Biomarkers and Preeclampsia Outcomes

Preeclampsia Clinical Trial

— REPORTS  

Official title:

Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03801447
• Other study ID #: DAC-003-REPORTS
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Dacima Consulting
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prospective, observational, monocentric, non-interventional study.

Description:

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Multiple pregnancies

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Tunisia	Maternity Center of Tunis	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
Dacima Consulting	Maternity Center of Tunis

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Biomarkers ratio	sFlt-1/PlGF ratio	Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia
Secondary	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
Secondary	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
Secondary	Fetal outcome	Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR < 7, or Prematurity	Date of delivery