NCT03509272

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. 1.NICCOMO and Maternal Venous Doppler Echography: impedance cardiograph and an echography of the heart and veins.
  2. 2.Maltron: bio-electronic impedance analyze
  3. 3.Remote monitoring of the high risk patients to become a more intensive follow-up

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
56mo left

Started May 2016

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
May 2016Dec 2030

Study Start

First participant enrolled

May 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

14.6 years

First QC Date

August 24, 2016

Last Update Submit

April 8, 2024

Conditions

PregnancyPre-eclampsia

Outcome Measures

Primary Outcomes (12)

  • Niccomo measurement

    The NICOMMO can record can record multiple haemodynamic parameters uninterrupted and reliable in an objective manner by using Impedance Cardiography. This technology is simple and non-invasive, and safe for pregnant women. The aim of this course is to describe the course of these parameters through normal pregnancies, and to examine any abnormalities in pre-eclamptic pregnancies. In view of the fact that in pre-eclampsia certain cardiovascular parameters are abnormal during several weeks before the disease becomes clinically manifest, this device might have a potential role in the prediction of pre-eclampsia in the future.

    10 weeks of pregnancy

  • Niccomo measurement

    The NICOMMO can record can record multiple haemodynamic parameters uninterrupted and reliable in an objective manner by using Impedance Cardiography. This technology is simple and non-invasive, and safe for pregnant women. The aim of this course is to describe the course of these parameters through normal pregnancies, and to examine any abnormalities in pre-eclamptic pregnancies. In view of the fact that in pre-eclampsia certain cardiovascular parameters are abnormal during several weeks before the disease becomes clinically manifest, this device might have a potential role in the prediction of pre-eclampsia in the future.

    20 weeks of pregnancy

  • Systolic and Diastolic Blood pressure monitoring

    10 weeks of pregnancy

  • Systolic and Diastolic Blood pressure monitoring

    20 weeks of pregnancy

  • a maternal Venous Doppler Echochraphy

    In cardiology, a combined ultrasound ECG study provides important information about the functioning of the heart, especially with regard to the "stiffening" of the heart and blood vessel walls. It is known that in pre-eclampsia the blood vessel walls stiffen. Up to now it has never been investigated whether a combined Echo-ECG study can provide information about the degree of vascular wall stiffening. This study component checks which reference values are in normal pregnancy and whether these differ from pre-eclamptic pregnancies.

    10 weeks of pregnancy

  • Maltron measurement

    The aim of this course is to describe the course of body composition and fluid balance through a normal pregnancy, and to examine any abnormalities in pre-eclamptic pregnancies.

    10 weeks of pregnancy

  • a maternal Venous Doppler Echochraphy

    In cardiology, a combined ultrasound ECG study provides important information about the functioning of the heart, especially with regard to the "stiffening" of the heart and blood vessel walls. It is known that in pre-eclampsia the blood vessel walls stiffen. Up to now it has never been investigated whether a combined Echo-ECG study can provide information about the degree of vascular wall stiffening. This study component checks which reference values are in normal pregnancy and whether these differ from pre-eclamptic pregnancies.

    20 weeks of pregnancy

  • Maltron measurement

    The aim of this course is to describe the course of body composition and fluid balance through a normal pregnancy, and to examine any abnormalities in pre-eclamptic pregnancies.

    20 weeks of pregnancy

  • Activity tracker

    Activity (amount of steps) will be checked to see if there is any correlation between the total amount of steps per day and the development of gestational hypertensive disorders.

    10 weeks of pregnancy

  • Weight

    10 weeks of pregnancy

  • Activity tracker

    Activity (amount of steps) will be checked to see if there is any correlation between the total amount of steps per day and the development of gestational hypertensive disorders.

    20 weeks of pregnancy

  • Weight

    20 weeks of pregnancy

Secondary Outcomes (4)

  • birth weight

    up to six weeks after delivery

  • gestational age

    at the moment of delivery

  • mode of delivery

    at the moment of delivery

  • intentioned start of delivery

    at the moment of delivery

Study Arms (2)

Control Group

NO INTERVENTION

remote monitoring group

EXPERIMENTAL
Device: remote monitoring

Interventions

remote monitoringDEVICE

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 Pressure Monitor Blood Pressure 2x/day Withings Pulse O² Activity Day and night Withings Smart Body Analyzer Weight 1x/day

remote monitoring group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \> 10 weeks of pregnancy, primipara and multipara

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ziekenhuis Maas en Kempen

Bree, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, 3500, Belgium

RECRUITING

Sint-Fransiscus Ziekenhuis

Heusden-Zolder, Belgium

RECRUITING

Heilig Hart Ziekenhuis

Mol, Belgium

RECRUITING

Mariaziekenhuis Oost-Limburg

Overpelt, Belgium

RECRUITING

Sint-Trudo ziekenhuis

Sint-Truiden, Belgium

RECRUITING

AZ-vesalius

Tongeren, Belgium

RECRUITING

Related Publications (2)

  • 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: 32748394DERIVED

  • 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: 31464190DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Wilfried Gyselaers, prof. dr.

    Hasselt University

    PRINCIPAL INVESTIGATOR

  • Nele Geusens, dr.

    Ziekenhuis Oost-Limburg

    STUDY CHAIR

Central Study Contacts

Dorien Lanssens, drs.

CONTACT

dorien.lanssens@uhasselt.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 24, 2016

First Posted

April 26, 2018

Study Start

May 1, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(8)