Biomarkers and Preeclampsia Outcomes

NCT ID: NCT03801447

Last Updated: 2022-08-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2022-06-30

Brief Summary

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Prospective, observational, monocentric, non-interventional study.

Detailed Description

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In practice, patients with preeclampsia are referred to the hospital for medical management only clinical signs \& symptoms and standard biological tests are available for patient individualized care. Hence, a new diagnostic tool to distinguish and stratify the different patients referred is in need of proper triage.

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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Preeclampsia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Suspected or confirmed preeclampsia
* Singleton pregnancy
* Between 26 weeks of gestation and 37 weeks of gestation \& 6 days

Exclusion Criteria

* Multiple pregnancies
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maternity Center of Tunis

UNKNOWN

Sponsor Role collaborator

Dacima Consulting

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Tunisia

Other Identifiers

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DAC-003-REPORTS

Identifier Type: -

Identifier Source: org_study_id

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