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Aspirin, Heparin and Miscarriage

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ClinicalTrials.gov Identifier: NCT01917799
Recruitment Status : Unknown
Verified August 2013 by Ishag Adam, University of Khartoum.
Recruitment status was:  Recruiting
First Posted : August 7, 2013
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
Ishag Adam, University of Khartoum

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.

Condition or disease Intervention/treatment Phase
Pregnancy Miscarriage Drug: Aspirin Drug: Heparin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage
Study Start Date : January 2009
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : December 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Aspirin
75mg tab of aspirin once daily
 Drug: Aspirin
75mg tab of LDA once daily for 7 months
Other Name: LDA
Active Comparator: Aspirin + heparin
75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin
 Drug: Aspirin
75mg tab of LDA once daily for 7 months
Other Name: LDA
Drug: Heparin
0.4 mL/day of the Enoxaparin
Other Name: Enoxaparin


Outcome Measures
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Primary Outcome Measures :
  1. Number of miscarriages [ Time Frame: 3 months ]
    To compare number of miscarriages between the two groups


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 48 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women
  • History of 2 or more of miscarriage

Exclusion Criteria:

  • Twins
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01917799


Locations
Libyan Arab Jamahiriya
Misurata Teaching Hospital Recruiting
Misurata, Libyan Arab Jamahiriya, 218
Contact: Mohamed O Elmahashi, MD    +249911259199    essadifathi@hotmail.com   
Contact: Bashir M Ashur, MD    +249911259199    bmashur@yahoo.com   
Sponsors and Collaborators
University of Khartoum
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ishag Adam, Professor, University of Khartoum
ClinicalTrials.gov Identifier: NCT01917799     History of Changes
Other Study ID Numbers: LDA and LMWH
First Posted: August 7, 2013    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: August 2013

Keywords provided by Ishag Adam, University of Khartoum:
Aspirin
Heparin
pregnancy
miscarriage

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticoagulants