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RECRUITING
NCT03509272
NA

LimPrOn: Limburg Pre-eclampsia Investigation

Sponsor: Hasselt University

View on ClinicalTrials.gov

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:

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

2000

Start Date

2016-05

Completion Date

2030-12

Last Updated

2024-04-09

Healthy Volunteers

Yes

Interventions

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

Locations (8)

Ziekenhuis Maas en Kempen

Bree, Belgium

Ziekenhuis Oost-Limburg

Genk, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Sint-Fransiscus Ziekenhuis

Heusden-Zolder, Belgium

Heilig Hart Ziekenhuis

Mol, Belgium

Mariaziekenhuis Oost-Limburg

Overpelt, Belgium

Sint-Trudo ziekenhuis

Sint-Truiden, Belgium

AZ-vesalius

Tongeren, Belgium