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Trial record 15 of 45 for:    severe preeclampsia AND proteinuria

Disease Modification in Toxaemia of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00175695
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 4, 2011
Sponsor:
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 15, 2005
Last Update Posted Date February 4, 2011
Study Start Date December 2004
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 12, 2008)
  • 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 ]
Original Primary Outcome Measures
 (submitted: September 13, 2005)
  • Antenatal: The primary safety outcome will be the incidence of peripartum bleeding, The primary efficacy outcome will be days of pregnancy prolongation
  • Postnatal: The primary safety outcome will be the incidence of postpartum bleeding. The primary efficacy outcome will be 'days alive and free of illness'
Change History
Current Secondary Outcome Measures
 (submitted: August 12, 2008)
We will assess disease activity (as measured by clinical and basic science indices). [ Time Frame: Unknown at this time ]
Original Secondary Outcome Measures
 (submitted: September 13, 2005)
We will assess disease activity (as measured by clinical and basic science indices).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Disease Modification in Toxaemia of Pregnancy
Official Title A Safety and Efficacy Trial of Recombinant Human Activated Protein C in Both Early-onset Pre-eclampsia and Severe Postpartum Pre-eclampsia.
Brief Summary

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Women with pre-eclampsia ('toxaemia of pregnancy').
Condition Pre-eclampsia
Intervention Drug: Recombinant human activated protein C or drotrecogin alpha
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 3, 2011)
30
Original Enrollment
 (submitted: September 13, 2005)
40
Actual Study Completion Date October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Scenario 1 is severe early-onset pre-eclampsia, where the fetal prognosis is dismal (<50% chance of intact survival [disease onset <27+0 weeks gestation and/or estimated fetal weight <600g].
  • Scenario 2 is postpartum pre-eclampsia, where there is either severe antenatal disease, deteriorating postpartum disease, or de novo postpartum disease.

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT00175695
Other Study ID Numbers C03-0230
F1K-CA-0013
9427-C2266-22C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Peter von Dadelszen, University of British Columbia
Study Sponsor University of British Columbia
Collaborators Not Provided
Investigators
Principal Investigator: Peter von Dadelszen, MD University of British Columbia
PRS Account University of British Columbia
Verification Date February 2011