Pregnancy RelatedeVOLVENCT06453954
Evaluating the Saving Babies Lives Care Bundle Version 2
An observational study of Pregnancy Related and Delivery of Health Care, run by University of Manchester at 1 site in United Kingdom.
Trial summary
The purpose of this study is to learn about the implementation of NHS England's Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality. It will explore whether the care bundle is effective at reducing stillbirth rates, neonatal death rates and preterm births in England. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Pregnancy Related, Delivery of Health Care
- How many people
- 1,773 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2023to 21 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Phase 1: births in England. Phase 2: women who received their antenatal care, labour and birth in 28 participating NHS maternity Trusts in England. Healthcare professionals currently employed in these 28 Trusts.
Who may be able to join
- women who have given birth in the last 12 months
- women who can understand English
- healthcare professionals involved in delivering the care bundle
Who cannot join
- women who gave birth more than 12 months ago
- women who cannot understand English
- women without access to the internet for online survey completion
- healthcare professionals not involved in delivering the care bundle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of the Saving Babies Lives Care Bundle Version 2 on Reducing Perinatal Mortality
The purpose of this study is to learn about the implementation of NHS England's Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality.
It will explore whether the care bundle is effective at reducing stillbirth rates, neonatal death rates and preterm births in England. It will also explore the lived experiences of women's maternity care and their babies neonatal care, and the views and experiences of healthcare professionals who are involved in delivering the care bundle.
Read more
The main questions it aims to answer are:
- Does the care bundle reduce perinatal mortality rates?
- What are women's views and experiences of their maternity and neonatal care?
- What are the barriers around delivering the care bundle and how can this be improved?
- How do health inequalities affect the care women receive?
- How does the workforce culture affect how healthcare professionals use the care bundle?
Perinatal mortality rates and other pregnancy outcomes will be obtained from national data sources. Women and healthcare professionals will be asked to complete a survey and we will interview select groups of participants to further explore their experiences.
Mortality rates will be compared before and after the implementationof the care bundle where data allows. Data from the surveys will be descriptive. Data from the interviews will be analysed using thematic analysis to determine patterns and recurring ideas in the data.
Read the detailed description
In April 2022, NHS England commissioned the University of Manchester to conduct an independent evaluation of the effectiveness of the Saving Babies' Lives Care Bundle Version 2 (SBLCBv2) on reducing perinatal mortality in England. The study was commissioned in two phases.
Phase 1 comprises a national (service) evaluation of the impact of the SBLCBv2 on perinatal mortality rates, associated clinical outcomes, and any unintended consequences using routine data derived from national databases. Phase 2 comprises a qualitative evaluation to further understand the impact on maternity services, women and their families.
Phase 2 will be conducted in a cohort of maternity units across England using a mixed-methods approach. The views and experiences of women and healthcare professionals towards maternity care in relation to the SBLCBv2 will be sought using surveys and interviews. Additionally, this study will interview organisational leads to assess how resources, leadership and governance may affect implementation in diverse hospital settings.
- Conditions
- Pregnancy Related, Delivery of Health Care
- Keywords
- Saving Babies Lives Care Bundle Version 2, NHS Maternity Care, Pregnancy, Stillbirth, Perinatal death
- Medical subject headings
- Stillbirth, Perinatal Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stillbirths in England
A baby born after 24 or more weeks completed gestation and which did not, at any time, breathe or show signs of life
Measured: Up to 60 months
Secondary outcomes (11)
Number of babies born preterm
A baby born before 37 weeks gestation
Measured: Up to 60 months
Number of neonatal deaths in England
A live born baby (born at 20+0 weeks gestational age or later, or with a birthweight of 400g or more where an accurate estimate of gestation is not available), who died before 28 completed days after birth
Measured: Up to 60 months
Number of babies born small for gestational age (SGA)
Birthweight less than the 10th percentile for gestational age
Measured: Up to 60 months
Number of women who had a caesarean section
Women delivering by emergency or elective caesarean section
Measured: Up to 60 months
Number of women who had induction of labour
Induced delivieries
Measured: Up to 60 months
Number of women who had an instrumental delivery
Women who had a forceps or ventouse delivery
Measured: Up to 60 months
Number of women who had a spontaneous delivery
Spontaneous delivery without forceps or ventouse delivery
Measured: Up to 60 months
Number of babies admitted to neonatal care
A baby first admitted at the given quarter to any neonatal care unit
Measured: Up to 84 months
Number of babies admitted to neonatal care by gestation
A baby first admitted at the given quarter to a neonatal care unit by gestation weeks at birth
Measured: Up to 84 months
Number of babies admitted to neonatal care by cause of death
A baby first admitted at the given quarter to a neonatal care unit by clinical diagnosis
Measured: Up to 84 months
Number of babies who died whilst on neonatal care
A baby first admitted at any given quarter to a neonatal care unit that died at any point
Measured: Up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start17 Oct 2023
- Primary completion31 Jan 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
- Investigators
- Alexander Heazell, Prof, Principal investigator, The University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453954
- Sponsor's protocol ID
- 325846
- Acronym
- eVOLVE
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If requested, site-specific data from the questionnaires may be shared with participating NHS Trusts. This data will be provided in an anonymous aggregated format, with only that specific site identified. No identifiable data will be shared with participating NHS Trusts (i.e. names and email addresses will not be shared with NHS sites). Following completion of the study, with consent a fully anonymised aggregated dataset \[e.g. including anonymous aggregated questionnaire responses\] will be deposited in Figshare at the University of Manchester library, which is an open data repository where it will be permanently stored. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check our analysis and results. Individual NHS Trusts will not be identified.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the Saving Babies Lives Care Bundle Version 2 on Reducing Perinatal Mortality
- ClinicalTrials.gov ID
- NCT06453954
- Acronym / sponsor ID
- eVOLVE / 325846
- Conditions
- Pregnancy Related, Delivery of Health Care
- Keywords
- Saving Babies Lives Care Bundle Version 2, NHS Maternity Care, Pregnancy, Stillbirth, Perinatal death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,773 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the implementation of NHS England's Saving Babies Lives Care Bundle Version 2 to reduce perinatal mortality.
It will explore whether the care bundle is effective at reducing stillbirth rates, neonatal death rates and preterm births in England. It will also explore the lived experiences of women's maternity care and their babies neonatal care, and the views and experiences of healthcare professionals who are involved in delivering the care bundle.
The main questions it aims to answer are:
- Does the care bundle reduce perinatal mortality rates?
- What are women's views and experiences of their maternity and neonatal care?
- What are the barriers around delivering the care bundle and how can this be improved?
- How do health inequalities affect the care women receive?
- How does the workforce culture affect how healthcare professionals use the care bundle?
Perinatal mortality rates and other pregnancy outcomes will be obtained from national data sources. Women and healthcare professionals will be asked to complete a survey and we will interview select groups of participants to further explore their experiences.
Mortality rates will be compared before and after the implementationof the care bundle where data allows. Data from the surveys will be descriptive. Data from the interviews will be analysed using thematic analysis to determine patterns and recurring ideas in the data.
Detailed description
In April 2022, NHS England commissioned the University of Manchester to conduct an independent evaluation of the effectiveness of the Saving Babies' Lives Care Bundle Version 2 (SBLCBv2) on reducing perinatal mortality in England. The study was commissioned in two phases.
Phase 1 comprises a national (service) evaluation of the impact of the SBLCBv2 on perinatal mortality rates, associated clinical outcomes, and any unintended consequences using routine data derived from national databases. Phase 2 comprises a qualitative evaluation to further understand the impact on maternity services, women and their families.
Phase 2 will be conducted in a cohort of maternity units across England using a mixed-methods approach. The views and experiences of women and healthcare professionals towards maternity care in relation to the SBLCBv2 will be sought using surveys and interviews. Additionally, this study will interview organisational leads to assess how resources, leadership and governance may affect implementation in diverse hospital settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Phase 1: births in England. Phase 2: women who received their antenatal care, labour and birth in 28 participating NHS maternity Trusts in England. Healthcare professionals currently employed in these 28 Trusts.
Key inclusion criteria (3 listed)
- women who have given birth in the last 12 months
- women who can understand English
- healthcare professionals involved in delivering the care bundle
Key exclusion criteria (4 listed)
- women who gave birth more than 12 months ago
- women who cannot understand English
- women without access to the internet for online survey completion
- healthcare professionals not involved in delivering the care bundle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of stillbirths in England
Time frame: Up to 60 months
A baby born after 24 or more weeks completed gestation and which did not, at any time, breathe or show signs of life
11 secondary outcomes
Number of babies born preterm
Time frame: Up to 60 months
Number of neonatal deaths in England
Time frame: Up to 60 months
Number of babies born small for gestational age (SGA)
Time frame: Up to 60 months
Number of women who had a caesarean section
Time frame: Up to 60 months
Number of women who had induction of labour
Time frame: Up to 60 months
Number of women who had an instrumental delivery
Time frame: Up to 60 months
Number of women who had a spontaneous delivery
Time frame: Up to 60 months
Number of babies admitted to neonatal care
Time frame: Up to 84 months
Number of babies admitted to neonatal care by gestation
Time frame: Up to 84 months
Number of babies admitted to neonatal care by cause of death
Time frame: Up to 84 months
Number of babies who died whilst on neonatal care
Time frame: Up to 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No. If requested, site-specific data from the questionnaires may be shared with participating NHS Trusts. This data will be provided in an anonymous aggregated format, with only that specific site identified. No identifiable data will be shared with participating NHS Trusts (i.e. names and email addresses will not be shared with NHS sites). Following completion of the study, with consent a fully anonymised aggregated dataset [e.g. including anonymous aggregated questionnaire responses] will be deposited in Figshare at the University of Manchester library, which is an open data repository where it will be permanently stored. Researchers at other institutions and others can access the anonymised data directly from the repository and use it for further research or to check our analysis and results. Individual NHS Trusts will not be identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Heazell, Prof principal investigator
The University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Delivery of Health Care, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of stillbirths in England (time frame: Up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.