Clinical trial of chlorhexidine vaginal irrigation to prevent peripartal infection in nulliparous women. Chlorhexidine vaginal irrigation for the prevention of peripartal infection: a placebo-controlled randomized clinical trial. Vaginal disinfection with chlorhexidine during childbirth.
The purpose of this study was to determine whether intrapartum chlorhexidine vaginal irrigations prevent peripartal infection in nulliparous women at >or=32 weeks of gestation.
                This was a double-blinded, placebo-controlled randomized clinical trial. Vaginal irrigations were performed with 200 mL of 0.2% chlorhexidine solution or sterile saline solution placebo every 6 hours during labor. The primary study outcome was clinically diagnosed maternal peripartal infection: chorioamnionitis or endometritis. Analysis was by intent to treat.
                One thousand forty-one women were assigned randomly to one of two groups (chlorhexidine therapy, 525 women; placebo, 516 women). The two groups were balanced for risk factors for infection. Rates of peripartal infection were 19.3% in the chlorhexidine group and 17.3% in the placebo group (relative risk 1.1; 95% CI, 0.9-1.4). Major and minor neonatal morbidities were similar between the groups. No major and one minor adverse reaction was attributed to chlorhexidine irrigation.
                Under the conditions of this trial, chlorhexidine vaginal irrigation lacked efficacy in the prevention of clinically diagnosed maternal and neonatal infectious morbidity. 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. 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.
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.