LimPrOn: Limburg Pre-eclampsia Investigation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 11
- 主要终点
- Maltron measurement
研究概览
简要总结
Background:
Multiple adaptations at the cardiovascular system occurs during pregnancy. In the pregnancy condition pre-eclampsia (PE), this adaptations are abnormal. Five to eight percent of all pregnant women worldwide will develop PE.
PE is a pregnancy condition which is characterized with a high blood pressure (>140/90 mm Hg) and the occurrence of proteinuria (>3g/dl/24h) after 20 weeks of gestation. When untreated, this condition can have severe complications for both mother and child. It's important to monitor women with a high risk for developing PE for an early detection and treatment of this condition.
For this reason, a multicenter study is set up with the following applications:
- NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins.
- Maltron: bio-electronic impedance analyze
- Remote monitoring of the high risk patients to become a more intensive follow-up
Number of inclusions: 2000 pregnant women from the prenatal consultations of eight different hospitals:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •> 10 weeks of pregnancy, primipara and multipara
排除标准
- •< 10 weeks of pregnancy and congenital malformations of the fetus
结局指标
主要结局
Maltron measurement
时间窗: 20 weeks of pregnancy
The aim of this course is to describe the course of body composition and fluid balance through a normal pregnancy, and to examine any abnormalities in pre-eclamptic pregnancies.
Weight
时间窗: 20 weeks of pregnancy
Activity tracker
时间窗: 20 weeks of pregnancy
Activity (amount of steps) will be checked to see if there is any correlation between the total amount of steps per day and the development of gestational hypertensive disorders.
Niccomo measurement
时间窗: 20 weeks of pregnancy
The NICOMMO can record can record multiple haemodynamic parameters uninterrupted and reliable in an objective manner by using Impedance Cardiography. This technology is simple and non-invasive, and safe for pregnant women. The aim of this course is to describe the course of these parameters through normal pregnancies, and to examine any abnormalities in pre-eclamptic pregnancies. In view of the fact that in pre-eclampsia certain cardiovascular parameters are abnormal during several weeks before the disease becomes clinically manifest, this device might have a potential role in the prediction of pre-eclampsia in the future.
Systolic and Diastolic Blood pressure monitoring
时间窗: 20 weeks of pregnancy
a maternal Venous Doppler Echochraphy
时间窗: 20 weeks of pregnancy
In cardiology, a combined ultrasound ECG study provides important information about the functioning of the heart, especially with regard to the "stiffening" of the heart and blood vessel walls. It is known that in pre-eclampsia the blood vessel walls stiffen. Up to now it has never been investigated whether a combined Echo-ECG study can provide information about the degree of vascular wall stiffening. This study component checks which reference values are in normal pregnancy and whether these differ from pre-eclamptic pregnancies.
次要结局
- birth weight(up to six weeks after delivery)
- gestational age(at the moment of delivery)
- mode of delivery(at the moment of delivery)
- intentioned start of delivery(at the moment of delivery)
研究者
Wilfried Gyselaers
Principal Investigator
Hasselt University