Kim Caron, Barnard Sharmani, Neilson James P, Hickey Martha, Vazquez Juan C, Dou Lixia
Department of Reproductive Health and Research, WHO, 20 Avenue Appia, Geneva, Switzerland, 1211.
Centre for Global Health, Kings College London, London, UK.
Cochrane Database Syst Rev. 2017 Jan 31;1(1):CD007223. doi: 10.1002/14651858.CD007223.pub4.
Miscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining placental tissues in the uterus ('evacuation of uterus'). However, medical treatments, or expectant care (no treatment), may also be effective, safe, and acceptable.
To assess the effectiveness, safety, and acceptability of any medical treatment for incomplete miscarriage (before 24 weeks).
We searched Cochrane Pregnancy and Childbirth's Trials Register (13 May 2016) and reference lists of retrieved papers.
We included randomised controlled trials comparing medical treatment with expectant care or surgery, or alternative methods of medical treatment. We excluded quasi-randomised trials.
Two review authors independently assessed the studies for inclusion, assessed risk of bias, and carried out data extraction. Data entry was checked. We assessed the quality of the evidence using the GRADE approach.
We included 24 studies (5577 women). There were no trials specifically of miscarriage treatment after 13 weeks' gestation.Three trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; 2 studies, 150 women, random-effects; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. For unplanned surgical intervention, we did not identify any difference between misoprostol and expectant care (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence).Sixteen trials involving 4044 women addressed the comparison of misoprostol (7 studies used oral administration, 6 studies used vaginal, 2 studies sublingual, 1 study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, 3862 women, random-effects; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, 3070 women, random-effects; very low-quality evidence) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, 2690 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. Nausea was more common with misoprostol (average RR 2.50, 95% CI 1.53 to 4.09; 11 studies, 3015 women, random-effects; low-quality evidence). We did not identify any difference in women's satisfaction between misoprostol and surgery (average RR 1.00, 95% CI 0.99 to 1.00; 9 studies, 3349 women, random-effects; moderate-quality evidence). More women had vomiting and diarrhoea with misoprostol compared with surgery (vomiting: average RR 1.97, 95% CI 1.36 to 2.85; 10 studies, 2977 women, random-effects; moderate-quality evidence; diarrhoea: average RR 4.82, 95% CI 1.09 to 21.32; 4 studies, 757 women, random-effects; moderate-quality evidence).Five trials compared different routes of administration, or doses, or both, of misoprostol. There was no clear evidence of one regimen being superior to another. Limited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches.
AUTHORS' CONCLUSIONS: The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Further studies, including long-term follow-up, are clearly needed to confirm these findings. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation.
10%至15%的妊娠会发生流产。传统的流产后治疗方法是进行手术以清除子宫内任何残留的胎盘组织（“清宫术”）。然而，药物治疗或期待疗法（不治疗）也可能有效、安全且可接受。
评估任何药物治疗不完全流产（妊娠24周前）的有效性、安全性和可接受性。
我们检索了Cochrane妊娠与分娩试验注册库（2016年5月13日）以及检索到的论文的参考文献列表。
我们纳入了比较药物治疗与期待疗法或手术，或不同药物治疗方法的随机对照试验。我们排除了半随机试验。
两位综述作者独立评估研究是否纳入，评估偏倚风险，并进行数据提取。检查了数据录入情况。我们使用GRADE方法评估证据质量。
我们纳入了24项研究（5577名女性）。没有关于妊娠13周后流产治疗的专门试验。三项涉及335名女性的试验比较了米索前列醇治疗（均经阴道给药）与期待疗法。完全流产方面无差异（平均风险比（RR）1.23，95%置信区间（CI）0.72至2.10；2项研究，150名女性，随机效应模型；极低质量证据），手术清宫需求方面也无差异（平均RR 0.62，95%CI 0.17至2.26；2项研究，308名女性，随机效应模型；低质量证据）。关于“死亡或严重并发症”的数据很少。对于计划外手术干预，我们未发现米索前列醇与期待疗法之间存在差异（平均RR 0.62，95%CI 0.17至2.26；2项研究，308名女性，随机效应模型；低质量证据）。16项涉及4044名女性的试验比较了米索前列醇（7项研究采用口服给药，6项研究采用阴道给药，2项研究采用舌下给药，1项研究采用阴道 + 口服联合给药）与手术清宫。米索前列醇治疗的完全流产发生率略低（平均RR 0.96，95%CI 0.94至0.98；15项研究，3862名女性，随机效应模型；极低质量证据），但两种方法的成功率都很高。总体而言，米索前列醇治疗后的手术清宫次数较少（平均RR 0.05，95%CI 0.02至0.11；13项研究，3070名女性，随机效应模型；极低质量证据），但计划外手术更多（平均RR 5.03，95%CI 2.71至9.35；11项研究，2690名女性，随机效应模型；低质量证据）。关于“死亡或严重并发症”的数据很少。米索前列醇治疗时恶心更常见（平均RR 2.50，95%CI 1.53至4.09；11项研究，3015名女性，随机效应模型；低质量证据）。我们未发现米索前列醇与手术治疗在女性满意度方面存在差异（平均RR 1.00，95%CI 0.99至1.00；9项研究，3349名女性，随机效应模型；中等质量证据）。与手术治疗相比，米索前列醇治疗时呕吐和腹泻的女性更多（呕吐：平均RR 1.97，95%CI 1.36至2.85；10项研究，2977名女性，随机效应模型；中等质量证据；腹泻：平均RR 4.82，95%CI 1.09至21.32；4项研究，757名女性，随机效应模型；中等质量证据）。五项试验比较了米索前列醇不同的给药途径、剂量或两者。没有明确证据表明一种给药方案优于另一种。有限的证据表明女性总体上似乎对治疗感到满意。一项纳入研究的长期随访发现三种治疗方法在后续生育能力方面无差异。
现有证据表明，鉴于有卫生服务资源支持所有三种方法，米索前列醇药物治疗和期待疗法都是常规手术清宫的可接受替代方法。显然需要进一步研究，包括长期随访，以证实这些发现。迫切需要针对妊娠13周后流产女性的研究。
