Disease Modification in Toxaemia of Pregnancy

NCT00175695 | Completed

• 3 other identifiers: C03-0230F1K-CA-00139427-C2266-22C
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-eclampsia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• We will assess disease activity (as measured by clinical and basic science indices).

  Unknown at this time

Interventions

Recombinant human activated protein C or drotrecogin alpha DRUG

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Women's Hospital and Health Centre

Vancouver, British Columbia, V6H 3N1, Canada

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Peter von Dadelszen, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 2004
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 4, 2011

Record last verified: 2011-02

Locations

CA (1)