Key result
Low molecular weight heparin with or without aspirin yielded comparable live birth rates to aspirin alone (p=0.843) in women with recurrent pregnancy loss and factor V Leiden mutation.
Why the study?
The study compared the effects of LMWH, LMWH plus low-dose aspirin, or low-dose aspirin alone on pregnancy outcomes in patients with recurrent pregnancy loss and factor V Leiden mutation.
Does enoxaparin, aspirin, or both improve live birth rates and prevent pregnancy complications in women with recurrent pregnancy loss and factor V Leiden mutation?
RCT (n=174)
randomly distributed
Does enoxaparin, aspirin, or both improve live birth rates and prevent pregnancy complications in women with recurrent pregnancy loss and factor V Leiden mutation?
p-value: p=0.843
In women with recurrent pregnancy loss and factor V Leiden mutation, LMWH alone or with aspirin does not improve live birth rates compared to aspirin alone, but may reduce the risk of preeclampsia and preterm birth.
Enoxaparin does not improve live birth rates versus aspirin alone; challenges routine LMWH addition while extending evidence for preeclampsia and preterm birth reduction.
Objective: The aim of this study was to compare the effects of low molecular weight heparin (LMWH), LMWH plus low dose aspirin, or low dose aspirin only on pregnancy outcomes in recurrent pregnancy loss (RPL) patients with factor V Leiden mutation (FVLM).Materials and methods: A total of 2764 RPL patients were evaluated in for the etiology of RPL. Mutations in factor V Leiden homozygous and heterozygous were determined. Subsequently, 196 of these patients were diagnosed with FVLM and included in the study; of these 174 completed the study. At the sixth week of gestation of subsequent pregnancy participants were randomly distributed into three groups. Group A (n = 61) was composed of patients with an oral dose of 100 mg aspirin daily, Group B (n = 59) consisted of patients using 40 mg enoxaparin and 100 mg orally aspirin daily, and Group C (n = 54) included patients using 40 mg enoxaparin daily during pregnancy.Results: Among the 174 patients who completed the study, the live birth and miscarriage rates were similar for the three groups (p = .843 and p = .694, respectively). There was no significant difference among the groups in rates of eclampsia, placental abruption, intrauterine fetal growth restriction and gestational diabetes mellitus. The number of preeclamptic patients was significantly higher in Group A than Groups B and C. The levels of preterm birth was significantly higher in Group A than Groups B and C.Conclusion: Using low dose aspirin, LMWH plus aspirin, or LMWH alone yielded comparable live birth rates in RPL patients with FVLM. However, LMWH decreased the risk of preeclampsia in this group of patients. LMWH might therefore have a preventive role regarding preeclampsia.
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Karadağ et al. (2019) conducted an RCT in Recurrent pregnancy loss with factor V Leiden mutation (n=174). Low molecular weight heparin (LMWH) with or without low dose aspirin vs. 100 mg aspirin daily was evaluated on Live birth rate (p=0.843). Low molecular weight heparin with or without aspirin yielded comparable live birth rates to aspirin alone (p=0.843) in women with recurrent pregnancy loss and factor V Leiden mutation.
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