sFlt-1/PlGF Ratio: Impact on the Management of Patients With Suspected Pre-eclampsia (PROSPE)
Pre-Eclampsia
About this trial
This is an interventional diagnostic trial for Pre-Eclampsia
Eligibility Criteria
Inclusion Criteria:
- Pregnant patient
- Affiliated to the Social Security
- Signature of informed consent
- Term > 24 week of amenorrhea and < 37 week of amenorrhea
Presence of at least 2 of the following signs: de novo hypertension (Systolic Blood Pressure ≥ 140 mmHg and/or Diastolic Blood Pressure ≥ 90 mmHg) or worsening of pre-existing hypertension (increase of more than 10 mmHg in usual Systolic Blood Pressure and/or Diastolic Blood Pressure)
- De novo proteinuria onset (24h proteinuria ≥ 0.3 g/24h or proteinuria/creatinuria ratio ≥ 0.3) or worsening of pre-existing proteinuria
- Criteria for clinical suspicion of pre-eclampsia: epigastric pain, excessive edema, headache, visual disturbances, sudden weight gain (> 1kg/week in the 3rd trimester)
- Biological signs related to pre-eclampsia: low platelet count (thrombocytopenia < 150 G/L), liver cytolysis (AST and/or ALT AST greater than 2 times normal)
- Suspicion of intrauterine growth retardation on obstetrical ultrasound with no other cause found
Exclusion Criteria:
- 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.
- 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.)
Sites / Locations
- Nice University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard
Biomarkers
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.
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