Status:
COMPLETED
PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
Lead Sponsor:
Hasselt University
Collaborating Sponsors:
Ziekenhuis Oost-Limburg
Universitaire Ziekenhuizen KU Leuven
Conditions:
Gestational Hypertension
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this project is thoroughly evaluate the added value of telemonitoring (TM) program for women at risk for gestational hypertensive disorders (GHD), by investigating it impact on prenatal fo...
Eligibility Criteria
Inclusion
- a risk \> 1/100 on the Fetal Medicine Foundation (FMF) tool, which is used from the following website: https://fetalmedicine.org/research/assess/preeclampsia/first-trimester
- CAPROM substudy: Pregnant women at risk for the development of GHD being followed-up via TM as part of the PREMOM II study (group 1) or usual care (group 2)
Exclusion
- congenital malformations of the newborn,
- pregnant women who doesn't have a Smartphone,
- pregnant women \< 18 years old,
- pregnant women who doesn't understand the Dutch/French/English language. -
Key Trial Info
Start Date :
June 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
1095 Patients enrolled
Trial Details
Trial ID
NCT04031430
Start Date
June 18 2019
End Date
February 1 2024
Last Update
October 2 2024
Active Locations (5)
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1
University hospital Antwerp
Antwerp, Belgium, 2000
2
AZ Sint-Lucas Brugge - Oostende
Bruges, Belgium, 8000
3
AZ Sint Jan Brugge - Oostende
Bruges, Belgium, 9000
4
Ziekenhuis Oost-Limburg
Genk, Belgium, 3600