Back to resultsAspirin, Heparin and Miscarriage
Primary Purpose
Pregnancy, Miscarriage
Status
Unknown status
Phase
Phase 4
Locations
Libyan Arab Jamahiriya
Study Type
Interventional
Intervention
Aspirin
Heparin
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy focused on measuring Aspirin, Heparin, pregnancy, miscarriage
Eligibility Criteria
Inclusion Criteria:
- Pregnant women
- History of 2 or more of miscarriage
Exclusion Criteria:
- Twins
Sites / Locations
- Misurata Teaching HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aspirin
Aspirin + heparin
Arm Description
75mg tab of aspirin once daily
75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin
Outcomes
Primary Outcome Measures
Number of miscarriages
To compare number of miscarriages between the two groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01917799
Brief Title
Aspirin, Heparin and Miscarriage
Official Title
Low Dose Aspirin and Low-molecular-weight Heparin in the Treatment of Pregnant Libyan Women With Recurrent Miscarriage
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy of low dose aspirin (LDA) versus LDA plus low-molecular-weight-heparin (LMWH) in patients with a history of recurrent miscarriages.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Miscarriage
Keywords
Aspirin, Heparin, pregnancy, miscarriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aspirin
Arm Type
Experimental
Arm Description
75mg tab of aspirin once daily
Arm Title
Aspirin + heparin
Arm Type
Active Comparator
Arm Description
75mg tab of aspirin once daily + 0.4 mL/day of injection of low molecular weight heparin
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
LDA
Intervention Description
75mg tab of LDA once daily for 7 months
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
Enoxaparin
Intervention Description
0.4 mL/day of the Enoxaparin
Primary Outcome Measure Information:
Title
Number of miscarriages
Description
To compare number of miscarriages between the two groups
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant women
History of 2 or more of miscarriage
Exclusion Criteria:
Twins
Facility Information:
Facility Name
Misurata Teaching Hospital
City
Misurata
ZIP/Postal Code
218
Country
Libyan Arab Jamahiriya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed O Elmahashi, MD
Phone
+249911259199
Email
essadifathi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Bashir M Ashur, MD
Phone
+249911259199
Email
bmashur@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
24405979
Citation
Elmahashi MO, Elbareg AM, Essadi FM, Ashur BM, Adam I. Low dose aspirin and low-molecular-weight heparin in the treatment of pregnant Libyan women with recurrent miscarriage. BMC Res Notes. 2014 Jan 9;7:23. doi: 10.1186/1756-0500-7-23.
Results Reference
derived
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Aspirin, Heparin and Miscarriage
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