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| Name | Class |
|---|---|
| Ahmed Elgazzar Hospital | OTHER |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enoxaparin 40 mg plus low dose aspirin | Experimental |
| |
| Heparin calcium 5,000 U twice daily plus low dose aspirin | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enoxaparin 40mg plus low dose aspirin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) | 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. | pregnancy > 24weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Minor and Major Bleeding | Duration of pregnancy and puerperium | |
| Thrombocytopenia | Duration of pregnancy and puerperium | |
| Preeclampsia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Usama M Fouda | Lecturer of obstetrics and Gynecology , Cairo university | Principal Investigator |
| Ahmed M Sayed | Assistant professor of obstetrics and Gynecology , Cairo university. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Elgazzar hospital | Cairo | Egypt | ||||
| Cairo university hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15749498 | Background | 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. doi: 10.1016/j.fertnstert.2004.11.002. | |
| 15307977 |
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This study was conducted between June 2006 to December 2009 at Cairo university hospital and Ahmed Elgazzar hospital ,Cairo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enoxaparin 40 mg /Day Plus Low Dose Aspirin | |
| FG001 | Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Heparin calcium5,000 U twice daily plus low dose aspirin | Drug | 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 . |
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| Pregnancy > 20 weeks gestation |
| IUFD | Pregnancy >24 weeks gestation |
| Preterm Delivery | 24 weeks gestation<Pregnancy <37weeks gestation |
| Spontaneous Osteoporotic Fractures | Duration of pregnancy and puerperium |
| Cairo |
| Egypt |
| 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. doi: 10.1016/s1701-2163(16)30644-2. |
| 32358837 | Derived | Hamulyak EN, Scheres LJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. Cochrane Database Syst Rev. 2020 May 2;5(5):CD012852. doi: 10.1002/14651858.CD012852.pub2. |
| 21251653 | Derived | Fouda UM, Sayed AM, Abdou AM, Ramadan DI, Fouda IM, Zaki MM. Enoxaparin versus unfractionated heparin in the management of recurrent abortion secondary to antiphospholipid syndrome. Int J Gynaecol Obstet. 2011 Mar;112(3):211-5. doi: 10.1016/j.ijgo.2010.09.010. Epub 2011 Jan 19. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Enoxaparin 40 mg /Day Plus Low Dose Aspirin | |
| BG001 | Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Live Birth Rate = (Number of Live Births / Total Number of Pregnancies) | 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. | Posted | Number | Percentage of pregnancies | pregnancy > 24weeks gestation |
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| Secondary | Minor and Major Bleeding | Not Posted | Duration of pregnancy and puerperium | ||||||||||||||||||||||||||||||||||||
| Secondary | Thrombocytopenia | Not Posted | Duration of pregnancy and puerperium | ||||||||||||||||||||||||||||||||||||
| Secondary | Preeclampsia | Not Posted | Pregnancy > 20 weeks gestation | ||||||||||||||||||||||||||||||||||||
| Secondary | IUFD | Not Posted | Pregnancy >24 weeks gestation | ||||||||||||||||||||||||||||||||||||
| Secondary | Preterm Delivery | Not Posted | 24 weeks gestation<Pregnancy <37weeks gestation | ||||||||||||||||||||||||||||||||||||
| Secondary | Spontaneous Osteoporotic Fractures | Not Posted | Duration of pregnancy and puerperium |
June 2006 to December 2009
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enoxaparin 40 mg /Day Plus Low Dose Aspirin | 0 | 30 | 0 | 30 | |||
| EG001 | Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin | 0 | 30 | 0 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe bleeding episodes , e.g antepartum hemorrhage or postpartum hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Usama .M .Fouda | Cairo university | +20123595106 | umfrfouda@yahoo.com |
| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| >=65 years |
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| Male |
|