LimPrOn: Limburg Pre-eclampsia Investigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: remote monitoring.
- Who it may be relevant to
- Registry conditions: Pregnancy, Pre-eclampsia. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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:
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 Pres
Primary outcome measures
- Niccomo measurement [Time frame: 10 weeks of pregnancy]
- Niccomo measurement [Time frame: 20 weeks of pregnancy]
- Systolic and Diastolic Blood pressure monitoring [Time frame: 10 weeks of pregnancy]
- Systolic and Diastolic Blood pressure monitoring [Time frame: 20 weeks of pregnancy]
- a maternal Venous Doppler Echochraphy [Time frame: 10 weeks of pregnancy]
- Maltron measurement [Time frame: 10 weeks of pregnancy]
- a maternal Venous Doppler Echochraphy [Time frame: 20 weeks of pregnancy]
- Maltron measurement [Time frame: 20 weeks of pregnancy]
- Activity tracker [Time frame: 10 weeks of pregnancy]
- Weight [Time frame: 10 weeks of pregnancy]
Secondary outcome measures (4)
- birth weight [Time frame: up to six weeks after delivery]
- gestational age [Time frame: at the moment of delivery]
- mode of delivery [Time frame: at the moment of delivery]
- intentioned start of delivery [Time frame: at the moment of delivery]
Eligibility criteria
Inclusion criteria
- > 10 weeks of pregnancy, primipara and multipara
Exclusion criteria
- < 10 weeks of pregnancy and congenital malformations of the fetus
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Belgium · 8 centers
- Ziekenhuis Maas en Kempen — Bree
- Ziekenhuis Oost-Limburg — Genk
- Jessa Ziekenhuis — Hasselt
- Sint-Fransiscus Ziekenhuis — Heusden-Zolder
- Heilig Hart Ziekenhuis — Mol
- Mariaziekenhuis Oost-Limburg — Overpelt
- Sint-Trudo ziekenhuis — Sint-Truiden
- AZ-vesalius — Tongeren
Publications
- 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. PMID 32748394
- 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. PMID 31464190
Identifiers
NCT: NCT03509272 · Limpron-001