Clinical trial NCT04170660: Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
Official title: AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suspected Placental Dysfunction, Ruled Out
Pregnancy Complications
Pre-Eclampsia
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women suspected of placental vascular disease

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.

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

Primary outcomes:
measure: Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)
timeFrame: trough participation period, an average of 4 months
Secondary outcomes:
measure: reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)
timeFrame: trough participation period, an average of 4 months
measure: reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)
timeFrame: trough participation period, an average of 4 months
measure: blood pressure (mmHg)
timeFrame: trough participation period, an average of 4 months
measure: number of patients with functional signs of hypertension
timeFrame: trough participation period, an average of 4 months
measure: number of patient with abnormal vascular and renal blood tests
timeFrame: trough participation period, an average of 4 months
measure: proteinuria (mg/mmol)
timeFrame: trough participation period, an average of 4 months
measure: Intra Uterine growth restriction (IUGR)
timeFrame: trough participation period, an average of 4 months
measure: fetal echography
timeFrame: trough participation period, an average of 4 months
measure: term of delivery (weeks of gestation)
timeFrame: at birth
measure: fetal weight at birth (g)
timeFrame: at birth
measure: number of hospitalized new born
timeFrame: at birth
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
Study officials:
References: