Venous Thromboembolism Prophylaxis Post Cesarean Section

• Conditions: Bleeding; Venous Thromboembolism
• Interventions: Drug: PLACEBO; Drug: TINZAPARIN

• Registration Number: NCT01321788
• Lead Sponsor: King Saud University

Brief 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.

Detailed Description

This is a double blind- a randomized controlled study of prophylactic LMWH in women at low risk for VTE following a cesarean section procedure. The sample size is 300 patients, Eligible, consenting, and randomized participants will receive once-daily injections of study drug (4,500 IU Tinzaparin Sodium \[Innohep®\] within 12- to 24-hours postpartum and continue for two weeks versus Placebo in the other arm and follow for six (6) weeks postpartum.

On the day of hospital discharge, bilateral leg imaging with compression, leg ultrasounds, and pelvic vein imaging with MRV will be completed. The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period. All outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-23
• Study First Posted: 2011-03-24
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-06
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CONTROL	PLACEBO	The group that will receive placebo for 14 days
STUDY GROUP	TINZAPARIN	will receive the study drug Innohep ® for 14 days

Primary Outcome Measures

Name	Time	Method
Deep Vein Thrombosis	24 months	The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.

Secondary Outcome Measures

Name	Time	Method
symptomatic DVT and bleeding	Symptomatic DVT	. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period.

Trial Locations

Locations (1)

Security Forces Hospital; 🇸🇦 Riyadh, Saudi Arabia