Bemiparin as a Thromboprophylaxis After Gynaecological Surgeries

Not Applicable

Completed

• Conditions: Deep Vein Thrombosis (DVT); Pulmonary Embolism
• Interventions: Drug: Bemiparin

• Registration Number: NCT01630148
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-27
• Study First Posted: 2012-06-28
• Study Start: 2012-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 774

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bemiparin	Bemiparin	group one will be women who are risky for venous thromboembolic diseases after benign gynaecological surgeries, each will receive Bemiparin

Primary Outcome Measures

Name	Time	Method
Evidences of clinical thromboembolic disease after gynaecological surgeries	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

Name	Time	Method
to determine the side effects of Bemiparin injection	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,

Trial Locations

Locations (1)

Shahla Kareem Alalaf; 🇮🇶 Erbil, Kurdistan Region, Iraq