Biomarkers and Preeclampsia Outcomes (REPORTS)
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|ClinicalTrials.gov Identifier: NCT03801447|
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 15, 2019
|Condition or disease|
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)
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Biomarkers ratio [ Time Frame: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia ]sFlt-1/PlGF ratio
- Biomarkers ratio [ Time Frame: Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia ]sFlt-1/PlGF ratio
- Biomarkers ratio [ Time Frame: Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia ]sFlt-1/PlGF ratio
- Maternal outcome [ Time Frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks ]Incidence of retroplacental hematoma, or HELLP syndrome (Hemolysis, Elevated liver enzyme levels, and Low Platelet levels), or Renal failure.
- Fetal outcome [ Time Frame: From date of inclusion until the date of first documented event, assessed up to 24 weeks ]Incidence of a composite fetal outcome (in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity)
- Fetal outcome [ Time Frame: Date of delivery ]Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801447
|Contact: Dalenda Chelli, MDemail@example.com|
|Contact: Rabie Razgallah, MDfirstname.lastname@example.org|
|Maternity Center of Tunis||Recruiting|
|Tunis, Tunisia, 1006|
|Contact: Dalenda Chelli, MD +21622889018 email@example.com|
|Contact: Rabie Razgallah, MD +21620509729 firstname.lastname@example.org|
|Study Chair:||Dalenda Chelli, MD||Maternité de la Rabta - Tunis|