Cui Mingling, Chen Xinglin, Zhang Xuejie, Zhang Yanyan, Huang Yan, Lin Jiajuan, Yang Zuming, Shen Lirong, Ma Yuelan
Department of Neonatology, the Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou, China.
Academic Department, Chinese National Academy of Folk Art, Beijing, China.
Transl Pediatr. 2025 Jul 31;14(7):1422-1431. doi: 10.21037/tp-2025-88. Epub 2025 Jul 28.
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.
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.
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).
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.
无菌手套作为一种成本低廉的手部卫生防护手段，在新生儿死亡率方面兼具保护作用和无效性。本研究旨在对一项整群随机对照试验（cRCT）进行事后二次分析，以探究产时使用无菌手套与新生儿死亡率之间的关联。
分析了赞比亚洗必泰应用试验的数据，该试验是2011年至2013年在赞比亚开展的一项关于4%洗必泰脐带护理的cRCT。一项随机对照试验（RCT）（NCT01241318）为孕妇提供了包含无菌手套的清洁分娩套件。比较了使用手套组和未使用手套组的新生儿死亡率。评估了组间差异并进行了多变量逻辑回归分析。
在37,003名新生儿中，96.9%使用了无菌手套，这在不同分娩地点存在显著差异。医院、健康中心和非医疗机构分娩的28天死亡率分别为2.7%、1.1%和1.3%（P<0.001）。在对混杂因素进行调整后，逻辑回归显示使用无菌手套与较低的新生儿死亡风险相关[比值比（OR）=0.10；95%置信区间（CI）：0.07 - 0.15]。围产期使用无菌手套与降低新生儿即刻死亡（<24小时）风险（OR =0.47；95% CI：0.24 - 0.91）和早期新生儿死亡（1 - 6天）风险（OR =0.26；95% CI：0.16 - 0.39）相关。
围产期使用无菌手套可能显著改善低收入和中等收入国家（LMICs）的新生儿结局。在低收入和中等收入国家提供无菌手套以促进新生儿健康可能是可行的。
