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LimPrOn: Limburg Pre-eclampsia Investigation (LimPrOn)

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ClinicalTrials.gov Identifier: NCT03509272
Recruitment Status : Recruiting
First Posted : April 26, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Ziekenhuis Oost-Limburg
Information provided by (Responsible Party):
Wilfried Gyselaers, 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: 1000 pregnant women from the prenatal consultations of eight different hospitals:


Condition or disease Intervention/treatment Phase
Pregnancy Pre-eclampsia Device: remote monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: LimPrOn: Limburg Pre-eclampsia Investigation
Study Start Date : May 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control Group
Experimental: remote monitoring group 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





Primary Outcome Measures :
  1. Niccomo measurement [ Time Frame: 10 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.

  2. Niccomo measurement [ Time Frame: 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.

  3. Systolic and Diastolic Blood pressure monitoring [ Time Frame: 10 weeks of pregnancy ]
  4. Systolic and Diastolic Blood pressure monitoring [ Time Frame: 20 weeks of pregnancy ]
  5. a maternal Venous Doppler Echochraphy [ Time Frame: 10 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.

  6. Maltron measurement [ Time Frame: 10 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.

  7. a maternal Venous Doppler Echochraphy [ Time Frame: 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.

  8. Maltron measurement [ Time Frame: 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.

  9. Activity tracker [ Time Frame: 10 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.

  10. Weight [ Time Frame: 10 weeks of pregnancy ]
  11. Activity tracker [ Time Frame: 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.

  12. Weight [ Time Frame: 20 weeks of pregnancy ]

Secondary Outcome Measures :
  1. birth weight [ Time Frame: up to six weeks after delivery ]
  2. gestational age [ Time Frame: at the moment of delivery ]
    These data will be measured at the moment of delivery

  3. mode of delivery [ Time Frame: at the moment of delivery ]
  4. intentioned start of delivery [ Time Frame: at the moment of delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • > 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509272


Contacts
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Contact: Dorien Lanssens, drs. dorien.lanssens@uhasselt.be

Locations
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Belgium
Ziekenhuis Maas en Kempen Recruiting
Bree, Belgium
Contact: Dorien Lanssens, drs.         
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Dorien Lanssens, drs.       dorien.lanssens@uhasselt.be   
Contact: Wilfried Gyselaers, prof.dr.       wilfried.gyselaers@zol.be   
Sub-Investigator: Nele Geusens, dr.         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Contact: Dorien Lanssens, drs.         
Sint-Fransiscus Ziekenhuis Recruiting
Heusden-Zolder, Belgium
Contact: Doriend Lanssens, drs.         
Heilig Hart Ziekenhuis Recruiting
MOL, Belgium
Contact: Dorien Lanssens, drs.         
Mariaziekenhuis Oost-Limburg Recruiting
Overpelt, Belgium
Contact: Dorien Lanssens, drs.         
Sint-Trudo ziekenhuis Recruiting
Sint-Truiden, Belgium
Contact: Dorien Lanssens, drs.         
AZ-vesalius Recruiting
Tongeren, Belgium
Contact: Dorien Lanssens, drs.         
Sponsors and Collaborators
Hasselt University
Ziekenhuis Oost-Limburg
Investigators
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Principal Investigator: Wilfried Gyselaers, prof. dr. Hasselt University
Study Chair: Nele Geusens, dr. Ziekenhuis Oost-Limburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wilfried Gyselaers, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT03509272     History of Changes
Other Study ID Numbers: Limpron-001
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Eclampsia
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications