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

This study has been completed.
Sponsor:
Collaborator:
Ahmed Elgazzar Hospital
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT01051778
First received: January 19, 2010
Last updated: July 29, 2011
Last verified: January 2010
Results First Received: May 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Recurrent Abortion
Interventions: Drug: enoxaparin 40mg plus low dose aspirin
Drug: Heparin calcium5,000 U twice daily plus low dose aspirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted between June 2006 to December 2009 at Cairo university hospital and Ahmed Elgazzar hospital ,Cairo.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Enoxaparin 40 mg /Day Plus Low Dose Aspirin No text entered.
Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin No text entered.

Participant Flow:   Overall Study
    Enoxaparin 40 mg /Day Plus Low Dose Aspirin     Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin  
STARTED     30 [1]   30 [1]
COMPLETED     30 [2]   30 [2]
NOT COMPLETED     0     0  
[1] June 2006
[2] November 2009



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Enoxaparin 40 mg /Day Plus Low Dose Aspirin No text entered.
Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin No text entered.
Total Total of all reporting groups

Baseline Measures
    Enoxaparin 40 mg /Day Plus Low Dose Aspirin     Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     30     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.47  ± 3.20     28.57  ± 3.48     28.016  ± 3.362  
Gender  
[units: participants]
     
Female     30     30     60  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Egypt     30     30     60  



  Outcome Measures

1.  Primary:   Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)   [ Time Frame: pregnancy > 24weeks gestation ]

2.  Secondary:   Minor and Major Bleeding   [ Time Frame: Duration of pregnancy and puerperium ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Thrombocytopenia   [ Time Frame: Duration of pregnancy and puerperium ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Preeclampsia   [ Time Frame: Pregnancy > 20 weeks gestation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   IUFD   [ Time Frame: Pregnancy >24 weeks gestation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Preterm Delivery   [ Time Frame: 24 weeks gestation<Pregnancy <37weeks gestation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Spontaneous Osteoporotic Fractures   [ Time Frame: Duration of pregnancy and puerperium ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Usama .M .Fouda
Organization: Cairo university
phone: +20123595106
e-mail: umfrfouda@yahoo.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Usama M. Fouda, Ahmed M .Sayed, Cairo university
ClinicalTrials.gov Identifier: NCT01051778     History of Changes
Other Study ID Numbers: Aps/UFH/enox40
Study First Received: January 19, 2010
Results First Received: May 10, 2010
Last Updated: July 29, 2011
Health Authority: Egypt: Institutional Review Board