Ahmed Sheikh Irfan, Ammerdorffer Anne, Moakes Catherine A, Cheshire James, Gülmezoglu Ahmet Metin, Coomarasamy Arri, Lissauer David, Wilson Amie
Aga Khan University Hospital, Karachi, Pakistan.
Concept Foundation, Geneva, Switzerland.
Cochrane Database Syst Rev. 2025 Apr 15;4(4):CD014844. doi: 10.1002/14651858.CD014844.pub2.
Procedural management of early pregnancy loss (EPL) involves removing any residual pregnancy tissue from the uterus. Clinical evidence and guidance are clear that antibiotic treatment is needed for women experiencing EPL, with signs and symptoms of infection. However, it is less clear whether prophylactic antibiotics are routinely required during procedural management in those without features of infection.
To evaluate the effectiveness of routine antibiotic prophylaxis for women undergoing uterine evacuation procedures to manage early pregnancy loss.
We searched the Cochrane Fertility Regulation Review Group trials register, CENTRAL, MEDLINE, Embase, Global Health (Ovid), Scopus (conference abstracts only), and grey literature in October 2023. We checked references and contacted study authors and experts in the field to identify additional studies.
We included randomised controlled trials comparing prophylactic antibiotics with placebo or no treatment. Trials with a cluster-randomised design and trials published only in abstract form were also eligible for inclusion. We included all types of EPL managed with surgical uterine evacuation. There was no gestational age limit. We excluded women with signs and symptoms of infection.
Two review authors independently assessed trials for inclusion and risk of bias, extracted and checked data for accuracy, and assessed the certainty of evidence using the GRADE approach. We contacted the authors of the ongoing trial for additional information.
We included six RCTs with a total of 4371 participants undergoing uterine evacuation procedures to manage EPL. Prophylactic antibiotics may have little or no effect on uterine infection after uterine evacuation for EPL compared with placebo or no treatment, but this evidence was uncertain (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.47 to 1.28; I² = 50%; 6 studies, 4371 participants; low-certainty evidence). Sensitivity analysis of three studies including 3737 participants (85% of total participants) showed that when only studies with low risk of bias were meta-analysed, the effect was larger and of high certainty, resulting in a 43% reduction in the risk of developing a uterine infection (RR 0.57, 95% CI 0.37 to 0.86; I² = 0%; 3 studies, 3737 participants; high-certainty evidence). Both the overall estimate and the sensitivity analysis limited to studies with low risk of bias were consistent with a reduction in uterine infection with prophylactic antibiotics. A single study reported on adverse effects. Prophylactic antibiotics likely result in little or no difference in the risk of vomiting (RR 1.20, 95% CI 0.61 to 2.38; 1 study, 3404 participants; moderate-certainty evidence), and likely result in little or no difference in the risk of having diarrhoea (RR 0.92, 95% CI 0.51 to 1.65; 1 study, 3404 participants; moderate-certainty evidence). Prophylactic antibiotics may increase the risk of allergy (RR 3.01, 95% CI 0.12 to 73.76; 1 study, 3404 participants; low-certainty evidence); the study reported no cases of anaphylaxis (very low-certainty evidence). Prophylactic antibiotics may reduce the need for antibiotic treatment to treat infection, but the evidence is very uncertain (RR 0.94, 95% CI 0.54 to 1.64; I = 63%; 3 studies, 3574 participants; very low-certainty evidence). Meta-analysis of three studies also found that prophylactic antibiotics may reduce hospitalisation for treatment of infection, but the effect was very uncertain (RR 0.76, 95% CI 0.40 to 1.46; I² = 0%; 3 studies, 3859 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS: When all studies were considered, the evidence suggested that routine antibiotic prophylaxis may reduce uterine infection amongst women undergoing uterine evacuation procedures to manage early pregnancy loss (EPL), but the evidence is of low certainty. It is important to note that the quality of the evidence included was seriously affected by poor follow-up and high non-compliance with antibiotic prophylaxis. A sensitivity analysis based on three trials assessed to have low risk of bias (85% of the total participants), demonstrated a larger effect size with high certainty, resulting in a 43% reduction in the risk of uterine infection rates with antibiotic prophylaxis. Prophylactic antibiotics may reduce hospitalisation for treatment of infection, and may reduce the need for a course of antibiotics to treat infection after uterine evacuation procedures to treat EPL, but this evidence is very uncertain. Data were limited and uncertain with regard to potential adverse effects, such as vomiting, diarrhoea, allergy, and anaphylaxis.
早期妊娠丢失(EPL)的手术管理涉及清除子宫内任何残留的妊娠组织。临床证据和指南明确指出,有感染体征和症状的EPL女性需要进行抗生素治疗。然而,对于在手术管理过程中没有感染特征的女性是否常规需要预防性使用抗生素,目前尚不清楚。
评估对接受子宫排空手术以处理早期妊娠丢失的女性进行常规抗生素预防的有效性。
我们于2023年10月检索了Cochrane生育调节综述组试验注册库、CENTRAL、MEDLINE、Embase、全球健康数据库(Ovid)、Scopus(仅会议摘要)和灰色文献。我们检查了参考文献,并联系了研究作者和该领域的专家以识别其他研究。
我们纳入了比较预防性抗生素与安慰剂或不治疗的随机对照试验。采用整群随机设计的试验以及仅以摘要形式发表的试验也符合纳入标准。我们纳入了所有通过手术子宫排空处理的EPL类型。没有孕周限制。我们排除了有感染体征和症状的女性。
两位综述作者独立评估试验是否纳入以及偏倚风险,提取并检查数据的准确性,并使用GRADE方法评估证据的确定性。我们联系了正在进行的试验的作者以获取更多信息。
我们纳入了6项随机对照试验,共有4371名参与者接受子宫排空手术以处理EPL。与安慰剂或不治疗相比,预防性抗生素对EPL子宫排空后的子宫感染可能几乎没有影响,但该证据尚不确定(风险比(RR)0.78,95%置信区间(CI)0.47至1.28;I² = 50%;6项研究,4371名参与者;低确定性证据)。对包括3737名参与者(占总参与者的85%)的三项研究进行的敏感性分析表明,当仅对偏倚风险低的研究进行荟萃分析时,效果更大且确定性高,导致发生子宫感染的风险降低43%(RR 0.57,95%CI 0.37至0.86;I² = 0%;3项研究,3737名参与者;高确定性证据)。总体估计以及仅限于偏倚风险低的研究的敏感性分析均与预防性抗生素可降低子宫感染一致。一项研究报告了不良反应。预防性抗生素可能导致呕吐风险几乎没有差异(RR 1.20,95%CI 0.61至2.38;1项研究,3404名参与者;中等确定性证据),并且可能导致腹泻风险几乎没有差异(RR 0.92,95%CI 0.51至1.65;1项研究,3404名参与者;中等确定性证据)。预防性抗生素可能增加过敏风险(RR 3.01,95%CI 0.12至73.76;1项研究,3404名参与者;低确定性证据);该研究报告无过敏反应病例(极低确定性证据)。预防性抗生素可能减少治疗感染所需的抗生素治疗,但证据非常不确定(RR 0.94,95%CI 0.54至1.64;I² = 63%;3项研究,3574名参与者;极低确定性证据)。对三项研究的荟萃分析还发现,预防性抗生素可能减少因感染治疗而住院的情况,但效果非常不确定(RR 0.76,95%CI 0.40至1.46;I² = 0%;3项研究,3859名参与者;极低确定性证据)。
当考虑所有研究时,证据表明常规抗生素预防可能会降低接受子宫排空手术以处理早期妊娠丢失(EPL)的女性的子宫感染,但证据的确定性较低。需要注意的是,纳入证据的质量受到随访不佳和抗生素预防依从性高的严重影响。基于三项评估为偏倚风险低的试验(占总参与者的85%)进行的敏感性分析表明,效果大小更大且确定性高,使用抗生素预防可使子宫感染率风险降低43%。预防性抗生素可能减少因感染治疗而住院的情况,并且可能减少子宫排空手术后治疗EPL感染所需的抗生素疗程,但该证据非常不确定。关于呕吐、腹泻、过敏和过敏反应等潜在不良反应的数据有限且不确定。