PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders

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 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.

Conditions

• Gestational Hypertension

Interventions

DEVICE

Telemonitoring

Women who are allocated to the PSM groep, will receive a connected blood pressure monitor. They have to measure their blood pressure twice a day and fill in their weight once a week in the App. These data are automatically transmitted via Bluetooth and Wi-Fi to the hospital, but the caregiver will not see those data, and can not react to it.

OTHER

Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication

Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication Registration of medication usage in the Medisafe app Assessment of their beliefs about medicine in general and during pregnancy and their perceptions regarding medication adherence by means of the 'Beliefs about Medicine Questionnaire' and the 'Probabilistic Medication Adherence Scale' at baseline and postpartum.

OTHER

CV profiling before and after the start/switch of antihypertensive medication

CV profiling before and after the start/switch of antihypertensive medication Registration of medication usage in the Medisafe app Assessment of their beliefs about medicine in general and during pregnancy and their perceptions regarding medication adherence by means of the 'Beliefs about Medicine Questionnaire' and the 'Probabilistic Medication Adherence Scale' at baseline and postpartum.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• AZ Sint-Jan AV

  collaborator OTHER

• AZ Sint-Lucas Brugge

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Hasselt University

  lead OTHER

Principal Investigators

• Wilfried Gyselaers, prof. dr. · Hasselt University

• Dorien Lanssens, dr. · Hasselt University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-18

Primary Completion

2024-02-01

Completion

2024-02-01

Countries

• Belgium

Study Locations