Effect of cleansing the birth canal with antiseptic solution on maternal and newborn morbidity and mortality in Malawi: clinical trial

Abstract

Objective: To determine if cleansing the birth canal with an antiseptic at delivery reduces infections in mothers and babies postnatally.

Design: Clinical trial; two months of no intervention were followed by three months of intervention and a final month of no intervention.

Setting: Queen Elizabeth Central Hospital (tertiary care urban hospital), Blantyre, Malawi.

Subjects: A total of 6965 women giving birth in a six month period and their 7160 babies.

Intervention: Manual wipe of the maternal birth canal with a 0.25% chlorhexidine solution at every vaginal examination before delivery. Babies born during the intervention were also wiped with chlorhexidine.

Main outcome measures: Effects of the intervention on neonatal and maternal morbidity and mortality.

Results: 3635 women giving birth to 3743 babies were enrolled in the intervention phase and 3330 women giving birth to 3417 babies were enrolled in the non-intervention phase. There were no adverse reactions related to the intervention among the mothers or their children. Among infants born in the intervention phase, overall neonatal admissions were reduced (634/3743 (16.9%) v 661/3417 (19.3%), P < 0.01), as were admissions for neonatal sepsis (7.8 v 17.9 per 1000 live births, P < 0.0002), overall neonatal mortality (28.6 v 36.9 per 1000 live births, P < 0.06), and mortality due to infectious causes (2.4 v 7.3 per 1000 live births, P < 0.005). Among mothers receiving the intervention, admissions related to delivery were reduced (29.4 v 40.2 per 1000 deliveries, P < 0.02), as were admissions due to postpartum infections (1.7 v 5.1 per 1000 deliveries, P = 0.02) and duration of hospitalisation (Wilcoxon P = 0.008).

Conclusions: Cleansing the birth canal with chlorhexidine reduced early neonatal and maternal postpartum infectious problems. The safety, simplicity, and low cost of the procedure suggest that it should be considered as standard care to lower infant and maternal morbidity and mortality.

PIP: A clinical trial of the effects of cleansing both the birth canal and the newborn with an antiseptic indicates that this simple procedure substantially reduces early neonatal and maternal postpartum infection. The antiseptic used, a 0.25% chlorhexidene solution, has been shown to reduce neonatal morbidity due to group B streptococcus and can neutralize HIV. Enrolled in the study were 6965 women giving birth to 7160 infants at Queen Elizabeth Central Hospital in Blantyre, Malawi, in a 6-month period in 1994. 2 months of no intervention were followed by 3 months of intervention and a final month of no intervention. Significant differences were recorded between the 3743 infants delivered during the intervention phase and the 3417 controls in terms of overall neonatal admissions (16.9 vs. 19.3/1000 live births), admissions for neonatal sepsis (7.8 vs. 17.9/1000 live births), overall neonatal mortality (28.6 vs. 36.9/1000 live births), and mortality due to infectious causes (2.4 vs. 7.3/1000 live births). Significant differences also were found between the 3635 mothers in the intervention group and the 3330 controls in delivery-related admissions (29.4 vs. 40.2/1000 deliveries), admissions due to postpartum infection (1.7 vs. 5.1/1000 deliveries), and the average duration of hospitalization (48.7 vs. 50.2 hours). The cleansing procedure was easily administered, required almost no extra staff time, and cost less than US $0.10 per patient, making it appropriate for standard care.