Venous Thromboembolic Diseases
Conditions
Keywords
Deep vein thrombosis, Pulmonary embolism, Low molecular weight heparin, Enoxaparin, Bemiparin
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
Interventions
DRUGBemiparin
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.
DRUGEnoxaparin
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.
Sponsors
Hawler Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
A prospective non-randomized clinical trial, no masking was applied to the 3 arms of the study
Intervention model description
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
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous thromboembolism | 40 days after delivery | compare two low molecular weight heparin (Bemiparin versus Enoxaparin) after delivery with non receiver participant for development of venous thromboembolic diseases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effects | after receiving the injections and till 40 days | bruising or pain at the site of injection,Bleeding,allergic skin reactions, itching, urticaria,wound hematoma, separation, or dehiscence |
Countries
Iraq
Outcome results
None listed