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

Phase 2

Completed

• Conditions: Recurrent Abortion
• Interventions: Drug: enoxaparin 40mg plus low dose aspirin; Drug: Heparin calcium5,000 U twice daily plus low dose aspirin

• Registration Number: NCT01051778
• Lead Sponsor: Cairo University

Brief 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).

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2009-11
• Study Completion: 2009-12
• Status Verified: 2010-01
• Study First Submitted: 2010-01-19
• Study First Submitted QC: 2010-01-19
• Study First Posted: 2010-01-20
• Results First Submitted: 2010-05-10
• Results First Submitted QC: 2011-07-29
• Last Update Submitted: 2011-07-29
• Results First Posted: 2011-08-29
• Last Update Posted: 2011-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enoxaparin 40 mg plus low dose aspirin	enoxaparin 40mg plus low dose aspirin	-
Heparin calcium 5,000 U twice daily plus low dose aspirin	Heparin calcium5,000 U twice daily plus low dose aspirin	-

Primary Outcome Measures

Name	Time	Method
Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)	pregnancy > 24weeks gestation	Live birth occurs when a fetus (\> 24 weeks ) , exits the maternal body and subsequently shows signs of life, such as voluntary movement, heartbeat, or pulsation of the umbilical cord.

Secondary Outcome Measures

Name	Time	Method
Minor and Major Bleeding	Duration of pregnancy and puerperium
Preeclampsia	Pregnancy > 20 weeks gestation
Spontaneous Osteoporotic Fractures	Duration of pregnancy and puerperium
Thrombocytopenia	Duration of pregnancy and puerperium
IUFD	Pregnancy >24 weeks gestation
Preterm Delivery	24 weeks gestation<Pregnancy <37weeks gestation

Trial Locations

Locations (2)

Cairo university hospital; 🇪🇬 Cairo, Egypt

Ahmed Elgazzar hospital; 🇪🇬 Cairo, Egypt