Diagnostic accuracy in pre-eclampsia using proteinuria assessment

Spot protein creatinine ratio (SPCr) and spot albumin creatinine ratio (SACr) in the assessment of pre-eclampsia: a diagnostic accuracy study with decision analytic model based economic evaluation and acceptability analysis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN82607486

Enrollment

3000

Registered

2012-10-16

Start date

2012-11-01

Completion date

Unknown

Last updated

2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia Pregnancy and Childbirth Moderate pre-eclampsia

Interventions

This study involves 3000 women who will provide urine samples during admission to hospital with suspected preeclampsia across England. Women will be in the study for the duration of pregnancy providin

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 2. To identify the most accurate laboratory assay method of 24 hour proteinuria in assessment of PE 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 4. To develop a decision analytic model to estimate the diagnostic utility potential of replacing the 24 hour protein with the SPCr or SACr 5. To assess the cost effectiveness of SPCr or SACr in comparison to the 24 hour urine protein measurement	—

Measure

Time frame

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 2. To identify the most accurate laboratory assay method of 24 hour proteinuria in assessment of PE 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 4. To develop a decision analytic model to estimate the diagnostic utility potential of replacing the 24 hour protein with the SPCr or SACr 5. To assess the cost effectiveness of SPCr or SACr in comparison to the 24 hour urine protein measurement

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026