LimPrOn: Limburg Pre-eclampsia Investigation

Study Overview
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Brief Summary
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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:

Official Title
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LimPrOn: Limburg Pre-eclampsia Investigation

Conditions
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Pregnancy, Pre-eclampsia

Intervention / Treatment
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* Device: remote monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 10 weeks of pregnancy, primipara and multipara Exclusion Criteria: < 10 weeks of pregnancy and congenital malformations of the fetus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br> | |
| Experimental: remote monitoring group<br> | Device: remote monitoring<br>* Intervention Description: Patients can participate in the study when they're 10 weeks pregnant. At 10 weeks: a NICCOMO, Maternal Venous Doppler Echography and Maltron measurement will be taken. This measurement will be repeated at 20 weeks of pregnancy, and 30 weeks of pregnancy when they're aberrant. When the measurements are abnormal, the patients will be included in the remote monitoring study. The following protocol and devices will be applied: Device What When Withings Wireless Blood Pressure Monitor Blood Pressure 2x/day Withings Pulse O² Activity Day and night Withings Smart Body Analyzer Weight 1x/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Niccomo measurement | 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. | 10 weeks of pregnancy | 
| Niccomo measurement | 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. | 20 weeks of pregnancy | 
| Systolic and Diastolic Blood pressure monitoring |  | 10 weeks of pregnancy | 
| Systolic and Diastolic Blood pressure monitoring |  | 20 weeks of pregnancy | 
| a maternal Venous Doppler Echochraphy | 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. | 10 weeks of pregnancy | 
| Maltron measurement | 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. | 10 weeks of pregnancy | 
| a maternal Venous Doppler Echochraphy | 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. | 20 weeks of pregnancy | 
| Maltron measurement | 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. | 20 weeks of pregnancy | 
| Activity tracker | 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. | 10 weeks of pregnancy | 
| Weight |  | 10 weeks of pregnancy | 
| Activity tracker | 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. | 20 weeks of pregnancy | 
| Weight |  | 20 weeks of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| birth weight |  | up to six weeks after delivery | 
| gestational age | These data will be measured at the moment of delivery | at the moment of delivery | 
| mode of delivery |  | at the moment of delivery | 
| intentioned start of delivery |  | at the moment of delivery |