Predicting Complications in Women With Toxaemia

NCT00175526 | Completed

• 1 other identifier: H03-70137
• Study Type: observational
• Target: 650
• Locations: 3 countries
• Sites: 6

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.

Conditions

Toxemia

Outcome Measures

Primary Outcomes (1)

• To identify the maternal and fetal variables predictive of a combined adverse maternal outcome occurring within one week of hospital admission for pre-eclampsia

  Unknown at this time

Secondary Outcomes (1)

• 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

  Unknown at this time

Interventions

preeclampsia BEHAVIORAL

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 w

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (6)

Children's and Women's Health Centre of BC

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

Ottawa Hospital-General Campus

Ottawa, Ontario, Canada

Location

le Centre hospitalier universitaire de Sherbrooke

Sherbrook, Quebec, Canada

Location

Christchurch Women's Hospital

Christchurch, New Zealand

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 1, 2016

Record last verified: 2016-05

Locations

GB (1); CA (4); NZ (1)