WHO recommendation against routine vaginal cleansing with chlorhexidine during labour for the purpose of preventing infectious morbidities

Pregnant woman in labour lying on hospital bed.

WHO recommendation against routine vaginal cleansing with chlorhexidine during labour for the purpose of preventing infectious morbidities

Recommendation

Routine vaginal cleansing with chlorhexidine during labour for the purpose of preventing infectious morbidities is not recommended.

(Moderate-quality evidence, strong recommendation)

Publication history

First published: September 2015 

Updated: no update planned 

Assessed as up-to-date:  September 2015

Remarks

  • This recommendation applies to women in whom vaginal birth is anticipated.
  • Vaginal cleansing in this context refers to vaginal douching or any mechanical irrigation or washing of the vaginal canal and cervix with chlorhexidine solution or vaginal application of chlorhexidine gel.
  • The infectious morbidities considered in the evidence base did not include GBS and HIV related infections. However, this intervention is also not recommended for preventing early neonatal GBS infection in women with GBS colonization (see Recommendation on routine vaginal cleansing with chlorhexidine during labour in women with group B Streptococcus (GBS) colonization for prevention of early neonatal GBS infection).

Background

Bacterial infections during labour and the puerperium are among the leading causes of maternal mortality worldwide, accounting for about one tenth of the global burden of maternal deaths.(1, 2) While the number of deaths arising from these infections has decreased considerably in high-income settings, the situation has not improved in resource-limited settings. Most of the estimated 75,000 maternal deaths occurring worldwide yearly as a result of infections are recorded in low-income countries.(3) Although the reported incidence in high-income countries is relatively low (between 0.1 and 0.6 per 1000 births), it is nonetheless an important direct cause of maternal mortality.(3, 4)

Apart from deaths and acute morbidities associated with infections during or following childbirth, long-term disabilities such as chronic pelvic pain, fallopian tube blockage and secondary infertility can also occur. Maternal infections around childbirth also have a considerable impact on newborn mortality, and an estimated 1 million newborn deaths are associated with such infections annually.(5, 6) In addition, infection-related morbidities and prolonged hospitalization can interfere with mother–infant bonding in the first days after birth.

Methods

The recommendation was developed using standardized operating procedures in accordance with the process described in the “WHO handbook for guideline development”, guided by the GRADE approach.(7) Outcomes used for this recommendation were aligned with the prioritized outcomes from the WHO recommendations on prevention and treatment of maternal peripartum infections (2015).(8)

A Cochrane systematic review was conducted on routine vaginal cleansing with an antiseptic agent during labour for the prevention of maternal and neonatal infections.(9) In the review, randomized controlled trials relevant to the key question were screened by review authors, and data on relevant outcomes and comparisons were extracted. Evidence profiles (in the form of GRADE tables) were prepared for comparisons of interest, including the assessment and judgments for each outcome, and the estimated risks.

WHO convened a Guideline Development Group (GDG) meeting on recommendations on prevention and treatment of maternal peripartum infections in September 2015, where this recommendation was developed. The GDG comprised of a group of independent experts, who used the evidence profiles to assess evidence on effects on the pre-specified outcomes. GDG members discussed the balance between desirable and undesirable effects, overall quality of supporting evidence, values and preferences of stakeholders, resource requirements, cost-effectiveness, acceptability, feasibility and equity, to formulate the recommendation. Remarks were added to clarify the recommendation, and aid implementation.

Recommendation question

For this recommendation, we aimed to answer the following question:

  • • Among pregnant women in labour (P), does vaginal cleansing with an antiseptic agent (I), compared with no vaginal cleansing with an antiseptic agent (C), prevent infectious morbidities and improve outcomes following vaginal birth (O)?

Evidence Summary

Evidence on routine vaginal cleansing with an antiseptic agent during labour for the prevention of maternal and neonatal infections was extracted from a Cochrane systematic review of three trials involving 3012 women.(9) All included studies were conducted in hospitals in the USA between 1997 and 2003. The trials included women admitted to the hospital prior to birth, ≥24 weeks pregnant and excluded women with GBS infections or known allergy to chlorhexidine. The intervention was chlorhexidine vaginal douching during labour versus sterile water. Two of the studies used 200 ml of 0.2% of chlorhexidine, while the third study used 20 ml of 0.4% chlorhexidine for vaginal irrigation during labour.

Chlorhexidine vaginal douching during labour versus placebo (EB Table 2)

  • No differences were observed in the incidence of chorioamnionitis (RR 1.10, 95% CI 0.86 to 1.42; 3 trials, 3012 women) or postpartum endometritis (RR 0.83, 95% CI 0.61 to 1.13; 3 trials, 3012 women). No side-effects from the use of chlorhexidine were observed among women in the two groups (2 trials, 2065 women).
  • There was no difference in perinatal mortality between the two groups (RR 1.00, 95% CI 0.17 to 5.79; 2 trials, 2017 neonates).
  • For neonatal outcomes, there were no differences between groups for neonatal sepsis (RR 0.75, 95 % CI 0.17 to 3.35; 3 studies, 2987 neonates), blood cultures confirming neonatal infections, (RR 0.75, 95% CI 0.17 to 3.35; 2 trials, 2077 neonates), neonatal pneumonia (RR 0.33, 95% CI 0.01 to 8.09, 1 trial, 910 neonates) or neonatal meningitis (RR 0.34, 95% CI 0.01 to 8.29, 1 trial, 1024 neonates). No difference was observed between groups of newborns who received antibiotic treatment (RR 1.65, 95% CI 0.73 to 3.74, 1 trial, 910 neonates).
  • The included trials did not report on any other critical outcomes.

 

Implementation considerations

  • The successful introduction of this recommendation into national programmes and health-care services depends on well-planned and participatory consensus-driven processes of adaptation and implementation. The adaptation and implementation processes may include the development or revision of existing national guidelines or protocols based on this recommendation.
  • The recommendation should be adapted into a locally appropriate document that can meet the specific needs of each country and health service. Any changes should be made in an explicit and transparent manner.
  • A set of interventions should be established to ensure that an enabling environment is created for the use of the recommendations, and that the behaviour of the healthcare practitioner changes towards the use of this evidence-based practice.
  • In this process, the role of local professional societies is important and an all-inclusive and participatory process should be encouraged.

 

Research implications

The GDG identified that further research on the following high-priority questions is needed: 

  • What is the comparative effectiveness and safety of chlorhexidine and povidone-iodine for vaginal cleansing among women undergoing caesarean section in preventing maternal infection morbidities?
  • What are the effects of vaginal cleansing immediately before caesarean section among women at potentially higher risk of infection (e.g. women with ruptured membranes)?
  • Is there any difference in the incidence of maternal infection morbidities between vaginal cleansing performed before or immediately after caesarean section?
  • What are the potential adverse effects of the use of iodine containing antiseptics for vaginal cleansing for the newborn if the mother is planning to breastfeed?

 

Related Links

WHO recommendations for prevention and treatment of maternal peripartum infections (2015) –full document and evidence tables

Supporting systematic review:

Lumbiganon P, Thinkhamrop J, Thinkhamrop B, Tolosa JE. Vaginal chlorhexidine during labour for preventing maternal and neonatal infections (excluding Group B Streptococcal and HIV). The Cochrane database of systematic reviews. 2014(9):Cd004070.

References

  1.  Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, et al. Global causes of maternal death: a WHO systematic analysis. The Lancet Global health. 2014;2(6):e323-33
  2.  Khan KS, Wojdyla D, Say L, Gulmezoglu AM, Van Look PF. WHO analysis of causes of maternal death: a systematic review. Lancet (London, England). 2006;367(9516):1066-74
  3. 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
  4. Cantwell R, Clutton-Brock T, Cooper G, Dawson A, Drife J, Garrod D, et al. Saving Mothers' Lives: Reviewing maternal deaths to make motherhood safer: 2006-2008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG : an international journal of obstetrics and gynaecology. 2011;118 Suppl 1:1-203.
  5. Black RE, Cousens S, Johnson HL, Lawn JE, Rudan I, Bassani DG, et al. Global, regional, and national causes of child mortality in 2008: a systematic analysis. Lancet (London, England). 2010;375(9730):1969-87.
  6.  Lawn JE, Cousens S, Zupan J. 4 million neonatal deaths: When? Where? Why? The Lancet.365(9462):891-900
  7. WHO Handbook for Guideline Development. Geneva: World Health Organization; 2014. World Health Organization. 2011.
  8. WHO recommendations for prevention and treatment of maternal peripartum infections. 2015
  9.  Lumbiganon P, Thinkhamrop J, Thinkhamrop B, Tolosa JE. Vaginal chlorhexidine during labour for preventing maternal and neonatal infections (excluding Group B Streptococcal and HIV). The Cochrane database of systematic reviews. 2014(9):Cd004070.

 

Citation

WHO recommendation against routine vaginal cleansing with chlorhexidine during labour for the purpose of preventing infectious morbidities (September 2015). The WHO Reproductive Health Library; Geneva: World Health Organization.