Disease Modification in Toxaemia of Pregnancy
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.
|Pre-eclampsia||Drug: Recombinant human activated protein C or drotrecogin alpha||Phase 2|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Safety and Efficacy Trial of Recombinant Human Activated Protein C in Both Early-onset Pre-eclampsia and Severe Postpartum Pre-eclampsia.|
- Antenatal: The primary safety outcome will be the incidence of peripartum bleeding, The primary efficacy outcome will be days of pregnancy prolongation [ Time Frame: Unknown at this time ]
- Postnatal: The primary safety outcome will be the incidence of postpartum bleeding. The primary efficacy outcome will be 'days alive and free of illness' [ Time Frame: Unknown at this time ]
- We will assess disease activity (as measured by clinical and basic science indices). [ Time Frame: Unknown at this time ]
|Study Start Date:||December 2004|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Drug: Recombinant human activated protein C or drotrecogin alpha
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175695
|Canada, British Columbia|
|BC Women's Hospital and Health Centre|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Peter von Dadelszen, MD||University of British Columbia|