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Article History

Received: 18 December 2018

Accepted: 6 May 2019

First Online: 28 May 2019

Ethics approval and consent to participate

: The trial protocol has been reviewed by the Regional Committee on Health Research Ethics (Jr. no. H-18015521). The intervention was assessed to be a low-risk add-on intervention to the standard care offered to pregnant women with chronic disease, and the board has judged that no known risk is involved with participating in the trial. The Regional Committee on Health Research Ethics therefore concluded that the study can be initiated without further ethical approval. The trial will be carried out in accordance with the principles of the National Committee on Health Research Ethics in Denmark [ ] and the principles of the Helsinki declaration [ ]. Written informed consent will be obtained, and all participants will be informed about the voluntary nature of their participation and their right to withdraw from the study. No side effects or harms to the participants are anticipated. If participants wish to withdraw from the trial, they will continue to receive standard care. If a participant wishes to withdraw from the trial, she will be asked for permission to retain her data for the final analysis. All data from participants will be handled anonymously and secured in a logged database. The trial has been approved by the Danish Data Protection Agency (Jr. no. RH_2017-346; I-suite no. 06055). If any important protocol modifications are made, these will be reported in the trial registry (ClinicalTrials.gov).

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: The authors declare that they have no competing interests.