Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

NCT ID: NCT04170660

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-18
• Study Completion Date: 2023-12-31

Brief Summary

In patients with suspected placental vascular disease who do not require hospitalization, the use of the sFlt-1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor)/ assay can most likely help teams to define the best possible management.

Detailed Description

Preeclampsia is a serious obstetric condition, affecting 2 to 5% of pregnancies and associated with maternal hypertension and renal dysfunction. It is a constant concern of obstetrical teams in the pre and post partum period. In case of diagnosis in the emergency unit, patients are usually hospitalized. However, in the case of a diagnosis of preeclampsia has been invalidated, but in presence of isolated or frustrated clinical functional signs, in the case of a history of placental vascular pathology, obstetric teams implement surveillance strategies that are binding on the patients.

The sFlt-1/ PlGF assay has a high negative predictive value for the coming week.

The use in clinical practice of these two biomarkers in the indication of negative prediction at one week could help teams in their management but the interest of this use needs to be evaluated.

Conditions

Suspected Placental Dysfunction, Ruled Out; Pregnancy Complications; Pre-Eclampsia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Diagnostic test

During a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years old
• Pregnant patients term ≥ at 24 weeks of amenorrhoea (SA),
• Management in obstetrical emergencies and at the Centre Hopsitalier Intercommunal (CHI) de Créteil functional exploration center, with prescription of a vascular-renal check-up (BVR) ((proteinuria/creatinuria ratio, blood count, platelets, blood ionogram, creatinemia, transaminases (ASAT, ALAT), haptoglobulinemia, lactate dehydrogenase (LDH), TP).
• Presenting either one of the following isolated or associated clinical parameters:
• HyperTension
• urinary tape proteinuria
• functional signs of hypertension (headaches, phosphenes, accouphènes)
• live osteotendinous reflexes
• epigastric pains
• weight gain, lower limb edema, facial edema
• oliguria
• vomiting
• or one of the following isolated or associated ultrasound parameters:
• fetal hypotrophy, fetal growth deflection
• fetal Doppler abnormalities (umbilical Doppler, cerebral Doppler)
• ooligo-anamnios with intact membranes
• patient who has been informed and has given her oral non-opposition

Exclusion Criteria

• Diagnosis of preeclampsia
• Refusal of the patient
• Patient whose symptomatology (clinical or paraclinical) leads to a decision to be hospitalized
• Age < 18 years old
• Non-affiliation to the general social security system

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Intercommunal de Créteil

Créteil, , France

Countries

France

Other Identifiers

AngioCHIC

Identifier Type: -

Identifier Source: org_study_id