Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06314555
Status:
COMPLETED
Last Update Posted:
2024-03-18
First Post:
2024-03-11
Brief Title:
Impact of the sFlt-1PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Impact of the sFlt-1PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Previous studies demonstrated that Placental Growth Factor PIGF and Vascular Endothelial Growth Factor VEGF produced by trophoblast cells decreases during Preeclampsia whereas soluble fms-like tyrosine kinase-1 sFlt-1 an antiangiogenic factor increases The ratio sFlt-1PlGF has a higher positive predictive value than the isolated measurement A ratio under 38 exclude risk of imminent preeclampsia and allows to outpatient follow-up with a negative predictive value of 993 A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 367 of preeclampsia at 4 weeks These findings suggest that the ratio can be used to select more appropriately women needing hospitalization for suspected preeclampsia
Detailed Description:
This is a single-center prospective and observational study conducted from the 1rst of October 2019 to the 27th of January 2021 including pregnant women suspected of preeclampsia above 24 weeks of gestation Values were measured using the Elecsys sFlt-1PlGF immunoassay ratio The investigators observed the clinical decision regarding hospitalization intensive patient monitoring corticosteroid administration and labor induction before and after knowing the ratio value
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None