Vaginal disinfection with chlorhexidine during childbirth. Chlorhexidine vs. Sterile vaginal wash during labor to prevent neonatal infection. Chlorhexidine vaginal irrigation for the prevention of peripartal infection: a placebo-controlled randomized clinical trial.
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. 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. 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.
There is no evidence to support the use of vaginal chlorhexidine during labour in preventing maternal and neonatal infections. There is a need for a well-designed randomized controlled trial using appropriate concentration and volume of vaginal chlorhexidine irrigation solution and with adequate sample size.