A kit test for prediction of high blood pressure in pregnancy

Not Applicable

Conditions: Health Condition 1: O140- Mild to moderate pre-eclampsia

Registration Number: CTRI/2020/09/028004

Lead Sponsor: Perkin Elmer India Private Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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)

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Clinical performance of urine congophilia test at visit 1 and/or subsequent visits <br/ ><br>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 <br/ ><br>2) visit 2- 24-28 weeks <br/ ><br>3) visit 3- 28-32 weeks <br/ ><br>4) visit 4- 32 weeks- delivery

Secondary Outcome Measures

Name	Time	Method
oClinical 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 <br/ ><br>Timepoint: within one and four weeks from visit 1