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LimPrOn: Limburg Pre-eclampsia Investigation (LimPrOn)

Primary Purpose

Pregnancy, Pre-eclampsia

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
remote monitoring
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • > 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria:

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

Sites / Locations

  • Ziekenhuis Maas en KempenRecruiting
  • Ziekenhuis Oost-LimburgRecruiting
  • Jessa ZiekenhuisRecruiting
  • Sint-Fransiscus ZiekenhuisRecruiting
  • Heilig Hart ZiekenhuisRecruiting
  • Mariaziekenhuis Oost-LimburgRecruiting
  • Sint-Trudo ziekenhuisRecruiting
  • AZ-vesaliusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

remote monitoring group

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Systolic and Diastolic Blood pressure monitoring
Systolic and Diastolic Blood pressure monitoring
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.
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.
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.
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.
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.
Weight
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.
Weight

Secondary Outcome Measures

birth weight
gestational age
These data will be measured at the moment of delivery
mode of delivery
intentioned start of delivery

Full Information

First Posted
August 24, 2016
Last Updated
August 24, 2021
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT03509272
Brief Title
LimPrOn: Limburg Pre-eclampsia Investigation
Acronym
LimPrOn
Official Title
LimPrOn: Limburg Pre-eclampsia Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2030 (Anticipated)
Study Completion Date
December 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Pre-eclampsia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Title
remote monitoring group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
remote monitoring
Intervention Description
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 Measure Information:
Title
Niccomo measurement
Description
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.
Time Frame
10 weeks of pregnancy
Title
Niccomo measurement
Description
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.
Time Frame
20 weeks of pregnancy
Title
Systolic and Diastolic Blood pressure monitoring
Time Frame
10 weeks of pregnancy
Title
Systolic and Diastolic Blood pressure monitoring
Time Frame
20 weeks of pregnancy
Title
a maternal Venous Doppler Echochraphy
Description
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.
Time Frame
10 weeks of pregnancy
Title
Maltron measurement
Description
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.
Time Frame
10 weeks of pregnancy
Title
a maternal Venous Doppler Echochraphy
Description
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.
Time Frame
20 weeks of pregnancy
Title
Maltron measurement
Description
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.
Time Frame
20 weeks of pregnancy
Title
Activity tracker
Description
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.
Time Frame
10 weeks of pregnancy
Title
Weight
Time Frame
10 weeks of pregnancy
Title
Activity tracker
Description
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.
Time Frame
20 weeks of pregnancy
Title
Weight
Time Frame
20 weeks of pregnancy
Secondary Outcome Measure Information:
Title
birth weight
Time Frame
up to six weeks after delivery
Title
gestational age
Description
These data will be measured at the moment of delivery
Time Frame
at the moment of delivery
Title
mode of delivery
Time Frame
at the moment of delivery
Title
intentioned start of delivery
Time Frame
at the moment of delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: > 10 weeks of pregnancy, primipara and multipara Exclusion Criteria: < 10 weeks of pregnancy and congenital malformations of the fetus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dorien Lanssens, drs.
Email
dorien.lanssens@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfried Gyselaers, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nele Geusens, dr.
Organizational Affiliation
Ziekenhuis Oost-Limburg
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Maas en Kempen
City
Bree
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.
Email
dorien.lanssens@uhasselt.be
First Name & Middle Initial & Last Name & Degree
Wilfried Gyselaers, prof.dr.
Email
wilfried.gyselaers@zol.be
First Name & Middle Initial & Last Name & Degree
Nele Geusens, dr.
Facility Name
Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.
Facility Name
Sint-Fransiscus Ziekenhuis
City
Heusden-Zolder
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doriend Lanssens, drs.
Facility Name
Heilig Hart Ziekenhuis
City
MOL
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.
Facility Name
Mariaziekenhuis Oost-Limburg
City
Overpelt
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.
Facility Name
Sint-Trudo ziekenhuis
City
Sint-Truiden
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.
Facility Name
AZ-vesalius
City
Tongeren
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorien Lanssens, drs.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32748394
Citation
Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.
Results Reference
derived
PubMed Identifier
31464190
Citation
Vandenberk T, Lanssens D, Storms V, Thijs IM, Bamelis L, Grieten L, Gyselaers W, Tang E, Luyten P. Relationship Between Adherence to Remote Monitoring and Patient Characteristics: Observational Study in Women With Pregnancy-Induced Hypertension. JMIR Mhealth Uhealth. 2019 Aug 28;7(8):e12574. doi: 10.2196/12574.
Results Reference
derived

Learn more about this trial

LimPrOn: Limburg Pre-eclampsia Investigation

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