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Completed

NCT Number: NCT01588171

Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

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.

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Key information

Conditions

Venous Thromboembolic Diseases Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

15 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hawler medical university

Erbil, Kurdistan Region, 383-65, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bemiparin

Drug

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.

Other names: Hibor; Laboratories Rovi Pharmaceuticals

Enoxaparin

Drug

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.

Other names: Clexane(Sanofi aventis)

Primary outcomes

  1. Venous thromboembolism

    Time frame: 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 outcomes

  1. adverse effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 30, 2012
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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