Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Department of Obstetrics and Gynecology, Södra Älvsborg Hospital, Borås, Sweden.
Acta Obstet Gynecol Scand. 2018 Nov;97(11):1365-1372. doi: 10.1111/aogs.13420. Epub 2018 Aug 9.
Recurrent pregnancy loss occurs in about 1% of fertile couples. Without proper evidence for an effect, different treatments have been used when no etiological factor has been detected. The present trial is the first randomized trial to compare 75 mg acetylsalicylic acid with placebo for women with recurrent pregnancy loss.
This randomized, double-blind, placebo-controlled trial was conducted at a single center between 2008 and 2015. Recurrent pregnancy loss was defined as at least 3 consecutive first-trimester miscarriages within the couple. Women < 40 years old with a body mass index < 35 kg/m were eligible if the workup was negative. Randomization was through a third party, who manufactured and delivered the study drugs, and occurred when fetal heartbeat was detected, to either 75 mg acetylsalicylic acid or placebo; 200 women in each group. Group allocation was concealed until all the study participants had a pregnancy outcome registered. All women attended the same control program. Primary outcome was live birth. Statistical analyses were according to intention-to-treat.
All 400 women completed the follow up. Live birth rate was 83.0% (n = 166) and 85.5% (n = 171) for the acetylsalicylic acid and placebo groups, respectively (P = 0.58). The difference was -2.5% (95% CI -10.1% to 5.1%). The risk ratio was 0.97 (95% CI 0.89-1.06).
Treatment with acetylsalicylic acid did not prevent recurrent miscarriage in women with at least three consecutive miscarriages in the first trimester, of unknown reasons and in the same relationship. The fertility prognosis is very good, the live birth rate being > 80% with or without acetylsalicylic acid.
复发性流产发生在大约 1%的生育夫妇中。由于没有适当的证据表明有效果，因此当没有检测到病因时，已经使用了不同的治疗方法。本试验是首次比较 75mg 乙酰水杨酸与安慰剂治疗复发性流产患者的随机试验。
这项随机、双盲、安慰剂对照试验于 2008 年至 2015 年在一家中心进行。复发性流产定义为至少 3 次连续的在同一对夫妇中发生的妊娠 10 周内的流产。如果检查结果为阴性，年龄<40 岁且体重指数<35kg/m2 的女性符合条件。当检测到胎儿心跳时，通过第三方进行随机分组，第三方制造并交付研究药物，将 200 名女性随机分为乙酰水杨酸 75mg 组或安慰剂组，每组 100 名。分组分配在所有研究参与者的妊娠结局登记后才公开。所有女性都参加了相同的对照方案。主要结局是活产。统计分析按照意向治疗进行。
所有 400 名女性均完成了随访。乙酰水杨酸组的活产率为 83.0%（n=166），安慰剂组为 85.5%（n=171）（P=0.58）。差异为-2.5%（95%CI-10.1%至 5.1%）。风险比为 0.97（95%CI 0.89-1.06）。
对于不明原因且处于同一关系中至少发生 3 次妊娠 10 周内流产的女性，乙酰水杨酸治疗并未预防复发性流产。生育预后非常好，活产率>80%，无论是否使用乙酰水杨酸。
