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

ewcastle Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 959 人开始时间: 2012年10月16日最近更新: 2021年1月5日

适应症

试验速览

•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

•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)

发起方

ewcastle Hospitals NHS Foundation Trust (UK)