Abstract
BACKGROUND: Assisted vaginal birth is a lifesaving procedure where health workers use special devices to expedite birth vaginally when some complications emerge, such as due to prolonged labor. When the use of assisted vaginal birth is possible and appropriate, it provides benefits over cesarean section. These benefits include shorter recovery, reduced hospital stays, lower risks of complications, cost savings, and greater likelihood of vaginal birth in future pregnancies. Despite these benefits, the use of assisted vaginal births has declined in recent years. Challenges remain on how to implement assisted vaginal birth effectively, equitably, and at scale in different health systems. Formative research is useful to understand local health system preparedness, acceptability, feasibility, and resource availability for designing and implementing health interventions. OBJECTIVE: We developed a generic formative research protocol that can be used to design and implement interventions to optimize use of assisted vaginal birth in any setting and context. METHODS: This formative research protocol is to be conducted in the setting where interventions to optimize assisted vaginal birth will be implemented. The formative research has three components: (1) document review, (2) readiness assessment, and (3) primary qualitative research. Document review will examine existing policy and guidelines, while readiness assessment will assess the service delivery context. The 2 components aim to identify potential barriers and facilitators to use of assisted vaginal birth. Primary qualitative research will involve women, families, community members, health workers, facility administrators, and policy makers. Interview questions are structured around potential interventions to optimize use of assisted vaginal birth. This protocol includes all the essential study instruments. RESULTS: This is a generic research protocol that can be used by any stakeholder aiming to optimize assisted vaginal birth in any setting. Serving as a preparatory guide, it provides a structured approach for planning and implementing evidence-based and context-specific strategies aligned with best practices in maternal health care. No data collection or analysis has been conducted to date. CONCLUSIONS: This generic protocol can serve as a guide in conducting formative research as intervention preparation to optimize use of assisted vaginal birth. The results can inform the design and implementation of appropriate interventions from the perspectives of important stakeholders. Therefore, we recommend that trialists, clinicians, researchers, administrators, and policy makers use this protocol before implementation to understand local context and incorporate perspectives of key stakeholders to promote equitable, high-quality, and women-centered care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/69808.