Chlorhexidine vaginal and neonatal wipes in home births in Pakistan - A Randomized controlled trial
Chlorhexidine vaginal and neonatal wipes in home births in Pakistan - A Randomized controlled trial
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DOI：
10.1097/01.aog.0000285653.17869.26
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发表时间：
2007-11-01
影响因子：
7.2
通讯作者：
Goldenberg, R. L.
中科院分区：
文献类型：
--
作者：
Saleem, S.;Reza, T.;Goldenberg, R. L.
目的：为了评估耐受性和安全性的0.6%洗必泰阴道和新生儿湿巾，以改善围产期的结果在巴基斯坦和传统的助产士和项目工作人员进行随机试验的intervention.Methods：重点人群的孕妇和非孕妇和深入采访的传统助产士探讨了使用洗必泰湿巾的障碍。然后，对由传统助产士在家里接生的妇女进行了一项研究。怀孕妇女被随机分配接受0.6%氯己定或生理盐水阴道和新生儿湿巾。在产后第7、14和28天对妇女及其婴儿进行随访。评估了阴道和新生儿湿巾的可接受性和耐受性，以及孕产妇和新生儿的结局。结果：焦点小组和访谈表明，妇女及其提供者可以接受氯己定干预措施。在213名合格的孕妇中，203名（950%）提供了知情同意书，并被招募和分配到各组。传统的助产士在家庭环境中使用洗必泰阴道和新生儿湿巾没有困难。在203例分娩中，103例（51%）接受了0.6%氯己定，未发生过敏反应、阴道瘙痒、烧灼感或要求终止研究。产后28天随访率达95%以上。虽然这项研究没有权力显示治疗组之间的新生儿结局的显着差异，在洗必泰组的一些新生儿不良临床结局率较低是令人鼓舞的。结论：使用0.6%洗必泰阴道和新生儿湿巾预防新生儿感染是耐受性良好，似乎是安全的。在家庭分娩环境中由传统助产士进行这种干预的试验是可行的。
Objective: To assess tolerance and safety of 0.6% chlorhexidine vaginal and neonatal wipes to improve perinatal outcomes in home deliveries in Pakistan and the ability of traditional birth attendants and project staff to perform a randomized trial of this intervention.Methods: Focus groups of pregnant and nonpregnant women and in-depth interviews of traditional birth attendants explored barriers to the use of chlorhexidine wipes. Then, a study was performed of women delivering at home attended by traditional birth attendants. Consenting women were randomly assigned to receive either 0.6% chlorhexidine or saline vaginal and neonatal wipes. Women and their infants were followed up on postpartum days 7, 14, and 28. Acceptability and tolerance of vaginal and neonatal wipes, as well as maternal and neonatal outcomes, were assessed.Results: The focus groups and interviews indicated that the chlorhexidine intervention would be acceptable to women and their providers. Of the 213 eligible pregnant women approached, 203 (950%) gave informed consent and were enrolled and allocated to groups. Traditional birth attendants had no difficulty administering chlorhexidine vaginal and neonatal wipes in a home setting. Of the 203 births, 103 (51%) of whom received 0.6% chlorhexidine, there were no allergic reactions, vaginal itching, burning, or requests for study termination. Follow-up at 28 days postpartum was more than 95%. Although this study was not powered to show significant differences in neonatal outcomes between treatment groups, the lower rates of some neonatal adverse clinical outcomes in the chlorhexidine group were encouraging.Conclusion: Use of 0.6% chlorhexidine vaginal and neonatal wipes for the prevention of neonatal infection is well-tolerated and seems safe. A trial of this intervention by traditional birth attendants in a home-delivery setting is feasible.