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LimPrOn: Limburg Pre-eclampsia Investigation

Study acronym: LimPrOn
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Aug 24, 2021, no change to tracked fieldsv4-v5
  2. Notable Enrollment target: 1000 to 2000
    • Primary and study completion dates: Dec 2019 to Dec 2030
    v3
  3. Notable Primary and study completion dates: Dec 2018 to Dec 2019v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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:
Trial Details
NCT Number NCT03509272
Lead Sponsor Hasselt University
Collaborators: Ziekenhuis Oost-Limburg
Conditions
(from sponsor)
Pregnancy, Pre-eclampsia
Related terms Pre-Eclampsia
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov