NCT05621512

Brief Summary

The aim of this study is to reduce sick leave and improve wellbeing. This is measured as physical and mental health, general work ability, work-life balance, manager support and completed work adjustments among pregnant health care professionals. It is hypothesised that pregnant employees participating in preventive sessions with their manager and a midwife in addition to the hospital standard pregnancy policy management will have less sick leave and report better wellbeing compared to the reference group.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

June 16, 2022

Last Update Submit

March 28, 2023

Conditions

Sick LeavePregnancyMidwifery

Keywords

Risk factorsHealth Care ProfessionalsInterventionWorkplace

Outcome Measures

Primary Outcomes (1)

  • Number of days on sick leave

    Sick leave is specified by mean number of days on sick leave and the proportion of employees on sick leave throughout pregnancy and within trimesters (first trimester defined as gestational week 1 - 12, second trimester being gestational week 13 - 27 and third trimester being gestational week 28 - maternity leave)

    gestational period until gestational week 32

Secondary Outcomes (5)

  • Self-rated health

    at inclusion and at gestational week 30

  • Work ability

    At inclusion and at gestational week 30

  • Psycho-social working environment

    At inclusion and at gestational week 30

  • Relation to immediate superior

    At inclusion and at gestational week 30

  • Influence

    At inclusion and at gestational week 30

Study Arms (2)

Intervention

EXPERIMENTAL

The intervention implies a letter of invitation for a session between the employee, the department manager, and a midwife concerning workplace risk assessment and agreement on feasible work adjustments if necessary. A second session within gestational week 26-28 is scheduled to follow-up and readjust if necessary. A systematic frame for sessions is developed by the research team and conclusions from the sessions are registered within a piloted standardized template. The employee and the manager can initiate contact with the midwife at any time, e.g in case of new symptoms or discomfort and need for support or guidance. If sick leave is considered, a new session is recommended and may be scheduled at any time. To ensure transparency of guidance and workplace adjustments for other relevant healthcare professionals, the employee is asked to inform her general practitioner (GP) and midwife of the program.

Other: Preventive sessions

Usual practice

NO INTERVENTION

Hospital pregnancy policy is usual practice and implies a meeting between the pregnant employee and her manager concerning an individual risk assessment. A risk assessment-template can be downloaded from the hospital website. If minimizing potential risks by adjustments is not possible the employee should be redeployed. If redeployment is not possible the pregnant employee may be absent due to pregnancy related symptoms. The pregnant employee is requested to inform her GP about agreements.

Interventions

Preventive sessionsOTHER

Preventive sessions between the pregnant employee, her manager and a midwife.

Intervention

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant employees working as health care professionals at Aarhus University Hospital

You may not qualify if:

  • Gest. week \> 20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Study Officials

  • Thomas Maribo, Reseracher

    Region MidtJylland Denmark

    STUDY CHAIR

Central Study Contacts

Anne Mette H Momsen, Researcher

CONTACT

0045 3082 8189Anne-Mette.Momsen@rm.dk

Pernille Pedersen, Reseracher

CONTACT

0045 2447 0964pelped@rm.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster randomization
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. prof.

Study Record Dates

First Submitted

June 16, 2022

First Posted

November 18, 2022

Study Start

September 1, 2021

Primary Completion

August 31, 2023

Study Completion

October 1, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

DK(1)