Short description of the primary purpose of the protocol intended for the lay public. Include
brief statement of study hypothesis
Pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in North
America. It also causes many complications for fetuses (unborn children) and neonates
(newborn children). Pre-eclampsia is defined by high blood pressure (hypertension), the loss
of protein into the urine (proteinuria), and disorders of many body systems, including the
blood clotting (coagulation) and inflammation. What is needed is a compound that will safely
prolong pregnancies, to give babies more time to grow inside their mothers, and will help the
recovery in those mothers after delivery.
We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that
has the potential to modify disease activity in pre-eclampsia by reducing coagulation and
inflammation disorders. rhAPC is effective in patients suffering from septic shock. We will
test rhAPC in women who develop severe pre-eclampsia in two ways. First, in women with severe
pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their
pregnancies). Second, in women who have had severe pre-eclampsia before their baby delivered
(including women in the first group), or whose disease develops/worsens after delivery
(intent: switch off the disease so dangerous complications do not arise).
This study is a preliminary one to look for possible risks and benefits for these women. Only
40 women will be studied to provide initial evidence on which to base a larger international
trial which is planned. We will study their pregnancy outcomes as well as markers of disease
activity, to gain a better understanding of the mechanisms by which these women become
unwell.