Biomarkers and Preeclampsia Outcomes

Completed

• Conditions: Preeclampsia

• Registration Number: NCT03801447
• Lead Sponsor: Dacima Consulting

Brief Summary

Prospective, observational, monocentric, non-interventional study.

Detailed 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)

Study Timeline

• Study Start: 2018-04-01
• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-19
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

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

Exclusion Criteria

• Multiple pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biomarkers ratio	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

Secondary Outcome Measures

Name	Time	Method
Biomarkers ratio	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
Fetal outcome	Date of delivery	Rate of in utero fetal death or, Intrauterine growth restriction, or APGAR \< 7, or Prematurity
Maternal outcome	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.

Trial Locations

Locations (1)

Maternity Center of Tunis; 🇹🇳 Tunis, Tunisia