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

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ClinicalTrials.gov Identifier: NCT04031430
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Ziekenhuis Oost-Limburg
Universitaire Ziekenhuizen Leuven
AZ Sint-Jan AV
AZ Sint-Lucas Brugge
University Hospital, Antwerp
Information provided by (Responsible Party):
Wilfried Gyselaers, Hasselt University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gestational Hypertension Device: Telemonitoring Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : April 14, 2023
Estimated Study Completion Date : April 14, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Gestational age (GA) [ Time Frame: Throug study completion, from the first contact with the gynaecologist (after fertilization) untill 34 weeks of gestation. ]
    Throug study completion

  2. hospitalization [ Time Frame: 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. ]
    Through study completion, from 32 weeks of gestation untill 34 weeks of gestation.


Secondary Outcome Measures :
  1. number of prenatal consults [ Time Frame: through study completion, ]
    prenatal follow- up, numeric value, every consult during pregnancy from the first consultation until delivery

  2. number of ultrasounds [ Time Frame: through study completion ]
    numeric value, every ultrasound during pregnancy from the first consultation until delivery

  3. number of CTG's [ Time Frame: through study completion ]
    numeric value, every CTG during pregnancy from the first consultation until delivery

  4. number of hospitalizations of the mother at the MIC department [ Time Frame: through study completion ]
    numeric value, every hospitalization at the MIC during pregnancy from the first consultation until delivery

  5. number of days admitted to the MIC [ Time Frame: through study completion ]
    numeric value, amount of days admitted to the MIC from the first consultation unitil delivery

  6. number of medication adaptations during pregnancy [ Time Frame: through study completion ]
    numeric value, every change from no medication intake/a specific medciation at a specific dose to another medication intake at a specific dose.

  7. development of gestational hypertensive disorders [ Time Frame: through study completion ]
    numeric, the diagnoses of gestational hypertension/pre-eclampsia/HELLP during pregnancy

  8. Onset of delivery [ Time Frame: through study completion ]
    categorical (spontaneous, induced, primary section)

  9. Onset of delivery [ Time Frame: through study completion ]
    categorical (spontaneous, induced, primary section) from birth until discharge from the hospital

  10. Mode of delivery [ Time Frame: through study completion ]
    categorical (vaginal, instrumental, primary/secondary section) from birth until discharge from the hospital

  11. Birthweight [ Time Frame: through study completion ]
    gram from birth until discharge from the hospital

  12. Apgar at 1' and 5' [ Time Frame: through study completion ]
    numeric (0-10) from birth until discharge from the hospital

  13. Admission to the neonatal intensive care (NIC) [ Time Frame: through study completion ]
    categorical(Yes/no) from birth until discharge from the hospital

  14. Number of days admitted to the NIC [ Time Frame: through study completion ]
    numeric value, amount of days admidtted to the NIC, from birth until discharge from the hospital

  15. Cost for the health care services (HCS) [ Time Frame: through study completion ]
    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.

  16. number of phone calls from the patient to the midwife for technical issues [ Time Frame: through study completion ]
    numeric scale, contributor to the added value of TM

  17. number of phone calls from the patient to the midwife for medical issues [ Time Frame: through study completion ]
    numeric scale, contributor to the added value of TM

  18. number of phone calls from the midwife to the patient for technical issues [ Time Frame: through study completion ]
    numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery

  19. number of phone calls from the midwife to the patient for medical issues [ Time Frame: through study completion ]
    numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery

  20. number of starts/adjustments to the antihypertensive medication [ Time Frame: through study completion ]
    numeric scale, contributor to the added value of TM from the inclusion in the study until the moment of delivery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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. -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031430


Contacts
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Contact: Wilfried Gyselaers, prof. dr. + 32 89 32 15 57 wilfried.gyselaers@zol.be
Contact: Dorien Lanssens, dr. + 32 89 32 15 57 dorien.lanssens@uhasselt.be

Locations
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Belgium
University hospital Antwerp Recruiting
Antwerp, Belgium, 2000
Contact: Yves Jacquemyn, prof.dr.    +32 34 58 40 04    yves.jacquemyn@uza.be   
Principal Investigator: Yves Jacquemyn, prof.dr.         
AZ Sint-Lucas Brugge - Oostende Recruiting
Brugge, Belgium, 8000
Contact: Hilde Logghe, dr.    +32 50 36 50 80    hilde.logghe@gmail.com   
Principal Investigator: Hilde Logghe, dr.         
AZ Sint Jan Brugge - Oostende Recruiting
Brugge, Belgium, 9000
Contact: Barbara Lebbe, dr.       barbara.lebbe@azsintjan.be   
Principal Investigator: Barbara Lebbe, dr.         
Ziekenhuis Oost-Limburg Recruiting
Genk, Belgium, 3600
Contact: Eric de Jonge, prof.dr.    +32 89 32 50 50    eric.dejonge@zol.be   
Contact: Dorien Lanssens, dr.    +32 89 32 15 57    dorien.lanssens@uhasselt.be   
Principal Investigator: Eric de Jonge, prof. dr.         
Universitaire Ziekenhuizen Leuven Recruiting
Leuven, Belgium, 3000
Contact: Roland Devlieger, prof. dr.    +32 16 34 42 04    roland.devlieger@uzleuven.be   
Principal Investigator: Roland Devlieger, prof. dr.         
Sponsors and Collaborators
Hasselt University
Ziekenhuis Oost-Limburg
Universitaire Ziekenhuizen Leuven
AZ Sint-Jan AV
AZ Sint-Lucas Brugge
University Hospital, Antwerp
Investigators
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Principal Investigator: Wilfried Gyselaers, prof. dr. Hasselt University
Study Chair: Dorien Lanssens, dr. Hasselt University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wilfried Gyselaers, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier: NCT04031430    
Other Study ID Numbers: PREMOM II
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wilfried Gyselaers, Hasselt University:
remote monitoring
gestational hypertensive disorders
pregnancy outcomes
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Hypertension
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications