Development and validation of a tool for advising primiparous women during early labour: study protocol for the GebStart Study

INTRODUCTION: Pregnant women experience early labour with different physical and emotional symptoms. Early admission to hospital has been found to be associated with increased intervention and caesarean section rates. However, primiparous women often contact the hospital before labour progresses because they encounter difficulties coping with symptoms of onset of labour on their own. An evidence-based instrument for assessing the individual needs to advise primiparous women during early labour is currently missing. The study aims to develop and validate a tool to inform the joint decision for or against hospital admission. METHODS AND ANALYSIS: A scale development and validation study will be conducted including following steps: (1) Generation of a pool with 99 items based on a scoping review and focus group discussions with primiparous women, (2) Assessment of content and face validity by an expert panel and item reduction to 32 items, (3) Multicentre data collection in six study sites in Switzerland, with application of the preliminary tool and the validation items with a target sample size of approximately n=400 women and (4), item reduction using exploratory factor analysis, factor loading and item-to-item correlation. Internal consistency of the tool will be assessed using Cronbach’s alpha and convergent validity computing correlations of items of the tool with the German versions of the Childbirth Self-Efficacy Inventory and the Cambridge-Worry Scale. Analyses will be performed using Stata V.17. ETHICS AND DISSEMINATION: Ethical approval was obtained by the Ethics Committees Zurich and Northwestern and Central Switzerland (BASEC-Nr. 2021-00687). Results will be disseminated at the final study conference, at national and international congresses and by peer reviewed and not peer-reviewed articles in scientific and professional journals. Approved and anonymised data will be shared. The dissemination of the findings will have a contributable impact on clinical practice, scientific discussions and future research. TRIAL REGISTRATION NUMBER: DRKS00025572, SNCTP000004555.