Clinical trial NCT01630148: Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries
Official title: Bemiparin as a Thromboprophylaxis After Benign Gynaecological Surgeries:A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis (DVT)
Pulmonary Embolism
Keywords: Thromboprophylaxis
Bemiparin
Low Molecular Weight Heparin
Major Gynaecological Surgeries
Benign Gynaecological Surgeries
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 774
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evidences of clinical thromboembolic disease after gynaecological surgeries
timeFrame: within the first 30 days after surgery the first 30 days
Secondary outcomes:
measure: to determine the side effects of Bemiparin injection
timeFrame: after receiving the injections and up to 30 days after surgery
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Shahla Kareem Alalaf
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: Shahla K. Alalaf, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawler Ministry of Health
name: Ariana K. Jawad, C.A.B.OG
role: STUDY_CHAIR
affiliation: Hawler Medical University
name: Rojan K. Jawad, Diploma
role: STUDY_CHAIR
affiliation: Hawler Ministry of Health
name: Mahabad S. Ali, Diploma
role: STUDY_CHAIR
affiliation: Hawler Medical University
name: Namir G. Al Tawil, Professor
role: STUDY_DIRECTOR
References: