Venous Thromboembolism Prophylaxis Post Cesarean Section (PROCS)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)|
- Deep Vein Thrombosis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]The primary outcome will be adjudicated, while DVT will be documented on ultrasounds or MRV on the day of hospital discharge.
- symptomatic DVT and bleeding [ Time Frame: Symptomatic DVT ] [ Designated as safety issue: Yes ]. Secondary outcomes will include symptomatic DVT and PE, death from PE, major and minor bleeding, and HIT during the six-week postpartum period.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
will receive the study drug Innohep ® for 14 days
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 Name: Innohep
The group that will receive placebo for 14 days
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.
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321788
|Contact: FARJAH H ALGAHTANI, MDfirstname.lastname@example.org|
|Security Forces Hospital||Recruiting|
|Riyadh, Saudi Arabia|
|Contact: Farjah H AlGahtani, MD 0505805919 email@example.com|
|Contact: , Pharm|
|Principal Investigator: Farjah H AlGahtani, MD|
|Sub-Investigator: Hessa AlDohami, MD|
|Principal Investigator:||FARJAH H ALGAHTANI, MD||King Saud University|