Status:
COMPLETED
Predicting Complications in Women With Toxaemia
Lead Sponsor:
University of British Columbia
Conditions:
Toxemia
Eligibility:
FEMALE
16-45 years
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 ...
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 do...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00175526
Start Date
September 1 2005
End Date
December 1 2010
Last Update
June 1 2016
Active Locations (6)
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1
Children's and Women's Health Centre of BC
Vancouver, British Columbia, Canada, V5Z 1L8
2
Kingston General Hospital
Kingston, Ontario, Canada
3
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
4
le Centre hospitalier universitaire de Sherbrooke
Sherbrook, Quebec, Canada