Venous Thromboembolism Prophylaxis Post Cesarean Section

• Status: Unknown status
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

Pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (VTE). VTE remains the most common cause of maternal death in the developed world. It is up to 10 times more common in pregnant women than non-pregnant women of comparable age. More than a third of pregnancy-related VTE occurs during the six weeks after delivery. When compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by three-fold.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Saud University
• Collaborator: King AbdulAziz City for Science and Technology
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

Inclusion Criteria:

1. Age > 18 years old.

2. Delivered by cesarean section (emergency or planned).

3. Signed, informed consent.

4. Ready access to a local health service.

5. Capable of using Tinzaparin.

Exclusion Criteria:

1. at high risk for thromboembolism (any one of the following):

• age more than 35 years old

• obesity (more than 80 kg)

• parity more than 4

• gross varicose veins

• current infection

• pre-eclampsia

• immobility prior to surgery (more than 4 days)

• Major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome.

• Extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy)

• Patients with a family history of VTE

• History of superficial phlebitis

2. More than 36 hours since delivery

3. Need for anticoagulation, including:

• women with a confirmed thrombophilia

• women with paralysis of lower limbs

• women with personal history of VTE

• women with antiphospholipid antibody syndrome (APLA)

• women with mechanical heart valves

4. Contraindication to heparin therapy, including history of heparin induced thrombocytopenia.