LimPrOn: Limburg Pre-eclampsia Investigation

Not Applicable

Recruiting

• Conditions: Pregnancy; Pre-eclampsia
• Interventions: Device: remote monitoring

• Registration Number: NCT03509272
• Lead Sponsor: Hasselt University

Brief Summary

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:

1. NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins.

2. Maltron: bio-electronic impedance analyze

3. 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:

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• > 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria

• < 10 weeks of pregnancy and congenital malformations of the fetus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
remote monitoring group	remote monitoring	-

Primary Outcome Measures

Name	Time	Method
Maltron measurement	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	20 weeks of pregnancy
Activity tracker	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	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	20 weeks of pregnancy
a maternal Venous Doppler Echochraphy	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.

Secondary Outcome Measures

Name	Time	Method
intentioned start of delivery	at the moment of delivery
birth weight	up to six weeks after delivery
gestational age	at the moment of delivery	These data will be measured at the moment of delivery
mode of delivery	at the moment of delivery

Trial Locations

Locations (8)

Ziekenhuis Maas en Kempen; 🇧🇪 Bree, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Heilig Hart Ziekenhuis; 🇧🇪 MOL, Belgium

Sint-Fransiscus Ziekenhuis; 🇧🇪 Heusden-Zolder, Belgium

Sint-Trudo ziekenhuis; 🇧🇪 Sint-Truiden, Belgium

Mariaziekenhuis Oost-Limburg; 🇧🇪 Overpelt, Belgium

AZ-vesalius; 🇧🇪 Tongeren, Belgium