Romero, Stefhanie http://orcid.org/0000-0002-8898-3069
Pettersson, Kristina
Yousaf, Khurram
Westgren, Magnus
Ajne, Gunilla
Funding for this research was provided by:
Stockholms Läns Landsting
VINNOVA
Karolinska Institute
Article History
Received: 21 September 2020
Accepted: 29 January 2021
First Online: 26 February 2021
Ethics approval and consent to participate
: Approved by Regionala Etik Prövnings Nämnden (EPN), part of Etikprövningsmyndigheten, Stockholm (DNR 2015/487–31/2). As stated in the method section, patients were informed about the ongoing clinical investigation with written information upon their arrival to the delivery ward and were able to decline their participation. Because of the urgency when a patient is in an advanced stage of delivery and in need of a vacuum extraction procedure, the EPN granted permission to randomize patients without written consent. None of the patients actively declined their participation, so all women that met the inclusion criteria were included using the vacuum extraction protocol.
: Not required.
: GA, MW and KY are owners of Genit Innovation, which is developing the technical device described in this work. KP and SR have no competing interests to declare. All authors have completed the ICMJE uniform disclosure.