Developing a Core Outcome Set for Interventions Undertaken During Caesarean Birth for the Management of an Impacted Fetal Head
Year: 2026
Type: study-registration
Abstract: Impacted fetal head (IFH) at caesarean birth is an obstetric emergency which can have potentially serious consequence for both the mother and/or fetus. Until recently, there was no universally accepted definition of IFH, which contributed to variation in clinical recognition and reporting. However, a consensus definition has now been developed through a formal stakeholder consensus process involving maternity professionals and has subsequently been published in the RCOG Scientific Impact Paper on the management of impacted fetal head at caesarean birth. This study will adopt that consensus definition throughout. The risks associated with IFH include increased maternal risks of bleeding and visceral injuries, and neonatal risks of hypoxic brain injury, intracranial haemorrhage and skull fracture.The exact incidence is unknown, however it is estimated that one in ten caesarean births are complicated by an IFH, amounting to approximately 1.5% of all births. The NHS Resolution Early Notification Scheme identified IFH as a contributory factor in nearly 9% of the most expensive maternity claims. A number of interventions can be employed at the time of caesarean once an IFH is identified to deliver the baby, reducing risk of maternal or neonatal harm. These range from simple measures such as the operator switching the hand used to deliver the baby, to medical interventions such as medications to relax the uterus, to more invasive surgical interventions to improve access into the uterus. However, there is no clear consensus on the safest and most effective of these techniques. There also remains controversy over some newer methods to manage disimpaction prior to or during caesarean birth, with recent evidence regarding the use of a Fetal Pillow™ device being scrutinised and retracted from within the literature. With the rising prevalence of IFH, and the concerns regarding its potential consequences for mother and baby, there is increasing momentum to research and evaluate the management options for the obstetric emergency. Systematic reviews have been undertaken in the area to give a clearer picture on the safest and most effective techniques at caesarean birth for managing an IFH. Reviews have suggested, however, that despite their being studies offering these comparisons, there is a high degree of heterogeneity of the outcomes reported in the individual studies, with a lack of standardisation in the measurement of outcomes. Additionally, one systematic review commented that there were very few data on specific neonatal outcomes. This leads to difficulty in combining results from studies to undertake meta-analyses and leads to inconclusive findings regarding the most effective management for IFH. One suggested method for overcoming the issue of heterogeneity of reported outcomes is to develop a core outcome set (COS) for interventions undertaken during caesarean birth to manage impacted fetal head. Previous work from the MIDAS study sought consensus regarding outcomes that should be included in a future randomised trial of interventions for impacted fetal head. However, this work was designed to inform the development of a specific clinical trial rather than establish a Core Outcome Set for all future research in this area. Furthermore, prioritisation was undertaken primarily among professional stakeholders. There remains no stakeholder-informed Core Outcome Set for interventions undertaken during caesarean birth to manage impacted fetal head. The present study therefore aims to develop a Core Outcome Set using established COS methodology, incorporating women, birth partners and healthcare professionals throughout outcome identification and prioritisation. A core outcome set is a minimum set of outcomes that should be reported on for all studies undertaken for a specific research area or intervention. They are created through a consensus driven process involving the stakeholders to whom the research will be of most interest and value, including patients and patients’ family, healthcare professionals, researchers and other interested organisations. Whilst a COS should be reported in all studies in a certain area of research, it does not preclude the measurement and reporting of other specific outcomes. Having a core set of outcomes reported by all studies in an area allows for better synthesis and analysis of studies producing higher quality evidence to support the use of interventions. This will then ultimately lead to improved quality of clinical care.
Source: Open Science Framework
Author: Andrew Demetri
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7215901596