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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2018/03/012508 |
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Date of registration:
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12-03-2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Preeclampsia study on first, second and third trimesters of pregnancy
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Scientific title:
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Prospective Validation of Prediction algorithms for Preeclampsia in the first, second and third Trimesters of pregnancy |
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Date of first enrolment:
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18-09-2017 |
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Target sample size:
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10000 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22498 |
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Study type:
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Observational |
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Study design:
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Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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N/A
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Countries of recruitment
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China
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Hong Kong
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India
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Indonesia
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Japan
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Singapore
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Taiwan
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Thailand
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Viet Nam
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Contacts
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Name:
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Dr Sudarshan Suresh
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Address:
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197, Mediscan Systems,
Dr. Natesan Road,
Mylapore
Chennai-600004
600004
Chennai, TAMIL NADU
India |
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Telephone:
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Email:
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msinfo@mediscan.org.in |
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Affiliation:
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Mediscan Systems |
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Name:
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Dr Sudarshan Suresh
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Address:
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197, Mediscan Systems,
Dr. Natesan Road,
Mylapore
Chennai-600004
600004
Chennai, TAMIL NADU
India |
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Telephone:
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Email:
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msinfo@mediscan.org.in |
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Affiliation:
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Mediscan Systems |
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Key inclusion & exclusion criteria
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Inclusion criteria: singleton pregnancy with live fetus
those who sign the Informed Consent Form
Exclusion criteria: multiple pregnancy, non viable fetus and not signing the consent form
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Primary Outcome(s)
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False positive and true positive for screening for all PreEclampsia and preterm-PE using Bayes theorem based in the first and second trimester of pregnancyTimepoint: December 2017 - 25 subjects with data quality validated by the sponsor have been enrolled
december 2018 study
outcome data after delivery
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Secondary Outcome(s)
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false positive and true positive frequencies for screening of SGA neonates and preterm and also deliveries before 37 weeksTimepoint: 37 weeks
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Source(s) of Monetary Support
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Mediscan systems
197, Dr. Natesan Road,
Mylapore, Chennai-600004
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Ethics review
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Status: Approved
Approval date: 05/06/2017
Contact:
Fetal care Research Foundation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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