NCT05228002: PROSPE

sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia

Completed NA Last updated 9 September 2025

What this trial tests

NA trial testing sFlt-1/PlGF ratio - Active Comparator: Standard in Pre-Eclampsia in 43 participants. Completed in 3 March 2025.

Timeline

23 May 2023

Primary endpoint
3 March 2025

3 March 2025

Quick facts

Lead sponsor	Centre Hospitalier Universitaire de Nice
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	43
Start date	23 May 2023
Primary completion	3 March 2025
Estimated completion	3 March 2025
Sites	1 location across France

Drugs / interventions tested

• sFlt-1/PlGF ratio - Active Comparator: Standard
• sFlt-1/PlGF ratio - Experimental: Biomarkers

Conditions studied

• Pre-Eclampsia — all drugs for Pre-Eclampsia →

Sponsor

Centre Hospitalier Universitaire de Nice

Who can join

18 and older, female only, with Pre-Eclampsia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pre-eclampsia is a specific pathology of pregnancy classically associating arterial hypertension with proteinuria. Its prevalence in industrialized countries is 3 to 8% of pregnancies, which makes it a frequent pathology, and it is responsible for 30% of premature deliveries. The consequences of this pathology can be very serious for the mother:renal insufficiency, hepatic cytolysis, retro-capsular hematoma of the liver, convulsions, disseminated intravascular coagulation. Moreover, the consequences on the fetus and the pregnancy are just as serious: intrauterine growth retardation, induced prematurity, retroplacental hematoma, fetal death in utero.

Pre-eclampsia therefore remains difficult to diagnose and to prognose. The diagnosis of pre-eclampsia based on blood pressure and proteinuria has a predictive value of 30% for adverse outcomes related to pre-eclampsia.

In recent years, new biomarkers have been studied: PlGF, a placental growth factor, and sFlt-1, the free fraction of its membrane receptor.The pathophysiology and specificity of these biomarkers, but especially their ratio, has been widely studied and demonstrated in the diagnosis and prognosis of preeclampsia.

Nevertheless, few studies have analyzed the impact of this report on the hospitalization of patients, except mainly a German study which showed a change in the decision to hospitalize in 16.9% of cases. On the other hand, no French study has been carried out on this subject. Finally, no professional recommendation fully integrates or clearly frames the use of the ratio in current practice. Its use therefore remains disparate between countries, but also within the same country, as in France, where few centers use it.

The decision to hospitalize a patient with suspected preeclampsia depends on the organization of the health care system. It therefore seems interesting to analyze the precise impact on hospitalizations of the use of a diagnostic and prognostic tool such as the sFlt-1/PlGF ratio with the specificities of the French health system, which favors outpatient management.The study would evaluate the use of this promising tool in the daily management of parturients, paving the way for the development of simple recommendations applicable in the various French maternity hospitals.

The hypothesis is that the use of the sFlt-1/PlGF ratio in patients with suspected pre-eclampsia would reduce the rate of hospitalization.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Placental Growth Factor (PlGF)- Based Biomarker Testing to Help Diagnose Pre-eclampsia in People With Suspected Pre-eclampsia: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2023 · cited 4× · PMID 37284279