Diagnostic accuracy in pre-eclampsia using proteinuria assessment

Not Applicable

Completed

• Conditions: Pre-eclampsia; Pregnancy and Childbirth; Moderate pre-eclampsia

• Registration Number: ISRCTN82607486
• Lead Sponsor: ewcastle Hospitals NHS Foundation Trust (UK)

Brief Summary

2017 results in https://pubmed.ncbi.nlm.nih.gov/29064366/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-10-16
• Study Completion: 2014-11-01
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 959

Inclusion Criteria

1. Pregnant women aged between 16- 45 years
2. More than 20 weeks gestation with confirmed gestational hypertension (systolic BP >140 mmHg and diastolic BP >90 mmHg)
3. Trace or more proteinuria on automated dipstick urinalysis. This is below the threshold of 1+ considered test positive by NICE and will thus allow exploration of the lower threshold for the index tests, i.e. below 300 mg/l protein
4. Ability of give informed consent

Exclusion Criteria

1. Women with gestational hypertension but no proteinuria on automated dipstick urinalysis
2. Proteinuria before 20 weeks gestation
3. Pre-existing renal disease, pre-gestational diabetes and chronic hypertension
4. Those who are unable to provide informed consent
5. Those women who are already participating in a clinical trial of an investigational medicinal product (CTIMP)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of point of care and laboratory assessments of Spot Protein Creatine Ratio (SPCr) and Spot Albumin Creatine Ratio (SACr) compared with 24 hour urine protein measurement at different thresholds in diagnosing and predicting severe Pre-Eclampsia (PE)

Secondary Outcome Measures

Name	Time	Method
<br> 1. To assess the accuracy of point of care assessments of SPCr and SACr at different thresholds in diagnosing PE compared to 24 hour urine protein measurement<br> 2. To identify the most accurate laboratory assay method of 24 hour proteinuria in assessment of PE<br> 3. To estimate the accuracy of both quantitative and point of care assessments of SPCr and SACr at different thresholds in predicting adverse fetal outcomes<br> 4. To develop a decision analytic model to estimate the diagnostic utility potential of replacing the 24 hour protein with the SPCr or SACr<br> 5. To assess the cost effectiveness of SPCr or SACr in comparison to the 24 hour urine protein measurement<br>