Clinical trial NCT03509272: LimPrOn: Limburg Pre-eclampsia Investigation
Official title: LimPrOn: Limburg Pre-eclampsia Investigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Pre-eclampsia
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2018-04-26
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:


Eligibility criteria: Inclusion Criteria:

* \> 10 weeks of pregnancy, primipara and multipara

Exclusion Criteria:

* \< 10 weeks of pregnancy and congenital malformations of the fetus

Primary outcomes:
measure: Niccomo measurement
timeFrame: 10 weeks of pregnancy
measure: Niccomo measurement
timeFrame: 20 weeks of pregnancy
measure: Systolic and Diastolic Blood pressure monitoring
timeFrame: 10 weeks of pregnancy
measure: Systolic and Diastolic Blood pressure monitoring
timeFrame: 20 weeks of pregnancy
measure: a maternal Venous Doppler Echochraphy
timeFrame: 10 weeks of pregnancy
measure: Maltron measurement
timeFrame: 10 weeks of pregnancy
measure: a maternal Venous Doppler Echochraphy
timeFrame: 20 weeks of pregnancy
measure: Maltron measurement
timeFrame: 20 weeks of pregnancy
measure: Activity tracker
timeFrame: 10 weeks of pregnancy
measure: Weight
timeFrame: 10 weeks of pregnancy
measure: Activity tracker
timeFrame: 20 weeks of pregnancy
measure: Weight
timeFrame: 20 weeks of pregnancy
Secondary outcomes:
measure: birth weight
timeFrame: up to six weeks after delivery
measure: gestational age
timeFrame: at the moment of delivery
measure: mode of delivery
timeFrame: at the moment of delivery
measure: intentioned start of delivery
timeFrame: at the moment of delivery
Other outcomes:
Locations:
city: Bree
country: Belgium
facility: Ziekenhuis Maas en Kempen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Heusden-Zolder
country: Belgium
facility: Sint-Fransiscus Ziekenhuis
city: MOL
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Overpelt
country: Belgium
facility: Mariaziekenhuis Oost-Limburg
city: Sint-Truiden
country: Belgium
facility: Sint-Trudo ziekenhuis
city: Tongeren
country: Belgium
facility: AZ-vesalius
Study officials:
affiliation: Hasselt University
name: Wilfried Gyselaers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuis Oost-Limburg
name: Nele Geusens, dr.
role: STUDY_CHAIR
References:
citation: Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.
citation: Vandenberk T, Lanssens D, Storms V, Thijs IM, Bamelis L, Grieten L, Gyselaers W, Tang E, Luyten P. Relationship Between Adherence to Remote Monitoring and Patient Characteristics: Observational Study in Women With Pregnancy-Induced Hypertension. JMIR Mhealth Uhealth. 2019 Aug 28;7(8):e12574. doi: 10.2196/12574.