NCT06314555

Impact of the sFlt-1/PlGF Ratio on Medical Decision-making and on Maternal and Neonatal Outcomes in Women Suspected of Preeclampsia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 314 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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-1/PlGF 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 99.3%. A ratio equal or higher than 38 permits to direct high-risk patients towards hospitalization with a positive predictive value of 36.7% 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-1/PlGF 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.

Conditions

• Preeclampsia Possible

Interventions

Type	Name	Description
OTHER	Blood sample	Blood sample to analyse the values of sFlt-1 and PlGF
OTHER	Vascular-renal sample	Usual vascular-renal sample to analyse the values of sFlt-1 and PlGF

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-01-27
• Completion: 2021-01-27
• First posted: 2024-03-18
• Last updated: 2024-03-18

Locations

1 site across 1 country: France