Gestational HypertensionPREMOM-IINCT04031430
PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
A study testing Telemonitoring, Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication and CV profiling before and after the start/switch of antihypertensive medication in people with Gestational Hypertension, run by Hasselt University at 5 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Telemonitoring, Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication and CV profiling before and after the start/switch of antihypertensive medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,095 participants
- Where
- 5 sitesBelgium
- Study dates
- 18 Jun 2019to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
University hospital Antwerp
Antwerp, 2000
AZ Sint-Lucas Brugge - Oostende
Bruges, 8000
AZ Sint Jan Brugge - Oostende
Bruges, 9000
Ziekenhuis Oost-Limburg
Genk, 3600
Universitaire Ziekenhuizen Leuven
Leuven, 3000
About this study
Official title: 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.
- Conditions
- Gestational Hypertension
- Being tested
- Telemonitoring, Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication, CV profiling before and after the start/switch of antihypertensive medication
- Keywords
- remote monitoring, gestational hypertensive disorders, pregnancy outcomes
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemonitoringDevice
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.
Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medicationOther
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.
CV profiling before and after the start/switch of antihypertensive medicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| telemonitoring group (TM) | Experimental | telemonitoring group (TM) Receives: Device: Telemonitoring |
| Patient self-monitoring group (PSM) | Active comparator | Patient self-monitoring group (PSM) Receives: Device: Telemonitoring |
| control group (CC) | No intervention | No intervention |
| CAPROM - Group 1 | Experimental | pregnant women randomly assigned to the TM group of PREMOM II Receives: Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication |
| CAPROM - Group 2 | Experimental | pregnant women followed-up via TM group as part of their usual care Receives: Other: CV profiling before and after the start/switch of antihypertensive medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Month 3 to month 9
systolic blood pressure
systolic blood pressure (mmHg),
Measured: Month 3 to month 9
diastolic blood pressure
diastolic blood pressure (mmHg),
Measured: Month 3 to month 9
Mean arterial blood pressure
Mean arterial blood pressure (mmHg),
Measured: Month 3 to month 9
Total body water
Total body water (liters)
Measured: Month 3 to month 9
extracellular water
extracellular water (liters)
Measured: Month 3 to month 9
intracellular water
intracellular water (liters)
Measured: Month 3 to month 9
ECW/ICW ratio
ECW/ICW ratio
Measured: Month 3 to month 9
stroke volume
stroke volume (ml)
Measured: Month 3 to month 9
hear rate (beats/min)
hear rate (beats/min)
Measured: Month 3 to month 9
cardiac output (l/min)
cardiac output (l/min)
Measured: Month 3 to month 9
velocity index (1/1,000/s)
velocity index (1/1,000/s)
Measured: Month 3 to month 9
acceleration index (1/100/s²)
acceleration index (1/100/s²)
Measured: Month 3 to month 9
total peripheral resistance (dyn·s·cm-5)
total peripheral resistance (dyn·s·cm-5)
Measured: Month 3 to month 9
Secondary outcomes (22)
number of prenatal consults
prenatal follow- up, numeric value, every consult during pregnancy from the first consultation until delivery
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Birthweight
gram from birth until discharge from the hospital
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: during pregnancy from the first consultation until delivery assessed up to 40 weeks
BMQ questionaire
Beliefs about Medicine Questionnaire
Measured: during pregnancy from the first consultation until delivery assessed up to 40 weeks
ProMAS Questionnaire
a Probabilistic Medication Adherence Scale
Measured: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start18 Jun 2019
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Universitaire Ziekenhuizen KU Leuven, AZ Sint-Jan AV, AZ Sint-Lucas Brugge, University Hospital, Antwerp
- Responsible party
- Principal investigator, Wilfried Gyselaers, Hasselt University
- Investigators
- Wilfried Gyselaers, prof. dr., Principal investigator, Hasselt UniversityDorien Lanssens, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031430
- Sponsor's protocol ID
- PREMOM-II
- Acronym
- PREMOM-II
- Status last verified
- Oct 2024
- First submitted
- 21 Nov 2018
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gerits ML, Bielen S, Lanssens D, Marneffe W; PREMOM II-consortium. Remote and self-monitoring for pregnant women at risk of gestational hypertensive disorders: a cost-effectiveness analysis. Eur J Health Econ. 2026 Sep 30. doi: 10.1007/s10198-026-01995-4. Online ahead of print.
PubMed 42814235Dreesen P, Lanssens D, Nouwen S, Volders P, Janssen F, Soubry A, Gyselaers W, Ceulemans M. Medication beliefs and adherence during and after pregnancy among women at risk for gestational hypertensive disorders. Front Drug Saf Regul. 2025 Aug 11;5:1610273. doi: 10.3389/fdsfr.2025.1610273. eCollection 2025.
PubMed 40978500Lanssens 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.
PubMed 33059633Ashworth 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.
PubMed 32748394
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREMOM II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
- ClinicalTrials.gov ID
- NCT04031430
- Acronym / sponsor ID
- PREMOM-II / PREMOM-II
- Conditions
- Gestational Hypertension
- Keywords
- remote monitoring, gestational hypertensive disorders, pregnancy outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Universitaire Ziekenhuizen KU Leuven, AZ Sint-Jan AV, AZ Sint-Lucas Brugge, University Hospital, Antwerp
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| telemonitoring group (TM) | Experimental | Device: Telemonitoringtelemonitoring group (TM) |
| Patient self-monitoring group (PSM) | Active comparator | Device: TelemonitoringPatient self-monitoring group (PSM) |
| control group (CC) | No intervention | –No intervention |
| CAPROM - Group 1 | Experimental | Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medicationpregnant women randomly assigned to the TM group of PREMOM II |
| CAPROM - Group 2 | Experimental | Other: CV profiling before and after the start/switch of antihypertensive medicationpregnant women followed-up via TM group as part of their usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemonitoringWomen 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. | Device | Patient self-monitoring group (PSM), telemonitoring group (TM) |
| Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medicationLongitudinal 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 | CAPROM - Group 1 |
| CV profiling before and after the start/switch of antihypertensive medicationCV 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. | Other | CAPROM - Group 2 |
Primary outcome
Gestational age (GA)
Time frame: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.
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.
hospitalization
Time frame: From 32 weeks of gestation until 34 weeks of gestation
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.
Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography
Time frame: Month 3 to month 9
The CV profile assessment consists of a simple, non-invasive method using the ECG with Doppler ultrasonography providing information about arteries and veins
changes in CV physiological parameters - impedance cardiography
Time frame: Month 3 to month 9
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
changes in CV physiological parameters - bio impedance
Time frame: Month 3 to month 9
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.
Arterial parameters - pulse transit time
Time frame: Month 3 to month 9
The Pulse Transit Method (PTT) as a non-invasive means to track Blood Pressure over a short period of time
Arterial parameters - pulsatility index
Time frame: Month 3 to month 9
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.
Arterial parameters - resistivity index of the left and right arcuate arteries
Time frame: Month 3 to month 9
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.
venous parameters - venous pulse transit time of the hepatic and left and right renal veins
Time frame: Month 3 to month 9
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
venous parameters - hepatic vein impedance index
Time frame: Month 3 to month 9
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.
venous parameters - left and right renal interlobar vein impedance indices
Time frame: Month 3 to month 9
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.
systolic blood pressure
Time frame: Month 3 to month 9
systolic blood pressure (mmHg),
diastolic blood pressure
Time frame: Month 3 to month 9
diastolic blood pressure (mmHg),
Mean arterial blood pressure
Time frame: Month 3 to month 9
Mean arterial blood pressure (mmHg),
Total body water
Time frame: Month 3 to month 9
Total body water (liters)
extracellular water
Time frame: Month 3 to month 9
extracellular water (liters)
intracellular water
Time frame: Month 3 to month 9
intracellular water (liters)
ECW/ICW ratio
Time frame: Month 3 to month 9
ECW/ICW ratio
stroke volume
Time frame: Month 3 to month 9
stroke volume (ml)
hear rate (beats/min)
Time frame: Month 3 to month 9
hear rate (beats/min)
cardiac output (l/min)
Time frame: Month 3 to month 9
cardiac output (l/min)
velocity index (1/1,000/s)
Time frame: Month 3 to month 9
velocity index (1/1,000/s)
acceleration index (1/100/s²)
Time frame: Month 3 to month 9
acceleration index (1/100/s²)
total peripheral resistance (dyn·s·cm-5)
Time frame: Month 3 to month 9
total peripheral resistance (dyn·s·cm-5)
22 secondary outcomes
number of prenatal consults
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of ultrasounds
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of CTG's
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of hospitalizations of the mother at the MIC department
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of days admitted to the MIC
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of medication adaptations during pregnancy
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
development of gestational hypertensive disorders
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Onset of delivery
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Mode of delivery
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Birthweight
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Apgar at 1' and 5'
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Admission to the neonatal intensive care (NIC)
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Number of days admitted to the NIC
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Cost for the health care services (HCS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
number of starts/adjustments to the antihypertensive medication
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Changes in CV profile throughout pregnancy and in response to medication
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
BMQ questionaire
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
ProMAS Questionnaire
Time frame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 42814235Gerits ML, Bielen S, Lanssens D, Marneffe W; PREMOM II-consortium. Remote and self-monitoring for pregnant women at risk of gestational hypertensive disorders: a cost-effectiveness analysis. Eur J Health Econ. 2026 Sep 30. doi: 10.1007/s10198-026-01995-4. Online ahead of print.
- Derived from this study: PubMed 40978500Dreesen P, Lanssens D, Nouwen S, Volders P, Janssen F, Soubry A, Gyselaers W, Ceulemans M. Medication beliefs and adherence during and after pregnancy among women at risk for gestational hypertensive disorders. Front Drug Saf Regul. 2025 Aug 11;5:1610273. doi: 10.3389/fdsfr.2025.1610273. eCollection 2025.
- Derived from this study: PubMed 33059633Lanssens 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.
- Derived from this study: PubMed 32748394Ashworth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilfried Gyselaers, prof. dr. principal investigator
Hasselt University
Dorien Lanssens, dr. study chair
Hasselt University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring, Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication and CV profiling before and after the start/switch of antihypertensive medication in people with Gestational Hypertension, run by Hasselt University at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age (GA) (time frame: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031430, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.