Development of a core outcome set (COS) for studies relating to awareness and clinical management of reduced fetal movement: study protocol

Dexter J. L. Hayes,Declan Devane,Jo C. Dumville,Tanya Walsh,Valerie Smith,Alexander E. P. Heazell

doi:10.1186/s13063-021-05839-9

Abstract

BackgroundConcerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Studies have aimed to improve pregnancy outcomes by evaluating interventions to raise awareness of RFM in pregnancy, such as kick counting, evaluating interventions for the clinical management of RFM, or both. However, there is not currently a core outcome set (COS) for studies of RFM. This study aims to create a COS for use in research studies that aim to raise awareness of RFM and/or evaluate interventions for the clinical management of RFM.MethodsA systematic review will be conducted, to identify outcomes used in randomised and non-randomised studies with control groups that aimed to raise awareness of RFM (for example by using mindfulness techniques, fetal movement counting, or other tools such as leaflets or mobile phone applications) and/or that evaluated the clinical management of RFM.An international Delphi consensus will then be used whereby stakeholders will rate the importance of the outcomes identified in the systematic review in (i) awareness and (ii) clinical management studies. The preliminary lists of outcomes will be discussed at a consensus meeting where one final COS for awareness and management, or two discrete COS (one for awareness and one for management), will be agreed upon.DiscussionA well-developed COS will provide researchers with the minimum set of outcomes that should be measured and reported in studies that aim to quantify the effects of interventions.

Highlights

Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth
70% of these pregnancies have a normal outcome [7,8,9], but observational studies have recurrently demonstrated that RFM are associated with adverse pregnancy outcomes, including fetal growth restriction (FGR) and stillbirth, supporting the potential for a common aetiology [10, 11]
Studies of awareness of or interventions for reduced fetal movement Studies have aimed to improve pregnancy outcomes by evaluating interventions that raise maternal and/or clinical awareness of RFM, such as mindfulness or kick counting [19, 20], and/or by evaluating clinical management interventions, for example, interventions comprised of further monitoring and/or clinical testing such as cardiotocography (CTG) or ultrasound (US) to identify whether RFM is an indicator of an underlying condition that may warrant further clinical intervention or even expedited birth [21, 22]

Summary

Introduction

Concerns regarding reduced fetal movements (RFM) are reported in 5–15% of pregnancies, and RFM are associated with adverse pregnancy outcomes including fetal growth restriction and stillbirth. Despite the association between RFM, stillbirth and FGR, a core outcome set (COS) for studies evaluating interventions that aim to raise awareness of RFM and/or studies evaluating the clinical management of RFM does not currently exist. This means that studies often measure and report different outcomes and employ different definitions for these outcomes, hindering meta-analysis of studies. This will further facilitate data synthesis and interpretation of the evidence based on prioritised outcomes

Objectives

Methods

Findings

Conclusion