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.
Investigators
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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