Comparison of 2 Low Molecular Heparin as a Thromboprophylaxis Postpartum
| Tracking Information | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | April 26, 2012 | ||||||||||||||||||||
| Last Updated Date | February 8, 2013 | ||||||||||||||||||||
| Start Date ICMJE | May 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Venous thromboembolism [ Time Frame: 40 days after delivery ] [ Designated as safety issue: Yes ] compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases. |
||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01588171 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
adverse effects [ Time Frame: after receiving the injections and till 40 days ] [ Designated as safety issue: Yes ] bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence |
||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | Comparison of 2 Low Molecular Heparin as a Thromboprophylaxis Postpartum | ||||||||||||||||||||
| Official Title ICMJE | Bemiparin Versus Enoxaparin as a Thromboprophylaxis Post Vaginal and Abdominal Deliveries: A Randomized Clinical Trial | ||||||||||||||||||||
| Brief Summary | The use of a new generation low molecular weight heparin (Bemiparin)and the well known LMWH (Enoxaparin) after Caesarean sections and vaginal deliveries in a risky group patients for venous thrombosis. |
||||||||||||||||||||
| Detailed Description | Venous thromboembolism (VTE) is the leading cause of maternal mortality and morbidity in the developed and developing world. Pulmonary embolism and deep vein thrombosis are the two components of a single disease called deep vein thrombosis (DVT). Pregnancy associated with an average 5 to 10 fold increase in the risk of VTE compared with non-pregnant women. The highest incidence occurring during the post partum period. There are many researches done a broad on the effect of LMWH to decrease the incidence of VTE after Caesarean section using the two LMWH (Enoxaparin and Bemiparin) alone but not in one research comparing both of them alone and both together against a control group. Also according to our knowledge there are no published literature on thromboprophylaxis after vaginal delivery |
||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
||||||||||||||||||||
| Condition ICMJE | Venous Thromboembolic Diseases | ||||||||||||||||||||
| Intervention ICMJE |
|
||||||||||||||||||||
| Study Arm (s) |
|
||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 4000 | ||||||||||||||||||||
| Estimated Completion Date | November 2013 | ||||||||||||||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||||||
| Gender | Female | ||||||||||||||||||||
| Ages | 15 Years to 45 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE | Not Provided | ||||||||||||||||||||
| Location Countries ICMJE | Iraq | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01588171 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | Hawler Medical University | ||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||
| Responsible Party | Assistant Prof. Shahla Alalaf, Hawler Medical University | ||||||||||||||||||||
| Study Sponsor ICMJE | Hawler Medical University | ||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||
| Information Provided By | Hawler Medical University | ||||||||||||||||||||
| Verification Date | February 2013 | ||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||