<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/NCT03002987</url>
  </required_header>
  <id_info>
    <org_study_id>AGp2016</org_study_id>
    <nct_id>NCT03002987</nct_id>
  </id_info>
  <brief_title>Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence</brief_title>
  <acronym>AGp</acronym>
  <official_title>Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a cluster randomized design it will be investigated whether teaching local leaders how to&#xD;
      implement active pregnancy policy results in less sickness absence among their pregnant&#xD;
      employees. Further it will be investigated to what extent Active pregnancy policy is&#xD;
      implemented at the departments and whether it results in higher sense of security and&#xD;
      wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will&#xD;
      be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: The majority of Danish women work during their reproductive years. Sickness&#xD;
      absence among pregnant women is frequent; more than one third of Danish women are on longterm&#xD;
      sick leave during pregnancy. Sick leave has been found associated with occupational exposures&#xD;
      and studies have shown that adjustment in exposure can reduce sick leave in pregnancy&#xD;
      indicating that there are potential preventive initiatives.&#xD;
&#xD;
      Design and outcomes: In a cluster randomized design it will be investigated whether teaching&#xD;
      local leaders how to implement active pregnancy policy results in less sickness absence among&#xD;
      their pregnant employees. It will further be investigated to what extent Active pregnancy&#xD;
      policy is implemented at the departments and whether it results in higher sense of security&#xD;
      and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention&#xD;
      will be analyzed.&#xD;
&#xD;
      The study takes place at hospitals in the two regions on Zealand, Denmark (The Capital region&#xD;
      of Denmark and Region Zealand) and in the daycare sector in 2 municipalities located in The&#xD;
      Capital region of Denmark. The randomization will be at the level of departments, which will&#xD;
      be randomized to either intervention or control:&#xD;
&#xD;
      Intervention: The leaders are invited to a 3 hours seminar, where they will be taught in how&#xD;
      to implement active pregnancy policy at their department.&#xD;
&#xD;
      Control: as usual&#xD;
&#xD;
      All employees at the involved departments getting pregnant during the year of intervention&#xD;
      will be included in the study. They are to answer a questionnaire at 28th week of gestation&#xD;
      and their days of sick leave during pregnancy will be recorded. All leaders at the&#xD;
      departments are to answer two questionnaires, one before randomization and one after&#xD;
      intervention.&#xD;
&#xD;
      The intervention: At the 3 hours seminar the leaders will receive education containing: 1)&#xD;
      Updates on evidence on pregnancy and risk of occupational exposures, 2) information about the&#xD;
      rules in the area and the leader's responsibilities, 3) Answers and solutions to frequent&#xD;
      issues relating pregnant employees at work and 4) Introduction to Active Pregnancy policy.&#xD;
&#xD;
      The content of Active Pregnancy Policy: A congratulation letter to the pregnant employee&#xD;
      inviting her to a meeting. At the meeting her job task will be discussed and fears and&#xD;
      worries taken hand on. The aim is to adjust the job tasks to the employee and her special&#xD;
      need during her pregnancy. During the pregnancy the leader regularly evaluate with the&#xD;
      pregnant employee on how it goes and if there are needs for other or further adjustments. A&#xD;
      minimum of 3 planned meetings have to be held during the pregnancy. Further the leader shall&#xD;
      inform the other employees at the workplace about the arrangements made with the pregnant&#xD;
      employee.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy related sick leave</measure>
    <time_frame>one year (intervention period)</time_frame>
    <description>difference in pregnancy related sick leave between the two randomized groups. In days and the proportion of pregnant employee with longterm sick leave (&gt; 4 weeks)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To what extent Active pregnancy policy is implemented at the departments/workplaces</measure>
    <time_frame>one year (intervention period)</time_frame>
    <description>Difference between the two randomized groups in relation to the proportion of pregnant employees who experienced active pregnancy policy (different parts: Received congratulation letter, had scheduled meetings discussing the possible occupational exposures, adjustment of work tasks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees</measure>
    <time_frame>one year</time_frame>
    <description>Difference between the two randomized groups in relation to the experience of security and wellbeing among the pregnant employees. Using the WHO-5 and variables concerning the psychosocial work environment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost effectiveness of the intervention</measure>
    <time_frame>one year</time_frame>
    <description>calculating the costs of the intervention: 1)Holding the seminars (place, salary for teachers, food supply etc.) 2) time used (the leaders salary) attending the seminars, 3) Teaching material and the cost of resources used at the departments (control vs. intervention): 1) time used hiring temporary employees, 2) time used talking with pregnant employees, 3) time used changing the work tasks of the pregnant employee, 4) Salary to hired temporary employees.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">866</enrollment>
  <condition>Pregnancy</condition>
  <condition>Sickness Absence</condition>
  <condition>Occupational Exposure</condition>
  <arm_group>
    <arm_group_label>Intervention, education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Pregnancy policy</intervention_name>
    <description>Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places</description>
    <arm_group_label>Intervention, education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnancy during intervention period, employed at one of the included&#xD;
             departments/workplaces&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  not being able to understand, write and read Danish&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luise Moelenberg Begtrup, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of occupational Medicine, Bipspebjerg Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of occupational and evironmental medicine</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Luise Mølenberg Begtrup</investigator_full_name>
    <investigator_title>MD, phD, postdoc</investigator_title>
  </responsible_party>
  <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/NCT03002987
org study id: AGp2016
nct id: NCT03002987
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In a cluster randomized design it will be investigated whether teaching local leaders how to
      implement active pregnancy policy results in less sickness absence among their pregnant
      employees. Further it will be investigated to what extent Active pregnancy policy is
      implemented at the departments and whether it results in higher sense of security and
      wellbeing among the pregnant employee. Finally the cost and benefits of the intervention will
      be analyzed.
Background: The majority of Danish women work during their reproductive years. Sickness
      absence among pregnant women is frequent; more than one third of Danish women are on longterm
      sick leave during pregnancy. Sick leave has been found associated with occupational exposures
      and studies have shown that adjustment in exposure can reduce sick leave in pregnancy
      indicating that there are potential preventive initiatives.

      Design and outcomes: In a cluster randomized design it will be investigated whether teaching
      local leaders how to implement active pregnancy policy results in less sickness absence among
      their pregnant employees. It will further be investigated to what extent Active pregnancy
      policy is implemented at the departments and whether it results in higher sense of security
      and wellbeing among the pregnant employee. Finally the cost and benefits of the intervention
      will be analyzed.

      The study takes place at hospitals in the two regions on Zealand, Denmark (The Capital region
      of Denmark and Region Zealand) and in the daycare sector in 2 municipalities located in The
      Capital region of Denmark. The randomization will be at the level of departments, which will
      be randomized to either intervention or control:

      Intervention: The leaders are invited to a 3 hours seminar, where they will be taught in how
      to implement active pregnancy policy at their department.

      Control: as usual

      All employees at the involved departments getting pregnant during the year of intervention
      will be included in the study. They are to answer a questionnaire at 28th week of gestation
      and their days of sick leave during pregnancy will be recorded. All leaders at the
      departments are to answer two questionnaires, one before randomization and one after
      intervention.

      The intervention: At the 3 hours seminar the leaders will receive education containing: 1)
      Updates on evidence on pregnancy and risk of occupational exposures, 2) information about the
      rules in the area and the leader's responsibilities, 3) Answers and solutions to frequent
      issues relating pregnant employees at work and 4) Introduction to Active Pregnancy policy.

      The content of Active Pregnancy Policy: A congratulation letter to the pregnant employee
      inviting her to a meeting. At the meeting her job task will be discussed and fears and
      worries taken hand on. The aim is to adjust the job tasks to the employee and her special
      need during her pregnancy. During the pregnancy the leader regularly evaluate with the
      pregnant employee on how it goes and if there are needs for other or further adjustments. A
      minimum of 3 planned meetings have to be held during the pregnancy. Further the leader shall
      inform the other employees at the workplace about the arrangements made with the pregnant
      employee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: pregnancy related sick leave
time frame: one year (intervention period)
description: difference in pregnancy related sick leave between the two randomized groups. In days and the proportion of pregnant employee with longterm sick leave (> 4 weeks)
measure: To what extent Active pregnancy policy is implemented at the departments/workplaces
time frame: one year (intervention period)
description: Difference between the two randomized groups in relation to the proportion of pregnant employees who experienced active pregnancy policy (different parts: Received congratulation letter, had scheduled meetings discussing the possible occupational exposures, adjustment of work tasks)
measure: Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees
time frame: one year
description: Difference between the two randomized groups in relation to the experience of security and wellbeing among the pregnant employees. Using the WHO-5 and variables concerning the psychosocial work environment
measure: cost effectiveness of the intervention
time frame: one year
description: calculating the costs of the intervention: 1)Holding the seminars (place, salary for teachers, food supply etc.) 2) time used (the leaders salary) attending the seminars, 3) Teaching material and the cost of resources used at the departments (control vs. intervention): 1) time used hiring temporary employees, 2) time used talking with pregnant employees, 3) time used changing the work tasks of the pregnant employee, 4) Salary to hired temporary employees.
arm group label: Intervention, education
arm group type: Active Comparator
description: Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces
arm group label: control
arm group type: No Intervention
description: as usual
intervention type: Behavioral
intervention name: Active Pregnancy policy
description: Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places
arm group label: Intervention, education
criteria: 
gender: Female
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luise Moelenberg Begtrup, MD
role: Principal Investigator
affiliation: Department of occupational Medicine, Bipspebjerg Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Luise Mølenberg Begtrup
investigator title: MD, phD, postdoc
sharing ipd: Undecided