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Dalteparin for the prevention of recurrence of placental‐mediated complications of pregnancy in women without thrombophilia: a pilot randomized controlled trial
Author(s) -
REY E.,
GARNEAU P.,
DAVID M.,
GAUTHIER R.,
LEDUC L.,
MICHON N.,
MORIN F.,
DEMERS C.,
KAHN S. R.,
MAGEE L. A.,
RODGER M.
Publication year - 2009
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/j.1538-7836.2008.03230.x
Subject(s) - medicine , thrombophilia , obstetrics , odds ratio , randomized controlled trial , pregnancy , confidence interval , low molecular weight heparin , birth weight , gestational age , gestation , gynecology , heparin , thrombosis , genetics , biology
Summary. Background: The role of anticoagulants for the prevention of placental‐mediated pregnancy complications is uncertain. Objectives: Our aim was to investigate the effectiveness of dalteparin, a low‐molecular‐weight heparin, in preventing the recurrence of these complications in women without thrombophilia. Patients/methods: Between August 1 2000 and June 20 2007, 116 pregnant women with: (i) ≤ 16 weeks’ gestation, (ii) no detectable thrombophilia, (iii) previous severe pre‐eclampsia, newborn weight ≤ 5th percentile, unexplained intrauterine death or abruptio placentae were randomized to either a prophylactic daily dose of dalteparin ( n = 58) or no dalteparin ( n = 58). The primary outcome was a composite of one or more of: severe pre‐eclampsia, newborn weight ≤ 5th percentile or major abruptio placentae . Secondary outcomes included non‐severe pre‐eclampsia, newborn weight at the 6–10th percentile and gestational age at delivery. Analyses were by intention to treat. P < 0.05 was considered to be significant. This study is registered as an International Standard Randomized Controlled Trial, number ISRCTN78732833. Results: Among the 110 women included in the final analysis, dalteparin was associated with a lower rate of the primary outcome [5.5% ( n = 3/55) vs . 23.6% ( n = 13/55), adjusted odds ratio (OR) 0.15, 95% confidence interval (CI) 0.03–0.70]. Secondary outcomes were not statistically different between the groups. Bleeding problems or thrombocytopenia did not occur. Conclusion: In this pilot study, dalteparin is effective in decreasing the recurrence of placental‐mediated complications in women without thrombophilia. Our results require confirmation in further randomized trials.