Development of a modified physiological birth programme integrated into Iran’s health system and its effect on maternal and neonatal outcomes: an embedded mixed-methods study protocol

INTRODUCTION: As recommended by the WHO, promotion of physiological birth is a main strategy to reduce the rate of caesarean section and achieve Sustainable Development Goals. A modified version of the physiological birth programme that may be included into the Iranian healthcare system was developed as a result of this mixed-methods research. METHODS AND ANALYSIS: This embedded mixed-methods study had a qualitative phase that was conducted before a clinical trial. This qualitative phase was conducted via semistructured in-depth targeted interviews with the recipients and the providers of physiological birth programme services. Data analysis was performed using a conventional content analysis approach. Then, for designing the intervention, national and international guidelines of physiological birth were reviewed, and a panel of experts was convened using the Delphi method. A randomised controlled trial was used in the second phase of the research to examine the impact of the physiological birth programme’s intended intervention on maternal and neonatal outcomes as well as mothers’ experiences during labour. It was conducted on 252 eligible pregnant women in two intervention and control groups. Finally, the results of qualitative and quantitative phases contributed to developing a physiological birth programme which can be integrated into the Iranian health system. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (IR.AJUMS.REC.1401.050). All participants gave their informed permission. The study’s findings will be shared via the publishing of peer-reviewed articles, talks at scientific conferences and meetings with related teams. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials (IRCT20220406054438N1).