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Profilaxis con antibióticos para la reparación de la episiotomía después del parto vaginal

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Referencias

Referencias de los estudios incluidos en esta revisión

Neto 1990 {published data only}

Neto S, Goncalves JA, de Andrade LF. Clinical evaluation of the chloramphenicol use as a prophylactic antibiotic in the vaginal delivery with episiotomy [Avaliacao clinica do emprego do cloranfenicol como antibiotico profilatico no parto normal com episiotomia]. ACM: Arquivos Catarinenses de Medicina 1990;19(2):97‐102. CENTRAL

Referencias adicionales

ACOG 2011

American College of Obstetricians and Gynecologist. ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstetrics and Gynecology 2011;117(6):1472‐83. [PUBMED: 21606770]

Bonet 2016a

Bonet M, Ota E, Chibueze CE, Oladapo OT. Routine antibiotic prophylaxis after normal vaginal birth for reducing maternal infectious morbidity. Cochrane Database of Systematic Reviews 2016, Issue 5. [DOI: 10.1002/14651858.CD012137]

Buppasiri 2014a

Buppasiri P, Lumbiganon P, Thinkhamrop J, Thinkhamrop B. Antibiotic prophylaxis for third‐ and fourth‐degree perineal tear during vaginal birth. Cochrane Database of Systematic Reviews 2014, Issue 10. [DOI: 10.1002/14651858.CD005125.pub4]

Carroli 2009

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

EURO‐PERISTAT 2013

EURO‐PERISTAT Project with SCPE and EUROCAT. European Perinatal Health Report. The health and care of pregnant women and babies in Europe in 2010. www.europeristat.com (accessed 2015) 2013.

Friedman 2015

Friedman AM, Ananth CV, Prendergast E, D' Alton ME, Wright JD. Variation in and factors associated with use of episiotomy. JAMA 2015;313(2):197‐9. [PUBMED: 25585333]

Graham 2005

Graham ID, Carroli G, Davies C, Medves JM. Episiotomy rates around the world: an update. Birth (Berkeley, Calif.) 2005;32(3):219‐23. [PUBMED: 16128977]

Gravett 2012

Gravett CA, Gravett MG, Martin ET, Bernson JD, Khan S, Boyle DS, et al. Serious and life‐threatening pregnancy‐related infections: opportunities to reduce the global burden. PLoS Medicine 2012;9(10):e1001324. [PUBMED: 23055837]

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 2011

Higgins JPT, Green S, editor(s). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.handbook.cochrane.org.

Hussein 2010

Hussein J, Walker L. Chapter 8. Puerperal sepsis in low‐ and middle‐income settings: past, present and future. Maternal and Infant Deaths: Chasing Millennium Development Goals 4 & 5. London: RCOG Press, 2010:131‐47.

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 and gynaecology 2012;119(5):522‐6. [ PubMed: 22304364] 2012;119(5):522‐6. [PUBMED: 22304364]

Kamel 2014

Kamel A, Khaled M. Episiotomy and obstetric perineal wound dehiscence: beyond soreness. Journal of Obstetrics and Gynaecology 2014;34(3):215‐7. [PUBMED: 24484355]

Kettle 2010

Kettle C, Dowswell T, Ismail KMK. Absorbable suture materials for primary repair of episiotomy and second degree tears. Cochrane Database of Systematic Reviews 2010, Issue 6. [DOI: 10.1002/14651858.CD000006.pub2]

Kettle 2012

Kettle C, Dowswell T, Ismail KMK. Continuous and interrupted suturing techniques for repair of episiotomy or second‐degree tears. Cochrane Database of Systematic Reviews 2012, Issue 11. [DOI: 10.1002/14651858.CD000947.pub3]

Kropp 2005

Kropp N, Hartwell T, Althabe F. Episiotomy rates from eleven developing countries. International Journal of Gynaecology and Obstetrics 2005;91(2):157‐9. [PUBMED: 16169552]

Liabsuetrakul 2014

Liabsuetrakul T, Choobun T, Peeyananjarassri K, Islam QM. Antibiotic prophylaxis for operative vaginal delivery. Cochrane Database of Systematic Reviews 2014, Issue 10. [DOI: 10.1002/14651858.CD004455.pub3]

Newton 2008

Newton ER. Antibiotics in Maternal‐Fetal Medicine. www.glowm.com/section_view/heading/Antibiotics%2520in%2520Maternal‐Fetal%2520Medicine/item/175 (accessed 23 February 2016) 2008.

NICE 2014

National Institute for Health and Care Excellence. Intrapartum care: care of healthy women and their babies during childbirth. (Clinical Guideline 109). www.nice.org.uk/guidance/cg190 (accessed 2015) 2014.

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.

Say 2014

Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, et al. Global causes of maternal death: a WHO systematic analysis. Lancet. Global Health 2014;2(6):e323‐33. [PUBMED: 25103301]

Schünemann 2013

Schünemann H, Brożek J, Guyatt G, Oxman A (editors), The GRADE Working Group. GRADE Handbook for Grading Quality of Evidence and Strength of Recommendations. Available from gdt.guidelinedevelopment.org/app/handbook/handbook.htmlUpdated October 2013.

Sharma 2008

Sharma JB, Gupta N, Aggarwal P, Mittal S. A survey of obstetricians' practice of using prophylactic antibiotics in vaginal deliveries and caesarean sections. Journal of the Indian Medical Association 2008;106(3):147‐9. [PUBMED: 18712132]

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(6):322‐38. [PUBMED: 6346168]

Tharpe 2008

Tharpe N. Postpregnancy genital tract and wound infections. Journal of Midwifery & Women's Health 2008;53(3):236‐46. [PUBMED: 18455098]

Van Dillen 2010

Van Dillen J, Zwart J, Schutte J, Van Roosmalen J. Maternal sepsis: epidemiology, etiology and outcome. Current Opinion in Infectious Diseases 2010;23(3):249‐54. [PUBMED: 20375891]

Van Schalkwyk 2010

Van Schalkwyk J, Van Eyk N. Antibiotic prophylaxis in obstetric procedures. Journal of Obstetrics and Gynaecology Canada: JOGC 2010;32(9):878‐92. [PUBMED: 21050523]

Viswanathan 2005 (AHRQ)

Viswanathan M, Hartmann K, Palmieri R, Lux L, Swinson T, Lohr KN, et al. The use of episiotomy in obstetrical care: a systematic review. Evidence Report/Technology Assessment No. 112. (Prepared by the RTI‐UNC Evidence‐based Practice Center, under Contract No. 290‐02‐0016). AHRQ Publication No. 05‐E009‐2. Rockville, MD: Agency for Healthcare Research and Quality2005.

WHO 2001

World Health Organization. WHO Global Strategy for Containment of Antimicrobial Resistance. 2001. www.who.int/drugresistance/WHO_Global_Strategy_English.pdf (accessed 21 January 2016).

WHO 2005

World Health Organization. The World Health Report 2005: Make every mother and child count. apps.who.int/iris/bitstream/10665/43131/1/9241562900.pdf (accessed 21 January 2016).

WHO 2014

World Health Organization. Antimicrobial Resistance Global Report on Surveillance. 2014. apps.who.int/iris/bitstream/10665/112642/1/9789241564748_eng.pdf. Geneva: WHO, (accessed 21 January 2016).

WHO 2015

World Health Organization. WHO Recommendations for Prevention and Treatment of Maternal Peripartum Infections. 2015. apps.who.int/iris/bitstream/10665/186171/1/9789241549363_eng.pdf (accessed 21 January 2016).

Referencias de otras versiones publicadas de esta revisión

Bonet 2016b

Bonet M, Ota E, Chibueze CE, Oladapo OT. Antibiotic prophylaxis for episiotomy repair following vaginal birth. Cochrane Database of Systematic Reviews 2016, Issue 5. [DOI: 10.1002/14651858.CD012136]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Neto 1990

Methods

Quasi‐randomised controlled trial

Participants

80 women with normal labour and episiotomy in 1 public hospital, recruited between October 1988 and September 1989.

Interventions

Intervention arm received oral chloramphenicol 500 mg 4 times daily for 72 hours after episiotomy repair. Control arm received no treatment.

Outcomes

A total of 73 women included in analysis, 34 in intervention arm and 39 in control arm. Outcomes measured included episiotomy dehiscence (wound rupture without signs of infection), episiotomy infection (pain, heat, redness, or purulent discharge and wound rupture), and puerperal endometritis assessed at 10 days postpartum (defined as 2 of the following; fever, hypogastric pain, uterine involution, abnormal lochia).

Notes

Florianopolis, Brazil. Exclusion of 7 women lost to follow‐up at 10 days postpartum. All women were from low socioeconomic class. All women attended by registrars.

Funding: not reported.

Conflicts of interest: not reported.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

High risk

Randomised according to protocol number (even and odd numbers)

Allocation concealment (selection bias)

High risk

Allocation concealment based on protocol number

Blinding of participants and personnel (performance bias)
All outcomes

High risk

Not double‐blinded. Control arm received no treatment

Blinding of outcome assessment (detection bias)
All outcomes

Unclear risk

Unknown. No information on whether physicians who evaluated the women at 10 days postpartum were blinded to the treatment allocation.

Incomplete outcome data (attrition bias)
All outcomes

High risk

6 women in intervention group and 1 in control group were missing for follow‐up, but no differences reported in baseline characteristics among those followed‐up.

Selective reporting (reporting bias)

Low risk

All outcomes were reported.

Other bias

Low risk

No other sources of bias noted.

Data and analyses

Open in table viewer
Comparison 1. Comparison 1. Antibiotic prophylaxis versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Episiotomy infection with wound dehiscence Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.13 [0.01, 2.28]

Analysis 1.1

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 1 Episiotomy infection with wound dehiscence.

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 1 Episiotomy infection with wound dehiscence.

2 Episiotomy wound dehiscence without infection Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.29, 2.34]

Analysis 1.2

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 2 Episiotomy wound dehiscence without infection.

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 2 Episiotomy wound dehiscence without infection.

3 Episiotomy wound dehiscence (overall with or without infection) Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.20, 1.35]

Analysis 1.3

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 3 Episiotomy wound dehiscence (overall with or without infection).

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 3 Episiotomy wound dehiscence (overall with or without infection).

4 Incidence of puerperal infection (endometritis) Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Analysis 1.4

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 4 Incidence of puerperal infection (endometritis).

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 4 Incidence of puerperal infection (endometritis).

Study flow diagram
Figuras y tablas -
Figure 1

Study flow diagram

Risk of bias summary: review authors' judgements about each 'risk of bias' domain
Figuras y tablas -
Figure 2

Risk of bias summary: review authors' judgements about each 'risk of bias' domain

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 1 Episiotomy infection with wound dehiscence.
Figuras y tablas -
Analysis 1.1

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 1 Episiotomy infection with wound dehiscence.

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 2 Episiotomy wound dehiscence without infection.
Figuras y tablas -
Analysis 1.2

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 2 Episiotomy wound dehiscence without infection.

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 3 Episiotomy wound dehiscence (overall with or without infection).
Figuras y tablas -
Analysis 1.3

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 3 Episiotomy wound dehiscence (overall with or without infection).

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 4 Incidence of puerperal infection (endometritis).
Figuras y tablas -
Analysis 1.4

Comparison 1 Comparison 1. Antibiotic prophylaxis versus no treatment, Outcome 4 Incidence of puerperal infection (endometritis).

Summary of findings for the main comparison. Antibiotic prophylaxis compared to no treatment for episiotomy repair following vaginal birth

Antibiotic prophylaxis compared to no treatment for episiotomy repair following vaginal birth

Patient or population: women with episiotomy repair following vaginal birth

Settings: public hospital, Brazil

Intervention: antibiotic prophylaxis with oral chloramphenicol 500 mg four times daily for 72 hours after episiotomy repair

Comparison: no treatment

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Risk with no treatment

Risk with antibiotic prophylaxis

Incidence of episiotomy wound infection with wound dehiscence

Study population

RR 0.13
(0.01 to 2.28)

73
(1 quasi‐RCT)

⊕⊝⊝⊝
very low1,2

103 per 1000

14 per 1000
(1 to 257)

Incidence of episiotomy wound dehiscence without wound infection

Study population

RR 0.82
(0.29 to 2.34)

73
(1 quasi‐RCT)

⊕⊝⊝⊝
very low1,2

179 per 1000

151 per 1000
(52 to 439)

Incidence of puerperal infection (endometritis)

Study population

not estimable

73
(1 quasi‐RCT)

⊕⊝⊝⊝
very low1,3

There were no events in either group.

0 per 1000

0 per 1000
(0 to 0)

Incidence of severe maternal infectious morbidity

Study population

0
(0 RCT)

trial did not measure this outcome

Discomfort or pain at episiotomy wound site

0
(0 RCT)

trial did not measure this outcome

Women's satisfaction with care

0
(0 RCT)

trial did not measure this outcome

Adverse effects of antibiotics

Study population

0
(0 RCT)

trial did not measure this outcome

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (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: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 One study with very serious design limitations (‐2)
2 Wide confidence interval crossing the line of no effect, and few events (‐1)
3 No events (‐1)

Figuras y tablas -
Summary of findings for the main comparison. Antibiotic prophylaxis compared to no treatment for episiotomy repair following vaginal birth
Comparison 1. Comparison 1. Antibiotic prophylaxis versus no treatment

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Episiotomy infection with wound dehiscence Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.13 [0.01, 2.28]

2 Episiotomy wound dehiscence without infection Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.82 [0.29, 2.34]

3 Episiotomy wound dehiscence (overall with or without infection) Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.52 [0.20, 1.35]

4 Incidence of puerperal infection (endometritis) Show forest plot

1

73

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

Figuras y tablas -
Comparison 1. Comparison 1. Antibiotic prophylaxis versus no treatment