Developing a core outcome set (COS) for clinical trials on interventions for the detection and management of reduced fetal movements in pregnancy

Historically fetal movements have been used to diagnose pregnancy and indicate fetal life. Conversely, reduced fetal movements (RFM) or an absence of fetal movements for an extended period of time is considered an indicator of increased risk of fetal compromise and has been associated with an increased incidence of intrauterine fetal death and fetal growth restriction. In recent years there has been a renewed interest in the topic of fetal movements in pregnancy, with numerous studies on aspects of both the detection and management of RFM in pregnancy appearing in the literature, including associated calls for larger randomised trials. Current systematic reviews and meta-analysis have highlighted problems with the quality of studies and their heterogeneity. Developing a COS for use in future trials on the topic of RFM in pregnancy is both timely and needed.

Contributors

Dexter Hayes, PhD candidate, School of Medical Sciences, Division of Departmental Biology and Medicine, Faculty of Biology, Medicine and Health, University of Manchester.

Professor Valerie Smith
Professor in Midwifery, School of Nursing and Midwifery, Trinity College Dublin

Professor Declan Devane
Professor of Midwifery, NUI Galway/Director, HRB-Trials Methodology Research network, NUIG, Ireland

Dr Alexander Heazell
Senior Clinical Lecturer in Obstetrics
5th floor (Research)
St Mary's Hospital, Oxford Road,
Manchester, M13 9WL, UK

Further Study Information

Current Stage: Ongoing
Date: September 2020 - March 2022
Funding source(s): Unfunded


Health Area

Disease Category: Pregnancy & childbirth

Disease Name: Reduced fetal movements, Stillbirth

Target Population

Age Range: 13 - 50

Sex: Female

Nature of Intervention: N/A

Stakeholders Involved

- Clinical experts
- Researchers
- Service users

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

• Systematic review to identify reported outcome measures in clinical trials on i) interventions for the detection and ii) management of RFM in pregnancy; ?
• E-Delphi survey to develop a preliminary COS for use in studies on RFM in pregnancy;
• Consensus meeting to discuss and agree on the final RFM-COS.

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