Oderkerk, Tamara J. http://orcid.org/0000-0003-2307-0338
Beelen, Pleun
Geomini, Peggy M. A. J.
Herman, Malou C.
Leemans, Jaklien C.
Duijnhoven, Ruben G.
Bosmans, Judith E.
Pannekoek, Justine N.
Clark, Thomas J.
Mol, Ben Willem J.
Bongers, Marlies Y.
Clinical trials referenced in this document:
Documents that mention this clinical trial
Endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding: study protocol of a multicentre randomised controlled trial; MIRA2 trial
https://doi.org/10.1186/s12905-022-01843-6
Funding for this research was provided by:
ZonMw, Leading the Change
Article History
Received: 27 April 2022
Accepted: 17 June 2022
First Online: 27 June 2022
Declarations
:
: The study will be conducted according to the principles of the Declaration of Helsinki and in accordance with the Medical Research Involving Human Subjects Act (WMO) of the Netherlands. This study protocol and the template informed consent forms has been approved by the medical ethics committee of the Máxima Medical Centre as the primary reviewing board (NL NL69895.015). Dutch Trial registration: NL7817 (ExternalRef removed). If a patient agrees to participate in the study, written informed consent will be obtained after which randomisation will be performed by the research nurse or researcher. Any modifications to the protocol which may impact on the conduct of the study, potential benefit of the patient or may affect patient safety, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment will be agreed upon by the project group, and approved by the medical ethics committee of the Máxima Medical Centre prior to implementation and notified to the health authorities and the participating sites in accordance with local regulations.
: Not applicable.
: The authors declare that they have no competing interests.