Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Jan 30;18(1):43.
doi: 10.1186/s12884-018-1672-x.

Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study

Kate Widdows  1 , Holly E Reid  1 , Stephen A Roberts  2 , Elizabeth M Camacho  3 , Alexander E P Heazell  4   5
Affiliations

Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study

Kate Widdows et al. BMC Pregnancy Childbirth. .

Abstract

Background: Reducing stillbirth and early neonatal death is a national priority in the UK. Current evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as the National Health Service (NHS) England's Saving Babies' Lives care bundle. However, there is significant variation in the degree of implementation of the care bundle between and within maternity units and the effectiveness in reducing stillbirth and improving service delivery has not yet been evaluated. This study aims to evaluate the impact of implementing the care bundle on UK maternity services and perinatal outcomes.

Methods: The Saving Babies' Lives Project Impact and Results Evaluation (SPiRE) study is a multicentre evaluation of maternity care delivered through the Saving Babies' Lives care bundle using both quantitative and qualitative methodologies. The study will be conducted in twenty NHS Hospital Trusts and will include approximately 100,000 births. It involves participation by both service users and care providers. To determine the impact of the care bundle on pregnancy outcomes, birth data and other clinical measures will be extracted from maternity databases and case-note audit from before and after implementation. Additionally, this study will employ questionnaires with organisational leads and review clinical guidelines to assess how resources, leadership and governance may affect implementation in diverse hospital settings. The cost of implementing the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a health economic analysis. The views and experiences of service users and service providers towards maternity care in relation to the care bundle will be also be sought using questionnaires.

Discussion: This protocol describes a pragmatic study design which is necessarily limited by the availability of data and limitations of timescales and funding. In particular there was no opportunity to prospectively gather pre-intervention data or design a phased implementation such as a stepped-wedge study. Nevertheless this study will provide useful practice-based evidence which will advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined.

Trial registration: www.clinicaltrials.gov NCT03231007 (26th July 2017).

Keywords: Fetal growth restriction; Fetal monitoring; Intrapartum fetal monitoring; Perinatal mortality; Quality improvement; Reduced fetal movements; Smoking cessation; Stillbirth.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

Health Research Authority (HRA) was obtained in June 2017, which included a review by the West Midlands NHS Research Ethics Committee (17/WM/0197). Written consent will be obtained from participants prior to completion of the questionnaire components.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Plan of Investigation identifying quantitative and qualitative components
See this image and copyright information in PMC

References

    1. Manktelow B.N., et al., MBRRACE-UK Perinatal Mortality Surveillance Report, UK Perinatal Deaths for Births from January to December 2015. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester, 2017.
    1. Office of National Statistics, Births and Deaths in England and Wales in 2015, 2016, Office of National Statistics: Fareham, Hampshire.
    1. Flenady V, et al. Stillbirths: recall to action in high-income countries. Lancet. 2016;387(10019):691–702. doi: 10.1016/S0140-6736(15)01020-X. - DOI - PubMed
    1. Manktelow BN, S. L., Seaton SE, Hyman-Taylor P, Kurinczuk JJ, field DJ, MBRRACE-UK Perinatal Mortality Surveillance Report, UK Perinatal Deaths for Births from Janurary to December 2014. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, University of Leicester, 2016.
    1. Draper ES, K.J., Kenyon S (Eds) on behalf of MBRRACE-UK, MBRRACE-UK Perinatal Confidential Enquiry: Term, singleton, normally formed, antepartum stillbirth. Leicester: The Infant Mortality and Morbidity Studies, Department of Health Sciences, Univesity of Leicester. 2015.

Publication types

MeSH terms

Associated data

LinkOut - more resources