Haas David M, Morgan Sarah, Contreras Karenrose, Kimball Savannah
Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
OB/GYN Residency, St. Vincent Women's Hospital, Indianapolis, Indiana, USA.
Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Cesarean delivery is one of the most common surgical procedures performed by obstetricians. Infectious morbidity after cesarean delivery can have a tremendous impact on the postpartum woman's return to normal function and her ability to care for her baby. Despite the widespread use of prophylactic antibiotics, postoperative infectious morbidity still complicates cesarean deliveries. This is an update of a Cochrane Review first published in 2010 and subsequently updated in 2012, twice in 2014, in 2017 and 2018.
To determine if cleansing the vagina with an antiseptic solution before a cesarean delivery decreases the risk of maternal infectious morbidities, including endometritis and wound complications. We also assessed the side effects of vaginal cleansing solutions to determine adverse events associated with the intervention.
We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (7 July 2019), and reference lists of retrieved studies.
We included randomized controlled trials (RCTs) and quasi-RCTs assessing the impact of vaginal cleansing immediately before cesarean delivery with any type of antiseptic solution versus a placebo solution/standard of care on post-cesarean infectious morbidity. Cluster-RCTs were eligible for inclusion, but we did not identify any. We excluded trials that utilized vaginal preparation during labor or that did not use antibiotic surgical prophylaxis. We also excluded any trials using a cross-over design. We included trials published in abstract form only if sufficient information was present in the abstract on methods and outcomes to analyze.
At least three of the review authors independently assessed eligibility of the studies. Two review authors were assigned to extract study characteristics, quality assessments, and data from eligible studies.
We included 21 trials, reporting results for 7038 women evaluating the effects of vaginal cleansing (17 using povidone-iodine, 3 chlorhexidine, 1 benzalkonium chloride) on post-cesarean infectious morbidity. Trials used vaginal preparations administered by sponge sticks, douches, or soaked gauze wipes. The control groups were typically no vaginal preparation (17 trials) or the use of a saline vaginal preparation (4 trials). One trial did not report on any outcomes of interest. Trials were performed in 10 different countries (Saudi Arabia, Pakistan, Iran, Thailand, Turkey, USA, Egypt, UK, Kenya and India). The overall risk of bias was low for areas of attrition, reporting, and other bias. About half of the trials had low risk of selection bias, with most of the remainder rated as unclear. Due to lack of blinding, we rated performance bias as high risk in nearly one-third of the trials, low risk in one-third, and unclear in one-third. Vaginal preparation with antiseptic solution immediately before cesarean delivery probably reduces the incidence of post-cesarean endometritis from 7.1% in control groups to 3.1% in vaginal cleansing groups (average risk ratio (aRR) 0.41, 95% confidence interval (CI) 0.29 to 0.58; 20 trials, 6918 women; moderate-certainty evidence). This reduction in endometritis was seen for both iodine-based solutions and chlorhexidine-based solutions. Risks of postoperative fever and postoperative wound infection are also probably reduced by vaginal antiseptic preparation (fever: aRR 0.64, 0.50 to 0.82; 16 trials, 6163 women; and wound infection: RR 0.62, 95% CI 0.50 to 0.77; 18 trials, 6385 women; both moderate-certainty evidence). Two trials found that there may be a lower risk of a composite outcome of wound complication or endometritis in women receiving preoperative vaginal preparation (RR 0.46, 95% CI 0.26 to 0.82; 2 trials, 499 women; low-certainty evidence). No adverse effects were reported with either the povidone-iodine or chlorhexidine vaginal cleansing. Subgroup analysis suggested a greater effect with vaginal preparations for those women in labour versus those not in labour for four out of five outcomes examined (post-cesarean endometritis; postoperative fever; postoperative wound infection; composite wound complication or endometritis). This apparent difference needs to be investigated further in future trials. We did not observe any subgroup differences between women with ruptured membranes and women with intact membranes.
AUTHORS' CONCLUSIONS: Vaginal preparation with povidone-iodine or chlorhexidine solution compared to saline or not cleansing immediately before cesarean delivery probably reduces the risk of post-cesarean endometritis, postoperative fever, and postoperative wound infection. Subgroup analysis found that these benefits were typically present whether iodine-based or chlorhexidine-based solutions were used and when women were in labor before the cesarean. The suggested benefit in women in labor needs further investigation in future trials. There was moderate-certainty evidence using GRADE for all reported outcomes, with downgrading decisions based on limitations in study design or imprecision. As a simple intervention, providers may consider implementing preoperative vaginal cleansing with povidone-iodine or chlorhexidine before performing cesarean deliveries. Future research on this intervention being incorporated into bundles of care plans for women receiving cesarean delivery will be needed.
剖宫产是产科医生实施的最常见的外科手术之一。剖宫产术后的感染性疾病对产后女性恢复正常功能以及照顾婴儿的能力会产生巨大影响。尽管预防性抗生素被广泛使用,但术后感染性疾病仍是剖宫产的并发症。这是一篇Cochrane系统评价的更新版,该评价首次发表于2010年,随后在2012年、2014年更新了两次、2017年和2018年也进行了更新。
确定剖宫产术前用消毒溶液清洁阴道是否能降低产妇感染性疾病的风险,包括子宫内膜炎和伤口并发症。我们还评估了阴道清洁溶液的副作用,以确定与该干预措施相关联的不良事件。
我们检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov、世界卫生组织(WHO)国际临床试验注册平台(ICTRP)(2019年7月7日)以及检索到的研究的参考文献列表。
我们纳入了随机对照试验(RCT)和半随机对照试验,评估剖宫产术前立即用任何类型的消毒溶液清洁阴道与用安慰剂溶液/标准护理相比,对剖宫产后感染性疾病的影响。整群随机对照试验符合纳入标准,但我们未检索到此类试验。我们排除了在分娩期间进行阴道准备或未使用抗生素手术预防的试验。我们还排除了任何采用交叉设计的试验。仅当摘要中包含足够的方法和结果信息以供分析时,我们才纳入仅以摘要形式发表的试验。
至少三位综述作者独立评估研究的纳入资格。两位综述作者被分配提取符合条件的研究的特征、质量评估和数据。
我们纳入了21项试验,报告了7038名女性的结果,评估了阴道清洁(17项使用聚维酮碘,3项使用氯己定,1项使用苯扎氯铵)对剖宫产后感染性疾病的影响。试验使用海绵棒、冲洗器或浸泡纱布擦拭进行阴道准备。对照组通常为不进行阴道准备(17项试验)或使用生理盐水进行阴道准备(4项试验)。一项试验未报告任何感兴趣的结果。试验在10个不同国家进行(沙特阿拉伯、巴基斯坦、伊朗、泰国、土耳其、美国、埃及、英国、肯尼亚和印度)。在失访、报告和其他偏倚方面,总体偏倚风险较低。约一半的试验选择偏倚风险较低,其余大多数试验的风险评估为不清楚。由于缺乏盲法,我们将近三分之一的试验的实施偏倚评为高风险,三分之一为低风险,三分之一为不清楚。剖宫产术前立即用消毒溶液进行阴道准备可能会将剖宫产后子宫内膜炎的发生率从对照组的7.1%降至阴道清洁组的3.1%(平均风险比(aRR)0.41,95%置信区间(CI)0.29至0.58;20项试验,6918名女性;中等确定性证据)。基于碘的溶液和基于氯己定的溶液均可降低子宫内膜炎的发生率。阴道消毒准备也可能降低术后发热和术后伤口感染的风险(发热:aRR 0.64,0.50至0.82;16项试验,6163名女性;伤口感染:RR 0.62,95%CI 0.50至0.77;18项试验,6385名女性;均为中等确定性证据)。两项试验发现,接受术前阴道准备的女性发生伤口并发症或子宫内膜炎复合结局的风险可能较低(RR 0.46,95%CI 0.26至0.82;2项试验,499名女性;低确定性证据)。聚维酮碘或氯己定阴道清洁均未报告不良反应。亚组分析表明,对于所检查的五项结局中的四项(剖宫产后子宫内膜炎;术后发热;术后伤口感染;伤口并发症或子宫内膜炎复合结局),正在分娩的女性与未分娩的女性相比,阴道准备的效果更大。这种明显差异需要在未来试验中进一步研究。我们未观察到胎膜破裂女性与胎膜完整女性之间的亚组差异。
与剖宫产术前立即用生理盐水或不进行清洁相比,用聚维酮碘或氯己定溶液进行阴道准备可能会降低剖宫产后子宫内膜炎、术后发热和术后伤口感染的风险。亚组分析发现,无论使用基于碘的溶液还是基于氯己定的溶液,以及女性在剖宫产术前是否正在分娩,这些益处通常都存在。对于正在分娩的女性的潜在益处需要在未来试验中进一步研究。对于所有报告的结局,使用GRADE方法有中等确定性证据,降级决策基于研究设计的局限性或不精确性。作为一种简单的干预措施,医疗服务提供者在进行剖宫产术前可考虑采用聚维酮碘或氯己定进行术前阴道清洁。未来需要对将该干预措施纳入剖宫产女性护理计划组合进行研究。