Effectiveness of antibiotic prophylaxis during surgical evacuation of the uterus for miscarriage management in low income countries. (AIMS Trial)

流产手术后的感染-一个全球性问题：全球每年有2.1亿妇女怀孕，但其中3300万以流产告终。大多数流产的妇女都要做手术。据报道，在低收入环境中，流产手术后的感染率高达30%。流产后感染可导致严重的疾病和死亡，以及长期的后果，包括异位妊娠，不孕症和持续性疼痛的发病率增加。预防性抗生素-一个潜在的解决方案：预防性抗生素，手术前给予，可能会改善结果。然而，对于流产手术，世界卫生组织、英国国家指南和低收入国家指南的现行指南不推荐预防性抗生素。这是因为证据有限。我们建议，预防性抗生素，在手术时使用，可能会提供一个解决方案，以减少严重的问题，感染后miscarriage.The现有的证据-一个试验是必要的：最近审查的所有证据的结论是，“没有足够的证据来评估政策的常规抗生素预防妇女不完全流产”和“有一个真实的和迫切需要找出是否抗生素应常规使用的情况下，不完全流产。这项研究产生的政策和成本影响将是巨大的，强烈建议进行随机临床试验，比较目前使用的抗生素与不使用抗生素。“拟议中的AIMS试验：问题是：在手术前给妇女服用抗生素能减少流产手术后的盆腔感染吗？研究中心：本研究将在撒哈拉以南非洲的3个国家进行：坦桑尼亚、马拉维和乌干达。选择这些国家是因为低收入国家的妇女流产后感染问题最严重，因此这是本研究可能对改善健康产生最大影响的地方。试验涉及：接受流产手术的妇女将被邀请参加，如果同意，将向妇女提供单剂量的抗生素，在手术前两小时口服我们计划在2年内招募2400名妇女，给予抗生素（400毫克强力霉素和400毫克甲硝唑）或安慰剂。妇女和临床医生不知道药片是抗生素还是假药丸。通过比较感染率和其他问题，如手术后前2周内的死亡或住院，我们可以确定抗生素是否有任何效果。临床医生对试验的支持：该试验得到国际专业组织的认可，来自23个低收入国家的124名从业者的调查压倒性地（87.5%）支持AIMS试验的必要性。用户支持和可接受性：在马拉维的布兰太尔和乌干达的姆巴莱，对妇科住院患者进行的半结构化访谈表明，流产后的潜在问题得到了认可，拟议的方案是可以接受的。参与者表示愿意参加并返回进行后续评估。这项试验也得到了流产协会的支持。这项试验的潜在好处是：流产手术很常见，感染性并发症也很常见和严重。预防性抗生素如果发现有效，可能提供一种简单和负担得起的干预措施，可以迅速实施，以减少低收入国家的孕产妇死亡率和疾病负担。这可能直接涉及千年发展目标5（降低孕产妇死亡率），而这方面的进展既不均衡又缓慢。

Infection following miscarriage surgery - A GLOBAL PROBLEM:Globally, 210 million women become pregnant each year, but 33 million of these pregnancies end in a miscarriage. A majority of women with a miscarriage will have surgery. In low income settings, the infection rate after miscarriage surgery has been reported to be as high as 30%. Infection after miscarriage can result in serious illness and death, as well as long term consequences including increased rates of ectopic pregnancy, infertility and persistent pain.Prophylactic antibiotics - A POTENTIAL SOLUTION:Prophylactic antibiotics, given before surgery, may improve outcomes. However, for miscarriage surgery, current guidelines from the WHO, UK national guidelines, and national guidelines from low income countries do not recommend prophylactic antibiotics. This is because of limited evidence. We propose that prophylactic antibiotics, used at the time of surgery, may offer a solution to reducing the serious problem of infection following miscarriage.The existing evidence - A TRIAL IS NEEDED:A recent review of all the evidence concluded that "there is not enough evidence to evaluate a policy of routine antibiotic prophylaxis to women with incomplete miscarriage" and "There is a real and urgent need to find out whether antibiotics should be routinely used in cases of incomplete miscarriage. The policy and cost implications arising from this research will be tremendous, and randomised clinical trials comparing antibiotics currently in use with no antibiotics are strongly recommended."The proposed AIMS trial:The question: Can pelvic infection after miscarriage surgery be reduced by giving antibiotics to women just before surgery?Study sites: The study will be conducted in 3 countries in Sub-Saharan Africa; Tanzania, Malawi and Uganda. These countries have been chosen as women have the greatest problems with infection after miscarriage in low income countries and this is therefore the place where this research could have the greatest impact to improve health.What the trial involves: Women having surgery for miscarriage will be invited to participate, and if consent is given, women will be offered a single dose of antibiotics, to be taken by mouth two hours before the surgery. We plan to recruit 2400 women in total over 2 years.The treatment given will be either antibiotics (400mg doxycycline and 400mg metronidazole) or a dummy pill (placebo). The women and clinician will not know if the tablet is the antibiotic or the dummy pill. By comparing the rate of infection and other problems such as death or admission to hospital during the first 2 weeks after surgery between the groups we can determine if the antibiotics are having any effect. Any women in whom an infection is found will have appropriate treatment and also further tests to identify the cause of the infection.Clinician support for the trial:The trial is endorsed by international professional organisations and a survey of 124 practitioners from 23 low income countries overwhelmingly (87.5%) supported the need for the AIMS trial.User support and acceptability:Semi-structured interviews with gynaecology inpatients in Blantyre, Malawi and Mbale, Uganda showed there was recognition of the potential problems following miscarriage and that the proposed protocol was acceptable. Participants indicated they would be willing to participate and return for follow up assessments. The trial has also been endorsed by the patient group the Miscarriage Association.The potential benefits of the trial:Miscarriage surgery is common, and infective complications are frequent and serious. Prophylactic antibiotics, if found effective, may offer a simple and affordable intervention which could be rapidly implemented to reduce the burden of maternal mortality and disease in low income countries. This may directly address MDG5 (reducing maternal mortality), where progress has been uneven and slow.