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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03509272
Other study ID # Limpron-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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