Phase
Condition
Pregnancy Complications
Treatment
sFlt-1/PlGF ratio - Experimental: Biomarkers
sFlt-1/PlGF ratio - Active Comparator: Standard
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 allowinclusion):
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 orjaundice;
Suspicion of intrauterine growth retardation on obstetric ultrasound, with noother cause found (no hypertension or proteinuria, no clinical or biologicalsigns of pre-eclampsia) and no abnormal fetal dopplers.
Exclusion
Exclusion Criteria:
Minor patient
Patient with poor clinical tolerance of hypertension and/or need for immediateintroduction of intravenous antihypertensive therapy
Patient with a specific complication of pre-eclampsia requiring immediate managementat 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) orworsening of pre- existing proteinuria;
Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessiveedema, 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 noother 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 toprotect his or her own interests may be inadequate (e.g., persons deprived ofliberty, minors, persons under guardianship, persons with mental or emotionaldisabilities in the broadest sense of the word, illiterate persons, refugees andasylum seekers, alcoholics and drug addicts, etc.)
Study Design
Connect with a study center
Nice University Hospital
Nice,
FranceActive - Recruiting
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