<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03246737</url>
  </required_header>
  <id_info>
    <org_study_id>14/078U</org_study_id>
    <nct_id>NCT03246737</nct_id>
  </id_info>
  <brief_title>Premom: Pregnancy Remote Monitoring</brief_title>
  <acronym>Premom</acronym>
  <official_title>Premom: Pregnancy Remote Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hasselt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ziekenhuis Oost-Limburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hasselt University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Multiple cardiovascular adaptations happen during pregnancy. When gestational hypertensive&#xD;
      disorders (GHD) occurs, these adaptations are abnormal. Approximately 5 - 8 % of all pregnant&#xD;
      women develop GHD.&#xD;
&#xD;
      GHD is an pregnancy complication which is characterized by an elevated blood pressure (≥&#xD;
      140/90 mm Hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks&#xD;
      of pregnancy. When this remains uncured, GHD can have severe complications for both mother&#xD;
      and child. For this reason, a close follow-up of women with a high risk for developing this&#xD;
      condition is recommended. This to detect and threat GHD early.&#xD;
&#xD;
      Patients can be included when they are at least 10 weeks pregnant. Every pregnant women&#xD;
      receives two devices to control daily here parameters in her home environment: a blood&#xD;
      pressure monitor and an activity tracker. The women will be asked to perform two blood&#xD;
      pressure measurements a day and to wear the activity tracker day and night. This data will be&#xD;
      send by Bluetooth and Wi-Fi to the investigator in the hospital. Also will the women be asked&#xD;
      to measure once a week her weight and send this to the hospital.&#xD;
&#xD;
      Name of the device Measurement Protocol Blood pressure monitor Blood pressure, heart rate&#xD;
      Twice a day (morning and evening) Activity tracker Activity- and sleep pattern Day and night&#xD;
      Weight scale (not remote) Weight Once a week (morning)&#xD;
&#xD;
      The investigator controls daily the incoming measurements and consults the responsible&#xD;
      gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. Depending&#xD;
      on the decisions of the gyneacologist, following actions can be performed:&#xD;
&#xD;
        -  Further observations&#xD;
&#xD;
        -  Extra monitor&#xD;
&#xD;
        -  Adjustments to the medication scheme&#xD;
&#xD;
        -  Performing an 24 hours urine collection&#xD;
&#xD;
        -  Admission to the prenatal observation ward When results are missing, the investigator&#xD;
           contacts the women to ask of this measurement is due to personal or technical causes.&#xD;
&#xD;
      The purpose of this study part is to detect early signs of PE.&#xD;
&#xD;
      When patients gave birth, the data about the delivery (duration of labour, complications,&#xD;
      mode of delivery, date of delivery, complications, parameters of the mother, specialties) and&#xD;
      the neonate (gestational age, date and hour of birth, Apgar score, birth weight, length,&#xD;
      complications and admission to the neonatal intensive care) will be collected. These data&#xD;
      will be compared to the data of women who were admitted to the hospital for GHD, but who&#xD;
      doesn't receive remote monitoring devices.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>prenatal follow-up</measure>
    <time_frame>up to 9 months (delivery)</time_frame>
    <description>total number of prenatal appointments, monitors, echo's, prenatal hospitalizations, hospitalizations until delivery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>maternal hemodynamic outcomes</measure>
    <time_frame>Day of delivery</time_frame>
    <description>occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>birth weight</measure>
    <time_frame>Day of delivery</time_frame>
    <description>neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>birth length</measure>
    <time_frame>Day of delivery</time_frame>
    <description>neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar at 1' and 5'</measure>
    <time_frame>Day of delivery</time_frame>
    <description>neonatal outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>admission to Neonatal Intensive Care</measure>
    <time_frame>Day of delivery</time_frame>
    <description>neonatal outcome</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Pregnancies, Cardiovascular Complications</condition>
  <arm_group>
    <arm_group_label>pregnant women</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>monitoring</intervention_name>
    <arm_group_label>pregnant women</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 10 weeks of gestation, in the possession of a Smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital malformations of the fetus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilfried Gyselaers, prof. dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hasselt University</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>February 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>August 8, 2017</last_update_submitted>
  <last_update_submitted_qc>August 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hasselt University</investigator_affiliation>
    <investigator_full_name>Wilfried Gyselaers</investigator_full_name>
    <investigator_title>prof. dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy Complications, Cardiovascular</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03246737
org study id: 14/078U
nct id: NCT03246737
lead sponsor: 
collaborator: 
has dmc: No
Multiple cardiovascular adaptations happen during pregnancy. When gestational hypertensive
      disorders (GHD) occurs, these adaptations are abnormal. Approximately 5 - 8 % of all pregnant
      women develop GHD.

      GHD is an pregnancy complication which is characterized by an elevated blood pressure (≥
      140/90 mm Hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks
      of pregnancy. When this remains uncured, GHD can have severe complications for both mother
      and child. For this reason, a close follow-up of women with a high risk for developing this
      condition is recommended. This to detect and threat GHD early.

      Patients can be included when they are at least 10 weeks pregnant. Every pregnant women
      receives two devices to control daily here parameters in her home environment: a blood
      pressure monitor and an activity tracker. The women will be asked to perform two blood
      pressure measurements a day and to wear the activity tracker day and night. This data will be
      send by Bluetooth and Wi-Fi to the investigator in the hospital. Also will the women be asked
      to measure once a week her weight and send this to the hospital.

      Name of the device Measurement Protocol Blood pressure monitor Blood pressure, heart rate
      Twice a day (morning and evening) Activity tracker Activity- and sleep pattern Day and night
      Weight scale (not remote) Weight Once a week (morning)

      The investigator controls daily the incoming measurements and consults the responsible
      gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. Depending
      on the decisions of the gyneacologist, following actions can be performed:

        -  Further observations

        -  Extra monitor

        -  Adjustments to the medication scheme

        -  Performing an 24 hours urine collection

        -  Admission to the prenatal observation ward When results are missing, the investigator
           contacts the women to ask of this measurement is due to personal or technical causes.

      The purpose of this study part is to detect early signs of PE.

      When patients gave birth, the data about the delivery (duration of labour, complications,
      mode of delivery, date of delivery, complications, parameters of the mother, specialties) and
      the neonate (gestational age, date and hour of birth, Apgar score, birth weight, length,
      complications and admission to the neonatal intensive care) will be collected. These data
      will be compared to the data of women who were admitted to the hospital for GHD, but who
      doesn't receive remote monitoring devices.
observational model: Cohort
time perspective: Prospective
measure: prenatal follow-up
time frame: up to 9 months (delivery)
description: total number of prenatal appointments, monitors, echo's, prenatal hospitalizations, hospitalizations until delivery
measure: maternal hemodynamic outcomes
time frame: Day of delivery
description: occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help
measure: birth weight
time frame: Day of delivery
description: neonatal outcome
measure: birth length
time frame: Day of delivery
description: neonatal outcome
measure: Apgar at 1' and 5'
time frame: Day of delivery
description: neonatal outcome
measure: admission to Neonatal Intensive Care
time frame: Day of delivery
description: neonatal outcome
arm group label: pregnant women
intervention type: Other
intervention name: monitoring
arm group label: pregnant women
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Wilfried Gyselaers, prof. dr.
role: Principal Investigator
affiliation: Hasselt University
responsible party type: Principal Investigator
investigator affiliation: Hasselt University
investigator full name: Wilfried Gyselaers
investigator title: prof. dr.
mesh term: Pregnancy Complications, Cardiovascular
sharing ipd: Undecided