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

Gestational Hypertension Clinical Trial

— PREMOM-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04031430
• Other study ID #: PREMOM-II
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2019
• Est. completion date: April 14, 2024

Study information

• Verified date: September 2023
• Source: Hasselt University
• Contact: Wilfried Gyselaers, prof. dr.
• Phone: + 32 89 32 15 57
• Email: wilfried.gyselaers[@]zol.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6107
• Est. completion date: April 14, 2024
• Est. primary completion date: April 14, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Gestational Hypertension
• Hypertension
• Hypertension, Pregnancy-Induced

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	University hospital Antwerp	Antwerp
Belgium	AZ Sint Jan Brugge - Oostende	Brugge
Belgium	AZ Sint-Lucas Brugge - Oostende	Brugge
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Universitaire Ziekenhuizen Leuven	Leuven

Sponsors (6)

Lead Sponsor	Collaborator
Hasselt University	AZ Sint-Jan AV, AZ Sint-Lucas Brugge, Universitaire Ziekenhuizen KU Leuven, University Hospital, Antwerp, Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	systolic blood pressure	systolic blood pressure (mmHg),	Month 3 to month 9
Primary	diastolic blood pressure	diastolic blood pressure (mmHg),	Month 3 to month 9
Primary	Mean arterial blood pressure	Mean arterial blood pressure (mmHg),	Month 3 to month 9
Primary	Total body water	Total body water (liters)	Month 3 to month 9
Primary	extracellular water	extracellular water (liters)	Month 3 to month 9
Primary	intracellular water	intracellular water (liters)	Month 3 to month 9
Primary	ECW/ICW ratio	ECW/ICW ratio	Month 3 to month 9
Primary	stroke volume	stroke volume (ml)	Month 3 to month 9
Primary	hear rate (beats/min)	hear rate (beats/min)	Month 3 to month 9
Primary	cardiac output (l/min)	cardiac output (l/min)	Month 3 to month 9
Primary	velocity index (1/1,000/s)	velocity index (1/1,000/s)	Month 3 to month 9
Primary	acceleration index (1/100/s²)	acceleration index (1/100/s²)	Month 3 to month 9
Primary	total peripheral resistance (dyn·s·cm-5)	total peripheral resistance (dyn·s·cm-5)	Month 3 to month 9
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Birthweight	gram from birth until discharge from the hospital	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	BMQ questionaire	Beliefs about Medicine Questionnaire	during pregnancy from the first consultation until delivery assessed up to 40 weeks
Secondary	ProMAS Questionnaire	a Probabilistic Medication Adherence Scale	during pregnancy from the first consultation until delivery assessed up to 40 weeks