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Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

Primary Purpose

Venous Thromboembolic Diseases

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Bemiparin
Enoxaparin
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolic Diseases focused on measuring Deep vein thrombosis, Pulmonary embolism, Low molecular weight heparin, Enoxaparin, Bemiparin

Eligibility Criteria

15 Years - 48 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hawler medical university
  • Hawler medical university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Bemiparin

Enoxaparin

control group

Arm Description

A new second generation Low Molecular Weight Heparin

A well known Low Molecular Weight Heparin

Risky group patients for VTE, but they will not receive any thromboprophylactic drug.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

adverse effects
bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence

Full Information

First Posted
April 26, 2012
Last Updated
March 17, 2015
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01588171
Brief Title
Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum
Official Title
Bemiparin Versus Enoxaparin as Thromboprophylaxis Following Vaginal and Abdominal Deliveries: A Prospective Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolic Diseases
Keywords
Deep vein thrombosis, Pulmonary embolism, Low molecular weight heparin, Enoxaparin, Bemiparin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7020 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bemiparin
Arm Type
Active Comparator
Arm Description
A new second generation Low Molecular Weight Heparin
Arm Title
Enoxaparin
Arm Type
Active Comparator
Arm Description
A well known Low Molecular Weight Heparin
Arm Title
control group
Arm Type
No Intervention
Arm Description
Risky group patients for VTE, but they will not receive any thromboprophylactic drug.
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Other Intervention Name(s)
Hibor; Laboratories Rovi Pharmaceuticals
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Other Intervention Name(s)
Clexane(Sanofi aventis)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Venous thromboembolism
Description
compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases.
Time Frame
40 days after delivery
Secondary Outcome Measure Information:
Title
adverse effects
Description
bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence
Time Frame
after receiving the injections and till 40 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahla K. Alalaf, Ass.Prof
Organizational Affiliation
Hawler Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rojan K. Jawad, High Diploma
Organizational Affiliation
Hawler Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Parez R. Muhammad, High Diploma
Organizational Affiliation
Hawler Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahabad S. Ali, High Diploma
Organizational Affiliation
Hawler ministry of Health, Directorate of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Namir G. Al Tawil, Professor
Organizational Affiliation
Hawler Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Hawler medical university
City
Erbil city
State/Province
Kurdistan region
ZIP/Postal Code
383-65
Country
Iraq
Facility Name
Hawler medical university
City
Erbil
State/Province
Kurdistan region
ZIP/Postal Code
383-65
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
33779986
Citation
Middleton P, Shepherd E, Gomersall JC. Venous thromboembolism prophylaxis for women at risk during pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2021 Mar 29;3(3):CD001689. doi: 10.1002/14651858.CD001689.pub4.
Results Reference
derived
PubMed Identifier
25884460
Citation
Alalaf SK, Jawad RK, Muhammad PR, Ali MS, Al Tawil NG. Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial. BMC Pregnancy Childbirth. 2015 Mar 28;15:72. doi: 10.1186/s12884-015-0515-2.
Results Reference
derived

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Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

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