NCT03002987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
866

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

December 19, 2016

Last Update Submit

April 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • pregnancy related sick leave

    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)

    one year (intervention period)

Secondary Outcomes (3)

  • To what extent Active pregnancy policy is implemented at the departments/workplaces

    one year (intervention period)

  • Wether active pregnancy policy lead to higher sense of security and wellbeing among the pregnant employees

    one year

  • cost effectiveness of the intervention

    one year

Study Arms (2)

Intervention, education

ACTIVE COMPARATOR

Education of leaders (3 hours) in how to implement Active Pregnancy policy at their departements/workplaces

Behavioral: Active Pregnancy policy

control

NO INTERVENTION

as usual

Interventions

Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places

Intervention, education

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • not being able to understand, write and read Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of occupational and evironmental medicine

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • Begtrup LM, Malmros P, Brauer C, Soegaard Toettenborg S, Flachs EM, Hammer PEC, Bonde JP. Manager-oriented intervention to reduce absence among pregnant employees in the healthcare and daycare sector: a cluster randomised trial. Occup Environ Med. 2021 Jan 12:oemed-2020-106794. doi: 10.1136/oemed-2020-106794. Online ahead of print.

Study Officials

  • Luise Moelenberg Begtrup, MD

    Department of occupational Medicine, Bipspebjerg Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, phD, postdoc

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 26, 2016

Study Start

September 1, 2017

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations