Interest of sFlt1/PlGF Ratio at Obstetric Emergencies (AngioCHIC)

AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pregnancy Complications; Pre-Eclampsia; Suspected Placental Dysfunction, Ruled Out
• Intervention / Treatment: Diagnostic test: Diagnostic test

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Centre Hospitalier Intercommunal de Créteil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

pregnant women suspected of placental vascular disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)	rate of reconvening	trough participation period, an average of 4 months
blood pressure (mmHg)	Blood pressure higher than 140/90 mm Hg	trough participation period, an average of 4 months
number of patients with functional signs of hypertension	phosphenes, accouphens, headaches, epigastric bar, edema	trough participation period, an average of 4 months
number of patient with abnormal vascular and renal blood tests	platelets, transaminase, uric acid, ionogram	trough participation period, an average of 4 months
proteinuria (mg/mmol)	urine protein-creatinine (P/C) ratio, mg/mmol	trough participation period, an average of 4 months
Intra Uterine growth restriction (IUGR)	estimate foetal weight < 10 percentile or < 5 percentile	trough participation period, an average of 4 months
fetal echography	umbilical and/or cerebral doppler	trough participation period, an average of 4 months
term of delivery (weeks of gestation)	Analysis of term delivery with stratification by sFlt-1/PlGF ratio	at birth
fetal weight at birth (g)	Analysis of fetal weight with stratification by sFlt-1/PlGF ratio	at birth
number of hospitalized new born	Analysis of number of hospitalized new born with stratification by sFlt-1/PlGF ratio	at birth

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2019
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Emergencies; Eclampsia; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: AngioCHIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No