Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Disease Modification in Toxaemia of Pregnancy

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175695
First received: September 13, 2005
Last updated: February 3, 2011
Last verified: February 2011

September 13, 2005
February 3, 2011
December 2004
October 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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'
Complete list of historical versions of study NCT00175695 on ClinicalTrials.gov Archive Site
We will assess disease activity (as measured by clinical and basic science indices). [ Time Frame: Unknown at this time ] [ Designated as safety issue: No ]
We will assess disease activity (as measured by clinical and basic science indices).
Not Provided
Not Provided
 
Disease Modification in Toxaemia of Pregnancy
A Safety and Efficacy Trial of Recombinant Human Activated Protein C in Both Early-onset Pre-eclampsia and Severe Postpartum Pre-eclampsia.

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Women with pre-eclampsia ('toxaemia of pregnancy').

Pre-eclampsia
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2010
October 2010   (final data collection date for primary outcome measure)

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:

-

Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00175695
C03-0230, F1K-CA-0013, 9427-C2266-22C
No
Dr. Peter von Dadelszen, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Peter von Dadelszen, MD University of British Columbia
University of British Columbia
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP