Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of British Columbia |
---|---|
Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00175695 |
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.
Condition | Intervention | Phase |
---|---|---|
Pre-Eclampsia |
Drug: Recombinant human activated protein C or drotrecogin alpha |
Phase II |
Study Type: | Observational |
Study Design: | Case-Only, 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. |
Estimated Enrollment: | 40 |
Study Start Date: | December 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Women with pre-eclampsia ('toxaemia of pregnancy').
Inclusion Criteria:
Exclusion Criteria:
-
Contact: Pamela Lutley | 604-875-2424 ext 6359 |
Canada, British Columbia | |
BC Women's Hospital and Health Centre | Recruiting |
Vancouver, British Columbia, Canada, V6H 3N1 | |
Contact: Pamela Lutley 604-875-2424 ext 6359 | |
Principal Investigator: Peter von Dadelszen, MD |
Principal Investigator: | Peter von Dadelszen, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Peter von Dadelszen ) |
Study ID Numbers: | C03-0230, F1K-CA-0013, 9427-C2266-22C |
Study First Received: | September 13, 2005 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00175695 |
Health Authority: | Canada: Health Canada |
Drotrecogin alfa activated Hypertension, Pregnancy-Induced Pregnancy Complications Protein C Eclampsia |
Pregnancy toxemia /hypertension Pre-Eclampsia Preeclampsia Toxemia Hypertension |
Anti-Infective Agents Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions |