NCT04031430Completed
PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
PREMOM II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
Source: ClinicalTrials.gov · Last updated 2 Oct 2024
Brief summary (registry, in English)
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 follow-up, health outcomes for mother and child, costs and satisfaction, and by specifically investigating what are the major contributors to this added value. A substudy (CAPROM) will be conducted at the Department of Obstetrics \& Gynecology at Ziekenhuis Oost-Limburg (ZOL) in collaboration with the Department of Physiology of Hasselt University in the framework of the Limburg Clinical Research Center (LCRC). CAPROM aims at evaluating the relationship between longitudinal (clinical) blood pressure measurements and changes in (subclinical) cardiovascular (CV) hemodynamics throughout pregnancy, as well as their responses to antihypertensive medication. To this end, CV profiling will be performed longitudinally on pregnant women at risk for developing GHD being included in the TM group of the PREMOM II study (group 1) or being followed-up via TM as part of their usual care (group 2). A separate ICF is signed for inclusion in the CAPROM substudy. The results of the CAPROM study will be performed by a researcher who is not involved in the PREMOM II main study. In addition, results of the CV profiling will not be communicated to the clinical decision makers of PREMOM II.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 1095 (actual)
- First submitted
- 21 Nov 2018
- Start date
- 18 Jun 2019
- Primary completion date
- 1 Feb 2024
- Lead sponsor
- Hasselt University
- Diseases
- High blood pressure
- NCT number
- NCT04031430
What you commit to
- Study type: Interventional
- Participants enrolled: 1095
- From 18 Jun 2019 to the primary completion date, 1 Feb 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- pregnant women \< 18 years old,
Other
- congenital malformations of the newborn,
- pregnant women who doesn't have a Smartphone,
- pregnant women who doesn't understand the Dutch/French/English language. -
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital, Antwerp Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| AZ Sint-Lucas Brugge - Oostende Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| AZ Sint-Jan Brugge-Oostende Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Ziekenhuis Oost-Limburg Coordinator of this site? Confirm its status | Genk | Belgium | Unknown status |
| Universitaire Ziekenhuizen Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.