Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

NCT01588171 | Completed

• 1 other identifier: Hawler Medical University
• Study Type: interventional
• Target: 7,020
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolic Diseases

Keywords

Deep vein thrombosis; Pulmonary embolism; Low molecular weight heparin; Enoxaparin; Bemiparin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• adverse effects

  after receiving the injections and till 40 days

Study Arms (3)

Bemiparin

ACTIVE COMPARATOR

A new second generation Low Molecular Weight Heparin

Drug: Bemiparin; Drug: Enoxaparin

Enoxaparin

ACTIVE COMPARATOR

A well known Low Molecular Weight Heparin

Drug: Enoxaparin

control group

NO INTERVENTION

Participants assigned to the Non-Interventional Arm will receive standard local hospital care as dictated by the attending physician and established clinical guidelines. Examples of standard care include, but are not limited to, patient rehydration protocols and support for ambulation or mobilization within the clinical setting. All standard safety and monitoring procedures will apply.

Interventions

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.

Also known as: Hibor; Laboratories Rovi Pharmaceuticals

Bemiparin

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.

Also known as: Clexane(Sanofi aventis)

Bemiparin; Enoxaparin

Eligibility Criteria

• Age: 15 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Presence of risk factors for venous thromboembolism
• Any parity
• Mode of delivery:vaginal, Emergency and Elective Caesarean section
• No any contraindications for Heparin

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Hawler medical university

Erbil, Kurdistan Region, 383-65, Iraq

Location

Related Publications (2)

• 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.

  PMID: 33779986 DERIVED

• 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.

  PMID: 25884460 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

bemiparin; Enoxaparin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Shahla K. Alalaf, Ass.Prof

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Namir G. Al Tawil, Professor

  Hawler Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: A prospective non-randomized clinical trial, no masking was applied to the 3 arms of the study
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective clinical trial with sequential group allocation Women eligible for participation were assigned to the three arms of the trial: the bemiparin, enoxaparin, and control groups. Based on a schema produced by a Microsoft Excel (2007) computer program, the first woman was recruited to the non intervention group (control), the second to the bemiparin group, and the third to the enoxaparin group, with this sequence repeated throughout the trial

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

IR (1)