Study design
This study was designed as a nationwide cohort study and included all
multicentre RCTs carried out within the Dutch Consortium for Women’s
Health Research, embedded within the professional society, i.e. Dutch
Society of Obstetrics and Gynaecology (NVOG)(11). The Dutch Consortium
for Women’s Health Research facilitated studies in obstetrics,
gynaecology and reproductive medicine.
Within the consortium, participating clinical centres are both academic
and non-academic hospitals. RCTs conducted within the Consortium are
supported by a clinical trial centre
(https://zorgevaluatienederland.nl/), a multidisciplinary trial bureau
with methodologists, data managers, contract managers and trial
managers. The trial centre staff supports research groups by advising on
the budget, logistics, methods, and ethics approval, developing
electronic case record forms, performing contract management and
monitoring, creating the interim reports for the data safety and
monitoring board and providing advice on the statistical analyses. We
constructed the manuscript according to the STROBE guideline(12).