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

Hasselt University

Status: Completed

Conditions: Gestational Hypertension

Treatments: Other: CV profiling before and after the start/switch of antihypertensive medication; Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication; Device: Telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04031430

PREMOM-II

Details and patient eligibility

About

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.

Enrollment: 1,095 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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. -

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,095 participants in 5 patient groups

telemonitoring group (TM)

Experimental group

Description:

telemonitoring group (TM)

Treatment:

Device: Telemonitoring

Patient self-monitoring group (PSM)

Active Comparator group

Description:

Patient self-monitoring group (PSM)

Treatment:

Device: Telemonitoring

control group (CC)

No Intervention group

Description:

No intervention

CAPROM - Group 1

Experimental group

Description:

pregnant women randomly assigned to the TM group of PREMOM II

Treatment:

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

CAPROM - Group 2

Experimental group

Description:

pregnant women followed-up via TM group as part of their usual care

Treatment:

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