The Evaluation of UTERO - Placental 3D Doppler Examination Potential Interest for Pre- Eclampsia Screening During Pregnancy. Observational Study in 100 Women at High Risk for Pre- Eclampsia and 70 Low Risk Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Existence of pre eclampsia and/or IUGR
研究概览
简要总结
Pre-eclampsia and intra uterine growth restriction (IUGR) represent major complications for pregnant women, with a high related maternal and fetal morbidity and mortality. It is now widely admitted that these pathologies, which can concern up to 7% of pregnancies, are in relation with hypo-perfusion of the placenta because of an early deficient trophoblast invasion and uterine vascular remodelling.Advances in ultrasound imaging now permit non invasive 3D volume and Doppler signal quantification using automatic acquisitions.Quantitative comparison of volumes and Doppler parameters between control pregnancies and IUGR ought to confirm the theory of UTERO-placental hypo-perfusion. This technique might allow an earlier prediction for IUGR. The aim of this study is to evaluate the interest of 3D Doppler quantification as a new screening tool for pre eclampsia and IUGR.
详细描述
One hundred high risk women and 70 low risk women will be included. Inclusion criteria for the high risk group are: personal history of pre eclampsia and/or IUGR in a previous pregnancy, diabetes, auto-immune syndrome such as LUPUS, hypertension, renal insufficiency, and anti-phospholipid syndrome.Patients (over 18 years old) will be included between 11 and 14(+6days) WG. Only singletons pregnancies will be included.3D Doppler standardized acquisitions of the UTERO-placental unit will be performed at each usual ultrasound examination of the pregnancy.Data will be analysed after delivery, in terms of quantified Doppler values, comparing two groups: pregnancies with pre eclampsia / IUGR (group with pathology) and normal pregnancies (control group).This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 是
入选标准
- •Age eligible for study up to 18 years
- •Gestational age between 11 to 14 weeks for the first visit (first-trimester pregnancy).-Singleton pregnancy
- •Consent to participate in the study
- •Patients affiliated to social security
- •Personal History of:
- •Preeclampsia during a previous pregnancy: Blood pressure more than 140 mmHg systolic and/or 90 mmHg diastolic + proteinuria
- •IUGR during a previous pregnancy (birth weight < 10th centile)
- •Hypertension
- •Renal insufficiency
- •Autoimmune Disease : Antiphospholipid syndrome
- •Group 2:Absence of all the Group 1 affiliation criteria.
排除标准
- •Participating in the study
- •Unability to understand the study
- •Set back of patient consent.
结局指标
主要结局
Existence of pre eclampsia and/or IUGR
时间窗: at the end of the pregnancy
次要结局
未报告次要终点