Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 68 of 251 for:    ASPIRIN AND low-dose aspirin

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01051778
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : August 29, 2011
Last Update Posted : August 29, 2011
Sponsor:
Collaborator:
Ahmed Elgazzar Hospital
Information provided by:
Cairo University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 60
Recruitment Details This study was conducted between June 2006 to December 2009 at Cairo university hospital and Ahmed Elgazzar hospital ,Cairo.
Pre-assignment Details  
Arm/Group Title Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 30 [1] 30 [1]
Completed 30 [2] 30 [2]
Not Completed 0 0
[1]
June 2006
[2]
November 2009
Arm/Group Title Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
30
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
27.47  (3.20) 28.57  (3.48) 28.016  (3.362)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
30
 100.0%
30
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Egypt Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Live Birth Rate = (Number of Live Births / Total Number of Pregnancies)
Hide Description 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.
Time Frame pregnancy > 24weeks gestation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 30 30
Measure Type: Number
Unit of Measure: Percentage of pregnancies
24 20
2.Secondary Outcome
Title Minor and Major Bleeding
Hide Description [Not Specified]
Time Frame Duration of pregnancy and puerperium
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Thrombocytopenia
Hide Description [Not Specified]
Time Frame Duration of pregnancy and puerperium
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Preeclampsia
Hide Description [Not Specified]
Time Frame Pregnancy > 20 weeks gestation
Outcome Measure Data Not Reported
5.Secondary Outcome
Title IUFD
Hide Description [Not Specified]
Time Frame Pregnancy >24 weeks gestation
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Preterm Delivery
Hide Description [Not Specified]
Time Frame 24 weeks gestation<Pregnancy <37weeks gestation
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Spontaneous Osteoporotic Fractures
Hide Description [Not Specified]
Time Frame Duration of pregnancy and puerperium
Outcome Measure Data Not Reported
Time Frame June 2006 to December 2009
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enoxaparin 40 mg /Day Plus Low Dose Aspirin Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Reproductive system and breast disorders     
Severe bleeding episodes , e.g antepartum hemorrhage or postpartum hemorrhage   0/30 (0.00%)  30 0/30 (0.00%)  30
Indicates events were collected by systematic assessment
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
Responsible Party: Usama M. Fouda, Ahmed M .Sayed, Cairo university
ClinicalTrials.gov Identifier: NCT01051778     History of Changes
Other Study ID Numbers: Aps/UFH/enox40
First Submitted: January 19, 2010
First Posted: January 20, 2010
Results First Submitted: May 10, 2010
Results First Posted: August 29, 2011
Last Update Posted: August 29, 2011