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Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

This study is currently recruiting participants.
Verified February 2013 by Hawler Medical University
Sponsor:
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University
ClinicalTrials.gov Identifier:
NCT01630148
First received: June 26, 2012
Last updated: February 8, 2013
Last verified: February 2013
History of Changes

June 26, 2012
February 8, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
Evidences of clinical thromboembolic disease after gynaecological surgeries [ Time Frame: within the first 30 days after surgery the first 30 days ] [ Designated as safety issue: Yes ]
to determine the efficacy of the new second generation LMWH in prevention Deep vein thrombosis and pulmonary embolism after gynaecological surgeries
Same as current
Complete list of historical versions of study NCT01630148 on ClinicalTrials.gov Archive Site
to determine the side effects of Bemiparin injection [ Time Frame: after receiving the injections and up to 30 days after surgery ] [ Designated as safety issue: Yes ]
To determine the safety of Bemiparin after gynaecological surgeries including bruising or pain at site of injection,itching,allergic skin reactions,urticaria, bleeding,
Same as current
Not Provided
Not Provided
 
Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial

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.

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 VTE is estimated to be 3% after gynaecological surgery if no thromboprophylaxis was used. The rate of VTE assumed to decrease to 0.04% if Low molecular weight heparin was 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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Deep Vein Thrombosis (DVT)
  • Pulmonary Embolism
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
  • Active Comparator: Bemiparin
    group one will be cases who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin
    Intervention: Drug: Bemiparin
  • No Intervention: control group
    cases 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
774
September 2013
July 2013   (final data collection date for primary outcome measure)

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.
Female
25 Years to 90 Years
No
Contact: Nazar P. Shabila, PHD 07504450611 ext 00964 nazarpauls@yahoo.com
Contact: Abubakir M. Salih, MSc,C.H.M 07504494656 ext 00964 abubakir.majeed@hmu.edu.iq
Iraq
 
NCT01630148
HMU
Yes
Assistant Prof. Shahla Alalaf, Hawler Medical University
Hawler Medical University
Not Provided
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, A.Prof Hawler Medical University
Hawler Medical University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP