Study objective: To compare the live birth rate of women presented with recurrent miscarriages in the first trimester due to antiphospholipid antibody syndrome (APS), randomized to either low molecular weight heparin (Bemiparin) or low dose aspirin (LDA) and to determine the maternal and fetal adverse effects in both treatment groups.
Patients and methods: A clinical comparative study was conducted in Maternity teaching Hospital, Erbil city, north of Iraq, Kurdistan region from 15th of September 2007 to the 1st of August 2010 on 141 women presented with 2 or more consecutive miscarriages due to APS, the women randomized to receive either prophylactic dose of Bemiparin with the diagnosis of pregnancy or LDA started preconceptioally and until 36 weeks gestation. The primary outcome was live birth rate in both treatment groups, the secondary outcomes were maternal and fetal complications in both trial groups.
Result: There was no statistically significant difference between the two groups regarding demographic characters (age groups, parity, gestational age and history of previous abortion), and mode of delivery of the viable newborns. There was a statistically significant difference between the two treatment groups regarding live birth rate. The proportions of women who gave birth to a live infant were 72.13% in the LDA group and 86.25% in the Hibor group, the mean difference between the live birth rate in both group was 0.141 (95% Confidence interval of the difference, 0.08, 0.274). The average birth weight for women received LDA was significantly lower than women who received Bemiparin.
Conclusion: The use of the new second generation LMWH (Bemiparin) in comparison to LDA during pregnancy for prevention of recurrent miscarriage in women with APS is a safe, reliable method with a high live birth rate and no maternal and fetal complications.