Status:
COMPLETED
Preeclampsia Ratio (sFlt-1/PlGF)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Conditions:
Preeclampsia
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The aim of the PRECOG study is to determine in a prospective interventional randomized study whether the implementation of a predictive test based on the sFLT-1/PlGF ratio improves perinatal care and ...
Detailed Description
Preeclampsia is a hypertensive disorder of pregnancy associated with placental insufficiency and is one of the major important of prematurity and maternal mortality worldwide. It complicates 2 to 7% o...
Eligibility Criteria
Inclusion
- Patient hospitalized for suspected preeclampsia between 24WG+ 0 days and 35WG + 6 days,
- Patiente with at least one of the following criteria:
- Arterial hypertension defined by systolic BP ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg
- Proteinuria greater than 0.3g / 24h or 0.3g / l or ≥ 3+
- Proteinuria / creatinine ratio ≥ 30 mg / mmol
- Pain in the epigastric bar
- Generalized edema
- Hepatic cytolysis\> 1.5N
- Thrombocytopenia \<150000 / mm3 Informed consent signed by both parties Non-opposition was accepted by parental authority Age ≥ 18 years
Exclusion
- Diagnosis of preeclampsia (arterial pressure\> 140/90 and proteinuria\> 0.3g / 24h or urine test\> 3+) or complete HELLP syndrome (Platelets \<100000 / mm3 and SGOT\> 2N and LDH and collapsed Haptoglobin)
- IUGR with absent or reverse diastolic umbilical flow
- Fetal heart rate abnormalities
- Gestational age \<24 WG and\> 35 WG
- Multiple pregnancy
- Patient without health insurance
- Non-consent of patient
- Minor patient
- Congenital malformation
Key Trial Info
Start Date :
April 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 27 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03289611
Start Date
April 26 2018
End Date
August 27 2020
Last Update
November 20 2025
Active Locations (1)
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1
CHU Cochin, Maternité Port Royal
Paris, France, 75014