Health Condition 1: O140- Mild to moderate pre-eclampsia
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Perkin Elmer India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1)Pregnant women >=18 years 2)Gestational week 20+0 days â?? 36+6 days 3)Signed written informed consent 4)Suspicion of clinical diagnosis of PE based on one or more of the following criteria: 1.BP more than 140/90 with or with out proteinuria 1+ 2.BP less than 140/90 with 2+ proteinuria 3.Symptoms of PE with normal BP 4.Aggravation of pre-existing hypertension (>=160 mmHg systolic and/or >=110 mmHg diastolic, single measurement)
Exclusion criteria
Exclusion criteria: 1)Proteinuria >=2+ (dipstick) (or in case available >=0.3 g protein/24 hours or >=30 mg/dL protein in spot urine or spot urine protein/creatinine ratio >=30 mg protein/mmol creatinine) AND elevated BP (>=140 mmHg systolic and/or >=90 mmHg diastolic, reproducible on two occasions) 2)Proteinuria >=2+ (dipstick) (or in case available >=0.3 g protein/24 hours or >=30 mg/dL protein in spot urine or spot urine protein/creatinine ratio >=30 mg protein/mmol creatinine) AND current anti-hypertensive treatment 3)Multiple pregnancy 4)Confirmed diagnosis of HELLP syndrome 5)Confirmed diagnosis of a fetal chromosomal abnormality 6)Concomitant participation in another clinical trial (with exception of existing Biobanks or observational studies site-specifically agreed upon with research development before enrollment 7)Investigational medicinal product received in the past 3 months (90 days)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Clinical performance of urine congophilia test at visit 1 and/or subsequent visits 2) changes of urine congophilia to predict PE / HELLP syndrome (according to diagnostic criteria) within one and four weeks from visit 1Timepoint: 1) visit 1- 20-24 weeks 2) visit 2- 24-28 weeks 3) visit 3- 28-32 weeks 4) visit 4- 32 weeks- delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| o Clinical performance of urine congophilia test at visit 1 and/or subsequent visits or changes of urine congophilia to evaluate PE-related adverse outcomes other than PE / eclampsia / HELLP syndrome of mother and fetus within one and four weeks from visit 1 Timepoint: within one and four weeks from visit 1 | — |
Countries
India
Contacts
Public ContactK Aparna Sharma
All India Institute Of Medical Sciences, New Delhi
Outcome results
None listed