Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

Hawler Medical University

Status: Completed

Conditions: Venous Thromboembolic Diseases

Treatments: Drug: Enoxaparin; Drug: Bemiparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01588171

Hawler Medical University

Details and patient eligibility

About

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.

Full 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

Enrollment: 7,020 patients

Sex: Female

Ages: 15 to 48 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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7,020 participants in 3 patient groups

Bemiparin

Active Comparator group

Description:

A new second generation Low Molecular Weight Heparin

Treatment:

Drug: Bemiparin

Drug: Enoxaparin

Enoxaparin

Active Comparator group

Description:

A well known Low Molecular Weight Heparin

Treatment:

Drug: Enoxaparin

control group

No Intervention group

Description:

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.