Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

Not Applicable

Completed

• Conditions: Venous Thromboembolic Diseases
• Interventions: Drug: Bemiparin; Drug: Enoxaparin

• Registration Number: NCT01588171
• Lead Sponsor: Hawler Medical University

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Study Start: 2012-05
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7020

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Bemiparin	Bemiparin	A new second generation Low Molecular Weight Heparin
Enoxaparin	Enoxaparin	A well known Low Molecular Weight Heparin
Bemiparin	Enoxaparin	A new second generation Low Molecular Weight Heparin

Primary Outcome Measures

Name	Time	Method
Venous thromboembolism	40 days after delivery	compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.

Secondary Outcome Measures

Name	Time	Method
adverse effects	after receiving the injections and till 40 days	bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence

Trial Locations

Locations (1)

Hawler medical university; 🇮🇶 Erbil, Kurdistan region, Iraq