Vaginal disinfection with chlorhexidine during childbirth. Prevention of excess neonatal morbidity associated with group B streptococci by vaginal chlorhexidine disinfection during labour. The Swedish Chlorhexidine Study Group. Chlorhexidine vs. Sterile vaginal wash during labor to prevent neonatal infection. Randomized study of vaginal chlorhexidine disinfection during labor to prevent vertical transmission of group B streptococci. Group B beta-hemolytic streptococcal colonization. Acquisition, persistence, and effect of umbilical cord treatment with triple dye. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. Chlorhexidine vaginal irrigation for the prevention of peripartal infection: a placebo-controlled randomized clinical trial. Bacterial colonization and neonatal infections. Effects of skin and umbilical disinfection in the nursery. [Umbilical colonization in normal newborns. A comparative study of 4 methods for umbilical antisepsis].
The purpose of this study was to determine whether chlorhexidine vaginal douching, applied by a squeeze bottle intra partum, reduced mother-to-child transmission of vaginal microorganisms including Streptococcus agalactiae (streptococcus serogroup B = GBS) and hence infectious morbidity in both mother and child. A prospective controlled study was conducted on pairs of mothers and their offspring. During the first 4 months (reference phase), the vaginal flora of women in labour was recorded and the newborns monitored. During the next 5 months (intervention phase), a trial of randomized, blinded placebo controlled douching with either 0.2% chlorhexidine or sterile saline was performed on 1130 women in vaginal labour. During childbirth, bacteria were isolated from 78% of the women. Vertical transmission of microbes occurred in 43% of the reference deliveries. In the double blind study, vaginal douching with chlorhexidine significantly reduced the vertical transmission rate from 35% (saline) to 18% (chlorhexidine), (P < 0.000 1, 95% confidence interval 0.12-0.22). The lower rate of bacteria isolated from the latter group was accompanied by a significantly reduced early infectious morbidity in the neonates (P < 0.05, 95% confidence interval 0.00-0.06). This finding was particularly pronounced in Str. agalactiae infections (P < 0.0 1). In the early postpartum period, fever in the mothers was significantly lower in the patients offered vaginal disinfection, a reduction from 7.2% in those douched using saline compared with 3.3% in those disinfected using chlorhexidine (P < 0.05, 95% confidence interval 0.01-0.06). A parallel lower occurrence of urinary tract infections was also observed, 6.2% in the saline group as compared with 3.4% in the chlorhexidine group (P < 0.01, 95% confidence p interval 0.00-0.05). This prospective controlled trial demonstrated that vaginal douching with 0.2% chlorhexidine during labour can significantly reduce both maternal and early neonatal infectious morbidity. The squeeze bottle procedure was simple, quick, and well tolerated. The beneficial effect may be ascribed both to mechanical cleansing by liquid flow and to the disinfective action of chlorhexidine. Streptococcus agalactiae transmitted to infants from the vagina during birth is an important cause of invasive neonatal infection. We have done a prospective, randomised, double-blind, placebo-controlled, multi-centre study of chlorhexidine prophylaxis to prevent neonatal disease due to vaginal transmission of S agalactiae. On arrival in the delivery room, swabs were taken for culture from the vaginas of 4483 women who were expecting a full-term single birth. Vaginal flushing was then done with either 60 ml chlorhexidine diacetate (2 g/l) (2238 women) or saline placebo (2245) and this procedure was repeated every 6 h until delivery. The rate of admission of babies to special-care neonatal units within 48 h of delivery was the primary end point. For babies born to placebo-treated women, maternal carriage of S agalactiae was associated with a significant increase in the rate of admission compared with non-colonised mothers (5.4 vs 2.4%; RR 2.31, 95% CI 1.39-3.86; p = 0.002). Chlorhexidine reduced the admission rate for infants born of carrier mothers to 2.8% (RR 1.95, 95% CI 0.94-4.03), and for infants born to all mothers to 2.0% (RR 1.48, 95% CI 1.01-2.16; p = 0.04). Maternal S agalactiae colonisation is associated with excess early neonatal morbidity, apparently related to aspiration of the organism, that can be reduced with chlorhexidine disinfection of the vagina during labour. Objective: The purpose of this study was to determine if a dilute solution of chlorhexidine used as a one-time vaginal wash intrapartum can reduce the use of postnatal antibiotics and neonatal infection.Methods: Term pregnant women in labor were prospectively randomized to receive either 20 cc of 0.4% chlorhexidine (n = 481) or 20 cc of sterile water (n = 466) placebo. Exclusion criteria included fetal distress, clinical infection, cervical dilatation >6 cm, and known allergy to chlorhexidine. Outcome variables included the incidence of neonatal pneumonia, culture proven neonatal sepsis, and use of the antibiotics in the neonate. Continuous variables were compared using the Mann-Whitney U-test and discrete variables were compared with the chi-square test.Results: The length of ruptured membranes (mean +/- S.D.) between the chlorhexidine group (408 +/- 589 min) and control group (352 +/- 318 min) was not significantly different (P = 0.85, 95% confidence interval 354-462). Fifteen neonates (3.2%) in the chlorhexidine group and 9 (1.9%) in the control group received antibiotics in the postnatal period (P = 0.32, 95% confidence interval 0.72-3.72). There was one case of pneumonia in the control group and no cases of sepsis in either group.Conclusions: A one-time chlorhexidine vaginal wash does not decrease the use of antibiotics or incidence of neonatal infection in our population. To evaluate the effect of vaginal disinfection with chlorhexidine gel during labor on vertical transmission of group B streptococcus, as a method to prevent vertical transmission and subsequent neonatal early onset group B streptococcal disease.
                A prospective study with randomization of 1020 parturients to one of three groups as soon as labor started. In all parturients, anus, introitus and cervix were cultured semiquantitatively. Two groups were treated double-blindly with 10 ml of either a 0.3% chlorhexidine gel or a placebo gel, applicated around the portio and into the fornices. If labor still continued, a second application was given after 10 h. The third group received no treatment. Ear, pharynx and umbilicus of all newborns were also cultured semiquantitatively.
                Nine hundred and eighty one women were evaluated. The overall incidence of group B streptococcal carriership was 19.4%. Vertical transmission was 52.4% in the chlorhexidine group, 71.4% in the placebo group and 66.7% in the control group (P = 0.069). When testing the transmission rates for the chlorhexidine versus the combined placebo plus control group (69.3%), the difference was 16.9% (P = 0.026).
                Vaginal disinfection with a chlorhexidine gel during labor modestly reduces group B streptococcal vertical transmission. Because the method is cheap, simple and safe, it should be considered for routine use. Our results indicate that it may reduce the incidence of early onset group B streptococcal sepsis by 2-32%. Following an outbreak of group B beta-hemolytic streptococcal neonatal infection (GBS), a prevalence survey of GBS colonization was performed on 238 infants. No important differences were noted in the prevalence of colonization when the infants were grouped according to age. Follow-up of 24 colonized babies for three months disclosed that most had persistence of GBS at the rectum and pharynx. Local umbilical cord care with triple dye (TD) or hexachlorophene skin cleanser was compared with untreated controls with respect to rates of GBS colonization. At birth the colonization rates of the three groups were similar. The rate of acquisition of colonization with GBS was 1.0% in the TD group, 6.3% in the hexachlorophene group, and 8.3% in the control group. Triple dye was much more effective than no specific cord care or hexachlorophene in preventing acquisition of GBS colonization. Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.
                We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting handwashing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006.
                187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) but no evidence of an effect of handwashing (RR=0·83, 0·61-1·13; p=0·24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1·08, 0·79-1·48; p=0·62). We recorded no serious adverse events.
                Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.
                The United States Agency for International Development.
                Copyright Â© 2012 Elsevier Ltd. All rights reserved. Our purpose was to determine whether chlorhexidine vaginal irrigation prevents maternal peripartal infection.
                A double-blinded, placebo-controlled, randomized trial was performed. Single 200 ml irrigations of either 0.2% chlorhexidine solution or sterile water placebo were given in active labor or before planned cesarean delivery. The primary outcome measure was the combined rate of chorioamnionitis and endometritis (which were mutually exclusive diagnoses).
                A total of 1024 patients were enrolled: 508 in the chlorhexidine group and 516 in the placebo group. The two groups were generally well balanced on important clinical factors but differed (p < 0.05) in rates of nulliparity (chlorhexidine 42%, placebo 52%), intrauterine pressure catheter usage (chlorhexidine 65%, placebo 72%), and presence of meconium (chlorhexidine 17%, placebo 22%). There were no recognized adverse maternal or neonatal reactions to irrigation. Rates of infection (chorioamnionitis + endometritis) did not differ significantly between the groups, chlorhexidine 10% versus placebo 13% (relative risk 0.8, 95% confidence interval 0.5 to 1.1). Stratified and logistic regression analyses supported the primary univariate analysis. Neonatal outcomes, including sepsis rates of 0.4%, were equivalent for the groups.
                As used in this trial, chlorhexidine lacked efficacy in the prevention of maternal peripartal infection. In a prospective randomized study different regimens for skin and umbilical disinfection in newborn infants were tested: daily whole body soap wash (control group), daily whole body soap wash and umbilical cleansing with (i) benzine solution, or (ii) 0.05% chlorhexidine, and daily whole body wash and umbilical cleansing with a 4% chlorhexidine detergent solution (Hibiscrub). Bacterial cultures were taken from the nose and umbilical area at discharge. Clinical infections were registered in the nursery, and after discharge until 6 weeks of age. Cultures were taken from infected areas. In the control group a high colonization rate was found for S. aureus (91%), E. coli (39%), and group B streptococci (GBS) (20%). The colonization rates were influenced by the Hibiscrub regimen (colonization rate for S. aureus 59%, E. coli 23%, and GBS 10%), but not by the other regimens. Infections (pemphigus, paronychia, conjunctivitis, umbilical infection) occurred in 12.9% of the infants, of whom 65% got infection after discharge from the nursery. 96% of the infections were caused by S. aureus, and 87% caused by strains colonizing the infants in the nursery. None of the tested regimens reduced the rate of infections during the first 6 weeks of life. We report the results of a prospective study in which the effectiveness of 70% alcohol (A), mercurochrome (M), a solution of alcohol and mercurochrome (AM) and 1% chlorhexidine (C) as umbilical antiseptics was tested on 311 normal newborn infants. Similar results were obtained by using A, M, or AM; however, when C was used umbilical colonization was significantly reduced as compared to when the other three antiseptic agents were used. The umbilical cords that had been scrubbed with A, M or AM were detached by the 8th day after birth, whereas those treated with C took 14 days to fall off. The use of chlorhexidine resulted in a marked increase in pure cultures positive for Gram negative bacteria (Proteus spp. and Pseudomonas spp.) which was not the case with the other three antiseptics tested.
Vaginal chlorhexidine resulted in a statistically significant reduction in GBS colonization of neonates, but was not associated with reductions in other outcomes. The review currently does not support the use of vaginal disinfection with chlorhexidine in labour for preventing EOD. Results should be interpreted with caution as the methodological quality of the studies was poor.