Interest of Circulating Endothelial Biomarkers in Vascular Pregnancy Complications
This is a prospective multicentric study including four clinical units of Gynecology and Obstetrics (3 public health hospitals and one private team), one research team in Hematology and one Center of Clinical investigation (CIC).
The objective is to identify, beside the pregnancy, in a population of patients with a preeclampsia (PE), with fetus presenting with growth restriction (IUGR) and a fetal demise (FD) a modification of circulating endothelial biomarkers compared with normal pregnancy.
We want to understand better the physiopathology of preeclampsia and propose to patients with an endothelial dysfunction a early prevention of preeclampsia.
Patients will be tested 3 times : At the pregnancy events; then 8 weeks and 12 months after the birth.
Four groups will be constituted among patients: PE, IUGR, FD and normal pregnancy.
Normal pregnancy will be tested as controls. The next pregnancy presenting in the unit to medical pregnancy follow up will be invited to participate.
The main judgment criteria will be the levels of endothelial microparticles 8 weeks after the event.
The study will last 3 years. The number of patient to include is 280.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Marseille、法国、13385
- Hôpital de la Conception
-
Marseille、法国、13015
- Hôpital Nord
-
Marseille、法国、13008
- Hôpital Saint-Joseph - Service de Gynécologie-Obstétrique
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Nice、法国
- Chu Nice Hopital de L'Archet
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- pregnant patients aged more than 18 years and more than 12 weeks of gestation for FD group, 20 weeks of gestation for PE or IUGR group , presenting either:
- PE (arterial pressure more than 140 mm Hg and 90 mm Hg) and at least a proteinuria evaluated on stick (one point) or 300 mg/24h.
- IUGR with biometries below 5° percentile according to the graphs of fetal echography college after 20 weeks of gestation.
- FD after 12 weeks of gestation or with a cranio-caudal length of more than 45 mm.
- Normal pregnancy adjusted for gestational age and parity : Patient should have no cardio-vascular past with a normal complication at the inclusion time and from which pregnancy remains uneventful until the term. The onset of premature delivery, hypertension or fetal growth restriction will exclude patients from the control group.
- social security cover
- written informed consent
Exclusion Criteria:
- Foetal malformation
- APLS known
- Set back of patient consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
假比较器：control group
|
验血
|
|
实验性的：prééclampsies group
|
验血
|
|
实验性的：RCIU group
|
验血
|
|
实验性的：MFIU group
|
验血
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Bring to light except the pregnancy within a population of presenting patients one EP, a RCIU and a MFIU a modification of biomarkers circulating endothéliaux with regard to the normal pregnancy.
大体时间：3 years
|
3 years
|
合作者和调查者
调查人员
- 首席研究员：Florence BRETELLE, PU-PH、Unité Mère-Enfant Hôpital Nord 13005 Marseille - Assistance Publique Hôpitaux de Marseille
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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