Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction...

Area of Science:

• Perinatal Medicine
• Clinical Trial Methodology
• Maternal-Fetal Medicine

Background:

• Selective fetal growth restriction in monochorionic twins poses significant risks for perinatal mortality and morbidity.
• Current interventions and research lack standardized outcome measures, hindering comparative analysis and clinical practice advancement.
• A core outcome set is needed to unify research efforts for this complex condition.

Purpose of the Study:

• To develop, disseminate, and implement a standardized core outcome set for research on selective fetal growth restriction in monochorionic twin pregnancies.
• To enhance the quality and comparability of future research studies in this area.
• To ultimately improve clinical practice and patient outcomes.

Main Methods:

• An international steering group will guide the development process.
• A systematic review will identify potential core outcomes.
• A three-round Delphi survey and modified Nominal Group Technique will achieve stakeholder consensus.

Main Results:

• The study is in the process of developing a core outcome set.
• Standardized definitions and measurement instruments will be established for agreed-upon outcomes.
• The process aims to achieve consensus among diverse stakeholders.

Conclusions:

• A standardized core outcome set will ensure consistent outcome reporting in future research.
• This standardization will facilitate data synthesis and advance the quality of evidence-based clinical practice.
• Improved research quality is expected to enhance maternal and perinatal care, including long-term neurodevelopmental outcomes.