| Registry | NCT03002987, acronym AGp |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 866 (Actual) |
| Sponsor | Bispebjerg Hospital (Other) |
| Conditions | Pregnancy, Sickness Absence, Occupational Exposure |
| Interventions | Active Pregnancy policy (Behavioral) |
| Dates | start 2017-09-01, primary completion 2019-12-01, completion 2020-03-01, first posted 2016-12-26, last updated 2020-04-24 |
| Locations | 1 site in Denmark |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intervention, education | Active comparator | Behavioral: Active Pregnancy policy | Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces |
| control | No intervention | as usual |
Sex: Female, ages: 15 Years to 50 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Department of occupational and evironmental medicine | Copenhagen | Denmark |