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.

Study Overview

• Status: Completed
• Conditions: Pre-eclampsia
• Intervention / Treatment: Drug: Recombinant human activated protein C or drotrecogin alpha

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6H 3N1
      • BC Women's Hospital and Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Antenatal: The primary safety outcome will be the incidence of peripartum bleeding, The primary efficacy outcome will be days of pregnancy prolongation	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'	Unknown at this time

Secondary Outcome Measures

Outcome Measure	Time Frame
We will assess disease activity (as measured by clinical and basic science indices).	Unknown at this time

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Peter von Dadelszen, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): February 4, 2011
• Last Update Submitted That Met QC Criteria: February 3, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Protein C; Drotrecogin alfa activated
• Other Study ID Numbers: C03-0230; F1K-CA-0013; 9427-C2266-22C