Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome
Condition: Recurrent Abortion
MeSH terms: Abortion, Habitual; Antiphospholipid Syndrome; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the efficacy and safety of Low molecular weight heparin
      (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with
      recurrent pregnancy loss associated with antiphospholipid syndrome (APS).
    

Detailed description: 
      Women with antiphospholipid syndrome (APS) have live birth rates as low as 10% in pregnancies
      without pharmacological treatment. Low dose aspirin (LDA) ,unfractionated heparin(UFH) , Low
      molecular weight heparin (LMWH) , prednisone, and intravenous immunoglobulin (IVIG) have been
      used either alone or in combination in order to improve the live birth rate in APS positive
      women with recurrent miscarriage. A Cochrane review of 13 randomized or quasi-randomized,
      controlled trials of various management options of pregnant women with a history of pregnancy
      loss and APL, revealed that combined UFH and aspirin was the treatment of choice which
      reduced pregnancy loss by 54% .

      During the past decade , low molecular weight heparins were widely used in the prophylaxis
      and treatment of patients with venous or arterial thrombosis ,with an efficacy and safety
      superior or at least equivalent to that of UFH .Although recent studies reported the use of
      LMWH in the management of patients recurrent pregnancy loss secondary to antiphospholipid
      syndrome resulted in encouraging results . It is not clear whether the efficacy and safety of
      LMWH is equivalent to that of UFH .

      Although LMWH is more expensive than UFH . LMWH has longer half life , greater
      bioavailability , more stable dose-response relationship than UFH and therefore can be
      administered once daily. Furthermore, LMWH requires less frequent monitoring than UFH and and
      has less adverse effect on bone mineral density and platelet count .These advantages make
      LMWH more attractive for the patients and physicians than UFH .

      There are only two studies which compared the efficacy of LMWH plus LDA with that of UFH plus
      LDA in the management of pregnant women with recurrent pregnancy loss secondary to APS. In
      addition ,no randomized controlled study has yet compared the efficacy of LMWH plus LDA with
      UFH plus LDA.

      The aim of this study is to compare the efficacy and safety of Low molecular weight heparin
      (LMWH) plus low dose aspirin (LDA) with unfractionated heparin(UFH) plus LDA in women with
      recurrent pregnancy loss associated with antiphospholipid syndrome (APS).
    

Intervention name(s): enoxaparin 40mg plus low dose aspirin; Heparin calcium5,000 U twice daily plus low dose aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Enoxaparin 40mg/day by subcutaneous injection ( Clexane 40 mg, Aventis international, Sanofi-aventis France ) is started when the serum pregnancy test become positive. Enoxaparin is stopped 2 days before planned induction of labor or cesarean section and twice-daily unfractionated heparin (UFH) is initiated. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop enoxaparin or UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID)) is started before conception and continued until 36 weeks gestation.; Heparin Calcium 5,000 U twice daily (Cal-Heparine, Amoun Pharmaceutical Co, Egypt) by subcutaneous injection is started when the serum pregnancy test become positive. The evening UFH dose is cancelled before planned caesarean section . The patients are asked to stop UFH with the beginning of labor pains . Low dose aspirin (75 mg/day)(Aspocid Paediatric ,Chemical Industries Development (CID))is started before conception and continued until 36 weeks gestation .
Other intervention name(s): Clexane 40 mg; Cal-Heparine
Intervention MeSH terms: Aspirin; Heparin; Enoxaparin; Calcium heparin; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent abortion; Antiphospholipid syndrome; unfractionated heparin; Low Molecular Weight Heparin