There is an emerging need to systematically investigate the increased cesarean section (CS) rates in Greece and develop interventions to substantially reduce them. This involves the need for Greek obstetricians to follow evidence-based guidelines and other educational, behavioral and organizational interventions, while managing labor. Herein discussed is the planned implementation of a stepped-wedge trial in Greek maternity units.

Twenty-two maternity units in Greece will participate in a multicentre stepped-wedge randomized trial involving 20.000 to 25.000 births, with two of them entering the intervention period each month (stepped randomization). Following a 3-13 month baseline phase, the maternity units will apply the interventions for a period of 6-16 months, depending on the time they are randomized to enter the intervention stage of the study. Study interventions will include implementation of Hellenic Society of Obstetrics and Gynecology (HSOG) guidelines on labor management and targeted training on cardiotocography, obstetric emergencies and the Robson criteria. During the intervention study period, the rates and indications for cesarean sections will be available on a live platform to participating units. During this phase, participating obstetricians will be able to see their and other units’ performance and also get feedback on their rates. Τhe final three-month phase of the study will be dedicated to completing follow-up questionnaires. The primary outcome assessed will be the change in cesarean section rate. Secondary outcomes include maternal and neonatal morbidity and mortality. Intervention and control periods will be compared using mixed effects logistic regression with adjustment for any underlying secular trends.

The study is expected to yield new information about interventions to reduce unnecessary cesarean sections in Greece. The results will inform efforts to improve the quality of maternal and neonatal care, particularly to reduce high CS rates in Greece.

Trial registration: The trial was prospectively registered to ClinicalTrials.gov: NCT04504500

Ethics Reference No: Bioethics and Conduct Committee, School of Medicine, National and Kapodistrian University of Athens, Greece, Ref No 320/23.6.2020

Funding Bodies: National and Kapodistrian University of Athens, GR / A. G. Leventis Foundation, UK / St George’s University of London, UK

Trial Sponsor: Hellenic Society of Obstetrics & Gynecology