PREMOM-II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders (PREMOM-II)

PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Hypertension
• Intervention / Treatment: Device: Telemonitoring; Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication; Other: CV profiling before and after the start/switch of antihypertensive medication

• Study Type: Interventional
• Enrollment (Estimated): 6107
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wilfried Gyselaers, prof. dr.; Phone Number: + 32 89 32 15 57; Email: wilfried.gyselaers@zol.be
• Study Contact Backup: Name: Dorien Lanssens, dr.; Phone Number: + 32 89 32 15 57; Email: dorien.lanssens@uhasselt.be

Study Locations

• Belgium
  • Antwerp, Belgium, 2000
    • Recruiting
    • University Hospital Antwerp
    • Contact: Yves Jacquemyn, prof.dr.; Phone Number: +32 34 58 40 04; Email: yves.jacquemyn@uza.be
    • Principal Investigator: Yves Jacquemyn, prof.dr.
  • Brugge, Belgium, 8000
    • Recruiting
    • AZ Sint-Lucas Brugge - Oostende
    • Contact: Hilde Logghe, dr.; Phone Number: +32 50 36 50 80; Email: hilde.logghe@gmail.com
    • Principal Investigator: Hilde Logghe, dr.
  • Brugge, Belgium, 9000
    • Recruiting
    • AZ Sint Jan Brugge - Oostende
    • Contact: Barbara Lebbe, dr.; Email: barbara.lebbe@azsintjan.be
    • Principal Investigator: Barbara Lebbe, dr.
  • Genk, Belgium, 3600
    • Recruiting
    • Ziekenhuis Oost-Limburg
    • Contact: Eric de Jonge, prof.dr.; Phone Number: +32 89 32 50 50; Email: eric.dejonge@zol.be
    • Contact: Dorien Lanssens, dr.; Phone Number: +32 89 32 15 57; Email: dorien.lanssens@uhasselt.be
    • Principal Investigator: Eric de Jonge, prof. dr.
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitaire Ziekenhuizen Leuven
    • Contact: Roland Devlieger, prof. dr.; Phone Number: +32 16 34 42 04; Email: roland.devlieger@uzleuven.be
    • Principal Investigator: Roland Devlieger, prof. dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telemonitoring group (TM)	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.
Active Comparator: Patient self-monitoring group (PSM)	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.
No Intervention: control group (CC); No intervention
Experimental: CAPROM - Group 1; pregnant women randomly assigned to the TM group of PREMOM II	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.
Experimental: CAPROM - Group 2; pregnant women followed-up via TM group as part of their usual care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age (GA)	difference of at least 10 days between the TM group and the CC was observed in our pilot studies, and will be used as a clinically relevant difference. An extension of the GA by even one day has a large impact on clinical outcomes for the neonate (both short- as long term). Moreover, the highest cost reductions were obtained in the group that delivered before 34 weeks of GA.	Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.
hospitalization	Numbers of hospitalization during pregnancy (Numeric. Available by hospital details of every patient who is included in the study. From the moment of hospitalization until the moment of discharge is 1 hospitalization.	From 32 weeks of gestation until 34 weeks of gestation
Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography	The CV profile assessment consists of a simple, non-invasive method using the ECG with Doppler ultrasonography providing information about arteries and veins	Month 3 to month 9
changes in CV physiological parameters - impedance cardiography	The CV profile assessment consists of a simple, non-invasive method using Impedance Cardiography using the Non-Invasive Continuous Cardiac Output (NICCOMO) monitor registering heart parameters	Month 3 to month 9
changes in CV physiological parameters - bio impedance	The CV profile assessment consists of a simple, non-invasive method using Bio-Impedance using the Maltron® Bioscan 920-II giving information about the fluid balance.	Month 3 to month 9
Arterial parameters - pulse transit time	The Pulse Transit Method (PTT) as a non-invasive means to track Blood Pressure over a short period of time	Month 3 to month 9
Arterial parameters - pulsatility index	Pulsatility index (PI) is defined as the difference between the peak systolic flow and minimum diastolic flow velocity, divided by the mean velocity recorded throughout the cardiac cycle. It is a non-invasive method of assessing vascular resistance with the use of Doppler ultrasonography.	Month 3 to month 9
Arterial parameters - resistivity index of the left and right arcuate arteries	The arterial resistive index is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.	Month 3 to month 9
venous parameters - venous pulse transit time of the hepatic and left and right renal veins	Maternal venous pulse transit times (VPTT) weredefined as the time interval (ms) between the maternalECG P-wave and corresponding Doppler A-wave, correctedfor the duration of the corresponding cardiac cycle	Month 3 to month 9
venous parameters - hepatic vein impedance index	ECG-Doppler parameters were impedance index at the level of hepatic veins (HVI) and renal interlobar veins (RIVI) together with venous pulse transit times (VPTT), as well as resistive and pulsatility index, and arterial pulse transit time (APTT) at the level of uterine arcuate arteries.	Month 3 to month 9
venous parameters - left and right renal interlobar vein impedance indices	ECG-Doppler parameters were impedance index at the level of hepatic veins (HVI) and renal interlobar veins (RIVI) together with venous pulse transit times (VPTT), as well as resistive and pulsatility index, and arterial pulse transit time (APTT) at the level of uterine arcuate arteries.	Month 3 to month 9
systolic blood pressure	systolic blood pressure (mmHg),	Month 3 to month 9
diastolic blood pressure	diastolic blood pressure (mmHg),	Month 3 to month 9
Mean arterial blood pressure	Mean arterial blood pressure (mmHg),	Month 3 to month 9
Total body water	Total body water (liters)	Month 3 to month 9
extracellular water	extracellular water (liters)	Month 3 to month 9
intracellular water	intracellular water (liters)	Month 3 to month 9
ECW/ICW ratio	ECW/ICW ratio	Month 3 to month 9
stroke volume	stroke volume (ml)	Month 3 to month 9
hear rate (beats/min)	hear rate (beats/min)	Month 3 to month 9
cardiac output (l/min)	cardiac output (l/min)	Month 3 to month 9
velocity index (1/1,000/s)	velocity index (1/1,000/s)	Month 3 to month 9
acceleration index (1/100/s²)	acceleration index (1/100/s²)	Month 3 to month 9
total peripheral resistance (dyn·s·cm-5)	total peripheral resistance (dyn·s·cm-5)	Month 3 to month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of prenatal consults	prenatal follow- up, numeric value, every consult during pregnancy from the first consultation until delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of ultrasounds	numeric value, every ultrasound during pregnancy from the first consultation until delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of CTG's	numeric value, every CTG during pregnancy from the first consultation until delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of hospitalizations of the mother at the MIC department	numeric value, every hospitalization at the MIC during pregnancy from the first consultation until delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of days admitted to the MIC	numeric value, amount of days admitted to the MIC from the first consultation unitil delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of medication adaptations during pregnancy	numeric value, every change from no medication intake/a specific medciation at a specific dose to another medication intake at a specific dose.	during pregnancy from the first consultation until delivery assessed up to 40 weeks
development of gestational hypertensive disorders	numeric, the diagnoses of gestational hypertension/pre-eclampsia/HELLP during pregnancy	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Onset of delivery	categorical (spontaneous, induced, primary section) from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Mode of delivery	categorical (vaginal, instrumental, primary/secondary section) from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Birthweight	gram from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Apgar at 1' and 5'	numeric (0-10) from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Admission to the neonatal intensive care (NIC)	categorical(Yes/no) from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Number of days admitted to the NIC	numeric value, amount of days admidtted to the NIC, from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Cost for the health care services (HCS)	Costs of the prenatal care as described in Secondary outcomes (1) and costs for the care during and after the delivery as described in Secondary outcomes (2), which are divided in: costs for the HCS, costs for the patient, costs for the RIZIV. All costs will be collected in Euros. rom the first contact with the gynaecologist until the discharge from the hospital of both the mother and the neonate.	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of phone calls from the patient to the midwife for technical issues	numeric scale, contributor to the added value of TM	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of phone calls from the patient to the midwife for medical issues	numeric scale, contributor to the added value of TM	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of phone calls from the midwife to the patient for technical issues	numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of phone calls from the midwife to the patient for medical issues	numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of starts/adjustments to the antihypertensive medication	numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Changes in CV profile throughout pregnancy and in response to medication	Changes in Cardiovascular profile throughout pregnancy and in response to medication	during pregnancy from the first consultation until delivery assessed up to 40 weeks
BMQ questionaire	Beliefs about Medicine Questionnaire	during pregnancy from the first consultation until delivery assessed up to 40 weeks
ProMAS Questionnaire	a Probabilistic Medication Adherence Scale	during pregnancy from the first consultation until delivery assessed up to 40 weeks

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Universitaire Ziekenhuizen KU Leuven; University Hospital, Antwerp; AZ Sint-Jan AV; Ziekenhuis Oost-Limburg; AZ Sint-Lucas Brugge
• Investigators: Principal Investigator: Wilfried Gyselaers, prof. dr., Hasselt University; Study Chair: Dorien Lanssens, dr., Hasselt University

Publications and helpful links

General Publications

• Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.
• Lanssens D, Thijs IM, Gyselaers W; PREMOM II - consortium. Design of the Pregnancy REmote MOnitoring II study (PREMOM II): a multicenter, randomized controlled trial of remote monitoring for gestational hypertensive disorders. BMC Pregnancy Childbirth. 2020 Oct 15;20(1):626. doi: 10.1186/s12884-020-03291-2.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2019
• Primary Completion (Estimated): April 14, 2024
• Study Completion (Estimated): April 14, 2024

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pregnancy outcomes; remote monitoring; gestational hypertensive disorders
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Hypertension, Pregnancy-Induced; Antihypertensive Agents
• Other Study ID Numbers: PREMOM-II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No