LimPrOn: Limburg Pre-eclampsia Investigation

Hasselt University

Status: Enrolling

Conditions: Pre-eclampsia; Pregnancy

Treatments: Device: remote monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03509272

Limpron-001

Details and patient eligibility

About

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:

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• > 10 weeks of pregnancy, primipara and multipara

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Control Group

No Intervention group

remote monitoring group

Experimental group

Treatment:

Device: remote monitoring