PROCS: Venous Thromboembolism Prophylaxis Post Cesarean Section

Sponsor

King Saud University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01321788

Collaborator

King AbdulAziz City for Science and Technology (Other)

300

Enrollment

Location

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bleeding Venous Thromboembolism	Drug: TINZAPARIN Drug: PLACEBO

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2013

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
STUDY GROUP will receive the study drug Innohep ® for 14 days	Drug: TINZAPARIN Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum. Other Names: Innohep
CONTROL The group that will receive placebo for 14 days	Drug: PLACEBO Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.

Arm

Intervention/Treatment

STUDY GROUP

will receive the study drug Innohep ® for 14 days

Drug: TINZAPARIN

Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.

Other Names:

Innohep

CONTROL

The group that will receive placebo for 14 days

Drug: PLACEBO

Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 18 years old.
Delivered by cesarean section (emergency or planned).
Signed, informed consent.
Ready access to a local health service.
Capable of using Tinzaparin.

Exclusion Criteria:

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