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NCT Number: NCT03509272

LimPrOn: Limburg Pre-eclampsia Investigation

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:

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Key information

Conditions

Pregnancy Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Maas en Kempen, Bree, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 10 weeks of pregnancy, primipara and multipara

Exclusion criteria

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

Treatment and study plan

remote monitoring

Device

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Dorien Lanssens, drs.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Ziekenhuis Oost-Limburg

Registry information

Acronym: LimPrOn

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Apr 26, 2018
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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