Clinical trial NCT05621512: Workplace Intervention Among Pregnant Hospital Employees
Official title: Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sick Leave
Pregnancy
Midwifery
Keywords: Risk factors
Health Care Professionals
Intervention
Workplace
Lead sponsor: Region MidtJylland Denmark
Sponsor class: OTHER
Collaborators: name: Defactum, Central Denmark Region
name: Aarhus University Hospital
name: Herning Hospital
First posted: 2022-11-18
Enrollment: 404
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomization
Primary purpose: PREVENTION

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.

Detailed description: Sick leave during pregnancy is frequent and studies report proportions of employees on sick leave between 36-75%. Reasons for sick leave in early pregnancy are nausea, vomiting and dizziness whereas Braxton Hicks contractions, low back and pelvic girdle pain are more common in late pregnancy. Further, sick leave is strongly associated with working conditions and appropriate work adjustment.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Gest. week \> 20

Primary outcomes:
measure: Number of days on sick leave
timeFrame: gestational period until gestational week 32
Secondary outcomes:
measure: Self-rated health
timeFrame: at inclusion and at gestational week 30
measure: Work ability
timeFrame: At inclusion and at gestational week 30
measure: Psycho-social working environment
timeFrame: At inclusion and at gestational week 30
measure: Relation to immediate superior
timeFrame: At inclusion and at gestational week 30
measure: Influence
timeFrame: At inclusion and at gestational week 30
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Region MidtJylland Denmark
name: Thomas Maribo, Reseracher
role: STUDY_CHAIR
References: