Pre-eclampsia, Pregnancy
Conditions
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: 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:
Interventions
DEVICEremote 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
Sponsors
Ziekenhuis Oost-Limburg
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* \> 10 weeks of pregnancy, primipara and multipara
Exclusion criteria
* \< 10 weeks of pregnancy and congenital malformations of the fetus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight | 10 weeks of pregnancy | — |
| Systolic and Diastolic Blood pressure monitoring | 10 weeks of pregnancy | — |
| a maternal Venous Doppler Echochraphy | 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 | 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. |
| Activity tracker | 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. |
| Niccomo measurement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| gestational age | at the moment of delivery | These data will be measured at the moment of delivery |
| mode of delivery | at the moment of delivery | — |
| intentioned start of delivery | at the moment of delivery | — |
| birth weight | up to six weeks after delivery | — |
Countries
Belgium
Contacts
Primary ContactDorien Lanssens, drs.
Outcome results
None listed