Low-molecular-weight Heparin (LMWH) Versus Unfractionated Heparin (UFH) in Pregnant Women With Recurrent Abortion Secondary to Antiphospholipid Syndrome
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|ClinicalTrials.gov Identifier: NCT01051778|
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : August 29, 2011
Last Update Posted : August 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Abortion||Drug: enoxaparin 40mg plus low dose aspirin Drug: Heparin calcium5,000 U twice daily plus low dose aspirin||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2006|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2009|
U.S. FDA Resources
|Experimental: enoxaparin 40 mg plus low dose aspirin||
Drug: enoxaparin 40mg plus low dose aspirin
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.
Other Name: Clexane 40 mg
|Active Comparator: Heparin calcium 5,000 U twice daily plus low dose aspirin||
Drug: Heparin calcium5,000 U twice daily plus low dose aspirin
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 Name: Cal-Heparine
- Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) [ Time Frame: 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.
- Minor and Major Bleeding [ Time Frame: Duration of pregnancy and puerperium ]
- Thrombocytopenia [ Time Frame: Duration of pregnancy and puerperium ]
- Preeclampsia [ Time Frame: Pregnancy > 20 weeks gestation ]
- IUFD [ Time Frame: Pregnancy >24 weeks gestation ]
- Preterm Delivery [ Time Frame: 24 weeks gestation<Pregnancy <37weeks gestation ]
- Spontaneous Osteoporotic Fractures [ Time Frame: Duration of pregnancy and puerperium ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051778
|Ahmed Elgazzar hospital|
|Cairo university hospital|
|Principal Investigator:||Usama M Fouda||Lecturer of obstetrics and Gynecology , Cairo university|
|Principal Investigator:||Ahmed M Sayed||Assistant professor of obstetrics and Gynecology , Cairo university.|