Vaginal cleansing with antiseptic solution before cesarean section brings down postoperative infection: Cochrane review

A simple and inexpensive intervention of vaginal cleaning with the chlorhexidine-based or iodine-based solution immediately before cesarean section probably reduces the risk of endometritis after the procedure. The benefit could be more for women who underwent cesarean section while in labor or after rupture of membranes reports the results of a Cochrane review published 17 July 2018.

The current review is the fifth update on vaginal preparation before cesarean section and risk of subsequent infection by Cochrane; the first review was published in 2010 and subsequently updated in 2012, and twice in 2014.

Cesarean section is the most commonly performed operation in obstetrics, with 1 in 3 babies being born by cesarean section. Nearly 25% of women have endometritis and 10% of women develop skin infection after C-section.

Pre-op or intra-op antibiotic prophylaxis has not been able to bring down the rate considerably.

The Cochrane researchers searched the Cochrane Pregnancy and Childbirth’s Trials Register, the WHO International Clinical Trials Registry Platform (ICTRP) (10 July 2017), ClinicalTrials.gov, and reference lists of retrieved studies.

The review included 11 trials with a total of 3403 women in whom vaginal preparation was done immediately before the start of the cesarean section. Most of the trials used Povidone-iodine (n=8), while the rest used chlorhexidine (n=2) and benzalkonium chloride (n=1).

The control group included women with no vaginal antisepsis preparation (eight trials) or those in whom saline vaginal preparation (three trials) was used.

Vaginal preparation with the antiseptic solution immediately before cesarean delivery probably reduced the risk of endometritis by 64% (average risk ratio (RR) 0.36, 95% confidence interval (CI) 0.20 to 0.63).

It was not possible to separately analyze the risk reduction in a subgroup of women who were in labor or in women whose membranes had ruptured when antiseptics were used. 

Risk of postoperative fever or surgical wound complications may also be brought down by the use of vaginal antisepsis, but the confidence interval around the effects for both outcomes was very wide consistent with insufficient data.

Composite outcome of wound complication or endometritis was reduced by 54% in two trials consisting of 499 women (RR 0.46, 95% CI 0.26 to 0.82).

No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing.

The quality of evidence using GRADE was moderate for all reported outcomes. The authors downgraded the outcome for post-cesarean endometritis and composite of wound complications or endometritis because of bias in the involved study and broader CI.

The recommend that healthcare providers may continue using vaginal antisepsis preparation by either using povidone-iodine or chlorhexidine before performing a cesarean delivery.

Abstract

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Vaginal cleaning before cesarean delivery significantly reduces infection: A Systematic Review and Meta-analysis.

A simple and inexpensive intervention of vaginal cleaning with an antiseptic solution before cesarean delivery brings down the rate of endometritis note the results of a Systematic Review and Meta-analysis published August 4 in Journal of Obstetrics and Gynecology.

The effect was significantly more in patients in labor or with ruptured membranes at the time of the procedure.

Claudia Caissutti, MD, from the Department of Experimental Clinical and Medical Science, Clinic of Obstetrics and Gynecology, University of Udine, Italy, and colleagues searched MEDLINE, Ovid, EMBASE, Scopus, Clinicaltrials.gov, and Cochrane Library from their inception to January 2017.

They included randomized trials comparing vaginal cleaning with any antiseptic against placebo or no cleaning at all. The final data for review came from 16 RCTs, with a total of 4,837 women in whom vaginal preparation was done immediately before the start of cesarean section.

Most of the trials used povidone–iodine (n = 11) as the cleaning agent, while rest used chlorhexidine diacetate solution n = 3) , metronidazole vaginal gel prep ( n =1), and Cetrimide ( n =1) .

The observed incidence of endometritis in women who received preoperative vaginal cleansing was nearly 50% less as compared to women with placebo or no cleaning (4.5% vs 8.7%; relative risk [RR], 0.52; 95% confidence interval [CI], 0.37 - 0.72). These group also had significantly lower incidence of postoperative fever (9.4% compared with 14.9%; RR, 0.65).

No significant difference was observed in postoperative wound infection among the groups.

In a separate planned subgroup analysis, the observed difference in rates of endometritis was only seen in women who were in active labor and for patients with rupture of membranes. Four trials stratified the data according to women were in labor or not and three trials looked into women with and without ruptured membranes.

When the data was stratified according to type of cleaning agent and prophylactic antibiotics, the results were in according to the overall analysis.

Women who received prophylactic antibiotics had a 67% decrease in endometritis incidence. The authors opined, "Surgical prophylaxis with intravenous antibiotics before cesarean delivery has been clearly demonstrated as beneficial in reducing postoperative infection morbidity, Thus, it is the standard of care and these findings could translate to current practice."

The results of study have confirmed the findings of earlier Cochrane database systematic review published in 2013.

Data is needed to assess the effect of vaginal cleaning in women not in labor and without ruptured membranes.

The authors concluded that, “Vaginal cleansing immediately before cesarean delivery in women in labor and in women with ruptured membranes reduces the risk of postoperative endometritis. We recommend preoperative vaginal preparation before cesarean delivery in these women with sponge stick preparation of povidone-iodine 10% for at least 30 seconds.”

Misoprostol as an add on to Oxytocin does not further reduce Postpartum hemorrhage in active management or treatment of PPH.

Clinical Pearls:

• Prophylactic misoprostol at a dose of 400 micrograms, added to oxytocin for active management of the third stage of labor, did not reduce the rate of postpartum hemorrhage, severe postpartum hemorrhage, or second-line procedures.
• Misoprostol will produce no further uterotonic effects after a prophylactic infusion of 10 international units of oxytocin.
• Findings of this trial do not support the use of misoprostol in addition to oxytocin for the prevention of postpartum hemorrhage. 
• Misoprostol may be useful in countries with poor health resources where facilities for refrigeration and skilled birth attendants are not freely available.
• Oxytocin should be used as prophylaxis and as the first line of treatment in active management of labor, especially in high income countries or countries with good healthcare facilities.

Postpartum hemorrhage remains the leading cause of maternal morbidity and mortality worldwide with a prevalence of 6% worldwide with Africa topping the list with 10.5% prevalence. It accounts for 30% of maternal deaths in Africa and Asia.[1]

Deaths due to PPH are preventable and considerable variation exist between developed and developing countries. Uterine Atony is the most common cause of PPH and active management of labor is promoted in developing countries to bring down the maternal mortality.

Oxytocin is the agent of choice because of high efficacy and low adverse effects.[2]

Misoprostol is a prostaglandin E1 analog often used off label in active management of labor because of cost, multiple route of administration and storage advantage.[3] An earlier large randomized multicentric trial compared the efficacy of oxytocin and misoprostol and showed that oxytocin was always the first agent of choice.[4]

After that another study suggested that they both could have synergist effect and reduce PPH further.

A large multicentric, double-blind, randomized, placebo-controlled trial recruited women across three French University hospitals from April 2010 to September 2013. The study subjects consist of women 18 years and older,36-42 weeks of pregnancy, in first stage of labor and under epidural anesthesia. The study was published on September 8 in Obstetrics& Gynecology.[5]

Women who met the inclusion criteria were randomized to receive two tablets of 200 micrograms misoprostol (ie, a total dose of 400 micrograms) or two tablets of placebo orally immediately after delivery of the newborn. Women in both the arm had active management of labor and received prophylactic intravenous injection of 10 international units’ oxytocin after delivery of the fetal anterior shoulder, early clamping of the umbilical cord, and controlled cord traction. 

If patient continued hemorrhaging after the treatment, they received treatment according to the standard protocol of PPH, but misoprostol was not repeated.   

There was not significant difference in both the groups in terms of primary outcome of postpartum hemorrhage greater than 500 mL within 2 hours of birth. (8.4% [68/806] in the misoprostol vs 8.3% [66/797] in the placebo group; P = .98).

After the analysis was performed on 1,721 patients enrolled in study, the trial was discontinued because the combination of misoprostol and oxytocin did nothing to reduce the PPH. Misoprostol when added to prophylactic Oxytocin did not further reduced Postpartum hemorrhage, but rather increased incidence of adverse events in mother. Misoprostol was associated with high rates of adverse effects like fever greater than 38°C (P<.001) and shivering (P<.001), diarrhea and vomiting.

"All in all, the findings of this trial do not support the use of misoprostol in addition to oxytocin for the prevention of postpartum hemorrhage," the authors write. "[D]espite misoprostol's ready availability, easy use, and utility for other pregnancy indications, oxytocin should remain the mainstay of prophylaxis of postpartum hemorrhage in high-income countries, and misoprostol should be used infrequently for this indication."

Misoprostol may be useful in countries with poor health resources where facilities for refrigeration and skilled birth attendants are not freely available.

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[1] http://apps.who.int/rhl/archives/guideline_pphprevention_fawoleb/en/

[2] Westhoff G, Cotter AM, Tolosa JE. Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage

[3] Tunçalp Ö, Hofmeyr GJ, Gülmezoglu AM. Prostaglandins for preventing postpartum haemorrhage.

[4] Gülmezoglu AM, Villar J, Ngoc NT, Piaggio G, Carroli G, Adetoro L, et al. WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet 2001;358:689–95.

[5] http://journals.lww.com/greenjournal/Fulltext/2016/10000/Active_Management_of_the_Third_Stage_of_Labor_With.17.aspx#P70