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Clinical Trials/ISRCTN40384046
ISRCTN40384046
Completed
N/A

Development and validation of a Prediction model for Risk of complications in Early onset Pre-eclampsia (PREP)

Queen Mary University of London (UK)0 sites500 target enrollmentFebruary 13, 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Early onset pre-eclampsia
Sponsor
Queen Mary University of London (UK)
Enrollment
500
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 13, 2012
End Date
TBD
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Queen Mary University of London (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Women admitted with diagnosis of 'superimposed pre\-eclampsia': this was defined as new\-onset proteinuria (as defined previously) in women with chronic hypertension and no proteinuria at base line. In women who had proteinuria at base line, the diagnosis of preeclampsia required an elevated serum alanine aminotransferase concentration (\>70 U per litre) or worsening hypertension (either two diastolic BP of at least 110 mm Hg four hours apart or one diastolic measurement of at least 110 mm Hg if the woman had been treated with an antihypertensive drug), plus one of the following: increasing proteinuria, persistent severe headaches, or epigastric pain.
  • 2\. Women with diagnosis of HELLP syndrome with no proteinuria or hypertension
  • 3\. Women with one episode of eclamptic seizures with no hypertension or proteinuria
  • 4\.1\. Gestational age between 20\+0 weeks and 33\+6 weeks
  • 4\.2\. Pre\-eclampsia defined as new onset hypertension (systolic BP \= 140 mm Hg or diastolic BP \= 90 mm Hg on 2 occasions 4 \-6 hours apart in women) after 20 weeks of pregnancy and presence of proteinuria (\= 2\+ in urine dipstick or PCR ratio of greater than 30mg/mmol or 300 mg of protein excretion in 24 hours)
  • 4\.3\. Be capable of understanding the information provided, with use of an interpreter if required
  • 4\.4\. Give written informed consent

Exclusion Criteria

  • 1\. There is occurrence of the outcome (including recurrent eclamptic seizures) prior to testing
  • 2\. There is insufficient time for gaining informed consent.
  • 3\. The mother does not comprehend spoken and written English adequately and a translator is not available.

Outcomes

Primary Outcomes

Not specified

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