Comparison of 2 Low Molecular Weight Heparin as a Thromboprophylaxis Postpartum

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7020 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Venous Thromboembolic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

A prospective non-randomized clinical trial, no masking was applied to the 3 arms of the study

Study Groups

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Bemiparin

A new second generation Low Molecular Weight Heparin

Group Type ACTIVE_COMPARATOR

Bemiparin

Intervention Type 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.

Enoxaparin

Intervention Type 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.

Enoxaparin

A well known Low Molecular Weight Heparin

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type 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.

control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Hibor; Laboratories Rovi Pharmaceuticals Clexane(Sanofi aventis)

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No