Clinical trial NCT03801447: Biomarkers and Preeclampsia Outcomes
Official title: Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Maternity Center of Tunis
First posted: 2019-01-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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)

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Multiple pregnancies

Primary outcomes:
measure: Biomarkers ratio
timeFrame: Every day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with severe preeclampsia
Secondary outcomes:
measure: Biomarkers ratio
timeFrame: Every two day from date of inclusion until date of delivery or up to 21 days whichever came first, in women with moderate preeclampsia
measure: Biomarkers ratio
timeFrame: Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia
measure: Maternal outcome
timeFrame: From date of inclusion until the date of first documented event, assessed up to 24 weeks
measure: Fetal outcome
timeFrame: From date of inclusion until the date of first documented event, assessed up to 24 weeks
measure: Fetal outcome
timeFrame: Date of delivery
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Maternity Center of Tunis
Study officials:
affiliation: Maternité de la Rabta - Tunis
name: Dalenda Chelli, MD
role: STUDY_CHAIR
affiliation: Maternité de la Rabta - Tunis
name: Youcef Djedid, MD
role: PRINCIPAL_INVESTIGATOR
References: