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Article History

Received: 6 June 2018

Accepted: 12 March 2019

First Online: 22 March 2019

Ethics approval and consent to participate

: The study will be conducted according to the principles of the Declaration of Helsinki (World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects, Version Fortaleza, Brazil, October 2013,) and is in accordance with the Medical Research Involving Human Subjects Act (WMO) [CitationRef removed]. The protocol is registered in the Dutch trial register (NTR 5357; registration date: 11 August 2015) and has been approved by the ethics committee of the Máxima Medical Centre in Veldhoven (ref. no 15.106; NL54779.015.15; date of approval 14 December 2015). The trial is ongoing and is currently in the process of including women. To date (17 November 2018), 152 women have been enrolled. Date of first subjects’ enrolment: February 18 2016. <i>Summary of the informed consent procedure:</i>The gynaecologist working in a participating hospital will inform eligible women about the study and refer them to dedicated research nurses if available. Women will receive a patient information letter and informed consent form. The research nurses or the local investigator will counsel women, after which women are allowed sufficient time to consider participation (one week). Subsequently, written informed consent for participation will be sought.

: Not applicable.

: The authors declare that they have no competing interests.

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