Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
600 participants
OBSERVATIONAL
2018-04-01
2022-06-30
Brief Summary
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Detailed Description
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REPORTS study aims to determine the diagnostic utility of 2 preeclampsia biomarkers (sFlt-1/PlGF ratio) in clinical decision making in preeclamptic women.
Data are collected by DACIMA Clinical Suite, according to FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation)
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Between 26 weeks of gestation and 37 weeks of gestation \& 6 days
Exclusion Criteria
20 Years
50 Years
FEMALE
No
Sponsors
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Maternity Center of Tunis
UNKNOWN
Dacima Consulting
OTHER
Responsible Party
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Principal Investigators
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Dalenda Chelli, MD
Role: STUDY_CHAIR
Maternité de la Rabta - Tunis
Youcef Djedid, MD
Role: PRINCIPAL_INVESTIGATOR
Maternité de la Rabta - Tunis
Locations
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Maternity Center of Tunis
Tunis, , Tunisia
Countries
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Other Identifiers
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DAC-003-REPORTS
Identifier Type: -
Identifier Source: org_study_id
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