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Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence (AGp)

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ClinicalTrials.gov Identifier: NCT03002987
Recruitment Status : Recruiting
First Posted : December 26, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Luise Mølenberg Begtrup, Bispebjerg Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pregnancy Sickness Absence Occupational Exposure Behavioral: Active Pregnancy policy Not Applicable

Detailed Description:

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 3 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Active Pregnancy Policy at Work. Greater Wellbeing and Lower Sickness Absence
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : March 1, 2020

Arm Intervention/treatment
Active Comparator: Intervention, education
Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces
Behavioral: Active Pregnancy policy
Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places

No Intervention: control
as usual



Primary Outcome Measures :
  1. pregnancy related sick leave [ Time Frame: one year (intervention period) ]
    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)


Secondary Outcome Measures :
  1. To what extent Active pregnancy policy is implemented at the departments/workplaces [ Time Frame: one year (intervention period) ]
    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)

  2. Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees [ Time Frame: one year ]
    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

  3. cost effectiveness of the intervention [ Time Frame: one year ]
    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.



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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnancy during intervention period, employed at one of the included departments/workplaces

Exclusion Criteria:

  • not being able to understand, write and read Danish

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): NCT03002987


Contacts
Contact: Luise Begtrup, MD + 45 21908721 luise.moelenberg.begtrup.02@regionh.dk
Contact: Jens Peter Bonde, Professor

Locations
Denmark
Department of occupational and evironmental medicine Recruiting
Copenhagen, Denmark, 2400
Contact: Luise Moelenberg Begtrup, MD    + 45 21908721    luise.moelenberg.begtrup.02@regionh.dk   
Contact: Jens Peter Bonde, Professor         
Principal Investigator: Luise Moelenberg Begtrup, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Luise Moelenberg Begtrup, MD Department of occupational Medicine, Bipspebjerg Hospital

Responsible Party: Luise Mølenberg Begtrup, MD, phD, postdoc, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03002987     History of Changes
Other Study ID Numbers: AGp2016
First Posted: December 26, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No