<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/NCT02979756</url>
  </required_header>
  <id_info>
    <org_study_id>ITMBelgium</org_study_id>
    <nct_id>NCT02979756</nct_id>
  </id_info>
  <brief_title>Improve Detection and Management of Gestational Diabetes Through the Primary Health Care Level in Morocco</brief_title>
  <official_title>Améliorer la Detection et la Prise en Charge du diabète Gestationnel au Niveau Des établissements de Soins de santé Primaires au Maroc</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ecole Nationale de Santé Publique, Rabat, Morocco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Tropical Medicine, Belgium</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco&#xD;
      revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in&#xD;
      receiving appropriate care. Based on the results of the situational analysis, the&#xD;
      investigators developed this proposal in close collaboration with the Moroccan research group&#xD;
      on gestational diabetes composed of representatives of the Ministry of Health, researchers,&#xD;
      members of professional organizations and specialists in the domains of endocrinology,&#xD;
      gynecology, neonatal health and nutrition. The investigators opted for an hybrid&#xD;
      implementation effectiveness trial to evaluate both clinical effectiveness of the proposed&#xD;
      screening and initial management strategy and its implementation at the first level of care.&#xD;
&#xD;
      The objectives of this study are thus to evaluate the feasibility of a decentralized strategy&#xD;
      of screening for GDM and the initialization of GDM treatment already through the primary&#xD;
      level of care and to assess its potential for scaling-up. Specific objectives of this study&#xD;
      are to augment universal access to screening and management of gestational diabetes and to&#xD;
      increase the competencies of health care providers at first level health care facilities to&#xD;
      detect, start initial treatment and to improve follow-up of affected women. By comparing&#xD;
      active screening and treatment initiation through first line health facilities with the&#xD;
      existing practices, the investigators would like to explore the effect of the new model on&#xD;
      maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery&#xD;
      complications and birth weight. The investigators will further assess the acceptability of&#xD;
      screening and initial management of GDM through first line health services by health care&#xD;
      providers and by pregnant women diagnosed with GDM and the impact of two different screening&#xD;
      approaches on the lifestyle of affected mothers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Actual">February 12, 2018</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Macrosomia</measure>
    <time_frame>within 6 months after being diagnosed with GDM</time_frame>
    <description>Difference in birth weight of babies of mothers detected with GDM in the different arms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptance of GDM screening</measure>
    <time_frame>within 6 months after being diagnosed with GDM</time_frame>
    <description>Assessing the acceptance GDM screening and initial management at primary health care level among providers and GDM affected women (Focus group discussions with providers and in-depth interviews with women affected by GDM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lifestyle impact of GDM</measure>
    <time_frame>within 6 months after being diagnosed with GDM</time_frame>
    <description>Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">215</enrollment>
  <condition>Gestational Diabetes Mellitus in Pregnancy</condition>
  <arm_group>
    <arm_group_label>Decentralized GDM screening and initial management</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, the intervention consists of screening all pregnant women for GDM using the nationally recommended oral glucose tolerance test that will take place during antenatal care consultations in 10 randomly selected primary health care facilities. Overall, 80 women who are diagnosed with GDM and who consent to participate will receive initial nutritional counseling and will be closely followed up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard GDM screening and management practice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this arm, screening for GDM will follow standard practice. 80 women diagnosed with GDM in 10 randomly selected primary health care facilities and who consent to participate will be followed up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Decentralized GDM screening and initial management</intervention_name>
    <description>Screening for GDM and initialization of nutritional therapy at the first level of care</description>
    <arm_group_label>Decentralized GDM screening and initial management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women attending ANC (screening)&#xD;
&#xD;
          -  Women diagnosed with GDM (follow-up)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women with pre-existing diabetes type 1 or 2&#xD;
&#xD;
          -  No informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bouchra Assarag, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ecole Nationale de Santé Publique, Rabat, Morocco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bettina Utz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Tropical Medicine, Antwerp, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vincent De Brouwere, MD</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Tropical Medicine, Antwerp, Belgium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>20 facilities in Marrakech and Al Haouz - Region Marrakech-Safi</name>
      <address>
        <city>Marrakech</city>
        <zip>40000</zip>
        <country>Morocco</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Morocco</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>February 28, 2018</last_update_submitted>
  <last_update_submitted_qc>February 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Pregnancy in Diabetics</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/NCT02979756
org study id: ITMBelgium
nct id: NCT02979756
lead sponsor: 
collaborator: 
has dmc: Yes
A situational analysis on gestational diabetes conducted in 2015 in two districts in Morocco
      revealed difficulties in accessing screening for gestational diabetes (GDM) and delays in
      receiving appropriate care. Based on the results of the situational analysis, the
      investigators developed this proposal in close collaboration with the Moroccan research group
      on gestational diabetes composed of representatives of the Ministry of Health, researchers,
      members of professional organizations and specialists in the domains of endocrinology,
      gynecology, neonatal health and nutrition. The investigators opted for an hybrid
      implementation effectiveness trial to evaluate both clinical effectiveness of the proposed
      screening and initial management strategy and its implementation at the first level of care.

      The objectives of this study are thus to evaluate the feasibility of a decentralized strategy
      of screening for GDM and the initialization of GDM treatment already through the primary
      level of care and to assess its potential for scaling-up. Specific objectives of this study
      are to augment universal access to screening and management of gestational diabetes and to
      increase the competencies of health care providers at first level health care facilities to
      detect, start initial treatment and to improve follow-up of affected women. By comparing
      active screening and treatment initiation through first line health facilities with the
      existing practices, the investigators would like to explore the effect of the new model on
      maternal and newborn outcomes such as weight gain in pregnancy, occurrence of delivery
      complications and birth weight. The investigators will further assess the acceptability of
      screening and initial management of GDM through first line health services by health care
      providers and by pregnant women diagnosed with GDM and the impact of two different screening
      approaches on the lifestyle of affected mothers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Macrosomia
time frame: within 6 months after being diagnosed with GDM
description: Difference in birth weight of babies of mothers detected with GDM in the different arms
measure: Acceptance of GDM screening
time frame: within 6 months after being diagnosed with GDM
description: Assessing the acceptance GDM screening and initial management at primary health care level among providers and GDM affected women (Focus group discussions with providers and in-depth interviews with women affected by GDM)
measure: Lifestyle impact of GDM
time frame: within 6 months after being diagnosed with GDM
description: Assessing the impact of GDM screening and management on women's life (questionnaire/ Likert-scales)
arm group label: Decentralized GDM screening and initial management
arm group type: Experimental
description: In this arm, the intervention consists of screening all pregnant women for GDM using the nationally recommended oral glucose tolerance test that will take place during antenatal care consultations in 10 randomly selected primary health care facilities. Overall, 80 women who are diagnosed with GDM and who consent to participate will receive initial nutritional counseling and will be closely followed up.
arm group label: Standard GDM screening and management practice
arm group type: No Intervention
description: In this arm, screening for GDM will follow standard practice. 80 women diagnosed with GDM in 10 randomly selected primary health care facilities and who consent to participate will be followed up.
intervention type: Procedure
intervention name: Decentralized GDM screening and initial management
description: Screening for GDM and initialization of nutritional therapy at the first level of care
arm group label: Decentralized GDM screening and initial management
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bouchra Assarag, MD
role: Principal Investigator
affiliation: Ecole Nationale de Santé Publique, Rabat, Morocco
last name: Bettina Utz, MD
role: Principal Investigator
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
last name: Vincent De Brouwere, MD
role: Study Director
affiliation: Institute of Tropical Medicine, Antwerp, Belgium
facility: 
country: Morocco
responsible party type: Sponsor
mesh term: Diabetes, Gestational
mesh term: Pregnancy in Diabetics
sharing ipd: Undecided