Feasibility Study of the Measurement of the Placental Perfusion During the First Trimester of Pregnancy by 3D Doppler Echo-angiography With a Contrast Agent
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- The measurement of signal strength
研究概览
简要总结
The purpose of this study is to quantify the placental perfusion during the first trimester of pregnancy by 3D Doppler ultrasound angiography without a contrast agent and by ultrasound with a contrast agent: SonoVue®
详细描述
The quality of the utero-placental vascularization is a major point for the foetal healthy development and for the healthy pregnancy. Pre-eclampsia (PE) and the Intra-Uterine Growth Retardation (IUGR) are currently two of the major pregnancy complications in the West. Those placental pathologies cause more than 30 per cent of the foetal and maternal morbidity-mortality. The relationship between these pathologies, affecting 4 to 7 per cent of pregnancies, and a chronic utero-placental hypoperfusion, which is caused by a failure of implantation during the first trimester of pregnancy, has been confirmed.
A hypoxic environment surrounds the embryonic implantation and the first steps of the placental development into uterus. Moreover, the maternal-foetal exchanges space (the Inter-Villi Space or IVS) is so maternal-bloodless. At the pregnancy first period are released there uterine secretions and a plasmatic ultra-filtrate. Indeed, the ends of the uterine arteries are plugged by trophoblastic plugs.
It was also accepted that the disappearance of these plugs, a major step in the implementation of the mother-fetal interface, occurred around 10 weeks of amenorrhea (10 SA). However, a recent study questions this dogma since the presence of blood in the intervilleous chamber has just been detected as early as 6 weeks of amenorrhea (6SA). In addition, an increase in blood flow within the IVS is found between 6 and 13 SA. Thus, it would appear that chronic placental hypoperfusion phenomena are more related to a vascular flow defect within the IVS than to the disappearance of endovascular plugs.
These new advances come from a single recent publication which was carried out on a small number of people (maximum 4 women per group).
It is therefore essential to carry out further studies to confirm that the infusion of IVS occurs very early and to evaluate the evolution of infusion kinetics with gestational age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and <65 years,
- •Gestational Age: 8 SA ≤ gestational age ≤ 8 SA + 6 days or 11 SA ≤ gestational age ≤ 11 SA + 6 days,
- •BMI ≤40 kg / m²,
- •Having confirmed his request for termination of pregnancy surgically
排除标准
- •Any medical contraindication for administration of
- •SonoVue including:
- •Hypersensitivity to sulfur hexafluoride or any of the other components of SonoVue®,
- •Women with recent acute coronary syndrome or suffering from an unstable ischemic heart disease,
- •women having a right-left shunt, severe pulmonary hypertension (pulmonary artery pressure> 90 mmHg), an uncontrolled systemic hypertension and woman with respiratory distress syndrome
- •Women with risk for IUGR / PE namely:
- •Previous history of PE or stunting staff
- •Autoimmune disease,
- •Chronic Hypertension
研究组 & 干预措施
surgical termination of pregnancy
Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients for ultrasound angiography during the termination of pregnancy. 2,4 mL are administrated per patient, divided into two injections of 1,2 mL.
干预措施: Contrast agent: SonoVue®. (Drug)
结局指标
主要结局
The measurement of signal strength
时间窗: 1 day
The measurement of signal strength (in arbitrary units) in the Inter-Villi Space in the first trimester (at 8SA, 11SA and 13SA) obtained by contrast ultrasound, in women who have confirmed a voluntary termination of pregnancy.
次要结局
- Comparison of quantitative data on uteroplacental vascularization obtained with the 2 techniques.(1 day)
- Obtaining analyzable placental villi for the study of the development and functions of the human placenta.(1 day)
- Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: signal strength(1 day)
- Measurement of the vascularization parameters of the Inter-Villi Space (IVS) and myometrium: infusion kinetics.(1 day)