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

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Pregnant patient

• Affiliated to the Social Security

• Signature of informed consent

• Term \> 24 week of amenorrhea and \< 37 week of amenorrhea

• Single criterion among the following: (only one box below must be ticked to allow inclusion):

‣ de novo hypertension (PAS ≥ 140 mmHg and/or PAD ≥ 90 mmHg) ;

⁃ worsening of pre-existing hypertension \>10 mmHg (on PAS or PAD ) ;

⁃ worsening of pre-existing proteinuria;

⁃ Excessive edema AND significant weight gain (minimum 2kg/week);

⁃ Headache AND another clinical sign (edema, rapid weight gain);

⁃ Visual disturbances (phosphenes and/or visual blur) AND/OR tinnitus;

⁃ Sudden weight gain (\> 1kg/week during the 3rd trimester);

⁃ Low platelet count (thrombocytopenia \< 150 G/L);

⁃ Hepatic cytolysis (ASAT and/or ALAT \> 2N) without associated pruritus or jaundice;

⁃ Suspicion of intrauterine growth retardation on obstetric ultrasound, with no other cause found (no hypertension or proteinuria, no clinical or biological signs of pre-eclampsia) and no abnormal fetal dopplers.

Locations
Other Locations
France
Nice University Hospital
Nice
Time Frame
Start Date: 2023-05-23
Completion Date: 2025-03-03
Participants
Target number of participants: 43
Treatments
Active_comparator: Standard
The monitoring criteria used will be the same as those usually used at the Nice University Hospital, according to the protocol of the department.~For patients in the standard group, the biomarker results will be masked and then revealed afterwards for statistical analysis.
Experimental: Biomarkers
The monitoring decision will be made based on the ratio calculation:~Ratio \< 38: Classic monitoring with one prenatal visit per month 38 ≤ Ratio ≤ 85: Close outpatient monitoring Ratio \> 85: Inpatient monitoring in Pathological Pregnancy
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov