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Poster Session 2

(665) Developing Core Endpoints with Stakeholders for Perinatal Clinical Trials

Thursday, January 30, 2025
4:00 PM – 6:00 PM  

    Submitting Author and Presenting Author(s)

  • Zoe Butters, BSc, MD

    MFM Fellow
    Royal Women's Hospital
    Melbourne, Victoria, Australia

    • Coauthor(s)

  • JA

    Jannik Aagerup, MPH

    Research Admin Officer
    NHMRC Clinical Trials Centre, University of Sydney
    Sydney, New South Wales, Australia

  • CW

    Clare Whitehead, BSc, MBBS, PhD

    Obstetrician - MFM, Senior Research Fellow, NHMRC Neil Hamilton Fairley Clinical Research Fellow
    Royal Women's Hospital, University of Melbourne
    Melbourne, Victoria, Australia

  • LS

    Lene Seidler, BSc, MSc, PhD

    Senior Research Fellow
    NHMRC Clinical Trials Centre, University of Sydney
    Sydney, New South Wales, Australia

Objective:

The use of core outcome sets (COS) in obstetric and perinatal clinical trials is essential to standardise trial reporting and allow evidence synthesis, but there has been limited assessment of how these outcomes were developed and how they can be used to compare endpoints in clinical trials. Identifying the outcomes that are most meaningful to patients, healthcare professionals and society and standardising their definitions will ensure trial endpoints can be reliably collected and allow results to more rapidly lead to changes in clinical practice.

Study Design:

MEDLINE, Embase, PsycINFO, CINAHL and the COMET registry were systematically searched in September 2023. Two authors independently screened abstracts/full texts and performed data extraction. A third reviewer resolved conflicts. The characteristics of each COS, stakeholders and consensus methods were extracted. The development methodology quality was evaluated according to the COS-STAR statement.

Results:

789 studies were screened and 29 COS included. The top 5 reported obstetric outcomes were maternal mortality, patient satisfaction with intervention, adverse outcome of intervention, delivery mode, and breastfeeding at discharge. The top 5 neonatal outcomes were neonatal mortality, gestational age at birth, birthweight, congenital anomaly, and hypoxic ischaemic encephalopathy. Only 59% of COS demonstrated compliance with COS-STAR. 100% included clinician/expert stakeholders. 90% included patients or patient representative stakeholders, although the proportion varied between 4.1% to 81.6%. Standardised definitions and measurement tools are proposed for each of the top 10 outcomes.

Conclusion:

We have identified a minimum COS with standardised definitions and measurement tools that can be included in perinatal trials in order to improve the quality of endpoint reporting and implementation. Future research will rank outcomes according to both clinician and patent preference, to develop an ordinal scale that improves trial efficiency and identification of clinically meaningful evidence.