Workplace Intervention Among Pregnant Hospital Employees
NCT ID: NCT05621512
Last Updated: 2023-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
404 participants
INTERVENTIONAL
2021-09-01
2024-10-01
Brief Summary
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Detailed Description
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The study design is cluster randomization with participation of all departments at Aarhus University Hospital (AUH), Denmark. Half of the departments are randomized to the intervention and the remaining to the reference group. The intervention group will receive a protocolized intervention with midwifery support as an add-on to usual practice. The reference group will receive protocolized usual practice.
Data are obtained from the hospital payment system and by survey (RedCap).
The sample size is calculated to find a difference of ≥ 7 days with a standard deviation of 25. To achieve a statistical power of 80% with a significance level of p ≤ 0.05 an estimated 202 participants will be required in each of the groups.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Intervention
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.
Preventive sessions
Preventive sessions between the pregnant employee, her manager and a midwife.
Usual practice
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.
No interventions assigned to this group
Interventions
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Preventive sessions
Preventive sessions between the pregnant employee, her manager and a midwife.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
45 Years
FEMALE
Yes
Sponsors
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Defactum, Central Denmark Region
OTHER_GOV
Aarhus University Hospital
OTHER
Herning Hospital
OTHER
Region MidtJylland Denmark
OTHER
Responsible Party
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Rikke Damkjær Maimburg
Ass. prof.
Principal Investigators
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Thomas Maribo, Reseracher
Role: STUDY_CHAIR
Region MidtJylland Denmark
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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29-2019-03
Identifier Type: -
Identifier Source: org_study_id
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