Venous Thromboembolism Clinical Trial
Official title:
Venous Thromboembolism Prophylaxis Post Cesarean Section(PRO-CS-Trial)
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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