LimPrOn: Limburg Pre-eclampsia Investigation

Last updated: April 8, 2024
Sponsor: Hasselt University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Pregnancy

Treatment

remote monitoring

Clinical Study ID

NCT03509272
Limpron-001
  • Ages 18-50
  • Female
  • Accepts Healthy Volunteers

Study 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:

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • > 10 weeks of pregnancy, primipara and multipara

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: remote monitoring
Phase:
Study Start date:
May 01, 2016
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • Ziekenhuis Maas en Kempen

    Bree,
    Belgium

    Active - Recruiting

  • Ziekenhuis Oost-Limburg

    Genk, 3600
    Belgium

    Active - Recruiting

  • Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Active - Recruiting

  • Sint-Fransiscus Ziekenhuis

    Heusden-Zolder,
    Belgium

    Active - Recruiting

  • Heilig Hart Ziekenhuis

    MOL,
    Belgium

    Active - Recruiting

  • Mariaziekenhuis Oost-Limburg

    Overpelt,
    Belgium

    Active - Recruiting

  • Sint-Trudo ziekenhuis

    Sint-Truiden,
    Belgium

    Active - Recruiting

  • AZ-vesalius

    Tongeren,
    Belgium

    Active - Recruiting

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