Pre-Eclampsia, Pregnancy Complications, Suspected Placental Dysfunction, Ruled Out
Conditions
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.
Interventions
DIAGNOSTIC_TESTDiagnostic test
During a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio.
Sponsors
Centre Hospitalier Intercommunal Creteil
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day) | trough participation period, an average of 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day) | trough participation period, an average of 4 months | rate of reconvening |
| blood pressure (mmHg) | trough participation period, an average of 4 months | Blood pressure higher than 140/90 mm Hg |
| number of patients with functional signs of hypertension | trough participation period, an average of 4 months | phosphenes, accouphens, headaches, epigastric bar, edema |
| number of patient with abnormal vascular and renal blood tests | trough participation period, an average of 4 months | platelets, transaminase, uric acid, ionogram |
| proteinuria (mg/mmol) | trough participation period, an average of 4 months | urine protein-creatinine (P/C) ratio, mg/mmol |
| reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day) | trough participation period, an average of 4 months | rate of reconvening |
| fetal echography | trough participation period, an average of 4 months | umbilical and/or cerebral doppler |
| term of delivery (weeks of gestation) | at birth | Analysis of term delivery with stratification by sFlt-1/PlGF ratio |
| fetal weight at birth (g) | at birth | Analysis of fetal weight with stratification by sFlt-1/PlGF ratio |
| number of hospitalized new born | at birth | Analysis of number of hospitalized new born with stratification by sFlt-1/PlGF ratio |
| Intra Uterine growth restriction (IUGR) | trough participation period, an average of 4 months | estimate foetal weight \< 10 percentile or \< 5 percentile |
Countries
France
Outcome results
None listed