跳至主要内容
临床试验/NCT05670145
NCT05670145进行中(未招募)不适用

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

Bispebjerg Hospital1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2023年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,600
试验地点
1
主要终点
Preterm birth

研究概览

简要总结

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.

详细描述

Background and impact In the Scandinavian countries, 75-80% of women are a part of the workforce and many of these are of reproductive age.(2) Physical workloads are a recurring issue in risk assessment and counselling of pregnant women regarding work. Epidemiological studies have indicated an association with preterm birth and foetal death, (3-9) but have been based on self-report mostly with a retrospective design with obvious limitations regarding recall bias, crude and no time specific exposure assessments. Few studies have applied Job Exposure Matrices (JEMs) for exposure assessments, but these studies have been small and/or based on self-report or expert assessment.(4, 10-14) Overall, previous studies have been limited by misclassification of exposures and a lack of exposure contrast with few highly exposed pregnant women.

Pregnancy discomforts are common and often reason for absence during pregnancy.(15-16) Since pregnancy discomforts only in extreme cases involve hospital contacts and thereby entry in the Danish registries, studies rely on self-report. To be able to prevent absence or other negative consequences, we need more knowledge on the importance of physical workloads in relation to development or aggravation of pregnancy discomforts.

Results from PRECISE will help improve current knowledge on physical workloads during pregnancy and advance national guidelines, which potentially can prevent negative outcomes in pregnancies and reduce worries and absence among pregnant employees. Further, the construction of trimester-specific JEMs based on objective exposure assessments will expand and support research in occupational reproduction and enable future investigations of associations with other outcomes in pregnancy and offspring.

Qualifications and previous related activities of the applicant PRECISE is a natural extension of the applicant Luise Mølenberg Begtrup´s commitment to secure safe working environments for mothers and offspring. In both her research and clinical practice Dr. Begtrup continously strive to improve guidance of healthcare professionals, employers and decision makers and provide information, advice and work planning for pregnant women. She is PI for projects focusing on the wellbeing of pregnant women and their retention at workplaces and was pivotal in the establishment of the nationwide occupational generation cohort DOC*X-G, and in research of night work and pregnancy outcomes. Dr. Begtrup has been involved in the National Board of Health´s update for maternal care, and recently finished a review to the Danish Working Environment Authority about work-related ergonomic exposures and pregnancy.

Research plan The project period of four years is organized in six interrelated work packages (WP1-WP6). The PhD-student covered by this application is planned to start 01/03/2023 and will be recruited through postings through the Capital Region of Denmark and the University of Copenhagen.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Preterm birth

时间窗: from 2000 - 2014

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

Pregnancy discomforts

时间窗: during pregnancy (from inclusion until birth)

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luise Mølenberg Begtrup

Doctor, phD, projectleader

Bispebjerg Hospital

研究点 (1)

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