Effect of perinatal sterile gloves on neonatal mortality: a post hoc analysis of a randomised clinical trial in Zambia.

Background: Sterile gloves, an inexpensive method of hand hygiene, are attributed both protective and useless characteristics concerning neonatal mortality. This study aimed to perform a post hoc secondary analysis of a cluster-randomised controlled trial (cRCT) to examine the association between intrapartum sterile gloves and neonatal mortality. Methods: Data from the Zambia Chlorhexidine Application Trial, a cRCT of 4% chlorhexidine umbilical cord care in Zambia from 2011-2013, were analyzed. A randomised controlled trial (RCT) (NCT01241318) provided pregnant women with clean delivery kits containing sterile gloves. Neonatal mortality was compared between the glove use and nonuse groups. Group differences were evaluated and multivariable logistic regression analyses were performed. Results: Sterile gloves were used in 96.9% of the 37,003 newborns, which varied significantly by place of delivery. The 28-day mortality rates for hospital, health center and nonfacility deliveries were 2.7%, 1.1% and 1.3%, respectively (P<0.001). After adjusting for confounders, logistic regression revealed that the use of sterile gloves was associated with a lower risk of neonatal mortality [odds ratio (OR) =0.10; 95% confidence interval (CI): 0.07-0.15]. The use of perinatal sterile gloves was associated with a reduced risk of immediate neonatal death (<24 hours) (OR =0.47; 95% CI: 0.24-0.91) and early neonatal death (1-6 days) (OR =0.26; 95% CI: 0.16-0.39). Conclusions: The use of perinatal sterile gloves may significantly improve neonatal outcomes in low- and middle-income countries (LMICs). The provision of sterile gloves to promote newborn health may be feasible in LMICs.