Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University
ClinicalTrials.gov Identifier:
NCT01588171
First received: April 26, 2012
Last updated: February 8, 2014
Last verified: February 2014

April 26, 2012
February 8, 2014
May 2012
October 2013   (final data collection date for primary outcome measure)
Venous thromboembolism [ Time Frame: 40 days after delivery ] [ Designated as safety issue: Yes ]
compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.
Same as current
Complete list of historical versions of study NCT01588171 on ClinicalTrials.gov Archive Site
adverse effects [ Time Frame: after receiving the injections and till 40 days ] [ Designated as safety issue: Yes ]
bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence
Same as current
Not Provided
Not Provided
 
Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum
Bemiparin Versus Enoxaparin as a Thromboprophylaxis Post Vaginal and Abdominal Deliveries: A Randomized Clinical Trial

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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Venous Thromboembolic Diseases
  • 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.
    Other Name: Hibor; Laboratories Rovi Pharmaceuticals
  • Drug: 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.
    Other Name: Clexane(Sanofi aventis)
  • Active Comparator: Bemiparin
    A new second generation Low Molecular Weight Heparin
    Interventions:
    • Drug: Bemiparin
    • Drug: Enoxaparin
  • Active Comparator: Enoxaparin
    A well known Low Molecular Weight Heparin
    Intervention: Drug: Enoxaparin
  • No Intervention: control group
    Risky group patients for VTE, but they will not receive any thromboprophylactic drug.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7020
November 2013
October 2013   (final data collection date for primary outcome measure)

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
Female
15 Years to 48 Years
No
Contact information is only displayed when the study is recruiting subjects
Iraq
 
NCT01588171
Hawler Medical University
No
Assistant Prof. Shahla Alalaf, Hawler Medical University
Hawler Medical University
Not Provided
Principal Investigator: Shahla K. Alalaf, Ass.Prof Hawler Medical University
Study Chair: Rojan K. Jawad, High Diploma Hawler Medical University
Study Chair: Parez R. Muhammad, High Diploma Hawler Medical University
Study Chair: Mahabad S. Ali, High Diploma Hawler ministry of Health, Directorate of Health
Study Director: Namir G. Al Tawil, Professor Hawler Medical University
Hawler Medical University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP