PRECISE - Objective Measures and Observations of Physical Exposures Among Pregnant Employees in the Danish Workforce

NCT05670145 | Active Not Recruiting DMC

• 1 other identifier: BispebjergHospital
• Study Type: observational
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Occupational physical activity during pregnancy may decrease blood supply to the uterus and be connected to negative pregnancy outcomes. Every year, this notion prompts many pregnant women to be absent from their workplace in order to protect themselves and their unborn children. However, little is known about the actual extent and impact of physical workloads among expecting mothers in Denmark and whether this high rate of pregnancy related absence is necessary. In consequence, current guidelines from the Danish Working Environment Agency have omitted former limits on lifting during pregnancy due to lack of evidence. (1) Former studies have mainly been based on self-reported data with no measurements of exposures. A comprehensive evaluation of physical exposures in Danish workplaces and potential consequences for pregnant women will provide a rational basis for organization of work with improved options for prevention of adverse health effects. By use of measurements, observations and real-time self-report, the overall aim of the project is to attain precise data on physical workloads (lifting, standing/walking and forward bending) among pregnant employees in the Danish workforce, and investigate how these relate to discomforts, complications and negative pregnancy outcomes.

Conditions

Pregnancy Complications; Pregnancy Related; Preterm Birth; Small for Gestational Age at Delivery

Outcome Measures

Primary Outcomes (2)

• Preterm birth

  Birth of a child between gestational week 22+0 and 36+6, obtained from the Danish Medical Birth Register

  from 2000 - 2014

• Pregnancy discomforts

  Pelvic girdle pain, low back pain and Braxton Hick contractions by weekly selfreport (questionaires)

  during pregnancy (from inclusion until birth)

Interventions

PRECISE OTHER

The target group is working pregnant women. Further, a smaller group of non-pregnant women from the same workplaces and with the same work tasks (colleagues) will be included. Around 95% of pregnant women in Denmark have a 1st trimester ultrasound scan.(17) To ensure a representative population, the recruitment to the project takes place at four obstetric departments. After giving informed written consent for participation, the pregnant women receive a baseline questionnaire followed by short weekly questionnaires by SMS until maternity leave. Exposure to occupational standing/walking and bending are measured by use of triaxial accelerometers (Axivity sensors) worn on the back and thigh for 24 hours/day. Exposure to lifting is quantified through continuous observations during a workday with registration of number of lifts, weight of burdens, and number of person-liftings.

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant employees in the Danish workforce

You may qualify if:

• Working pregnant women who went to the first trimester scanning at four different hospitals en Denmark

You may not qualify if:

• Pregnant women who do not work or do not speak danish

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• University of Zealand Hospital: collaborator
• Holbaek Sygehus: collaborator

Study Sites (1)

Department of occupational and evironmental medicine

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Pregnancy Complications; Premature Birth

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Mølenberg Begtrup

  Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, phD, projectleader

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: January 4, 2023
• Study Start: January 2, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)