Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

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

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolic Diseases
• Intervention / Treatment: Drug: Bemiparin; Drug: Enoxaparin

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 Type: Interventional
• Enrollment (Actual): 7020
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan region
    • Erbil, Kurdistan region, Iraq, 383-65
      • Hawler Medical University
    • Erbil city, Kurdistan region, Iraq, 383-65
      • Hawler Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bemiparin; A new second generation Low Molecular Weight Heparin	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 Names: 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 Names: Clexane(Sanofi aventis)
Active Comparator: Enoxaparin; A well known Low Molecular Weight Heparin	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 Names: Clexane(Sanofi aventis)
No Intervention: control group; Risky group patients for VTE, but they will not receive any thromboprophylactic drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: 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

Publications and helpful links

General Publications

• 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:CD001689. doi: 10.1002/14651858.CD001689.pub4.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: April 26, 2012
• First Submitted That Met QC Criteria: April 27, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Estimate): March 18, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Deep vein thrombosis; Pulmonary embolism; Low molecular weight heparin; Enoxaparin; Bemiparin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Bemiparin
• Other Study ID Numbers: Hawler Medical University

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No