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

NCT04031430 | Completed

• 1 other identifier: PREMOM-II
• Study Type: interventional
• Target: 1,095
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Gestational Hypertension

Keywords

remote monitoring; gestational hypertensive disorders; pregnancy outcomes

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (22)

• number of prenatal consults

  during pregnancy from the first consultation until delivery assessed up to 40 weeks

• number of ultrasounds

  during pregnancy from the first consultation until delivery assessed up to 40 weeks

• number of CTG's

  during pregnancy from the first consultation until delivery assessed up to 40 weeks

• number of hospitalizations of the mother at the MIC department

  during pregnancy from the first consultation until delivery assessed up to 40 weeks

• number of days admitted to the MIC

  during pregnancy from the first consultation until delivery assessed up to 40 weeks

Study Arms (5)

telemonitoring group (TM)

EXPERIMENTAL

telemonitoring group (TM)

Device: Telemonitoring

Patient self-monitoring group (PSM)

ACTIVE COMPARATOR

Patient self-monitoring group (PSM)

Device: Telemonitoring

control group (CC)

NO INTERVENTION

No intervention

CAPROM - Group 1

EXPERIMENTAL

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

CAPROM - Group 2

EXPERIMENTAL

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

Interventions

Longitudinal CV profiling during pregnancy and 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 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 1

Telemonitoring 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); telemonitoring group (TM)

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

CAPROM - Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• AZ Sint-Jan AV: collaborator
• AZ Sint-Lucas Brugge: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (5)

University hospital Antwerp

Antwerp, 2000, Belgium

Location

AZ Sint-Lucas Brugge - Oostende

Bruges, 8000, Belgium

Location

AZ Sint Jan Brugge - Oostende

Bruges, 9000, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Universitaire Ziekenhuizen Leuven

Leuven, 3000, Belgium

Location

Related Publications (3)

• Dreesen 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.

  PMID: 40978500 DERIVED

• 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.

  PMID: 33059633 DERIVED

• 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.

  PMID: 32748394 DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Lead

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Wilfried Gyselaers, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Dorien Lanssens, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: July 24, 2019
• Study Start: June 18, 2019
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

BE (5)