Liabsuetrakul Tippawan, Choobun Thanapan, Peeyananjarassri Krantarat, Islam Q Monir
Prince of Songkla University, Epidemiology Unit, Faculty of Medicine, Hat Yai, Songkhla, Thailand, 90110.
Prince of Songkla University, Department of Obstetrics and Gynecology, Faculty of Medicine, Hat Yai, Songkhla, Thailand, 90110.
Cochrane Database Syst Rev. 2020 Mar 26;3(3):CD004455. doi: 10.1002/14651858.CD004455.pub5.
Vacuum and forceps assisted vaginal deliveries are reported to increase the incidence of postpartum infections and maternal readmission to hospital compared to spontaneous vaginal delivery. Prophylactic antibiotics may be prescribed to prevent these infections. However, the benefit of antibiotic prophylaxis for operative vaginal deliveries is still unclear. This is an update of a review last published in 2017.
To assess the effectiveness and safety of antibiotic prophylaxis in reducing infectious puerperal morbidities in women undergoing operative vaginal deliveries including vacuum or forceps delivery, or both.
For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 July 2019), and reference lists of retrieved studies.
All randomised controlled trials comparing any prophylactic antibiotic regimens with placebo or no treatment in women undergoing vacuum or forceps deliveries were eligible. Participants were all pregnant women without evidence of infections or other indications for antibiotics of any gestational age. Interventions were any antibiotic prophylaxis (any dosage regimen, any route of administration or at any time during delivery or the puerperium).
Two review authors assessed trial eligibility and risk of bias. Two review authors extracted the data independently using prepared data extraction forms. Any discrepancies were resolved by discussion and a consensus reached through discussion with all review authors. We assessed methodological quality of the two included studies using the GRADE approach.
Two studies, involving 3813 women undergoing either vacuum or forceps deliveries, were included. One study involving 393 women compared the antibiotic intravenous cefotetan after cord clamping compared with no treatment. The other study involving 3420 women compared a single dose of intravenous amoxicillin and clavulanic acid with placebo using 20 mL of intravenous sterile 0.9% saline. The evidence suggests that prophylactic antibiotics reduce superficial perineal wound infection (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.40 to 0.69; women = 3420; 1 study; high-certainty evidence), deep perineal wound infection (RR 0.46, 95% CI 0.31 to 0.69; women = 3420; 1 study; high-certainty evidence) and probably reduce wound breakdown (RR 0.52, 95% CI 0.43 to 0.63; women = 2593; 1 study; moderate-certainty evidence). We are unclear about the effect on organ or space perineal wound infection (RR 0.11, 95% CI 0.01 to 2.05; women = 3420; 1 study) and endometritis (average RR 0.32, 95% CI 0.04 to 2.64; 15/1907 versus 30/1906; women = 3813; 2 studies) based on low-certainty evidence with wide CIs that include no effect. Prophylactic antibiotics probably lower serious infectious complications (RR 0.44, 95% CI 0.22 to 0.89; women = 3420; 1 study; high-certainty evidence). They also have an important effect on reduction of confirmed or suspected maternal infection. The two included studies did not report on fever or urinary tract infection. It is unclear, based on low-certainty evidence, whether prophylactic antibiotics have any impact on maternal adverse reactions (RR 2.00, 95% CI 0.18 to 22.05; women = 2593; 1 study) and maternal length of stay (MD 0.09 days, 95% CI -0.23 to 0.41; women = 393; 1 study) as the CIs were wide and included no effect. Prophylactic antibiotics slightly improve perineal pain and health consequences of perineal pain and probably reduce costs. Prophylactic antibiotics did not have an important effect on dyspareunia (difficult or painful sexual intercourse) or breastfeeding at six weeks. Antibiotic prophylaxis may slightly improve maternal hospital re-admission and maternal health-related quality of life. Neonatal adverse reactions were not reported in any included trials.
AUTHORS' CONCLUSIONS: Prophylactic intravenous antibiotics are effective in reducing infectious puerperal morbidities in terms of superficial and deep perineal wound infection or serious infectious complications in women undergoing operative vaginal deliveries without clinical indications for antibiotic administration after delivery. Prophylactic antibiotics slightly improve perineal pain and health consequences of perineal pain, probably reduce the costs, and may slightly reduce the maternal hospital re-admission and health-related quality of life. However, the effect on reduction of endometritis, organ or space perineal wound infection, maternal adverse reactions and maternal length of stay is unclear due to low-certainty evidence. As the evidence was mainly derived from a single multi-centre study conducted in a high-income setting, future well-designed randomised trials in other settings, particularly in low- and middle-income settings, are required to confirm the effect of antibiotic prophylaxis for operative vaginal delivery.
据报道,与自然阴道分娩相比,真空吸引和产钳助产阴道分娩会增加产后感染的发生率以及产妇再次入院的几率。可能会开具预防性抗生素来预防这些感染。然而,手术阴道分娩使用抗生素预防的益处仍不明确。这是对2017年发表的一篇综述的更新。
评估抗生素预防在降低接受包括真空吸引或产钳助产或两者皆有的手术阴道分娩的女性产后感染性疾病方面的有效性和安全性。
对于本次更新,我们检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)(2019年7月5日)以及检索到的研究的参考文献列表。
所有比较任何预防性抗生素方案与安慰剂或未治疗的随机对照试验,纳入接受真空吸引或产钳助产的女性均符合条件。参与者为所有无感染证据或任何孕周使用抗生素的其他指征的孕妇。干预措施为任何抗生素预防(任何剂量方案、任何给药途径或在分娩或产褥期的任何时间)。
两位综述作者评估试验的合格性和偏倚风险。两位综述作者使用准备好的数据提取表格独立提取数据。任何差异通过讨论解决,并通过与所有综述作者讨论达成共识。我们使用GRADE方法评估纳入的两项研究的方法学质量。
纳入了两项研究,涉及3813名接受真空吸引或产钳助产的女性。一项涉及393名女性的研究比较了脐带钳夹后静脉注射头孢替坦抗生素与未治疗的情况。另一项涉及3420名女性的研究将单剂量静脉注射阿莫西林克拉维酸与使用20 mL静脉注射无菌0.9%生理盐水的安慰剂进行了比较。证据表明,预防性抗生素可降低浅表会阴伤口感染(风险比(RR)0.53,95%置信区间(CI)0.40至0.69;女性 = 3420;1项研究;高确定性证据)、深部会阴伤口感染(RR 0.46,95% CI 0.31至0.69;女性 = 3420;1项研究;高确定性证据),并且可能降低伤口裂开(RR 0.52,95% CI 0.43至0.63;女性 = 2593;1项研究;中等确定性证据)。基于低确定性证据且置信区间较宽(包括无效应),我们尚不清楚对器官或间隙性会阴伤口感染(RR 0.11,95% CI 0.01至2.05;女性 = 3420;1项研究)和子宫内膜炎(平均RR 0.32,95% CI 0.04至2.64;15/1907对30/1906;女性 = 3813;2项研究)的影响。预防性抗生素可能降低严重感染并发症(RR 0.44,95% CI 0.22至0.89;女性 = 3420;1项研究;高确定性证据)。它们对减少确诊或疑似的产妇感染也有重要作用。纳入的两项研究均未报告发热或尿路感染情况。基于低确定性证据,尚不清楚预防性抗生素是否对产妇不良反应(RR 2.00,95% CI 0.18至22.05;女性 = 2593;1项研究)和产妇住院时间(MD 0.09天,95% CI -0.23至0.41;女性 = 393;1项研究)有影响,因为置信区间较宽且包括无效应。预防性抗生素可轻微改善会阴疼痛以及会阴疼痛对健康的影响,并且可能降低成本。预防性抗生素对性交困难或疼痛以及六周时的母乳喂养没有重要影响。抗生素预防可能会轻微改善产妇再次入院情况以及与产妇健康相关的生活质量。纳入的任何试验均未报告新生儿不良反应。
对于产后无抗生素使用临床指征而接受手术阴道分娩的女性,预防性静脉使用抗生素在降低浅表和深部会阴伤口感染或严重感染并发症等产后感染性疾病方面是有效的。预防性抗生素可轻微改善会阴疼痛以及会阴疼痛对健康的影响,可能降低成本,并且可能轻微降低产妇再次入院率以及与健康相关的生活质量。然而,由于低确定性证据,其对降低子宫内膜炎、器官或间隙性会阴伤口感染、产妇不良反应和产妇住院时间的影响尚不清楚。由于证据主要来自在高收入环境中进行的一项单一多中心研究,因此需要在其他环境,特别是低收入和中等收入环境中进行未来设计良好的随机试验,以确认手术阴道分娩使用抗生素预防的效果。