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

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
Email: oratile.kgosidialwa2@hse.ie

Delia Bogdanet; College of Medicine, Nursing and Health Sciences; National University Ireland, Galway, Ireland
Email: deliabogdanet@gmail.com

Linda Biesty; Lecturer in Midwifery; School of Nursing and Midwifery; National University of Galway, Ireland
Email: linda.biesty@nuigalway.ie

Declan Devane; Director of HRB Trials Methodology Research Network and Professor of Midwifery; School of Nursing and Midwifery, National University of Ireland Galway, Ireland
Email: declan.devane@nuigalway.ie

Paula O’Shea; Consultant Clinical Biochemist, University Hospital Galway, Ireland
Email: paulam.oshea@hse.ie

Aoife M. Egan; Assistant Professor of Medicine, Division of Endocrinology and Metabolism; Mayo Clinic, Rochester, USA
Email: egan.aoife@mayo.edu

Fidelma P. Dunne; Consultant Endocrinologist and Personal Professor; University Hospital Galway and National University of Ireland Galway, Ireland
Email: fidelma.dunne@nuigalway.ie

Further Study Information

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

Health Area

Disease Category: Endocrine & metabolic, Pregnancy & childbirth

Disease Name: Diabetes mellitus

Target Population

Age Range: 16 - 50

Sex: Female

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research


- 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.

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