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

NCT05670145 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1600

Last updated 2024-05-14

No results posted yet for this study

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

Interventions

OTHER

PRECISE

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.

Sponsors & Collaborators

  • University of Zealand Hospital

    collaborator UNKNOWN
  • Holbaek Sygehus

    collaborator OTHER
  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Mølenberg Begtrup · Bispebjerg and Frederiksberg Hospital

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-02
Primary Completion
2024-08-31
Completion
2025-08-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05670145 on ClinicalTrials.gov