Deep Vein Thrombosis Clinical Trial
Official title:
The Cesarean Section Thromboprophylaxis Pilot Study:A Randomized Open-Label Controlled Pilot Study of Prophylactic Low Molecular Weight Heparin in High Risk Postpartum Women Following Cesarean Section
Venous thromboembolism (VTE) remains the most common cause of maternal death in the developed
world. VTE includes two conditions, deep vein thrombosis (DVT) and pulmonary embolism (PE).
DVT refers to a blood clot that has formed in a deep vein, often in the legs and/or pelvis
and PE refers to the passage of these clots into the lungs (which can be fatal). VTE 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 occur during the 6 weeks after delivery. When compared with
vaginal delivery, cesarean delivery further increases the risk of pregnancy associated VTE by
three-fold.
A medication called low molecular weight heparin is sometimes prescribed during pregnancy and
after delivery to prevent VTE. However, clinical practice varies because there hasn't been
adequate research to determine that this medication is safe and effective at preventing VTE
during this time. The potential benefits of the medication must also be weighed against its
cost and possible side effects.
The researchers are conducting a study that will assess the effectiveness and safety of low
molecular weight heparin in women who are at moderate to high risk of VTE after a cesarean
section. They will monitor these women to determine if those who received the medication have
fewer blood clots. Participants will also be monitored closely for any side effects.
BACKGROUND: Venous thromboembolism (VTE) remains the most common cause of maternal mortality
in the developed world. VTE 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 occur during the brief
postpartum period (6 weeks). When compared with vaginal delivery, cesarean delivery further
increases the risk of pregnancy associated VTE by three-fold. Pregnancy associated VTE is
unique in that isolated iliac vein thrombosis is more likely and long term morbidity
(post-phlebitic syndrome) is common.
There is an absence of randomized controlled trials (RCTs) of thromboprophylaxis after
C-section to guide practice. Many national societies have guidelines on thromboprophylaxis
however these are not evidence based and compliance with these guidelines is poor.
Thromboprophylaxis may be associated with adverse effects (bleeding, heparin induced
thrombocytopenia, skin reactions), inconvenience and cost. It is critical that the efficacy
and safety of thromboprophylaxis following cesarean delivery be assessed in well designed and
conducted randomized trials.
OBJECTIVES: We are conducting a randomized double-blind placebo-controlled pilot study. The
pilot study seeks to answer the question: Is a randomized double-blind placebo-controlled
multicentre trial of low molecular weight heparin thromboprophylaxis feasible in moderate to
high risk women post cesarean section with DVT detected by pelvic vein (MRV) or leg vein (leg
compression ultrasound) imaging? Our ultimate goal is to determine:
1. Is LMWH effective in preventing postpartum DVT following cesarean section in women at
moderate to high risk of VTE?
2. Is LMWH safe in preventing postpartum DVT following cesarean section in women at
moderate to high risk of VTE?
3. Is LMWH cost effective in preventing postpartum DVT following cesarean section in women
at moderate to high risk of VTE?
STUDY DESIGN: We propose a randomized double-blind placebo-controlled pilot study of
prophylactic LMWH in women at moderate to high risk for VTE following cesarean section.
Eligible, consenting and randomized participants will receive once-daily injections of study
drug (4,500 IU tinzaparin sodium (Innohep®;) or placebo) within 6 to 24 hours postpartum and
continue until 3 to 7 days 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 DVT 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, HIT during the six week postpartum period. All outcomes will be
adjudicated by an independent committee of experts blinded to study drug allocation.
With a sample size of 134 patients we will have over 80% power to detect a 50% relative risk
reduction in the primary outcome event rate and a large enough sample to determine the
feasibility objectives of the pilot study (i.e. obtain a precise estimate of the primary
outcome event rate [DVT], a precise estimate of the multicentre recruitment rate, feasibility
and acceptability of blinded study drug and placebo administration, feasibility of obtaining
local study centre MRV and central interpretation of MRV and a preliminary relative risk
reduction estimate with study drug compared to placebo to inform final study sample size
determination).
RELEVANCE: Maternal mortality is a devastating outcome with far reaching emotional and
societal implications. Evidence to guide thromboprophylaxis in women at risk for the number 1
cause of maternal mortality is required.
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