«The aim of the study is to investigate the effects of the WHO’s new guideline for monitoring labor and assessing its progress. The study is being conducted at 10 maternity clinics in Norway and will continue until May 2026. It is conducted using passive consent for the part of the study where routinely collected data is utilized. The term ‘passive consent’ means that the study has been approved with an exemption from consent with the right to opt out, in accordance with Section 29 of the Norwegian Health Personnel Act for research purposes.
The Regional Committee for Medical and Health Research Ethics (REK) has been authorized to grant an exemption from the duty of confidentiality under Section 29 of the Health Personnel Act for research purposes. Following a comprehensive assessment, the committee has approved access to patient records to retrieve the specified data/variables necessary for conducting the study.
Summary:
For the part of the study aimed at evaluating clinical changes following the implementation of the LCG template, the committee has granted an exemption from consent on the condition that information with the right to opt out is provided. For the part of the study where participants are asked to complete a questionnaire, active consent will be obtained.»