Development of a Complex Intervention for Perinatal Bladder Management Among Pregnant Women Based on the Medical Research Council Framework: A Development Study

Background/Objectives: Postpartum urinary retention (PUR) is a common childbirth complication that may lead to bladder dysfunction and adverse maternal outcomes if not promptly identified and managed. Although existing guidelines address aspects of perinatal bladder care, a standardized, context-specific intervention is still lacking. This study aimed to develop a comprehensive perinatal bladder management intervention for pregnant women using the Medical Research Council (MRC) framework for complex interventions. Methods: This intervention development study was conducted in accordance with the development phase of the updated MRC framework. A multidisciplinary group was established, including experts in obstetrics, anesthesia, midwifery, nursing management, and evidence-based practice. The intervention was informed by a review of the physiological mechanisms underlying postpartum voiding dysfunction and a qualitative study guided by the Theoretical Domains Framework (TDF), involving 16 women after vaginal delivery and 18 healthcare professionals. Evidence was identified and appraised from clinical guidelines, evidence summaries, systematic reviews, expert consensus statements, and randomized controlled trials. A two-round Delphi consultation with 18 experts was conducted to refine and validate the intervention framework. Results: Twelve evidence sources were included: four guidelines, three evidence summaries, three expert consensus documents, one systematic review, and one randomized controlled trial. Thirty-four evidence-based recommendations were synthesized across four domains: antenatal bladder management, intrapartum bladder management, postpartum bladder management, and management of urinary retention. Health education was integrated as a cross-cutting theme. After two Delphi rounds, the final intervention comprised four primary domains and 29 components. Both Delphi rounds achieved 100% response rates, with high expert authority coefficients (Cr = 0.956 and 0.972). Conclusions: Using the MRC framework, this study developed a theory-informed and evidence-based perinatal bladder management intervention integrating evidence synthesis, clinical expertise, and stakeholder perspectives. The intervention provides a structured basis for future feasibility, implementation, and effectiveness evaluations. However, its clinical effectiveness, safety, feasibility, and external validity remain to be established.