LimPrOn: Limburg Pre-eclampsia Investigation

Pregnancy Clinical Trial

— LimPrOn  

Official title:

LimPrOn: Limburg Pre-eclampsia Investigation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03509272
• Other study ID #: Limpron-001
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Hasselt University
• Contact: Dorien Lanssens, drs.
• Email: dorien.lanssens[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• > 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia
• Pregnancy

Intervention

Device:
• remote monitoring
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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Maas en Kempen	Bree
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Sint-Fransiscus Ziekenhuis	Heusden-Zolder
Belgium	Heilig Hart Ziekenhuis	MOL
Belgium	Mariaziekenhuis Oost-Limburg	Overpelt
Belgium	Sint-Trudo ziekenhuis	Sint-Truiden
Belgium	AZ-vesalius	Tongeren

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Systolic and Diastolic Blood pressure monitoring		10 weeks of pregnancy
Primary	Systolic and Diastolic Blood pressure monitoring		20 weeks of pregnancy
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Weight		10 weeks of pregnancy
Primary	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
Primary	Weight		20 weeks of pregnancy
Secondary	birth weight		up to six weeks after delivery
Secondary	gestational age	These data will be measured at the moment of delivery	at the moment of delivery
Secondary	mode of delivery		at the moment of delivery
Secondary	intentioned start of delivery		at the moment of delivery