Biomarkers and Preeclampsia Outcomes
REPORTS
Ratio of Angiogenesis-related Biomarkers (sFlt-1/PlGF) in the Prediction Of mateRnal & feTal outcomeS
1 other identifier
observational
600
1 country
1
Brief Summary
Prospective, observational, monocentric, non-interventional study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2018
CompletedFirst Submitted
Initial submission to the registry
May 27, 2018
CompletedFirst Posted
Study publicly available on registry
January 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedAugust 22, 2022
August 1, 2022
4.2 years
May 27, 2018
August 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Biomarkers 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
Weekly from date of inclusion until date of delivery or up to 3 weeks whichever came first, in women with mild preeclampsia
Maternal outcome
From date of inclusion until the date of first documented event, assessed up to 24 weeks
Fetal outcome
From date of inclusion until the date of first documented event, assessed up to 24 weeks
Fetal outcome
Date of delivery
Eligibility Criteria
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)
You may qualify if:
- Suspected or confirmed preeclampsia
- Singleton pregnancy
- Between 26 weeks of gestation and 37 weeks of gestation \& 6 days
You may not qualify if:
- Multiple pregnancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dacima Consultinglead
- Maternity Center of Tuniscollaborator
Study Sites (1)
Maternity Center of Tunis
Tunis, 1006, Tunisia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Dalenda Chelli, MD
Maternité de la Rabta - Tunis
- PRINCIPAL INVESTIGATOR
Youcef Djedid, MD
Maternité de la Rabta - Tunis
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2018
First Posted
January 11, 2019
Study Start
April 1, 2018
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
August 22, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share