Comparison of 2 Low Molecular Heparin as a Thromboprophylaxis Postpartum
This study is currently recruiting participants.
Verified February 2013 by Hawler Medical University
Sponsor:
Hawler Medical University
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University
ClinicalTrials.gov Identifier:
NCT01588171
First received: April 26, 2012
Last updated: February 8, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Venous Thromboembolic Diseases |
Drug: Bemiparin Drug: Enoxaparin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Bemiparin Versus Enoxaparin as a Thromboprophylaxis Post Vaginal and Abdominal Deliveries: A Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Hawler Medical University:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 4000 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Bemiparin
A new second generation Low Molecular Weight Heparin
|
Drug: Bemiparin
Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days.
Other Name: Hibor; Laboratories Rovi Pharmaceuticals
Drug: Enoxaparin
Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.
Other Name: Clexane(Sanofi aventis)
|
|
Active Comparator: Enoxaparin
A well known Low Molecular Weight Heparin
|
Drug: Enoxaparin
Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.
Other Name: Clexane(Sanofi aventis)
|
|
No Intervention: control group
Risky group patients for VTE, but they will not receive any thromboprophylactic drug.
|
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
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Presence of risk factors for venous thromboembolism
- Any parity
- Mode of delivery:vaginal, Emergency and Elective Caesarean section
- No any contraindications for Heparin
Exclusion Criteria:
- Active antenatal or postpartum vaginal bleeding.
- Placenta previa
- Thrombocytopenia
- Sever renal or liver diseases
- Uncontrolled sever hypertension
- Any patient who is already on Heparin during pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588171
Locations
| Iraq | |
| Hawler medical university | Recruiting |
| Erbil, Kurdistan region, Iraq, 383-65 | |
| Contact: Nazar P. shabila, PHD 009647504450611 nazarpauls@yahoo.com? | |
| Contact: Abubakir M. Saleh, Msc.C.H.M 009647504494656 abubakir.majeed@hmu.edu.iq | |
| Hawler medical university | Recruiting |
| Erbil city, Kurdistan region, Iraq, 383-65 | |
| Contact: Nazar P. Shabila, PHD 009647504450611 nazarpauls@yahoo.com | |
| Contact: Abubakir M. Saleh, MSc,C.H.M 009647504494656 abubakir.majeed@hmu.edu.iq | |
| Principal Investigator: Shahla K. Alalaf, Clinical M.D | |
| Sub-Investigator: Rojan J. Khalis, High Diploma | |
Sponsors and Collaborators
Hawler Medical University
Investigators
| Principal Investigator: | Shahla K. Alalaf, Ass.Prof | Hawler Medical University |
| Study Chair: | Rojan K. Jawad, High Diploma | Hawler Medical University |
| Study Chair: | Parez R. Muhammad, High Diploma | Hawler Medical University |
| Study Chair: | Mahabad S. Ali, High Diploma | Hawler ministry of Health, Directorate of Health |
| Study Director: | Namir G. Al Tawil, Ass.Prof | Hawler Medical University |
More Information
No publications provided
| Responsible Party: | Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University |
| ClinicalTrials.gov Identifier: | NCT01588171 History of Changes |
| Other Study ID Numbers: | Hawler Medical University |
| Study First Received: | April 26, 2012 |
| Last Updated: | February 8, 2013 |
| Health Authority: | Iraq,Kurdistan region:Hawler Directorate of Health |
Keywords provided by Hawler Medical University:
|
Deep vein thrombosis Pulmonary embolism Low molecular weight heparin Enoxaparin Bemiparin |
Additional relevant MeSH terms:
|
Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis Heparin Heparin, Low-Molecular-Weight Dalteparin Enoxaparin |
Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013