Abstract
BackgroundRecurrent 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.MethodsAn 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.ResultsCompared 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.ConclusionThe combination of LDA and LMWH is better than LDA alone for the maintenance of pregnancy in patients with recurrent first trimester miscarriage.Trial registrationNCT01917799
Highlights
Recurrent miscarriage is a major women’s health problem
Low-molecular weight heparin (LMWH) and low dose aspirin (LDA) are generally considered safe [10,11], there is no direct evidence of their efficacy for miscarriage prevention
The combination group had a significantly lower number of miscarriages (22 [29%] vs. 43 [47%], P < 0.001) and a significantly higher number of live births compared with the group that received LDA alone (53 [71%] vs. 32 [42%], P < 0.001)
Summary
Recurrent miscarriage is a major women’s health problem. Recurrent pregnancy loss is a major women's health issue; 1% to 2% of women of reproductive age have experienced three or more successive pregnancy losses, and approximately 5% have lost at least two successive pregnancies [1]. Preliminary data examining pregnancy success with the use of antithrombotic therapy in women with heritable thrombophilia are inconclusive [8,9]. Because two successive pregnancy losses are relatively common and distressing, and there are no other effective treatments, antithrombotic therapy is often prescribed for these women. Low-molecular weight heparin (LMWH) and low dose aspirin (LDA) are generally considered safe [10,11], there is no direct evidence of their efficacy for miscarriage prevention. There have been repeated calls for randomized trials in this area, a comparison of anticoagulant treatment with no pharmacological intervention [9,12]
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