LimPrOn: Limburg Pre-eclampsia Investigation (LimPrOn)

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:

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Pre-eclampsia
• Intervention / Treatment: Device: remote monitoring

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dorien Lanssens, drs.; Email: dorien.lanssens@uhasselt.be

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• > 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Systolic and Diastolic Blood pressure monitoring		10 weeks of pregnancy
Systolic and Diastolic Blood pressure monitoring		20 weeks of pregnancy
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
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
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
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
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
Weight		10 weeks of pregnancy
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
Weight		20 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
birth weight		up to six weeks after delivery
gestational age	These data will be measured at the moment of delivery	at the moment of delivery
mode of delivery		at the moment of delivery
intentioned start of delivery		at the moment of delivery

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Ziekenhuis Oost-Limburg
• Investigators: Principal Investigator: Wilfried Gyselaers, prof. dr., Hasselt University; Study Chair: Nele Geusens, dr., Ziekenhuis Oost-Limburg

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 24, 2016
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: Limpron-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO