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Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome

Information source: Cairo University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Recurrent Abortion

Intervention: enoxaparin 40mg plus low dose aspirin (Drug); Heparin calcium5,000 U twice daily plus low dose aspirin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Cairo University

Official(s) and/or principal investigator(s):
Usama M Fouda, Principal Investigator, Affiliation: Lecturer of obstetrics and Gynecology , Cairo university
Ahmed M Sayed, Principal Investigator, Affiliation: Assistant professor of obstetrics and Gynecology , Cairo university.

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).

Clinical Details

Official title: Low-molecular-weight Heparin Versus Unfractionated Heparin in Pregnant Women With History of Recurrent Abortion Secondary to Antiphospholipid Syndrome. A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)

Secondary outcome:

Minor and Major Bleeding

Thrombocytopenia

Preeclampsia

IUFD

Preterm Delivery

Spontaneous Osteoporotic Fractures

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).

Eligibility

Minimum age: 19 Years. Maximum age: 37 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients with a minimum of three consecutive pregnancy losses before 10 weeks

gestation

- Positive lupus anticoagulant and/or anticardiolipin antibodies (IgG and IgM) on at

least two occasions twelve weeks apart .

- Age between 19 - 37 years,

- Body mass index between 19-30

Exclusion Criteria:

- Parental chromosomal abnormalities

- Uterine abnormalities

- Luteal phase defect

- Systemic lupus erythematosus

- Previous thromboembolism

- Sensitivity to aspirin.

Locations and Contacts

Ahmed Elgazzar hospital, Cairo, Egypt

Cairo university hospital, Cairo, Egypt

Additional Information

Related publications:

Noble LS, Kutteh WH, Lashey N, Franklin RD, Herrada J. Antiphospholipid antibodies associated with recurrent pregnancy loss: prospective, multicenter, controlled pilot study comparing treatment with low-molecular-weight heparin versus unfractionated heparin. Fertil Steril. 2005 Mar;83(3):684-90.

Stephenson MD, Ballem PJ, Tsang P, Purkiss S, Ensworth S, Houlihan E, Ensom MH. Treatment of antiphospholipid antibody syndrome (APS) in pregnancy: a randomized pilot trial comparing low molecular weight heparin to unfractionated heparin. J Obstet Gynaecol Can. 2004 Aug;26(8):729-34.

Starting date: June 2006
Last updated: July 29, 2011

Page last updated: August 23, 2015

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