Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

This study has been completed.
Sponsor:
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, 2014
Last verified: February 2014
  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


Enrollment: 7020
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: October 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 48 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588171

Locations
Iraq
Hawler medical university
Erbil, Kurdistan region, Iraq, 383-65
Hawler medical university
Erbil city, Kurdistan region, Iraq, 383-65
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, Professor 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, 2014
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 September 14, 2014