Clinical trial NCT04031430: PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
Official title: PREMOM II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Hypertension
Keywords: remote monitoring
gestational hypertensive disorders
pregnancy outcomes
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
name: Universitaire Ziekenhuizen KU Leuven
name: AZ Sint-Jan AV
name: AZ Sint-Lucas Brugge
name: University Hospital, Antwerp
First posted: 2019-07-24
Enrollment: 1095
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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. -

Primary outcomes:
measure: Gestational age (GA)
timeFrame: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation.
measure: hospitalization
timeFrame: From 32 weeks of gestation until 34 weeks of gestation
measure: Changes in CV physiological parameters - electrocardiogram (ECT) with Doppler ultrasonography
timeFrame: Month 3 to month 9
measure: changes in CV physiological parameters - impedance cardiography
timeFrame: Month 3 to month 9
measure: changes in CV physiological parameters - bio impedance
timeFrame: Month 3 to month 9
measure: Arterial parameters - pulse transit time
timeFrame: Month 3 to month 9
measure: Arterial parameters - pulsatility index
timeFrame: Month 3 to month 9
measure: Arterial parameters - resistivity index of the left and right arcuate arteries
timeFrame: Month 3 to month 9
measure: venous parameters - venous pulse transit time of the hepatic and left and right renal veins
timeFrame: Month 3 to month 9
measure: venous parameters - hepatic vein impedance index
timeFrame: Month 3 to month 9
measure: venous parameters - left and right renal interlobar vein impedance indices
timeFrame: Month 3 to month 9
measure: systolic blood pressure
timeFrame: Month 3 to month 9
measure: diastolic blood pressure
timeFrame: Month 3 to month 9
measure: Mean arterial blood pressure
timeFrame: Month 3 to month 9
measure: Total body water
timeFrame: Month 3 to month 9
measure: extracellular water
timeFrame: Month 3 to month 9
measure: intracellular water
timeFrame: Month 3 to month 9
measure: ECW/ICW ratio
timeFrame: Month 3 to month 9
measure: stroke volume
timeFrame: Month 3 to month 9
measure: hear rate (beats/min)
timeFrame: Month 3 to month 9
measure: cardiac output (l/min)
timeFrame: Month 3 to month 9
measure: velocity index (1/1,000/s)
timeFrame: Month 3 to month 9
measure: acceleration index (1/100/s²)
timeFrame: Month 3 to month 9
measure: total peripheral resistance (dyn·s·cm-5)
timeFrame: Month 3 to month 9
Secondary outcomes:
measure: number of prenatal consults
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of ultrasounds
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of CTG's
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of hospitalizations of the mother at the MIC department
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of days admitted to the MIC
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of medication adaptations during pregnancy
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: development of gestational hypertensive disorders
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Onset of delivery
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Mode of delivery
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Birthweight
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Apgar at 1' and 5'
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Admission to the neonatal intensive care (NIC)
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Number of days admitted to the NIC
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Cost for the health care services (HCS)
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of phone calls from the patient to the midwife for technical issues
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of phone calls from the patient to the midwife for medical issues
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of phone calls from the midwife to the patient for technical issues
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of phone calls from the midwife to the patient for medical issues
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: number of starts/adjustments to the antihypertensive medication
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: Changes in CV profile throughout pregnancy and in response to medication
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: BMQ questionaire
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
measure: ProMAS Questionnaire
timeFrame: during pregnancy from the first consultation until delivery assessed up to 40 weeks
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University hospital Antwerp
city: Brugge
country: Belgium
facility: AZ Sint-Lucas Brugge - Oostende
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge - Oostende
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: Hasselt University
name: Wilfried Gyselaers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Dorien Lanssens, dr.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.