Sonographic Evaluation of the Mechanism of Active Labor (SonoLabor Study): observational study protocol regarding the implementation of the sonopartogram

Abstract

IntroductionOver the last decades, a large body of literature has shown that intrapartum clinical digital pelvic estimations of fetal head position, station and progression in the pelvic canal are less accurate, compared with ultrasound (US) scan. Given the increasing evidence regarding the advantages of using US to evaluate the mechanism of labour, our study protocol aims to develop sonopartograms for fetal cephalic presentations. They will allow for a more objective evaluation of labour progression than the traditional labour monitoring, which could enable more rapid decisions regarding the mode of delivery.Methods/analysisThis is a prospective observational study performed in three university hospitals, with an unselected population of women admitted in labour at term. Both clinical and US evaluations will be performed assessing fetal head position, descent and rotation. Specific US parameters regarding fetal head position, progression and rotation will be recorded to develop nomograms in a similar way that partograms were developed. The primary outcome is to develop nomograms for the longitudinal US assessment of labour in unselected nulliparous and multiparous women with fetal cephalic presentation. The secondary aims are to assess the sonopartogram differences in occiput anterior and posterior deliveries, to compare the labour trend from our research with the classic and other recent partogram models and to investigate the capability of the US labour monitoring to predict the outcome of spontaneous vaginal delivery.Ethics and disseminationAll protocols and the informed consent form comply with the Ministry of Health and the professional society ethics guidelines. University ethics committees approved the study protocol. The trial results will be published in peer-reviewed journals and at the conference presentations. The study will be implemented and reported in line with the Strengthening the Reporting of Observational Studies in Epidemiology statement.Trial registration numberClinicalTrials.gov Registry (NCT02326077).