LimPrOn: Limburg Pre-eclampsia Investigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorHasselt University
About this trial
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:
Eligibility criteria
This trial accepts healthy volunteersQualifiers
> 10 weeks of pregnancy, primipara and multipara
Disqualifiers
< 10 weeks of pregnancy and congenital malformations of the fetus
Trial design
Design model
Parallel
Treatments tested in this trial
remote monitoring
DeviceIntervention 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
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: remote monitoring groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 weeks of pregnancy2
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.
Time frame
20 weeks of pregnancy3
Systolic and Diastolic Blood pressure monitoring
Time frame
10 weeks of pregnancy4
Systolic and Diastolic Blood pressure monitoring
Time frame
20 weeks of pregnancySecondary outcomes
1
birth weight
Time frame
up to six weeks after delivery2
gestational age
These data will be measured at the moment of delivery
Time frame
at the moment of delivery3
mode of delivery
Time frame
at the moment of delivery4
intentioned start of delivery
Time frame
at the moment of deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Hasselt University
Lead sponsor
Ziekenhuis Oost-Limburg
Collaborator
Source ClinicalTrials.gov