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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

Tracking Information
First Submitted Date  ICMJE November 21, 2018
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE June 18, 2019
Estimated Primary Completion Date April 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • 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
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • number of prenatal consults [ Time Frame: through study completion, ]
    prenatal follow- up, numeric value, every consult during pregnancy from the first consultation until delivery
  • number of ultrasounds [ Time Frame: through study completion ]
    numeric value, every ultrasound during pregnancy from the first consultation until delivery
  • number of CTG's [ Time Frame: through study completion ]
    numeric value, every CTG during pregnancy from the first consultation until delivery
  • 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
  • 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
  • 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.
  • development of gestational hypertensive disorders [ Time Frame: through study completion ]
    numeric, the diagnoses of gestational hypertension/pre-eclampsia/HELLP during pregnancy
  • Onset of delivery [ Time Frame: through study completion ]
    categorical (spontaneous, induced, primary section)
  • Onset of delivery [ Time Frame: through study completion ]
    categorical (spontaneous, induced, primary section) from birth until discharge from the hospital
  • Mode of delivery [ Time Frame: through study completion ]
    categorical (vaginal, instrumental, primary/secondary section) from birth until discharge from the hospital
  • Birthweight [ Time Frame: through study completion ]
    gram from birth until discharge from the hospital
  • Apgar at 1' and 5' [ Time Frame: through study completion ]
    numeric (0-10) from birth until discharge from the hospital
  • Admission to the neonatal intensive care (NIC) [ Time Frame: through study completion ]
    categorical(Yes/no) from birth until discharge from the hospital
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders
Official Title  ICMJE PREMOM II: Pregnancy Remote Monitoring of Women With Gestational Hypertensive Disorders
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Gestational Hypertension
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: telemonitoring group (TM)
    Intervention: Device: Telemonitoring
  • Active Comparator: Patient self-monitoring group (PSM)
    Intervention: Device: Telemonitoring
  • No Intervention: control group (CC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)
6107
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 14, 2023
Estimated Primary Completion Date April 14, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. -
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04031430
Other Study ID Numbers  ICMJE PREMOM II
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wilfried Gyselaers, Hasselt University
Study Sponsor  ICMJE Hasselt University
Collaborators  ICMJE
  • Ziekenhuis Oost-Limburg
  • Universitaire Ziekenhuizen Leuven
  • AZ Sint-Jan AV
  • AZ Sint-Lucas Brugge
  • University Hospital, Antwerp
Investigators  ICMJE
Principal Investigator: Wilfried Gyselaers, prof. dr. Hasselt University
Study Chair: Dorien Lanssens, dr. Hasselt University
PRS Account Hasselt University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP