Abstract

A randomized controlled trial (RCT) is a prospective, comparative, quantitative study/experiment performed under controlled conditions with random allocation of interventions to comparison groups. The RCT is the most rigorous and robust research method of determining whether a cause-effect relationship exists between an intervention and an outcome. High quality evidence can be generated by performing an RCT when evaluating the effectiveness and safety of an intervention. Furthermore, RCTs yield themselves well to systematic review and meta-analysis providing a solid base for synthesizing evidence generated by such studies. Evidence-based clinical practice improves patient outcomes, safety, and is generally cost-effective. Therefore, RCTs are becoming increasingly popular in all areas of clinical medicine including perinatology. However, designing and conducting an RCT, analyzing data, interpreting findings and disseminating results can be challenging as there are several practicalities to be considered. In this review, we provide a simple descriptive guidance on planning, conducting, analyzing and reporting RCTs.