Wise, Michelle R. http://orcid.org/0000-0001-9194-9585
Marriott, Joy
Battin, Malcolm
Thompson, John M. D.
Stitely, Michael
Sadler, Lynn
Funding for this research was provided by:
New Zealand Health Research Council (16-807)
Auckland District Health Board A+ Trust (6907)
Maurice and Phyllis Paykel Trust (2018)
Hawkes Bay Medical Research Foundation (2019)
Mercia Barnes Trust RANZCOG (2019)
Article History
Received: 27 August 2019
Accepted: 9 January 2020
First Online: 17 February 2020
Ethics approval and consent to participate
: This trial received ethics approval through the Health and Disability Ethics Committee (HDEC) NZ full review pathway, granted on 23 November 2016 (16/CEN/121). Protocol amendment granted on 17 September 2017. Progress reports are provided regularly to HDEC.The clinician discusses the study with their patient, if eligible, and ascertains if they would like to participate. If so, they provide the Patient Information Sheet (PIS) and Consent Form (CF). Alternatively, the clinician can inform their patient about the study through provision of a study pamphlet, and asks if she is willing to be contacted by the research team. If so, the researcher then provides information to the woman and answers questions, and offers to email them the PIS and CF. This consent process occurs between 1 to 7 days prior to the IOL (differs by research site). On the day of IOL at the hospital, the patient completes written informed consent; the original form is kept with the study data pack, a copy is provided to the participant and another copy is kept in the clinical notes. There are no plans for compensation for potential harms caused by participation in the trial.
: Not applicable
: The authors declare that they have no competing interests.