Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

Pre-Eclampsia Clinical Trial

— AngioCHIC  

Official title:

AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04170660
• Other study ID #: AngioCHIC
• Status: Active, not recruiting
• Start date: November 18, 2019
• Est. completion date: December 2023

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Emergencies
• Pre-Eclampsia
• Pregnancy Complications
• Suspected Placental Dysfunction, Ruled Out

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)	At the end of pregnancy, calculation of the average time between the 1st consultation and the 1st reconvening in patients with an sFlt1/PlGF ratio <38, unknown during pregnancy, to determine if consultations could have been avoided.	trough participation period, an average of 4 months
Secondary	reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)	rate of reconvening	trough participation period, an average of 4 months
Secondary	reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)	rate of reconvening	trough participation period, an average of 4 months
Secondary	blood pressure (mmHg)	Blood pressure higher than 140/90 mm Hg	trough participation period, an average of 4 months
Secondary	number of patients with functional signs of hypertension	phosphenes, accouphens, headaches, epigastric bar, edema	trough participation period, an average of 4 months
Secondary	number of patient with abnormal vascular and renal blood tests	platelets, transaminase, uric acid, ionogram	trough participation period, an average of 4 months
Secondary	proteinuria (mg/mmol)	urine protein-creatinine (P/C) ratio, mg/mmol	trough participation period, an average of 4 months
Secondary	Intra Uterine growth restriction (IUGR)	estimate foetal weight < 10 percentile or < 5 percentile	trough participation period, an average of 4 months
Secondary	fetal echography	umbilical and/or cerebral doppler	trough participation period, an average of 4 months
Secondary	term of delivery (weeks of gestation)	Analysis of term delivery with stratification by sFlt-1/PlGF ratio	at birth
Secondary	fetal weight at birth (g)	Analysis of fetal weight with stratification by sFlt-1/PlGF ratio	at birth
Secondary	number of hospitalized new born	Analysis of number of hospitalized new born with stratification by sFlt-1/PlGF ratio	at birth