Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study

NCT03231007 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4952

Last updated 2018-12-04

No results posted yet for this study

Summary

The 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 from six NHS Strategic Clinical Networks totalling 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.

This study will provide practice-based evidence to advance knowledge about the processes that underpin successful implementation of the care bundle so that it can be further developed and refined. This has the potential to translate into substantial improvements in the rate of late stillbirth in the UK should the care bundle be proved effective.

Conditions

  • Stillbirth

Interventions

OTHER

Questionnaire

A structured questionnaire will be administered to maternity service users. Another structured questionnaire will be administered to maternity healthcare professionals, and another to Organisational Leads (e.g. Clinical Directors at each site).

Sponsors & Collaborators

  • Somerset NHS Foundation Trust

    collaborator OTHER
  • Royal Devon and Exeter NHS Foundation Trust

    collaborator OTHER
  • University Hospital Plymouth NHS Trust

    collaborator OTHER
  • Royal United Hospital Bath NHS Trust

    collaborator OTHER
  • North Bristol NHS Trust

    collaborator OTHER
  • Liverpool Women's NHS Foundation Trust

    collaborator OTHER
  • St Helens & Knowsley Teaching Hospitals NHS Trust

    collaborator OTHER
  • Countess of Chester NHS Foundation Trust

    collaborator OTHER
  • University Hospitals of Morecambe Bay NHS Trust

    collaborator OTHER
  • Barnsley Hospital NHS Foundation Trust

    collaborator OTHER
  • Doncaster And Bassetlaw Hospitals NHS Foundation Trust

    collaborator OTHER
  • York Teaching Hospitals NHS Foundation Trust

    collaborator OTHER
  • Hull University Teaching Hospitals NHS Trust

    collaborator OTHER_GOV
  • Mid Yorkshire Teaching NHS Trust

    collaborator OTHER
  • Oxford University Hospitals NHS Trust

    collaborator OTHER
  • Gateshead Health NHS Foundation Trust

    collaborator OTHER
  • North Cumbria University Hospitals NHS Trust

    collaborator OTHER
  • Sherwood Forest Hospitals NHS Foundation Trust

    collaborator OTHER
  • Manchester University NHS Foundation Trust

    collaborator OTHER_GOV
  • Birmingham Women's NHS Foundation Trust

    collaborator OTHER_GOV
  • University of Manchester

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2018-02-28
Completion
2018-07-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03231007 on ClinicalTrials.gov