Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial.

نویسندگان

  • Elisabeth Pasquier
  • Luc de Saint Martin
  • Caroline Bohec
  • Céline Chauleur
  • Florence Bretelle
  • Gisèle Marhic
  • Grégoire Le Gal
  • Véronique Debarge
  • Frédéric Lecomte
  • Christine Denoual-Ziad
  • Véronique Lejeune-Saada
  • Serge Douvier
  • Michel Heisert
  • Dominique Mottier
چکیده

It is common practice in many centers to offer antithrombotic medications to women with unexplained recurrent miscarriage, in the presence or absence of inherited thrombophilia. Although no benefit of aspirin vs placebo has been clearly demonstrated, a double-blind placebo-controlled trial on the effect of low-molecular-weight heparin is lacking. We enrolled 258 pregnant women with a history of unexplained recurrent miscarriage (≥2 consecutive miscarriages before 15 weeks' gestation) and a negative thrombophilia workup. They were randomly assigned to receive one daily subcutaneous injection of enoxaparin 40 mg or placebo until 35 weeks' gestation. We included 256 women (mean age 32 years, ≥3 miscarriages: 72%; mean gestational age 39 days of amenorrhea) in the intention-to-treat analysis; 66.6% of 138 who received enoxaparin had a live birth vs 72.9% of 118 who received placebo. The absolute difference was -6% (95% CI, -17.1 to 5.1), excluding a 10% increase in the rate of live-birth on enoxaparin (P = .34). In this first randomized, double-blind, placebo-controlled trial, enoxaparin (40 mg once daily) did not improve the chance of a live birth in nonthrombophilic women with unexplained recurrent miscarriage. This trial is registered at www.ClinicalTrials.gov as #NCT00740545 and the French National Health and Drug Safety Agency (EudraCT #2006-003350-18).

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Enoxaparin for prevention of unexplained recurrent miscarriage: a multicenter randomized double-blind placebo-controlled trial Short title: Enoxaparin for prevention of Recurrent Miscarriage

CIC-INSERM 1412, La Cavale Blanche Hospital, 29609 Brest, France EA 3878 (GETBO), CIC-INSERM 1412, La Cavale Blanche Hospital, 29609 Brest, France Division of Gynaecology, Lille University Hospital, 59037 Lille Division of Internal Medicine, Bretagne Sud Hospital, 56100 Lorient. Division of Gynaecology, Caen University Hospital, Clemenceau hospital, 14033 Caen Division of Gynaecology, Paris Uni...

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عنوان ژورنال:
  • Blood

دوره 125 14  شماره 

صفحات  -

تاریخ انتشار 2015