Clinical trial NCT00175526: Predicting Complications in Women With Toxaemia
Official title: PIERS (Pre-eclampsia Integrated Estimate of RiSk) Model: Predicting Adverse Maternal Outcomes in Pre-eclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Toxemia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 650
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with pre-eclampsia ('toxaemia of pregnancy') which is the most common cause for women to die during or shortly after pregnancy.

Brief summary: At present, the management of pre-eclampsia is guided by expert opinions that are not well-based on firm evidence. What is required is a clinical tool that can accurately determine a women's risk for adverse outcomes, and thereby reduce the risk for women while safely prolonging pregnancies remote from term (to improve fetal outcomes). This research project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is specific to the condition. This severity score will be used clinically (to guide management) and in research (in both clinical trials and basic science research), and will provide an evidence base on which to build future practice, improving outcomes for pregnant women and their babies. In addition, this project is part of a three part strategy to better understand the mechanisms of disease in pre-eclampsia and to investigate a potential disease-modifying therapy, namely, recombinant human activated protein C.

Detailed description: In North America, pre-eclampsia ('toxaemia of pregnancy') is the most common cause for women to die during or shortly after pregnancy. It is also the most common reason for babies who are otherwise doing well to be delivered prematurely; this is with the intent purpose of protecting maternal health and safety. In many ways it is similar to the systemic inflammatory response syndrome ('septicaemia').

This project is part of a three part strategy to better understand the mechanisms of disease in pre-eclampsia and to investigate a potential disease-modifying therapy, namely, recombinant human activated protein C. We have surveyed Canadian practice, and undertaken both feasibility and pilot studies for this project.

At present, the management of pre-eclampsia is guided by expert opinions that are not well-based on firm evidence. What is required is a clinical tool that can accurately determine a women's risk for adverse outcomes, and thereby reduce the risk for women while safely prolonging pregnancies remote from term (to improve fetal outcomes). This research project, 'a severity score for pre-eclampsia,' will develop such a clinical tool that is specific to the condition. To develop and validate the tool we will recruit 3000 women in Canada, the UK, and Australasia who are admitted to a hospital with either pre-eclampsia or one of its variants. At the same time, because the majority of deaths associated with pre-eclampsia occur in low and middle income countries, we will recruit 3000 women from Uganda, China, Fiji, South Africa and Pakistan with pre-eclampsia. We will use this cohort to test the model and ensure it accurately predicts risk in this new population.

This severity score will be used clinically (to guide management) and in research (in both clinical trials and basic science research), and will provide an evidence base on which to build future practice, improving outcomes for pregnant women and their babies.

Eligibility criteria: Inclusion Criteria:

These criteria reflect the evidence that pre-eclampsia is more than hypertension and proteinuria, particularly at onset:

* Hypertension. sBP \>140mmHg and/or dBP \>90mmHg, twice, \>4h apart after 20 weeks' gestation. sBP will be included to reflect international guidelines.
* Proteinuria. 24h urinary protein \>0.3g/d3, or in the absence of a 24h urine collection: \>2+ dipstick proteinuria after 20wk or a random protein:creatinine ratio \>30mg protein/mmol creatinine106-108.
* HELLP syndrome that is non-hypertensive and non-proteinuric, using Sibai's criteria109,
* One eclamptic seizure without preceding hypertension or proteinuria ('BEST' definition of eclampsia38).
* Women admitted with suspected 'superimposed pre-eclampsia' will also be included (e.g., those with a history of pre-existing hypertension with new proteinuria (\>2+) or accelerated hypertension3;23;24).

Exclusion Criteria:

* Occurrence of the maternal outcome (e.g., recurrent eclampsia) prior to collection of the predictors.
* Admission to hospital in spontaneous labour (as clinicians will not attempt to stop these labours).

Primary outcomes:
measure: To identify the maternal and fetal variables predictive of a combined adverse maternal outcome occurring within one week of hospital admission for pre-eclampsia
timeFrame: Unknown at this time
Secondary outcomes:
measure: To identify whether these also predict the combined adverse maternal outcome at any time following admission ii to identify whether these variables can predict a combined adverse perinatal outcome both (a) within one week and (b) at any time foll
timeFrame: Unknown at this time
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of BC
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital-General Campus
state: Ontario
city: Sherbrook
country: Canada
facility: le Centre hospitalier universitaire de Sherbrooke
state: Quebec
city: Christchurch
country: New Zealand
facility: Christchurch Women's Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: University of British Columbia
name: Peter von Dadelszen, MD
role: PRINCIPAL_INVESTIGATOR
References: