Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01630148
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : October 6, 2014
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University

Brief Summary:
The use of prophylaxis for venous thromboembolism (VTE) remains grossly underused for women who undergo gynecologic surgery for benign conditions world wide and especially in developing countries including our region. Having a research in our locality for the first time might raise awareness of the importance of VTE prophylaxis.

Condition or disease Intervention/treatment
Deep Vein Thrombosis (DVT) Pulmonary Embolism Drug: Bemiparin

Detailed Description:

Deep vein thrombosis (DVT) and pulmonary embolism (PE), also referred to as venous thromboembolic events (VTE), are two major complications after gynaecological surgeries that can result in significant morbidity and mortality. The incidence of VTE after gynaecologic surgery varies depending on the method used for diagnosis. The rate of clinical DVT is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.4% if Low molecular weight heparin was used as a thromboprophylaxis.

According to our knowledge there are no published researches on the effect of the new second generation Low molecular Weight Heparin Bemiparin as a thromboprophylaxis after benign gynaecological surgery in comparison to a control group.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
Study Start Date : July 2012
Primary Completion Date : March 2014
Study Completion Date : March 2014

Arm Intervention/treatment
Active Comparator: Bemiparin
group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
Drug: Bemiparin
Bemiparin Sodium 3,500IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group (Moderate, High and Highest risk groups for thromboembolism) 6 hours after surgery and then daily for up to 7 days.
Other Name: Hibor; Laboratories Rovi pharmaceuticals
No Intervention: control group
women will undergo benign gynaecological surgeries and are risky for venous thrombosis, they will not receive any intervention. The patients will be followed up to 30 days after surgery.

Primary Outcome Measures :
  1. Evidences of clinical thromboembolic disease after gynaecological surgeries [ Time Frame: within the first 30 days after surgery the first 30 days ]
    to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries

Secondary Outcome Measures :
  1. to determine the side effects of Bemiparin injection [ Time Frame: after receiving the injections and up to 30 days after surgery ]
    To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • female undergoing Benign gynecological surgeries.
  • Having moderate,high and very high risk factors for venous thromboembolism.
  • No contraindications for the use of Heparin.

Exclusion Criteria:

  • Having mild risk factors for thromboembolism.
  • Active vaginal bleeding.
  • Thrombocytopaenia.
  • any patient who is already on anticoagulant.
  • Sever renal or Liver diseases.

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 identifier (NCT number): NCT01630148

Hawler medical university
Erbil city, Kurdistan region, Iraq, 383-65
Sponsors and Collaborators
Hawler Medical University
Principal Investigator: Shahla K. Alalaf, M.D Hawler Medical University
Study Chair: Ariana K. Jawad, C.A.B.OG Hawler Ministry of Health
Study Chair: Rojan K. Jawad, Diploma Hawler Medical University
Study Chair: Mahabad S. Ali, Diploma Hawler Ministry of Health
Study Director: Namir G. Al Tawil, Professor Hawler Medical University

Responsible Party: Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University Identifier: NCT01630148     History of Changes
Other Study ID Numbers: HMU
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014

Keywords provided by Assistant Prof. Shahla Alalaf, Hawler Medical University:
Low Molecular Weight Heparin
Major Gynaecological Surgeries
Benign Gynaecological Surgeries

Additional relevant MeSH terms:
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action