears in primiparous Iranian women. International Journal of Gynecology & Obstetrics 2009;104(3):241‐2. CENTRAL

Roy 2015 {published data only}

Roy P, Sujatha MS, Biswas B, Chatterjee A, Roy P. A comparative study of perineal morbidity in vaginal delivery with and without episiotomy. International Journal of Reproduction, Contraception, Obstetrics and Gynecology 2015;4(5):1442‐5. CENTRAL

Sawant 2015 {published data only}

Sawant G, Kumar D. Randomized trial comparing episiotomies with Braun‐Stadler episiotomy scissors and EPISCISSORS‐60. Medical Devices: Evidence and Research 2015;8:251‐4. CENTRAL

Shembekar 2009 {published data only}

Shembekar C, Tajpuriya S. Comparison of routine versus selective episiotomy in normal labour: a randomized controlled study. International Journal of Gynecology & Obstetrics 2009;107(Suppl 2):S336. CENTRAL

Swift 2014 {published data only}

ACTRN12612000285853. A prospective, randomised study Comparing cUrved versus straighT scissors to reduce episiotomy extension The CUT Trial. anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362182 Date first received: 1 March 2012. CENTRAL
Swift A, Webster J, Conroy AM, Hampton S, Kirby SJ, Minuzzo L, et al. Curved versus straight scissors to avoid 3rd and 4th degree perineal tears: a randomised feasibility study. Women and Birth 2014;27(3):163‐7. CENTRAL

Werner 1991 {published data only}

Werner CH, Schuler W, Meskendahl I. Midline episiotomy versus medio‐lateral episiotomy ‐ a randomized prospective study. International Journal of Gynecology and Obstetrics 1991;36 Suppl:33. CENTRAL

NCT02356237 {published data only}

NCT02356237. The effect of episiotomy on advanced perineal tears and other maternal and fetal outcomes ‐ randomized controlled multicentric trial (EPITRIAL). clinicaltrials.gov/show/NCT02356237 Date first received: 1 February 2015. CENTRAL

TCTR20150212001 {published data only}

TCTR20150212001. Restrictive versus routine episiotomy: a randomized controlled trial. clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=1307 Date first received 12 February 2015. CENTRAL

ACOG 2006

American College of Obstetricians and Gynecologists. ACOG practice bulletin. Episiotomy. Clinical management guidelines for obstetrician‐gynecologists. Number 71, April 2006. Obstetrics & Gynecology 2006;107(4):957‐62.

Banta 1982

Banta D, Thacker SB. The risks and benefits of episiotomy: a review. Birth 1982;9(1):25‐30.

Borghi 2002

Borghi J, Fox‐Rushby J, Bergel E, Abalos E, Hutton G, Carroli G. The cost‐effectiveness of routine versus restrictive episiotomy in Argentina. American Journal of Obstetrics & Gynecology 2002;186(2):221‐8.

Cargill 2004

Cargill YM, MacKinnon CJ, Arsenault MY, Bartellas E, Daniels S, Gleason T, et al. Clinical Practice Obstetrics Committee. Guidelines for operative vaginal birth. Journal of Obstetrics & Gynaecology Canada: JOGC 2004;26(8):747‐61.

Catling‐Paull 2013

Catling‐Paull C, Coddington RL, Foureur MJ, Homer CSE, on behalf of the Birthplace in Australia Study and the National Publicly‐funded Homebirth Consortium. Publicly funded homebirth in Australia: a review of maternal and neonatal outcomes over 6 years. Medical Journal of Australia 2013;198(11):616‐20. [PUBMED: 23919710]

Cunningham 1993

Cunningham FG. Conduct of normal labor and delivery. In: Cunningham FG, MacDonald PC, Gant NF, Leveno KJ, Gilstrap LC editor(s). Williams Obstetrics. 19. Norwalk, CT: Appleton and Lange, 1993:371‐93.

Fernando 2006

Fernando R, Sultan AH, Kettle C, Thakar R, Radley S. Methods of repair for obstetric anal sphincter injury. Cochrane Database of Systematic Reviews 2006, Issue 3. [DOI: 10.1002/14651858.CD002866.pub2]

FIGO 2012

FIGO Safe Motherhood and Newborn Health (SMNH) Committee. Management of the second stage of labor. International Federation of Gynecology and Obstetrics 2012;119:110‐6.

Frankman 2009

Frankman EA, Wang L, Bunker CH, Lowder JL. Episiotomy in the United States: has anything changed?. American Journal of Obstetrics and Gynecology 2009;200(5):e1‐e7.

Garner 1982

Garner P. Dyspareunia after episiotomy. British Journal of Sexual Medicine 1982;1:1‐3.

GRADE Working Group 2009

GRADE Working Goup. List of GRADE working group publications and grants. www.gradeworkinggroup.org/publications/index.htm2009.

Graham 1997

Graham ID. Episiotomy‐Challenging Obstetric Interventions. Blackwell Science, 1997.

Graham 2005

Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an update. Birth 2005;7(313):21.

Guyatt 2008

Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck‐Ytter Y, Alonso‐Coello P, et al. GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650):924‐6.

Hamilton 1861

Hamilton G. Classical observations and suggestions in obstetrics. Edinburgh Medical Journal 1861;7(313):21.

Hartmann 2005

Hartmann K, Viswanathan M, Palmieri R, Gartlehner G, Thorp J, Lohr KN. Outcomes of routine episiotomy: a systematic review. JAMA 2005;293(17):2141‐8. [PUBMED: 15870418]

Higgins 2003

Higgins JPT, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003;327:557‐60.

Higgins 2011

Higgins JPT, Altman DG, Sterne JAC (editors). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.handbook.cochrane.org.

Homsi 1994

Homsi R, Daikoku NH, Littlejohn J, Wheeless CR. Episiotomy: risks of dehiscence and rectovaginal fistula. Obstetrical & Gynecological Survey 1994;49:803‐8.

Kalis 2012

Kalis V, Laine K, De Leeuw JW, Ismail KM, Tincello DG. Classification of episiotomy: towards a standardisation of terminology. BJOG: an international journal of obstetrics & gynaecology 2012;119(5):522‐6.

Kettle 2008

Kettle C, Tohill S. Perineal care. Clinical Evidence 2008;9:1401.

Kliner 2014

Kliner M, Garner P. When trial authors write Cochrane Reviews: competing interests need to be better managed. Cochrane Database of Systematic Reviews2014; Vol. 9. [DOI: 10.1002/14651858.ED000089]

Lede 1991

Lede R, Moreno M, Belizan JM. Reflections on the routine indications for episiotomy. Sinopsis Obstétrico‐Ginecológica 1991;38:161‐6.

Liberati 2009

Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta‐analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Medicine 2009;6:e1000100.

Lynch 1997

Lynch CM, Pinelli DM, Cruse CW, Spellacy WN, Sinnott JT, Shashy RG. Maternal death from postpartum necrotizing fasciitis arising in an episiotomy: a case report. Infectious Diseases in Obstetrics and Gynecology 1997;5(5):341‐4.

Melo 2014

Melo I, Katz L, Coutinho I, Amorim MM. Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial. Reproductive Health 2014;11(1):66. CENTRAL

Murphy 2008a

Murphy DJ, Macleod M, Bahl R, Goyder K, Howarth L, Strachan B. A randomised controlled trial of routine versus restrictive use of episiotomy at operative vaginal delivery: a multicentre pilot study. BJOG: an international journal of obstetrics and gynaecology 2008;115(13):1695‐703. CENTRAL

Ould 1741

Ould F. A Treatise of Midwifery. London: J Buckland, 1741.

Priddis 2013

Priddis H, Dahlen H, Schmied V, Sneddon A, Kettle A, Brown C, et al. Risk of recurrence, subsequent mode of birth and morbidity for women who experienced severe perineal trauma in a first birth in New South Wales between 2000 ‐ 2008: a population based data linkage study. BMC Pregnancy and Childbirth 2013;13:89.

Qian 2001

Qian X, Smith H, Zhou L, Liang J, Garner P. Evidence‐based obstetrics in four hospitals in China: an observational study to explore clinical practice, women's preferences and provider's views. BMC Pregnancy and Childbirth 2001;1:1.

RCOG 2007

Royal College of Obstetricians and Gynaecologists. The Management of Third‐ and Fourth‐Degree Perineal Tears. Green‐Top Guideline. 2nd Edition. RCOG, 2007.

RevMan 2014 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager 5 (RevMan 5). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Räisänen 2011

Räisänen S, Vehviläinen‐Julkunen K, Gisler M, Heinonen S. A population‐based register study to determine indications for episiotomy in Finland. International Journal of Gynecology and Obstetrics 2011;115:26‐30.

Steiner 2012

Steiner N, Weintraub AY, Wiznitzer A, Sergienko R, Sheiner E. Episiotomy: the final cut?. Archives of Gynecology and Obstetrics 2012;286(6):1369‐73.

Thacker 1983

Thacker SB, Banta HD. Benefits and risks of episiotomy: an interpretative review of the English language literature, 1860‐1980. Obstetrical & Gynecological Survey 1983;38:322‐38.

Referencias de otras versiones publicadas de esta revisión

Carroli 2009

Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database of Systematic Reviews 2009, Issue 1. [DOI: 10.1002/14651858.CD000081.pub2]

Carroli 2012

Carroli G, Mignini L. Episiotomy for vaginal birth. Cochrane Database of Systematic Reviews 2012, Issue 2. [DOI: 10.1002/14651858.CD000081.pub2]

Hay‐Smith 1995a

Hay‐Smith J. Liberal use of episiotomy for spontaneous vaginal delivery. [revised 05 May 1994]. In: Enkin MW, Keirse MJNC, Renfrew MJ, Neilson JP, Crowther CA (eds) Pregnancy and Childbirth Module. In: The Cochrane Pregnancy and Childbirth Database [database on disk and CD ROM]. The Cochrane Collaboration; Issue 2, Oxford: Update Software; 1995.

Hay‐Smith 1995b

Hay‐Smith J. Midline vs mediolateral episiotomy. [revised 26 January 1994]. In: Enkin MW, Keirse MJNC, Renfrew MJ, Neilson JP, Crowther CA (eds) Pregnancy and Childbirth Module. In: The Cochrane Pregnancy and Childbirth Database [database on disk and CD ROM]. The Cochrane Collaboration; Issue 2, Oxford: Update Software; 1995.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ali 2004

Methods

RCT

Participants

Women after admission to the labour ward, I00 primigravidae in each group

Inclusion criteria: primigravidae in labour at term with a singleton fetus in cephalic presentation.

Exclusion criteria: participants with gross fetal malformations.

Interventions

Intervention group: episiotomy was avoided and was only given for fetal distress or when severe perineal trauma was judged to be imminent.

Control group: right mediolateral episiotomy was made in all primigravidae according to hospital policy.

Outcomes

Severe perineal trauma, rate of episiotomy

Notes

Right mediolateral episiotomies. Epsiotomy rates were 32% for the selective group and 100% for the routine group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Low risk

Woman was asked to open one of the two envelopes each envelope containing intervention for the either group as mentioned above (routine and selective use of episiotomy groups) for randomised selection

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

High risk

No description of loss to follow‐up. Exactly 100 in each group. Table of patient variables does not give numbers of women on which these data are based. There appears to be a differential loss to follow‐up (at 7th day postpartum), 19 women were lost from the selective group, and 12 from the routine group.

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

The authors claim no "severe perineal trauma" but table 2 indicates there is 100% in both groups, leading to questions about the integrity of the data.

Belizan 1993

Methods

Generation of randomisation by computer from a random sample generator programme, organised in balanced blocks of 100, with stratification by centre and by parity (nulliparous and primiparous)

Allocation concealment by sequentially‐numbered, sealed, opaque envelopes, divided according to parity.

Participants

N: 2606 women; 1298 women in the intervention group and 1308 women in the control group. 1555 were nulliparous (778 in the selective group and 777 in the routine group) and 1051 primiparous (520 in the selective and 531 in the routine group).
Inclusion criteria: uncomplicated labour; 37 to 42 weeks’ gestation; nulliparous or primiparous. Single fetus
Cephalic presentation; no previous caesarean section or severe perineal tears

Interventions

Intervention: selective ‐ try to avoid an episiotomy if possible and only do it for fetal indications or if severe perineal trauma was judged to be imminent

Control: routine ‐ do an episiotomy according to the hospital’s policy prior to the trial

Outcomes

Severe perineal trauma (primary outcome); middle/upper vaginal tears; anterior trauma; any posterior surgical repair; posterior perineal surgical repair; perineal pain at discharge; haematoma at discharge; healing complications, infection and dehiscence at 7 days.

Apgar score less than 7 at 1st minute.

Notes

Mediolateral episiotomies. Epsiotomy rates were 30% for the restricted group and 80.6% for the routine group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The description "Random treatment assignments were derived from a random sample generator programme and was organized in balanced blocks of 100, with stratification by centre and parity".

Allocation concealment (selection bias)

Low risk

The description "Each centre was supplied with a set of sequentially‐ numbered, sealed, opaque envelopes, which contained the trial instructions".

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

The description "Healing and morbidity were assessed at the time of discharge from hospital and on the seventh postpartum day by an independent physician who did not know the trial allocation". However, it was not clear whether the primary outcome "perineal trauma" "assessed by the attending physician at the time of delivery" was done with blinding. It was not clear whether participants were blinded.

Blinding of outcome assessment (detection bias)
All outcomes

Low risk

The description "Healing and morbidity were assessed at the time of discharge from hospital and on the seventh postpartum day by an independent physician who did not know the trial allocation". The assessment was blinded, but no details reported for other outcomes, e.g. severe perineal trauma at delivery.

Incomplete outcome data (attrition bias)
All outcomes

High risk

The primary outcome was with a 5% loss to follow‐up at delivery. 93.0% of women in the selective group and 92.9% in the routine were assessed when discharged from hospital. This is high. However, 42.7% and 43.1% followed up for the selective and routine group respectively on the seventh day postpartum. More than half of women in both groups were not assessed, but no detailed information about this

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge as no trial protocol

Other bias

Unclear risk

Not enough information to judge

Dannecker 2004

Methods

Random generation: not stated

Allocation concealment: sealed opaque envelopes

Participants

Number randomised: 146 (selective 70, routine 76)

Inclusion criteria: primiparous, > 34 weeks of gestation, with an uncomplicated pregnancy and with a live singleton fetus. Women were intending to have a vaginal delivery.

Exclusion criteria: previous surgery at the pelvic floor, or neurologic disorder

Interventions

Intervention: restrictive ‐ try to avoid an episiotomy even if severe perineal trauma was judged to be imminent and only do it for fetal indications.

Control: liberal ‐ in addition to fetal indications use of episiotomy when a tear is judged to be imminent.

Outcomes

Reduction of episiotomies, increase of intact perinea and only minor perineal trauma, perineal pain (displayed in score) in the postpartum period, percentage change in overall anterior perineal trauma, difference of the PH of the umbilical artery, percentage of umbilical artery PH less than 7.15, percentage of Apgar scores less than 7 at 1 and 5 minutes, maternal blood loss at delivery (measured by mean difference pre/post haemoglobin), percentage of severe perineal trauma, dyspareunia, urinary incontinence

Notes

Mediolateral episiotomies. Episiotomy rates were 70% for restricted group and 79% for the routine group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

Not stated

Allocation concealment (selection bias)

Low risk

The description "Random treatment assignments were carried out using two opaque envelopes with the different policies enclosed for every particular participant"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Loss to follow‐up reported with reason, but unable to fully judge. For follow‐up approximately 6 months or more later, the overall dropout was around 40%, 45% in selective, and 32% in routine

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

No enough information to judge

Eltorkey 1994

Methods

Random generation: not stated
Allocation concealment: sealed opaque envelopes

Participants

N: 200 women (100 in each)

Inclusion criteria: primigravid women with live, singleton fetus, cephalic presentation of at least 37 weeks of gestational age, having a spontaneous vaginal delivery. Women were not suffering from any important medical or psychiatric disorder.

Interventions

Intervention: selective ‐ the intention was not to perform an episiotomy unless it was absolutely necessary for maternal or fetal reasons
Control: elective ‐ the intention was to perform an episiotomy unless it was considered absolutely unnecessary

Outcomes

First‐, second‐, third‐ and fourth‐degree tears, anterior trauma, need for suturing, and neonatal outcomes: Apgar score at 1 and 5 minutes, and stay in NICU

Notes

Mediolateral episiotomies. Epsiotomy rates were 53% for the restricted group and 83% for the routine group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Low risk

The description "Entry to the trial, which was signalled by opening a sealed opaque envelope, was postponed until the attending midwife had decided to 'scrub up' in expectation of a spontaneous vaginal delivery"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No details reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No details reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

No detailed reported

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

No enough information to judge

Harrison 1984

Methods

Generation method of randomisation not established

Concealment allocation method not established

"Allocated randomly"

Participants

N: 181 (intervention, N = 92; control, N = 89).

Inclusion criteria: women primigravid, vaginal delivery, at least 16 years old, no less than 38 weeks’ gestational age, not suffering from any important medical or psychiatric conditions or eclampsia

Interventions

Intervention: not to undergo episiotomy unless it was considered to be medically essential by the person in charge, that is the accoucheur could see that a woman was going to sustain a greater damage or if the intact perineum was thought to be hindering the achievement of a safe normal or operative delivery.

Control: to undergo mediolateral episiotomy

Outcomes

Severe maternal trauma. Any posterior perineal trauma. Need for suturing perineal trauma

Notes

Mediolateral episiotomies. Epsiotomy rates were 7.6% for restricted group and 100% for the routine group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Unclear risk

No details reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No details reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No details reported

Incomplete outcome data (attrition bias)
All outcomes

High risk

Data were not reported by randomisation group

Selective reporting (reporting bias)

Unclear risk

No enough information to judge

Other bias

Unclear risk

No enough information to judge

House 1986

Methods

Generation method of randomisation not established

Concealment method of allocation by envelopes

Participants

Number of participants not established. There is only information for 165 women available to follow‐up but information about women lost to follow‐up is lacking, either because 1 of the study authors was not available, or because of the early discharge scheme. 98 primigravidae and 67 multigravidae. 94 in the intervention and 71 in the control group.

Inclusion criteria: women were at least 37 weeks’ gestational age, cephalic presentation and vaginal delivery.

Exclusion criteria: lack of consent, labour at less than 37 weeks pregnant, presentation other than vertex, caesarean section and the unavailability of an accoucheur willing to abide by the research protocol. Women who subsequently had a forceps delivery were not excluded

Interventions

Intervention: restrict ‐ not to perform specifically to prevent laceration

Control: liberal ‐ to receive standard current management whereby perineal damage was avoided by control of the descent of the head and supporting the perineum at crowning. An episiotomy was made if there was fetal distress, or for maternal reasons to shorten the 2nd stage such as severe exhaustion, inability to complete expulsion or unwillingness to continue pushing. Episiotomy was performed if the perineum appeared to be too tight or rigid to permit delivery without laceration, or if a laceration appeared imminent.

Outcomes

Second‐degree tear. Third‐degree tear. Need for perineal suturing. Any perineal pain at 3 days. Healing at 3 days. Tenderness at 3 days. Perineal infection at 3 days. Blood loss during delivery

Notes

Mediolateral episiotomies. Epsiotomy rate for restricted group were 18% and for the routine group were 69%

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Low risk

Judge from the description "This involved the selection of envelopes containing a questionnaire and management group"

Blinding of participants and personnel (performance bias)
All outcomes

Low risk

The description "Women were not informed of the management group allocated"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No details reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

The study involved above 165 women over a 12‐month period. Authors did not provide how many participants were recruited at the recruitment

Selective reporting (reporting bias)

Unclear risk

No enough information to judge

Other bias

Unclear risk

Unclear risk of bias of measuring blood loss at delivery since the study used visual inspection for blood loss estimation without specific training. Not enough information to judge for other bias

Juste‐Pina 2007

Methods

Generation method of randomisation not established

Concealment method of randomisation not stated. Experimental study, controlled, with random allocation of women to the control group who were given routine episiotomy or to the experimental group who were given a selective episiotomy

Participants

N: 402 (intervention, N = 200; control, N = 202)
Inclusion criteria: nulliparous women who fulfilled the inclusion criteria (nulliparous, to full term, single live fetus, cephalic presentation, gestational age to term and of Spanish nationality)

Interventions

Intervention: selective episiotomy (by fetal or maternal indication)
Control: routine episiotomy (with the aim of trying to prevent tears)

Outcomes

Weight gain during gestation, maternal weight at the time of delivery
Gestation control, maternal education and the gestational age
Delivery: beginning of delivery (spontaneous or induced), use of oxytocin, epidural analgesia, duration of the dilation and expulsive stages
Motives for carrying out the episiotomy or not
Subsequent first‐, second‐, third‐ and fourth‐degree perineum tears
Previous perineum tears (lip tears)
The newborn: Apgar test, weight, need for admittance to neonatology and the reasons
Immediate puerperium: fever, use of antibiotics, use of analgesia, perineal oedema, perineal hematoma and application of ice, local infection, dehiscence, urinary incontinence and lactation
Immediate puerperium pain, in the hospital and after 3 months: pain in general, pain with urination, bowel movement, walking and sedestation
Time of commencement of sexual relations, dyspareunia

Notes

Medio‐lateral; 118 of 200 women had episiotomy in the selective group; 169 of 202 women had episiotomy in the control group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Unclear risk

No details reported

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No details reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

There was the description "On the third day after puerperium, a different midwife carried out a personalised survey and assessed the perineum". However, it was not clear whether the midwife was blinded for the group allocation

Incomplete outcome data (attrition bias)
All outcomes

Low risk

402 women began the study. 14 women who received an early discharge which impeded them from being interviewed during hospital puerperium; at 3 months postpartum, 21 participants were excluded due to not being able to be contacted; at 3 years after childbirth, 37 participants from the initial sample were excluded due to the fact that it was impossible to contact women

Selective reporting (reporting bias)

Unclear risk

No details reported

Other bias

Unclear risk

No details reported

Klein 1992

Methods

Generation method of randomisation not established

Concealment of allocation by opaque, sequentially‐numbered envelopes

Participants

N: 703 randomised (N = 353; control, N = 350).

Inclusion criteria: women had a parity of 0, 1, or 2, between the ages of 18 and 40 years, carried a single fetus, spoke English or French, and were of medical and obstetrical low risk as determined by their physician.

Exclusion criteria: prematurity, that is gestation less than 37 weeks, medical conditions developing late in pregnancy, fetal distress, caesarean deliveries and planned forceps

Interventions

Intervention: restricted ‐ "Try to avoid an episiotomy". The physician should only use episiotomy for fetal indications (late fetal distress: fetal bradycardia, tachycardia, or meconium‐stained amniotic fluid) or rarely for maternal perineal indications (severe tear anticipated)

Control: liberal ‐ "Try to avoid a tear". The physician was expected to use episiotomy liberally as the usual or routine method for preventing tears

Outcomes

Perineal trauma including first, second, third and fourth degree and sulcus tears. Perineal pain at 1, 2, 10 days. Dyspareunia. Urinary incontinence and perineal bulging. Time on resumption and pain of sexual activity. Pelvic floor function. Admission to special care baby unit

Notes

Midline episiotomies. Epsiotomy rates were 43.8% for restricted group and 65% for the routine group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Low risk

The description "Usage of opaque envelopes that were sequentially numbered, and contained instructions printed on opaque cards"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not blinded. As stated in the text "Blinding of the staff to subject group membership was not possible. The subjects, while they usually knew if they had received an episiotomy, were generally naive as to their study group membership (base on intention to treat)"

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No details reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

A loss to follow‐up rate around 1% at delivery and 3 months postpartum.

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

No details reported

Murphy 2008b

Methods

RCT. Random allocation to:

A. restrictive use of episiotomy for instrumental vaginal delivery

B. routine use of episiotomy for instrumental vaginal delivery

Participants

N: 200 women (intervention, N = 101; control, N = 99)

Inclusion criteria: primigravid women in the third trimester of pregnancy (> 36 weeks) with a singleton cephalic pregnancy who were English speakers and had no contra‐indication to vaginal birth

Exclusion criteria: women who were: non‐English speakers; who had contra‐indication to vaginal birth; multiple pregnancy; malpresentation; multiparous women as the rate of instrumental delivery is significantly lower in these women making the effort of recruitment unjustified; women who had not given written informed consent prior to the onset of labour.

Interventions

Intervention: restrictive use of episiotomy for instrumental vaginal delivery (only if tearing becomes apparent)

Control: routine use of episiotomy for instrumental vaginal delivery (in all cases)

Outcomes

Extensive perineal tearing involving the anal sphincter (third‐ or fourth‐degree tears) Postpartum haemorrhage, shoulder dystocia, the mother's perception of pain, the length of postnatal hospital stay, urinary or bowel symptoms and the rate of healing complications, low Apgar scores, low arterial blood gases, admission to the neonatal intensive care unit and trauma, estimated blood loss

Notes

Unclear for the mediolateral or midline episiotomies

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

The description "The randomisation was performed by computer program using a randomisation sequence generated by a statistician unconnected with the study. Allocation was stratified by maternity unit using randomly permuted blocks of 10"

Allocation concealment (selection bias)

Low risk

The description "The allocation was revealed immediately prior to commencing the OVD. Some randomisation were allocated using opaque envelopes due to technical difficulties with the programme. Adherence to the allocation was confirmed by the research midwife each day"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Not stated

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Not stated

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Loss to follow‐up reported without reasons (described as unobtained), unable to fully judge

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

No details reported

Rodriguez 2008

Methods

Ralloc software (Boston College Department of Economics, Boston, MA) was used to create a random sequence of numbers in blocks with 2, 4, and 6 size permutations.
Participants were assigned either to the routine episiotomy or the selective episiotomy group, depending of the basis of the randomisation sequence kept at the institution.

Participants

N: 446 randomised, 223 in each group (intervention, N = 222 analysed; control, N = 223).

Inclusion criteria: nulliparous women with pregnancies more than 28 weeks of gestation who had vaginal deliveries

Exclusion criteria: women with multiple pregnancies, and with breech presentations and those who did not sign the informed consent or refused to participate in the study

Interventions

Intervention: selective ‐ to undergo the procedure only in cases of forceps delivery, fetal distress, or shoulder dystocia or when the operator considered that a severe laceration was impending and could only be avoided by performing an episiotomy.
Control: routine ‐ to undergo the procedure at the time the fetal head was distending the introitus.

Outcomes

The primary outcome of severe laceration to perineal tissues was defined as a third‐degree laceration when the extent of the lesion included the external anal sphincter totally or partially, and fourth‐degree laceration when the rectal mucosa was involved.

Notes

Midline episiotomies. Epsiotomy rates were 24.3% for restricted group and 100% for the routine group.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Random sequence of numbers was established, and block size reported

Allocation concealment (selection bias)

Unclear risk

Inadequate information to judge as it was described "randomisation sequence was kept at the institution"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No details reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No details reported

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

Reported numbers of loss with reason, but unable to fully judge

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

No enough information to judge

Sleep 1984

Methods

Generation method of randomisation not established

Concealment of allocation by opaque sealed envelopes

Participants

N: 1000 (intervention, N = 498; control, N = 502)

Inclusion criteria: women randomised with spontaneous vaginal deliveries, live singleton fetus, at least 37 completed weeks of gestational age, cephalic presentation

From the 1000 original women randomised in the original trial, 922 were available for follow‐up and 674 of them responded to a postal questionnaire which are the women included in the analysis

Interventions

Intervention: restrict policy ‐ “Try to avoid episiotomy”: the intention should be to avoid an episiotomy and performing it only for fetal indications (fetal bradycardia, tachycardia, or meconium‐stained liquor)

Control: liberal policy ‐ “Try to prevent a tear”: the intention being that episiotomy should be used more liberally to prevent tears

Outcomes

Severe maternal trauma: extension through the anal sphincter or to the rectal mucosa or to the upper 3rd of the vagina
Apgar score less than 7 at 1 minute
Severe or moderate perineal pain 10 days after delivery
Admission to special care baby unit in first 10 days of life. Perineal discomfort 3 months after delivery
Number of resumption of sexual intercourse within a month and 3 months after delivery
Any dyspareunia in 2 years. Any incontinence of urine at 3 years. Urinary incontinence severe to wear a pad at 3 years

Notes

Mediolateral episiotomies. Epsiotomy rates were 10.2% for restricted group and 51.4% for the routine group

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Low risk

Sealed opaque envelope was used for group allocation

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

Although 1 of the outcomes was described as "Perineal discomfort three months after delivery reported by mothers who in most cases blind to the allocation", but not enough information to judge how they were blinded

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Perineal pain 10 days after delivery, admission to special care baby unit in first 10 days of life, were assessed by community midwife blind to the allocation; not enough information to judge

Incomplete outcome data (attrition bias)
All outcomes

Unclear risk

"One thousand women (93% of those who met the criteria for entry) were allocated at random to one of two management policies. But 885 were assessed on 10 days postpartum, and 895 assessed on three months postpartum." The follow‐up rate at both 10 days and 3 months after delivery was 89%.

For 3‐years' follow‐up, the loss to follow‐up was about 33%. There was the description "no attempt was made to contact 15 women: eight were known to speak little English; two had refused to adoption; open baby had been taken into care; and one baby had died in the neonatal period. 481 (49%) of the remaining 985 participants had changed their address in the three years since the original study, of whom 303 (31%) were still living within West Berkshire Health Authority. The new address of 100 of the remaining 178 women was not known". Another 63 women were unable to trace because they had "registered in different name (one woman had changed her name six times during the three days), or failed to reregister for medical care in a different area, or because their husbands had been transferred to military posts overseas; one mother had died"

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

Not enough information to judge

Sulaiman 2013

Methods

Generation method of randomisation not established
Concealment method of allocation by opening a sealed opaque envelope

Participants

N: 209 randomised, 171 analysed (intervention, N = 89; control, N = 82).

Inclusion criteria: Women live singleton pregnancy with cephalic presentation, gestation beyond 37 weeks, primigravida, women with no history of severe perineal injuries, no life‐threatening medical or psychiatric conditions

Interventions

Intervention: selective ‐ women in the selective group were not to undergo episiotomy unless considered essential for various reasons such as fetal distress or imminent extended perineal injury

Control: routine‐ all women in the routine group were to undergo the usual hospital protocol

Outcomes

Prevalence of obstetrical anal sphincter injuries, incidence of first‐, second‐, third‐ and fourth‐degree perineal tears, blood loss, mean birthweight, and newborns with pH less than 7.2 and admission to the NICU, blood loss, intact perineum

Notes

Mediolateral. Half in the selective group had episiotomy and all (100%) women in the routine group were subjected to an episiotomy

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Unclear risk

No details reported

Allocation concealment (selection bias)

Low risk

The description "Randomization into selective and routine episiotomy group was performed by opening a sealed opaque envelope"

Blinding of participants and personnel (performance bias)
All outcomes

Unclear risk

No details reported

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

No details reported

Incomplete outcome data (attrition bias)
All outcomes

Low risk

No loss to follow‐up

Selective reporting (reporting bias)

Unclear risk

All outcomes stated were reported but unable to fully judge

Other bias

Unclear risk

Unclear risk of bias of measuring blood loss at delivery since the study used visual inspection for blood loss estimation without specific training. Not enough information to judge for other bias

NICU: neonatal intensive care unit
RCT: randomised controlled trial

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Amorim 2015

This study examined a policy of no episiotomy versus selective episiotomy; this comparison was not covered in this review which focused on selective versus routine episiotomy

Coats 1980

Quasi‐randomised controlled trial, participants were allocated by the last digit of their hospital numbers and the appropriate episiotomy was performed if needed

Detlefsen 1980

This study did not compare the restrictive use of episiotomy versus the routine use of episiotomy. It compared median and medio‐lateral episiotomy.

Dong 2004

This study focused on 2 approaches of mediolateral episiotomy (with different angles), rather than the comparison between restrictive and routine episiotomy. There was no description on the process of randomisation and how pain was scored.

El‐Din 2014

This paper compared 2 incision angles of mediolateral episiotomy, not the restrictive use of episiotomy and routine use of episiotomy.

Golmakani 2011

Only translated abstract was available. Degrees of perineal trauma not clear from the abstract. The abstract only included the overall proportion of perineal trauma.

Henriksen 1992

As described in the Summary, it was a quasi‐randomised study. (Design: The study was a population‐based observational study. 2 approaches were used in the analyses: At first we considered the women giving birth as quasi randomised to 1 of 3 equally sized groups of midwives, where episiotomy was used to different extents. Next, we studied the effect of episiotomy on the state of the anal sphincter as well as birthweight, parity and the duration of the second stage of labour.)

Islam 2013

The study compared the use of episiotomy or not, rather than the restrictive use and routine use of episiotomy.

Javed 2007

The comparison was not conducted between the restrictive use of episiotomy and routine use of episiotomy, but to compare the use of episiotomy or not. Furthermore, participants were not randomly allocated to the 2 groups. (Page 107, 300 primigravida were selected randomly by lottery system but when a patient included in group B, who was not to undergo episiotomy, needed that due to fetal indication, she was shifted to the other group A who were to undergo episiotomy, medio‐lateral in every case.)

Karbanova 2013

The studies aimed to compare mediolateral versus lateral episiotomy, and to compare the effect of episiotomy performed before and at time of crowning in primiparous women, not for restrictive use of episiotomy and routine use of episiotomy.

Moini 2009

To compare the use of episiotomy and non‐use of episiotomy

Roy 2015

The study compared the use of episiotomy or not, not comparing the selective use and routine use of episiotomy.

Sawant 2015

To compare episiotomy suture angles with Braun‐Stadler episiotomy scissors with the new fixed angle EPISCISSORS‐60.

Shembekar 2009

Only abstract is available, excluded

Swift 2014

This study did not compare restrictive use of episiotomy and routine use of episiotomy. It compared curved versus straight scissors to avoid 3rd and 4th degree tears.

Werner 1991

The study compared midline versus mediolateral episiotomy rather than selective versus routine episiotomy. There is no reference about the method of randomisation used. The effects are not shown in a quantitative format making the data uninterpretable.

Characteristics of ongoing studies [ordered by study ID]

NCT02356237

Trial name or title

The effect of episiotomy on maternal and fetal outcomes (EPITRIAL)

Methods

RCT

Participants

14,842 women in 7 northern public Israeli hospitals from February 2015‐February 2019

Inclusion criteria
18‐50 years old; women in labour, or women scheduled for induction of labour, or women attending for a routine follow‐up examination during third trimester of pregnancy
First vaginal delivery
Singleton pregnancy above 34 gestational weeks
Vertex presentation

Women who are able to understand and sign the informed consent forms
Exclusion criteria
Absolute contraindications for vaginal delivery (e.g. placenta previa, fetal macrosomia above 4.5 kg, genital herpes)

Interventions

Intervention: avoidance of episiotomy

Episiotomy will not be performed in this group. Deviation from protocol (i.e. episiotomy performance) will be allowed only according to the discretion of obstetrician in charge of the delivery, in cases of unequivocal benefit to the fetus.

Control: no episiotomy

The decision to perform episiotomy in this group will be based on routine delivery care, i.e. indistinguishable from any other delivery not participating in the trial.

Outcomes

Obstetric anal sphincter injury (time frame: from the delivery to 1 h after delivery) (Designated as safety issue: no
Advanced (3rd and 4th degree) perineal tears, i.e. perineal lacerations involving the anal sphincter, diagnosed by a senior obstetrician

Starting date

February 2015

Contact information

Lena Sagi‐Dain, email: [email protected]

Notes

TCTR20150212001

Trial name or title

Restrictive versus routine episiotomy: a randomised controlled trial.

Methods

RCT

Participants

3 study hospitals will be included, Srinagarind Hospital, a super tertiary care university hospital; Khon Kaen Hospital, a regional tertiary care hospital; Kalasin Hospital. Women who agree to participate in the trial after having signed the consent form will be randomly allocated to be delivered with either restrictive or routine episiotomy. A total of 3006 women will be recruited ‐ for primi‐parity group 1100 women (550 per arm); for multi‐parity group 1906 women (953 per arm)

Inclusion criteria

Age > 18 years old and able to read and write

Singleton pregnancy

Gestational age at least 37 weeks

Cephalic presentation

Planned vaginal delivery

Exclusion criteria

Women planned for cesarean delivery

Interventions

Intervention: restrictive episiotomy ‐ to avoid episiotomy unless indicated for fetal indications and/or to avoid severe laceration

Control: routine episiotomy ‐ all women receive episiotomy, either medio‐lateral or midline according to attending personnel

Outcomes

Primary outcome: severe perineal trauma (third‐degree and fourth‐degree laceration)

Secondary outcomes

  • Maternal outcomes

    • Duration of second stage of labour

    • Posterior perineal trauma

    • Anterior perineal trauma

    • Blood loss

    • Need for suturing

    • Duration of suturing

    • Medication for perineal pain relief

    • Perineal wound haematoma (at time of discharge)

    • Perineal wound dehiscence (at time of discharge)

    • Perineal wound infection (at time of discharge)

  • (2) Fetal outcomes

    • Birth asphyxia (Apgar score 4‐6 at 5 min after birth)

    • Severe birth asphyxia (Apgar score < 4 at 5 min after birth)

    • Need for admission to special care baby unit

Starting date

Pending (not yet recruiting as of August 2016)

Contact information

Jadsada Thinkhamrop; email: [email protected]

Notes

RCT: randomised controlled trial

Data and analyses

Open in table viewer
Comparison 1. Restrictive versus routine episiotomy (where non‐instrumental was intended)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe perineal/vaginal trauma Show forest plot

11

6177

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

Analysis 1.1

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 1 Severe perineal/vaginal trauma.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 1 Severe perineal/vaginal trauma.

2 Severe perineal/vaginal trauma (grouped by trial implementation success) Show forest plot

11

6177

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

Analysis 1.2

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 2 Severe perineal/vaginal trauma (grouped by trial implementation success).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 2 Severe perineal/vaginal trauma (grouped by trial implementation success).

2.1 Difference in episiotomy rate < 30%

3

1300

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.63, 1.69]

2.2 Difference in episiotomy rate 30% +

8

4877

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.38, 0.81]

3 Blood loss at delivery (mL) Show forest plot

2

336

Mean Difference (IV, Random, 95% CI)

‐27.16 [‐74.80, 20.49]

Analysis 1.3

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 3 Blood loss at delivery (mL).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 3 Blood loss at delivery (mL).

4 Newborn Apgar score < 7 at 5 minutes Show forest plot

2

511

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.01, 0.01]

Analysis 1.4

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 4 Newborn Apgar score < 7 at 5 minutes.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 4 Newborn Apgar score < 7 at 5 minutes.

5 Perineal infection Show forest plot

3

1467

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.45, 1.82]

Analysis 1.5

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 5 Perineal infection.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 5 Perineal infection.

6 Moderate or severe pain (visual analogue scale) Show forest plot

1

165

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.48, 1.05]

Analysis 1.6

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 6 Moderate or severe pain (visual analogue scale).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 6 Moderate or severe pain (visual analogue scale).

7 Dyspareunia long term (≥ 6 m) Show forest plot

3

1107

Risk Ratio (M‐H, Fixed, 95% CI)

1.14 [0.84, 1.53]

Analysis 1.7

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 7 Dyspareunia long term (≥ 6 m).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 7 Dyspareunia long term (≥ 6 m).

8 Genital prolapse long term (≥ 6 m) Show forest plot

1

365

Risk Ratio (M‐H, Fixed, 95% CI)

0.30 [0.06, 1.41]

Analysis 1.8

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 8 Genital prolapse long term (≥ 6 m).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 8 Genital prolapse long term (≥ 6 m).

9 Urinary incontinence long term (≥ 6 m) Show forest plot

3

1107

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.67, 1.44]

Analysis 1.9

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 9 Urinary incontinence long term (≥ 6 m).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 9 Urinary incontinence long term (≥ 6 m).

10 Need for perineal suturing Show forest plot

6

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

Analysis 1.10

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 10 Need for perineal suturing.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 10 Need for perineal suturing.

11 Admission to special care baby unit Show forest plot

5

2471

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.56, 1.07]

Analysis 1.11

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 11 Admission to special care baby unit.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 11 Admission to special care baby unit.

12 Pain at different time points (any measure) Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

Analysis 1.12

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 12 Pain at different time points (any measure).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 12 Pain at different time points (any measure).

12.1 Any perineal pain at discharge

2

2587

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.25, 2.86]

12.2 Any pain at 10 days

1

885

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.78, 1.27]

12.3 Moderate‐severe pain in first 10 days

3

1127

Risk Ratio (M‐H, Random, 95% CI)

1.14 [0.61, 2.12]

12.4 Severe or moderate pain at 3 months postpartum

1

895

Risk Ratio (M‐H, Random, 95% CI)

1.51 [0.65, 3.49]

Open in table viewer
Comparison 2. Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe perineal/vaginal trauma Show forest plot

11

6177

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

Analysis 2.1

Comparison 2 Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity), Outcome 1 Severe perineal/vaginal trauma.

Comparison 2 Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity), Outcome 1 Severe perineal/vaginal trauma.

1.1 Primiparae

11

4137

Risk Ratio (M‐H, Fixed, 95% CI)

0.68 [0.50, 0.93]

1.2 Multiparae

4

2040

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.35, 2.01]

Open in table viewer
Comparison 3. Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe vaginal/perineal trauma Show forest plot

10

5977

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

Analysis 3.1

Comparison 3 Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral), Outcome 1 Severe vaginal/perineal trauma.

Comparison 3 Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral), Outcome 1 Severe vaginal/perineal trauma.

1.1 Midline

2

1143

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.51, 1.07]

1.2 Mediolateral

8

4834

Risk Ratio (M‐H, Fixed, 95% CI)

0.62 [0.37, 1.04]

Open in table viewer
Comparison 4. Restrictive versus routine episiotomy (operative vaginal birth was intended)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe perineal/vaginal trauma Show forest plot

1

175

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [0.55, 3.07]

Analysis 4.1

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 1 Severe perineal/vaginal trauma.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 1 Severe perineal/vaginal trauma.

2 Apgar < 7 at 5 minutes Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

Analysis 4.2

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 2 Apgar < 7 at 5 minutes.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 2 Apgar < 7 at 5 minutes.

3 Perineal infection Show forest plot

1

175

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.04, 5.11]

Analysis 4.3

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 3 Perineal infection.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 3 Perineal infection.

4 Moderate/severe dyspareunia long term (≥ 6 m) Show forest plot

1

108

Risk Ratio (M‐H, Fixed, 95% CI)

3.71 [0.43, 32.16]

Analysis 4.4

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 4 Moderate/severe dyspareunia long term (≥ 6 m).

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 4 Moderate/severe dyspareunia long term (≥ 6 m).

5 Urinary incontinence long term (≥ 6 m) Show forest plot

1

108

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.09, 2.43]

Analysis 4.5

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 5 Urinary incontinence long term (≥ 6 m).

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 5 Urinary incontinence long term (≥ 6 m).

6 Admission to special care baby unit Show forest plot

1

175

Risk Ratio (M‐H, Fixed, 95% CI)

2.13 [0.68, 6.64]

Analysis 4.6

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 6 Admission to special care baby unit.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 6 Admission to special care baby unit.

The rationale commonly used to justify routine episiotomy
Figures and Tables -
Figure 1

The rationale commonly used to justify routine episiotomy

Study flow diagram
Figures and Tables -
Figure 2

Study flow diagram

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
Figures and Tables -
Figure 3

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

Risk of bias summary: review authors' judgements about each risk of bias item for each included study
Figures and Tables -
Figure 4

Risk of bias summary: review authors' judgements about each risk of bias item for each included study

Funnel plot of comparison: 1 Restrictive versus routine episiotomy (planned non‐instrumental), outcome: 1.1 Severe perineal/vaginal trauma
Figures and Tables -
Figure 5

Funnel plot of comparison: 1 Restrictive versus routine episiotomy (planned non‐instrumental), outcome: 1.1 Severe perineal/vaginal trauma

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 1 Severe perineal/vaginal trauma.
Figures and Tables -
Analysis 1.1

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 1 Severe perineal/vaginal trauma.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 2 Severe perineal/vaginal trauma (grouped by trial implementation success).
Figures and Tables -
Analysis 1.2

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 2 Severe perineal/vaginal trauma (grouped by trial implementation success).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 3 Blood loss at delivery (mL).
Figures and Tables -
Analysis 1.3

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 3 Blood loss at delivery (mL).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 4 Newborn Apgar score < 7 at 5 minutes.
Figures and Tables -
Analysis 1.4

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 4 Newborn Apgar score < 7 at 5 minutes.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 5 Perineal infection.
Figures and Tables -
Analysis 1.5

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 5 Perineal infection.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 6 Moderate or severe pain (visual analogue scale).
Figures and Tables -
Analysis 1.6

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 6 Moderate or severe pain (visual analogue scale).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 7 Dyspareunia long term (≥ 6 m).
Figures and Tables -
Analysis 1.7

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 7 Dyspareunia long term (≥ 6 m).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 8 Genital prolapse long term (≥ 6 m).
Figures and Tables -
Analysis 1.8

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 8 Genital prolapse long term (≥ 6 m).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 9 Urinary incontinence long term (≥ 6 m).
Figures and Tables -
Analysis 1.9

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 9 Urinary incontinence long term (≥ 6 m).

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 10 Need for perineal suturing.
Figures and Tables -
Analysis 1.10

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 10 Need for perineal suturing.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 11 Admission to special care baby unit.
Figures and Tables -
Analysis 1.11

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 11 Admission to special care baby unit.

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 12 Pain at different time points (any measure).
Figures and Tables -
Analysis 1.12

Comparison 1 Restrictive versus routine episiotomy (where non‐instrumental was intended), Outcome 12 Pain at different time points (any measure).

Comparison 2 Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity), Outcome 1 Severe perineal/vaginal trauma.
Figures and Tables -
Analysis 2.1

Comparison 2 Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity), Outcome 1 Severe perineal/vaginal trauma.

Comparison 3 Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral), Outcome 1 Severe vaginal/perineal trauma.
Figures and Tables -
Analysis 3.1

Comparison 3 Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral), Outcome 1 Severe vaginal/perineal trauma.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 1 Severe perineal/vaginal trauma.
Figures and Tables -
Analysis 4.1

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 1 Severe perineal/vaginal trauma.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 2 Apgar < 7 at 5 minutes.
Figures and Tables -
Analysis 4.2

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 2 Apgar < 7 at 5 minutes.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 3 Perineal infection.
Figures and Tables -
Analysis 4.3

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 3 Perineal infection.

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 4 Moderate/severe dyspareunia long term (≥ 6 m).
Figures and Tables -
Analysis 4.4

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 4 Moderate/severe dyspareunia long term (≥ 6 m).

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 5 Urinary incontinence long term (≥ 6 m).
Figures and Tables -
Analysis 4.5

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 5 Urinary incontinence long term (≥ 6 m).

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 6 Admission to special care baby unit.
Figures and Tables -
Analysis 4.6

Comparison 4 Restrictive versus routine episiotomy (operative vaginal birth was intended), Outcome 6 Admission to special care baby unit.

Summary of findings for the main comparison. Selective versus routine episiotomy: all vaginal births where operative vaginal delivery was not anticipated

Selective versus routine episiotomy: all vaginal births where operative vaginal delivery was not anticipated

Patient or population: Women in labour where operative delivery was not anticipated. (Women were above 16 years old and between 28 gestational weeks and full term, with a live singleton fetus, without severe medical or psychiatric conditions, and had vaginal birth.)
Setting: Hospitals in high‐, middle‐ and low‐income countries. (Studies were carried out between July 1982 and October 2009, in Argentina, Canada, Columbia, Germany, Ireland, Malaysia, Pakistan, Saudi Arabia, Spain, and the UK. Five studies were carried out in university teaching hospitals, and one of these five studies recruited some participants from a mid‐complexity level hospital. The other six studies were conducted in maternity units with inadequate information to judge the institution's level.)

Intervention: Selective episiotomy (episiotomy rates in the selective group ranged from 8% to 59%).

Comparison: Routine episiotomy (episiotomy rates in the routine group ranged from 61% to 100%; episiotomy rate differences between the groups within trials varied from 21% to 91%).

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Certainty of the evidence
(GRADE)

Comments

Risk with routine episiotomy

Risk with selective episiotomy

Severe perineal/vaginal trauma

3.6 per 100

2.5 per 100
(1.9 to 3.4)

RR 0.70
(0.52 to 0.94)

5375
(8 RCTs)

⊕⊕⊝⊝
low1,2,3

due to imprecision and inconsistency

Selective episiotomy compared to routine may reduce severe perineal/vaginal trauma

Blood loss at delivery

The mean blood loss at delivery was 278 mL

27 mL less (95% CI from 75 mL less to 20 mL more)

336
(2 RCTs)

⊕⊝⊝⊝

very low4,5,6

due to risk of bias, imprecision and inconsistency

We do not know if selective episiotomy compared to routine affects blood loss at delivery

Babies with newborn Apgar score < 7 at 5 minutes

0 per 100

0 per 100

no events

501
(2 RCTs)

⊕⊕⊕⊝

moderate7,8

Due to imprecision

Both selective episiotomy and routine probably has little or no effect on Apgar < 7 at 5 minutes

Perineal infection

2 per 100

2 per 100
(0.9 to 3.6)

RR 0.90
(0.45 to 1.82)

1467
(3 RCTs)

⊕⊕⊝⊝
low9

Due to imprecision

Selective episiotomy compared to routine may result in little or no difference in perineal infection

Women with moderate or severe pain (measured by visual analogue scale)

45.1 per 100

32 per 100
(21.6 to 47.3)

RR 0.71
(0.48 to 1.05)

165
(1 RCT)

⊕⊝⊝⊝
very low10,11,12

Due to imprecision and indirectness

We do not know if selective episiotomy compared to routine results in fewer women with moderate or severe perineal pain

Women with long‐term dyspareunia (≥ 6 months)

12.9 per 100

14.8 per 100
(10.9 to 19.8)

RR 1.14
(0.84 to 1.53)

1107
(3 RCTs)

⊕⊕⊕⊝
moderate13

Due to imprecision

Selective episiotomy compared to routine probably results in little or no difference in women with dyspareunia at > 6 months

Women with long‐term urinary incontinence

(≥ 6 months)

32.2 per 100

31 per 100
(21.5 to 46.3)

RR 0.98
(0.67 to 1.44)

1107
(3 RCTs)

⊕⊕⊝⊝
low13,14

Due to risk of bias and imprecision

Selective episiotomy compared to routine results may have little or no difference in the number of women with urinary incontinence > 6 months

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)

CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

1Downgraded by 1 for imprecision: confidence intervals range from no important difference to large difference.
2Downgraded by 1 for heterogeneity: there is moderate heterogeneity. Random‐effects model gives confidence intervals that cross 1 (RR 0.67, 95% CI 0.41 to 1.09). However, a subgroup analysis shows that the selective episiotomy has been well implemented (episiotomy rate difference between intervention and control > 30%) there was a more substantial effect (RR 0.55, 95% CI 0.38 to 0.81; 8 trials; n = 4877).
3Funnel plot suggests publication bias with small studies showing that routine episiotomy results in higher perineal trauma.
4Downgraded by 1 for risk of bias: both studies used visual inspection with no specific training, but visual EBL consistently results in underestimation of large volumes and over estimation of large volumes.
5Downgraded by 1 for imprecision: confidence intervals range from no important average loss to an important average loss
6Downgraded by 1 for inconsistency: large, probably clinically important effect in 1 trial and no effect evident in the other trial
7Downgraded by 1 for imprecision as there were no events. Risk difference 0.0 (‐0.01 to 0.01). The risk difference provides confidence intervals indicating we are confident in there being little or no difference, although for rare but important events a larger sample size is required.
8Apgar < 7 at 1 minute was measured in 4 trials, with RR 1.04 (95% CI 0.76 to 1.43), with no detectable heterogeneity.
9Downgraded by 2 for imprecision: few events, and CI included appreciable benefit and harm. (The analysis is under‐powered to detect a difference between groups; the sample size required to half 2% infection rate in the control group to 1% in the intervention group with 90% power at 5% significance would be 6202)
10Downgraded by 2 for imprecision: sample size to lower the 30% pain in the selective episiotomy compared to routine would need a total size of 586 with 90% power at 5% significance level, and wide confidence intervals from substantively fewer to no fewer
11Downgraded by 1 for indirectness: only one trial conducted 32 years ago. Conditions, expectations, and pain relief strategies have changed, and we don't know how representative this trial is.
12Additional trials report on average pain scores in the first 5 days, in a total of 355 women. Pain scores in all 3 trials were similar between the 2 groups (additional table 5).
13Downgraded by 1 for imprecision: confidence intervals have a wide range.
14Downgraded by 1 for risk of bias: 3 trials included, 2 trials, 1 with small sample size and 1 with large sample size had high rate of loss to follow‐up, around 35%, 1 trial with large sample size had low loss to follow‐up, less than 10%.

Figures and Tables -
Summary of findings for the main comparison. Selective versus routine episiotomy: all vaginal births where operative vaginal delivery was not anticipated
Table 1. Included studies: parity, operative vaginal delivery and period of follow‐up

Trial

Primigravidae

Follow‐up

N

per cent (%)

Immediate (< 1 month)

Short‐term (1‐6 months)

Long‐term (≥ 6 months)

Ali 2004

200

100

Discharge & day 7

No data

No data

Belizan 1993

1555/2606

60a

Discharge & day 7

No data

No data

Dannecker 2004

146

100

Discharge

Several months

A mean follow‐up time of 7.3 months (SD 3.4)

Eltorkey 1994

200

100

Delivery only

No data

No data

Harrison 1984

181

100

4 days

6 weeks

No data

House 1986

98/165

59

3 days

3 months

No data

Juste‐Pina 2007

402

100

No data

3 months

3 years

365/402 (91%)

Klein 1992

356/703

51

Discharge

3 months

No data

Murphy 2008b

200

100

Discharge

6 weeks

1 year

Rodriguez 2008

446

100

Delivery only

N

No data

Sleep 1984

420/1000

42

2 & 10 days

3 months

3 years

Sulaiman 2013

209

100

Delivery only

No data

No data

aStratified analysis (primary outcome only)

Figures and Tables -
Table 1. Included studies: parity, operative vaginal delivery and period of follow‐up
Table 2. Episiotomy rates for included studies (non‐operative vaginal delivery anticipated)

Trial

Selective

Routine

Difference (%)

n/N

%

n/N

%

Klein 1992

124/349

36

198/349

57

21

Juste‐Pina 2007

118/200

59

169/202

84

25

Eltorkey 1994

53/100

53

83/100

83

30

Dannecker 2004

20/49

41

46/60

77

36

Sleep 1984

51/498

10

258/502

51

41

House 1986

17/94

18

49/71

69

51

Belizan 1993

391/1298

30

1080/1308

83

53

Sulaiman 2013

39/89

44

82/82

100

56

Ali 2004

32/100

32

100/100

100

68

Rodriguez 2008

54/222

24

223/223

100

76

Harrison 1984

7/92

8

89/89

100

92

Figures and Tables -
Table 2. Episiotomy rates for included studies (non‐operative vaginal delivery anticipated)
Table 3. Operative vaginal delivery rates (OVD) in included studies

Trial

OVD Included

In trial

Total

Included in analysis

Intervention

Control

Belizan 1993

Y

56/2599

Y

24/1302

32/1297

Dannecker 2004

Y

13/109

Y

4/49

9/60

Eltorkey 1994

Y

9/200

Y

4/100

5/100

Harrison 1984

Y

Unknown

Y

4/92

Unknown

House 1986

Y

20/165

Y

10/94

10/71

Juste‐Pina 2007

Unclear

/

/

/

/

Klein 1992

Y

20/703

Y

Unknown

Unknown

Murphy 2008b

ALL

200/200

101/101

99/99

Rodriguez 2008

Y

7/445

Y

3/222

4/223

Sleep 1984

Unknown

/

/

/

/

Ali 2004

Unknown

/

/

/

/

Sulaiman 2013

Unclear

/

/

/

/

Figures and Tables -
Table 3. Operative vaginal delivery rates (OVD) in included studies
Table 4. Trial primary outcomes, and outcomes closest to review primary outcome

Trial

Primary outcome

Outcome related to review primary outcome

Description

Match?

Belizan 1993

Severe perineal trauma

Same

"Extension through the anal sphincter and/or the anal or rectal mucosa (3rd or 4th degree lacerations)"

Matches

Ali 2004

Severe perineal trauma

Same

Severe perineal trauma (3rd and 4th degree tear)

Matches

Dannecker 2004

Not specified

Severe perineal trauma

"extension through the anal sphincter or rectal mucosa"

Matches

Eltorkey 1994

Not specified

Third‐degree tear

"complete tear including the anal sphincter"

Matches

Harrison 1984

Not specified

Third‐degree tear

"a complete tear including the anal sphincter, usually extending 2 cm or more up the anal canal"

Matches

House 1986

Not specified

Third‐degree tear

"one in which the anal sphincter was involved"

Matches

Juste‐Pina 2007

Not specified

Serious case of perineal trauma

"third or fourth degree tear"

Matches

Klein 1992

Not specified

Third‐ or fourth‐degree tear

As stated

Matches

Murphy 2008ba

Third‐/fourth‐degree tear

Same

Extensive perineal tearing involving the anal sphincter

Matches

Rodriguez 2008

Severe laceration to perineal tissues

Same

Third‐degree laceration when the extent of the lesion including the external anal sphincter totally or partially and 4th degree laceration when the rectal mucosa was involved

Matches

Sleep 1984

Not known

Severe maternal trauma

Extension through the anal sphincter or to the rectal mucosa or to the upper 3rd of the vagina

Matches

Sulaiman 2013

Obstetrical anal sphincter injuries

3rd/4th degree

No further details given

Matches

aMurphy included only women where operative delivery was anticipated and this is described and analysed separately.

Figures and Tables -
Table 4. Trial primary outcomes, and outcomes closest to review primary outcome
Table 5. Pain assessed using visual analogue scale (3 trials)

Trial

Parity

Time assessed

Outcome

Selective n/N (%)

Routine n/N (%)

House 1986

All parities

day 3

Moderate and severe pain (defined by score categories)

30/94 (32%)

32/71 (45%)

Klein 1992

Primigravida

day 2

Average score

Score 1.4, SD 0.8 (N 150)

Score 1.3, SD 0.7 (N 156)

Klein 1992

Multigravida

day 2

Average score

Score 0.9, SD 0.8 (N 156)

Score 0.9, SD 0.7 (N 145)

Dannecker 2004

Primigravida

1‐5 days

Average score

Score 51, SD 25, 22 (N 49)

Score 69, SD 23, 31 (N 60)

Figures and Tables -
Table 5. Pain assessed using visual analogue scale (3 trials)
Table 6. Dyspareunia in included studies (4 trials)

Trial

Parameter measured

Collection

Selective

n/N (%)

Routine

n/N (%)

Dannecker 2004

Pain during sex in the last 4 weeks

Questionnaire. Follow up average time of 7.3 months in about 65% of those randomised.

6/29 (21%)

13/39 (33%)

Juste‐Pina 2007

Dyspareunia at 3 months; and pain with coitus at 3 years postpartum

Telephone survey 3 months postpartum and interview by telephone at 3 years postpartum. Loss to follow up was 6% in the selective, 5% in the routine group at 3 months; and 8% in the selective, 11% in the routine group at 3 years postpartum.

3 months postpartum: 42/189 (22%)

3 years postpartum: 20/185 (11%)

3 months postpartum:67/192 (35%)

3 years postpartum: 15/180 (8%)

Klein 1992

Not reported

Collected but not reported

NA

NA

Sleep 1984

Reported dyspareunia at 3 months postpartum

Self administered postal questionnaire. Follow up rate 66% in selective, and 69% in routine at 3 years postpartum.

3 months postpartum:

87/394 (22%)

3 years postpartum: 52/329 (16%)

3 months postpartum: 74/411 (18%)

3 years postpartum: 45/345 (13%)

Figures and Tables -
Table 6. Dyspareunia in included studies (4 trials)
Table 7. Urinary incontinence in included studies (4 trials)

Trial

Parameter measured

Collection

Selective

n/N (%)

Routine

n/N (%)

Dannecker 2004

Urinary incontinence was considered as present whenever a participant gave an answer other than 'never' when replying to "How often do you leak urine involuntarily?"

Questionnaire. Follow‐up average time of 7.3 months in about 65% of those randomised

13/27 (48%)

11/41 (27%)

Juste‐Pina 2007

Urinary incontinence at 3 years postpartum

Telephone survey 3 years postpartum. Loss to follow‐up was 8% in the selective, 11% in the routine group at 3 years postpartum

34/180 (19%)

49/185 (26%)

Klein 1992

Urinary incontinence at 3 months

Questions employing a 4‐point scale

57/337 (17%)

60/337 (18%)

Sleep 1984

Reported urinary incontinence at 3 months after delivery; Reported incontinence of urine at 3 years postpartum

Standardised postal questionnaire administered by mothers at 3 months and 3 years postpartum. Follow‐up rate 62% in selective, and 67% in routine at 3 months postpartum; follow‐up rate 66% in selective, and 69% in routine at 3 years postpartum

3 months postpartum: 83/438 (19%)

3 years postpartum: 112/329 (34%)

3 months postpartum: 87/457 (19%)

3 years postpartum:

124/345 (36%)

Figures and Tables -
Table 7. Urinary incontinence in included studies (4 trials)
Comparison 1. Restrictive versus routine episiotomy (where non‐instrumental was intended)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe perineal/vaginal trauma Show forest plot

11

6177

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

2 Severe perineal/vaginal trauma (grouped by trial implementation success) Show forest plot

11

6177

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

2.1 Difference in episiotomy rate < 30%

3

1300

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.63, 1.69]

2.2 Difference in episiotomy rate 30% +

8

4877

Risk Ratio (M‐H, Fixed, 95% CI)

0.55 [0.38, 0.81]

3 Blood loss at delivery (mL) Show forest plot

2

336

Mean Difference (IV, Random, 95% CI)

‐27.16 [‐74.80, 20.49]

4 Newborn Apgar score < 7 at 5 minutes Show forest plot

2

511

Risk Difference (M‐H, Fixed, 95% CI)

0.0 [‐0.01, 0.01]

5 Perineal infection Show forest plot

3

1467

Risk Ratio (M‐H, Fixed, 95% CI)

0.90 [0.45, 1.82]

6 Moderate or severe pain (visual analogue scale) Show forest plot

1

165

Risk Ratio (M‐H, Fixed, 95% CI)

0.71 [0.48, 1.05]

7 Dyspareunia long term (≥ 6 m) Show forest plot

3

1107

Risk Ratio (M‐H, Fixed, 95% CI)

1.14 [0.84, 1.53]

8 Genital prolapse long term (≥ 6 m) Show forest plot

1

365

Risk Ratio (M‐H, Fixed, 95% CI)

0.30 [0.06, 1.41]

9 Urinary incontinence long term (≥ 6 m) Show forest plot

3

1107

Risk Ratio (M‐H, Random, 95% CI)

0.98 [0.67, 1.44]

10 Need for perineal suturing Show forest plot

6

Risk Ratio (M‐H, Random, 95% CI)

Totals not selected

11 Admission to special care baby unit Show forest plot

5

2471

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.56, 1.07]

12 Pain at different time points (any measure) Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

12.1 Any perineal pain at discharge

2

2587

Risk Ratio (M‐H, Random, 95% CI)

0.85 [0.25, 2.86]

12.2 Any pain at 10 days

1

885

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.78, 1.27]

12.3 Moderate‐severe pain in first 10 days

3

1127

Risk Ratio (M‐H, Random, 95% CI)

1.14 [0.61, 2.12]

12.4 Severe or moderate pain at 3 months postpartum

1

895

Risk Ratio (M‐H, Random, 95% CI)

1.51 [0.65, 3.49]

Figures and Tables -
Comparison 1. Restrictive versus routine episiotomy (where non‐instrumental was intended)
Comparison 2. Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe perineal/vaginal trauma Show forest plot

11

6177

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

1.1 Primiparae

11

4137

Risk Ratio (M‐H, Fixed, 95% CI)

0.68 [0.50, 0.93]

1.2 Multiparae

4

2040

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.35, 2.01]

Figures and Tables -
Comparison 2. Restrictive versus routine episiotomy (non‐instrumental, subgroup by parity)
Comparison 3. Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe vaginal/perineal trauma Show forest plot

10

5977

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.52, 0.94]

1.1 Midline

2

1143

Risk Ratio (M‐H, Fixed, 95% CI)

0.74 [0.51, 1.07]

1.2 Mediolateral

8

4834

Risk Ratio (M‐H, Fixed, 95% CI)

0.62 [0.37, 1.04]

Figures and Tables -
Comparison 3. Restrictive versus routine episiotomy (non‐instrumental, subgroup midline‐midlateral)
Comparison 4. Restrictive versus routine episiotomy (operative vaginal birth was intended)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Severe perineal/vaginal trauma Show forest plot

1

175

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [0.55, 3.07]

2 Apgar < 7 at 5 minutes Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3 Perineal infection Show forest plot

1

175

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.04, 5.11]

4 Moderate/severe dyspareunia long term (≥ 6 m) Show forest plot

1

108

Risk Ratio (M‐H, Fixed, 95% CI)

3.71 [0.43, 32.16]

5 Urinary incontinence long term (≥ 6 m) Show forest plot

1

108

Risk Ratio (M‐H, Fixed, 95% CI)

0.46 [0.09, 2.43]

6 Admission to special care baby unit Show forest plot

1

175

Risk Ratio (M‐H, Fixed, 95% CI)

2.13 [0.68, 6.64]

Figures and Tables -
Comparison 4. Restrictive versus routine episiotomy (operative vaginal birth was intended)