Status:
COMPLETED
sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Pre-Eclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Minor patient
- Patient with poor clinical tolerance of hypertension and/or need for immediate introduction of intravenous antihypertensive therapy
- Patient with a specific complication of pre-eclampsia requiring immediate management at the time of inclusion: in utero fetal death, retroplacental hematoma, disseminated intravascular coagulation or emergency cesarean section.
- Association of at least 2 of the following criteria:
- De novo proteinuria (24h proteinuria ≥ 0.3 g/24h or P/C ratio ≥ 0.3) or worsening of pre- existing proteinuria;
- Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessive edema, headaches, visual disturbances, sudden weight gain (\> 1kg/week in the 3rd trimester);
- Biological signs associated with pre-eclampsia: low platelet count (thrombocytopenia \< 150 G/L), hepatic cytolysis (ASAT and/or ALAT \> 2N);
- Suspicion of intrauterine growth retardation on obstetrical ultrasound, with no other cause found.
- A combination of at least 2 of these criteria raises the suspicion of pre-eclampsia, and, according to the new CNGOF recommendations of 2024, requires systematic initial hospitalization.
- \- Vulnerable person requiring enhanced protection, i.e., relatively (or totally) unable to protect their own interests. Specifically, the person's power, intelligence, education, resources, strength, or other attributes necessary to protect his or her own interests may be inadequate (e.g., persons deprived of liberty, minors, persons under guardianship, persons with mental or emotional disabilities in the broadest sense of the word, illiterate persons, refugees and asylum seekers, alcoholics and drug addicts, etc.)
Key Trial Info
Start Date :
May 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05228002
Start Date
May 23 2023
End Date
March 3 2025
Last Update
September 9 2025
Active Locations (1)
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1
Nice University Hospital
Nice, France