Elmahashi Mohamed O, Elbareg Aisha M, Essadi Fathi M, Ashur Bashur M, Adam Ishag
Department of Obstetrics and Gynecology, University of Khartoum, Khartoum, Sudan.
BMC Res Notes. 2014 Jan 9;7:23. doi: 10.1186/1756-0500-7-23.
Recurrent miscarriage is a major women's health problem. Aspirin and heparin have been shown to have potentially beneficial effects on trophoblast implantation. However, few published data on this issue are available from developing countries.
An open clinical trial was conducted at the Department of Obstetrics and Gynecology at Misurata Teaching Hospital in Libya from January 2009 to December 2010 to investigate the effects of treatment with low dose aspirin (LDA) versus treatment with low-molecular-weight-heparin (LMWH) in combination with LDA on patients with a history of recurrent miscarriages. A total of 150 women were enrolled in the study. Women were eligible for the study if they had a history of three or more consecutive miscarriages. Participants were randomly assigned to receive either LDA (75 mg daily) alone or a combination of LDA and LMWH (75 women per treatment group). The primary outcomes were the rate of miscarriages and live births for each group.
Compared with the group who received LDA alone, the combination group had a significantly lower number of miscarriages (22/75 [29%] vs. 43/75 [47%], P < 0.001) and had a significantly higher number of live births (53/75 [71%] vs. 32/75 [42%], P < 0.001). Two preterm infants in the LDA group and three in the combination group were admitted to the neonatal intensive care unit. There were no significant differences in the mean (SD) birth weights of neonates born in either group (2955.4 ± 560 vs. 3050 ± 540 g for the LDA and combination groups, respectively, P = 0.444). There were no congenital abnormalities detected in either group.
The combination of LDA and LMWH is better than LDA alone for the maintenance of pregnancy in patients with recurrent first trimester miscarriage.
NCT01917799.
复发性流产是一个主要的女性健康问题。阿司匹林和肝素已被证明对滋养层植入可能具有有益作用。然而,发展中国家关于这个问题的已发表数据很少。
2009年1月至2010年12月在利比亚米苏拉塔教学医院妇产科进行了一项开放临床试验,以研究低剂量阿司匹林(LDA)治疗与低分子量肝素(LMWH)联合LDA治疗对有复发性流产病史患者的影响。共有150名女性参与该研究。如果女性有连续三次或更多次流产史,则符合研究条件。参与者被随机分配接受单独的LDA(每日75毫克)或LDA与LMWH的联合治疗(每个治疗组75名女性)。主要结局是每组的流产率和活产率。
与单独接受LDA治疗的组相比,联合治疗组的流产次数显著减少(分别为22/75 [29%] 对43/75 [47%],P < 0.001),活产次数显著增加(分别为53/75 [71%] 对32/75 [42%],P < 0.001)。LDA组有2名早产儿,联合治疗组有3名早产儿被送入新生儿重症监护病房。两组出生的新生儿平均(标准差)体重没有显著差异(LDA组和联合治疗组分别为2955.4 ± 560克和3050 ± 540克,P = 0.444)。两组均未检测到先天性异常。
对于复发性孕早期流产患者,LDA与LMWH联合治疗在维持妊娠方面优于单独使用LDA。
NCT01917799。