PregnancyLimPrOnNCT03509272
LimPrOn: Limburg Pre-eclampsia Investigation
A study testing remote monitoring in people with Pregnancy and Pre-eclampsia, run by Hasselt University at 8 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Pre-eclampsia
- What is being tested?
- remote monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 8 sitesBelgium
- Study dates
- May 2016to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- > 10 weeks of pregnancy, primipara and multipara
Who cannot join
- < 10 weeks of pregnancy and congenital malformations of the fetus
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dorien Lanssens, drs. contact
8 sites in 1 country
Belgium8 sites, 8 recruiting
- Recruiting
Ziekenhuis Maas en Kempen
Bree
Dorien Lanssens, drs.
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
Dorien Lanssens, drs., dorien.lanssens@uhasselt.be
Wilfried Gyselaers, prof.dr., wilfried.gyselaers@zol.be
- Recruiting
Jessa Ziekenhuis
Hasselt, 3500
Dorien Lanssens, drs.
- Recruiting
Sint-Fransiscus Ziekenhuis
Heusden-Zolder
Doriend Lanssens, drs.
- Recruiting
Heilig Hart Ziekenhuis
Mol
Dorien Lanssens, drs.
- Recruiting
Mariaziekenhuis Oost-Limburg
Overpelt
Dorien Lanssens, drs.
- Recruiting
Sint-Trudo ziekenhuis
Sint-Truiden
Dorien Lanssens, drs.
- Recruiting
AZ-vesalius
Tongeren
Dorien Lanssens, drs.
About this study
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.
Read more
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:
- Conditions
- Pregnancy, Pre-eclampsia
- Being tested
- remote monitoring
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote monitoringDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| remote monitoring group | Experimental | Not described Receives: Device: remote monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 20 weeks of pregnancy
Systolic and Diastolic Blood pressure monitoring
Measured: 10 weeks of pregnancy
Systolic and Diastolic Blood pressure monitoring
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks of pregnancy
Weight
Measured: 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.
Measured: 20 weeks of pregnancy
Weight
Measured: 20 weeks of pregnancy
Secondary outcomes (4)
birth weight
Measured: up to six weeks after delivery
gestational age
These data will be measured at the moment of delivery
Measured: at the moment of delivery
mode of delivery
Measured: at the moment of delivery
intentioned start of delivery
Measured: at the moment of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study startMay 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Wilfried Gyselaers, Hasselt University
- Investigators
- Wilfried Gyselaers, prof. dr., Principal investigator, Hasselt UniversityNele Geusens, dr., Study chair, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509272
- Sponsor's protocol ID
- Limpron-001
- Acronym
- LimPrOn
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2016
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 32748394Vandenberk 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.
PubMed 31464190
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LimPrOn: Limburg Pre-eclampsia Investigation
- ClinicalTrials.gov ID
- NCT03509272
- Acronym / sponsor ID
- LimPrOn / Limpron-001
- Conditions
- Pregnancy, Pre-eclampsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- May 2016
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| remote monitoring group | Experimental | Device: remote monitoring |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- > 10 weeks of pregnancy, primipara and multipara
Key exclusion criteria (1 listed)
- < 10 weeks of pregnancy and congenital malformations of the fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote monitoringIntervention 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 | Device | remote monitoring group |
Primary outcome
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.
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.
Systolic and Diastolic Blood pressure monitoring
Time frame: 10 weeks of pregnancy
Systolic and Diastolic Blood pressure monitoring
Time frame: 20 weeks of pregnancy
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.
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.
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.
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.
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.
Weight
Time frame: 10 weeks of pregnancy
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.
Weight
Time frame: 20 weeks of pregnancy
4 secondary outcomes
birth weight
Time frame: up to six weeks after delivery
gestational age
Time frame: at the moment of delivery
mode of delivery
Time frame: at the moment of delivery
intentioned start of delivery
Time frame: at the moment of delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 32748394Ashworth 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.
- Derived from this study: PubMed 31464190Vandenberk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorien Lanssens, drs. contact
Wilfried Gyselaers, prof. dr. principal investigator
Hasselt University
Nele Geusens, dr. study chair
Ziekenhuis Oost-Limburg
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote monitoring in people with Pregnancy and Pre-eclampsia, run by Hasselt University at 8 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dorien Lanssens, drs. (dorien.lanssens@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Niccomo measurement (time frame: 10 weeks of pregnancy). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03509272, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.