Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

Venous Thromboembolic Diseases Clinical Trial

Official title:

Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588171
• Other study ID #: Hawler Medical University
• Status: Completed
• Phase: N/A
• First received: April 26, 2012
• Last updated: March 17, 2015
• Start date: May 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2015
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iraq,Kurdistan region:Hawler Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7020
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 48 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolic Diseases

Intervention

Drug:
• Bemiparin
Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days.
• Enoxaparin
Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.

Locations

Country	Name	City	State
Iraq	Hawler medical university	Erbil	Kurdistan region
Iraq	Hawler medical university	Erbil city	Kurdistan region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous thromboembolism	compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.	40 days after delivery	Yes
Secondary	adverse effects	bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence	after receiving the injections and till 40 days	Yes