Biomarkers and Preeclampsia Outcomes (REPORTS)

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

Prospective, observational, monocentric, non-interventional study.

Study Overview

• Status: Completed
• Conditions: Preeclampsia

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 Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1006
    • Maternity Center of Tunis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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:

• presented with new onset hypertension and or proteinuria at or after 20 weeks of gestation
• developed an aggravation of their preexisting hypertension and or preexisting proteinuria
• or if they presented with symptoms such as right upper quadrant abdominal pain or headache with visual disturbances or PE-related findings (low platelets, elevated liver transaminases, Vascular Fetal Growth Restriction)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Dacima Consulting
• Collaborators: Maternity Center of Tunis
• Investigators: Study Chair: Dalenda Chelli, MD, Maternité de la Rabta - Tunis; Principal Investigator: Youcef Djedid, MD, Maternité de la Rabta - Tunis

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): June 30, 2022
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: May 27, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (ACTUAL): January 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia
• Other Study ID Numbers: DAC-003-REPORTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No