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

NCT03231007 | Completed

• 1 other identifier: R04666
• Study Type: observational
• Target: 4,952
• Locations: 1 country
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stillbirths

  All stillbirths (singletons and multiples). Stillbirths will be defined according to the UK definition as the death of a baby before or during birth after 24 weeks of gestation.

  1st April 2012-1st October 2017

Secondary Outcomes (13)

• Term, normally formed singleton stillbirths (antepartum and intrapartum).

  1st April 2012-1st October 2017

• Preterm births

  1st April 2012-1st October 2017

• Babies' gestation

  1st April 2012-1st October 2017

• Number of reported incidents

  1st April 2012-1st October 2017

• Admission to NICU

  1st April 2012-1st October 2017

Other Outcomes (41)

• Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery

  10th July 2017-31st August 2017

• Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test

  10th July 2017-31st August 2017

• Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test

  10th July 2017-31st August 2017

Study Arms (4)

Innovators

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

Other: Questionnaire

Early Adopters

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

Other: Questionnaire

Late Adopters

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

Other: Questionnaire

Low Adopters

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

Other: Questionnaire

Interventions

Questionnaire OTHER

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).

Early Adopters; Innovators; Late Adopters; Low Adopters

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Postnatal service users who have received antenatal care and given birth in one of the 20 study sites. Healthcare professionals who are involved in delivering maternity care in one of the 20 study sites.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \- Staff who were employed after the care bundle was implemented

Sponsors & Collaborators

• University of Manchester: lead
• Somerset NHS Foundation Trust: collaborator
• Royal Devon and Exeter NHS Foundation Trust: collaborator
• University Hospital Plymouth NHS Trust: collaborator
• Royal United Hospital Bath NHS Trust: collaborator
• North Bristol NHS Trust: collaborator
• Liverpool Women's NHS Foundation Trust: collaborator
• St Helens & Knowsley Teaching Hospitals NHS Trust: collaborator
• Countess of Chester NHS Foundation Trust: collaborator
• University Hospitals of Morecambe Bay NHS Trust: collaborator
• Barnsley Hospital NHS Foundation Trust: collaborator
• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: collaborator
• York Teaching Hospitals NHS Foundation Trust: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator
• Mid Yorkshire Teaching NHS Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Gateshead Health NHS Foundation Trust: collaborator
• North Cumbria University Hospitals NHS Trust: collaborator
• Sherwood Forest Hospitals NHS Foundation Trust: collaborator
• Manchester University NHS Foundation Trust: collaborator
• Birmingham Women's NHS Foundation Trust: collaborator

Study Sites (20)

Barnsley Hospital NHS Foundation Trust

Barnsley, United Kingdom

Location

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

Location

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

North Cumbria University Hospitals NHS Trust

Carlisle, United Kingdom

Location

Countess of Chester Hospital NHS Foundation Trust

Chester, United Kingdom

Location

Doncaster and Bassetlaw Hospitals NHS Foundation Trust

Doncaster, United Kingdom

Location

Royal Devon & Exeter NHS Foundation Trust

Exeter, United Kingdom

Location

Gateshead Health NHS Foundation Trust

Gateshead, United Kingdom

Location

Oxford University Hospitals NHS Trust

Headington, United Kingdom

Location

Hull and East Yorkshire Hospital NHS Trust

Hull, United Kingdom

Location

University Hospitals of Morecambe Bay NHS Foundation Trust

Kendal, United Kingdom

Location

Liverpool Women's NHS Foundation Trust

Liverpool, United Kingdom

Location

Central Manchester University Hospitals NHS Foundation Trust

Manchester, United Kingdom

Location

Plymouth Hospital NHS Trust

Plymouth, United Kingdom

Location

St Helens and Knowsley Teaching Hospitals NHS Trust

Prescot, United Kingdom

Location

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, United Kingdom

Location

Taunton and Somerset NHS Foundation Trust

Taunton, United Kingdom

Location

The Mid Yorkshire Hospitals NHS Trust

Wakefield, United Kingdom

Location

York Teaching Hospital NHS Foundation Trust

York, United Kingdom

Location

Related Publications (10)

• Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.

  BACKGROUND

• Flenady V, Wojcieszek AM, Middleton P, Ellwood D, Erwich JJ, Coory M, Khong TY, Silver RM, Smith GCS, Boyle FM, Lawn JE, Blencowe H, Leisher SH, Gross MM, Horey D, Farrales L, Bloomfield F, McCowan L, Brown SJ, Joseph KS, Zeitlin J, Reinebrant HE, Cacciatore J, Ravaldi C, Vannacci A, Cassidy J, Cassidy P, Farquhar C, Wallace E, Siassakos D, Heazell AEP, Storey C, Sadler L, Petersen S, Froen JF, Goldenberg RL; Lancet Ending Preventable Stillbirths study group; Lancet Stillbirths In High-Income Countries Investigator Group. Stillbirths: recall to action in high-income countries. Lancet. 2016 Feb 13;387(10019):691-702. doi: 10.1016/S0140-6736(15)01020-X. Epub 2016 Jan 19.

  PMID: 26794070 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Widdows K, Roberts SA, Camacho EM, Heazell AEP. Stillbirth rates, service outcomes and costs of implementing NHS England's Saving Babies' Lives care bundle in maternity units in England: A cohort study. PLoS One. 2021 Apr 19;16(4):e0250150. doi: 10.1371/journal.pone.0250150. eCollection 2021.

  PMID: 33872334 BACKGROUND

• Gardosi J, Madurasinghe V, Williams M, Malik A, Francis A. Maternal and fetal risk factors for stillbirth: population based study. BMJ. 2013 Jan 24;346:f108. doi: 10.1136/bmj.f108.

  PMID: 23349424 BACKGROUND

• Marufu TC, Ahankari A, Coleman T, Lewis S. Maternal smoking and the risk of still birth: systematic review and meta-analysis. BMC Public Health. 2015 Mar 13;15:239. doi: 10.1186/s12889-015-1552-5.

  PMID: 25885887 BACKGROUND

• RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.

  BACKGROUND

• Alfirevic Z, Devane D, Gyte GM. Continuous cardiotocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labour. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD006066. doi: 10.1002/14651858.CD006066.

  PMID: 16856111 BACKGROUND

• Widdows K, Reid HE, Roberts SA, Camacho EM, Heazell AEP. Saving babies' lives project impact and results evaluation (SPiRE): a mixed methodology study. BMC Pregnancy Childbirth. 2018 Jan 30;18(1):43. doi: 10.1186/s12884-018-1672-x.

  PMID: 29378526 DERIVED

MeSH Terms

Conditions

Stillbirth

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 27, 2017
• Study Start: July 10, 2017
• Primary Completion: February 28, 2018
• Study Completion: July 5, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (20)