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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1095 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2024-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility of Home Telehealth Monitoring for Improvement in Management of Hypertension for Secondary Stroke Prevention

NCT03517709

Stroke Hypertension

WITHDRAWN NA

A Home Telemonitoring System for Wearable Fetal-ECG and EHG Acquisition During Pregnancy

NCT06031142

Uterine Contractions; Prolonged Fetal Heart Rate or Rhythm Abnormality Affecting Fetus Pregnancy Related +1 more

COMPLETED

Hypertension Management Using Remote Patient Monitoring: Study 2

NCT04764318

Hypertension

COMPLETED

Testing a Wearable Monitor for Fetal Heart Rate Estimation, Fetal Movement and Uterine Activity Detection

NCT04450251

Pregnancy

COMPLETED

Validation Study in Patients of a Non-invasive Blood Pressure Monitor for Perioperative Use

NCT03795831

Intraoperative Hypotension

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

telemonitoring group (TM)

Group Type EXPERIMENTAL

Telemonitoring

Intervention Type DEVICE

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.

Patient self-monitoring group (PSM)

Group Type ACTIVE_COMPARATOR

Telemonitoring

Intervention Type DEVICE

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.

control group (CC)

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

CAPROM - Group 1

pregnant women randomly assigned to the TM group of PREMOM II

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

CAPROM - Group 2

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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. -

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No