AngioCHIC : Interest of sFlt1/PlGF Ratio at Obstetric Emergencies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
Reconvening period in patients with an sFlt1 (Soluble FMS like tyrosin-kinase-1)/PlGF (Placental Growth Factor) ratio <38 (day)
时间窗: 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.
次要结局
- reconvening period in patients with an sFlt1/PlGF ratio between 38 and 85 (day)(trough participation period, an average of 4 months)
- reconvening period in patients with an sFlt1/PlGF ratio superior to 85 (day)(trough participation period, an average of 4 months)
- blood pressure (mmHg)(trough participation period, an average of 4 months)
- number of patients with functional signs of hypertension(trough participation period, an average of 4 months)
- number of patient with abnormal vascular and renal blood tests(trough participation period, an average of 4 months)
- proteinuria (mg/mmol)(trough participation period, an average of 4 months)
- Intra Uterine growth restriction (IUGR)(trough participation period, an average of 4 months)
- fetal echography(trough participation period, an average of 4 months)
- term of delivery (weeks of gestation)(at birth)
- fetal weight at birth (g)(at birth)
- number of hospitalized new born(at birth)