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

University of Manchester

Status: Completed

Conditions: Stillbirth

Treatments: Other: Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT03231007

R04666

Details and patient eligibility

About

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.

Full description

Reducing stillbirth and early neonatal death is a national priority. Best practice and key evidence indicates this is potentially achievable through application of four key interventions within routine maternity care delivered as NHS England's Saving Babies' Lives care bundle. However, adoption of the care bundle by UK maternity services is still in its infancy and there is significant variation in the degree of implementation between and within units. The effectiveness of the care bundle, when implemented as a package, in reducing stillbirth and 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.

Enrollment: 4,952 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Maternity Service Users:

• Women who received their antenatal care, delivered and were discharged from the same maternity unit
• Women who have given birth after 28 weeks of gestation

Exclusion Criteria for Maternity Service Users:

• Maternal age ≤ 16 years
• Individuals who cannot understand/not fluent in English (to enable consent without interpreter)
• Multiple pregnancy
• Fetuses known to have any congenital or severe structural abnormalities
• Home births

Inclusion Criteria for Maternity Healthcare Professionals:

• Midwives working before and after implementation of the care bundle (including antenatal ward, antenatal clinic, community-based staff, antenatal assessment unit and labour ward)
• Community midwives working before and after implementation of the care bundle
• Sonographers working before and after implementation of the care bundle
• Junior doctors working before and after implementation of the care bundle
• Consultant obstetricians working before and after implementation of the care bundle
• Clinical Directors and Heads of Midwifery working before and after implementation of the care bundle

Exclusion Criteria for Maternity Healthcare Professionals:

• Staff who were employed after the care bundle was implemented

Trial design

4,952 participants in 4 patient groups

Innovators

Description:

Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'.

Treatment:

Other: Questionnaire

Early Adopters

Description:

Maternity units that implemented the Care Bundle to the second-highest level (according to an NHS survey in 2015) are categorised as 'Early Adopters'.

Treatment:

Other: Questionnaire

Late Adopters

Description:

Maternity units that implemented the Care Bundle to the third-highest level (according to an NHS survey in 2015) are categorised as 'Late Adopters'.

Treatment:

Other: Questionnaire

Low Adopters

Description:

Maternity units that implemented the Care Bundle to the fourth-highest level (according to an NHS survey in 2015) are categorised as 'Low Adopters'.

Treatment:

Other: Questionnaire