Study design
This study, labelled the EWE Study, was designed as a randomised,
controlled parallel-group trial with a 1:1 allocation ratio.
Participants were randomised from August 2016–September 2018 at
Copenhagen University Hospital, Rigshospitalet, Denmark, with follow-up
until April 2019. The hospital is a tertiary referral center with 5,406
deliveries in 2018 and serves as a primary birth facility for residents
of Copenhagen.
The EWE Study was designed in accordance with the Consolidated Standards
of Reporting Trials (CONSORT) (18). The Ethics Committee of the capital
region of Denmark (Journal no.: H-15019905) and the Danish Data
Protection Agency (Journal no.: 2012-58-0004) approved the study. The
study was registered at ClinicalTrials.gov (NCT02833519), and a detailed
study protocol has been published (19).