Core Outcome Measures in Effectiveness Trials

A core outcome set for randomised trials evaluating interventions for treatment of pregnant women with pregestational diabetes

General Information

Women with pregestational diabetes and their babies are at an increased risk of poor outcomes. In the last number of years, there has been an increase in interventions for the treatment (including education, technology and treatment options) of pregestational diabetes in pregnant women. The aim of developing this core outcome set (COS) is to agree a core set of outcomes to be included in all trials of interventions for the treatment of pregestational diabetes in pregnant women.

On behalf of the INSPIRED (INternational collaboration for Studies in PREgnacy and Diabetes) research group

Oratile Kgosidialwa; Research fellow; University Hospital Galway and National University of Ireland Galway, Ireland

Delia Bogdanet; College of Medicine, Nursing and Health Sciences; National University Ireland, Galway, Ireland

Linda Biesty; Lecturer in Midwifery; School of Nursing and Midwifery; National University of Galway, Ireland

Declan Devane; Director of HRB Trials Methodology Research Network and Professor of Midwifery; School of Nursing and Midwifery, National University of Ireland Galway, Ireland

Paula O’Shea; Consultant Clinical Biochemist, University Hospital Galway, Ireland

Aoife M. Egan; Assistant Professor of Medicine, Division of Endocrinology and Metabolism; Mayo Clinic, Rochester, USA

Fidelma P. Dunne; Consultant Endocrinologist and Personal Professor; University Hospital Galway and National University of Ireland Galway, Ireland

Further Study Information

Current Stage:
October 2019 - September 2020
Funding source(s):
Existing research fund of Prof Fidelma Dunne and Prof Declan Dunne

Health Area

Disease Category
Endocrine & metabolic
Pregnancy & childbirth

Disease Name
Diabetes mellitus

Target Population

Age Range
16 - 50


Nature / type of Intervention


Consensus meeting
Delphi process
Systematic review

1. A systematic review to generate a list of outcomes reported previously.
2. A real time e-Delphi process to allow key stakeholders to rate these outcomes.
3. A face-to-face consensus meeting to finalise the final COS.

Stakeholders Involved

Clinical experts
Service providers
Service users

Study Type

COS for clinical trials or clinical research

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