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| Name | Class |
|---|---|
| Maternity Center of Tunis | UNKNOWN |
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Prospective, observational, monocentric, non-interventional study.
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)
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| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers ratio | sFlt-1/PlGF ratio | Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers ratio | sFlt-1/PlGF ratio | Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia |
| Biomarkers ratio | sFlt-1/PlGF ratio |
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Inclusion Criteria:
Exclusion Criteria:
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Preeclampsia was defined according to the ACOG (The American College of Obstetricians and Gynecologists). The diagnosis of Preeclampsia was based on clinical judgment and routine laboratory findings at inclusion.
Patients were suspected of Preeclampsia if they:
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| Name | Affiliation | Role |
|---|---|---|
| Dalenda Chelli, MD | Maternité de la Rabta - Tunis | Study Chair |
| Youcef Djedid, MD | Maternité de la Rabta - Tunis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity Center of Tunis | Tunis | 1006 | Tunisia |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia |
| Maternal outcome | Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure. | From date of inclusion until the date of first documented event, assessed up to 24 weeks |
| Fetal outcome | Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity) | From date of inclusion until the date of first documented event, assessed up to 24 weeks |
| Fetal outcome | Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity | Date of delivery |