Development and validation of a Midwife-led core outcome set (M-COS) for healthy women and babies

Midwife-led sensitive outcome measures are quality indicators of care interventions delivered during pregnancy and childbirth. Traditionally outcomes have been measured with a focus on maternal-neonatal mortality and morbidity. However, in the last decade, there has been a paradigm shift towards measuring outcomes in a salutogenically-focused framework, which reflect positive health and wellbeing rather than illness or adverse event prevention. To the best of our knowledge, a standardized core outcome set of midwife-led sensitive outcome measures for healthy women with low-risk pregnancies and their babies is not available yet at national level in Italy. Therefore, this project aims to develop and validate an Italian-specific midwife-led core outcome set (M-COS) that takes into account: (a) low-risk pregnancies, (b) midwife-led care model and (c) both maternal and salutogenically-focused fetal/neonatal outcome measures. This project could also drive cross-national research – as it is useful to identify midwife-led sensitive outcome measures beyond the available physiological maternal-neonatal indicators.


Principal investigator:
Giulia Maga, MSc, RM, University of Pavia, Pavia (Italy)

Project team:
Elsa Del Bo, MSc, RM, Director of Bachelor’s degree in Midwifery, University of Pavia, Pavia (Italy)
Rosaria Cappadona, MSc, RM, Director of Bachelor’s degree in Midwifery and Master’s degree in Nursing and Midwifery, University of Ferrara, Ferrara (Italy)
Lia Brigante, MSc, RM, Quality and Standards Advisor at the Royal College of Midwives, London (UK)
Sabina Candeloro, MSc, RM, University of Pavia, Pavia (Italy)
Chiara Ogliari, MSc, RM, University of Pavia, Pavia (Italy)
Sara Puzzarini, MSc, RM, University of Ferrara, Ferrara (Italy)
Arianna Magon, PhD(s) MSN, RN. Health Profession Research and Development Unit, IRCCS Policlinico San Donato, Milan (Italy)

Further Study Information

Current Stage: Completed – pending publication
Date: November 2020 - 2021
Funding source(s): None

Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Maternity care

Target Population

Age Range: 0 - 50

Sex: Either

Nature of Intervention: Other

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Methodologists
- Policy makers
- Researchers
- Service users
- Statisticians

Study Type

- COS for clinical trials or clinical research
- COS for practice


- Consensus meeting
- Delphi process
- Literature review
- Survey
- Systematic review

The research project is developing according to COS-STAD recommendations:
1. Scope specification: a systematic literature review will be conducted to develop an evidence-based core outcome set. This phase aims to identify and select midwife-led physiological outcomes for women with low-risk pregnancies and their babies.
2. Stakeholders: three main groups of stakeholders will be involved: group 1 encompasses clinicians and researchers as potential users of the M-COS; in group 2, a panel of midwives will be involved as experts in the field; and group 3, it will be characterized by women.
3. Consensus process: two main methodological phases will be carried out to validate the core outcome set (i.e., M-COS). The first phase encompasses a psychometric validation of M-COS based on the expert panel's responses to Group 2. In the second phase, a Delphi technique approach will reach a consensus among the stakeholder groups.