<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03231007</url>
  </required_header>
  <id_info>
    <org_study_id>R04666</org_study_id>
    <nct_id>NCT03231007</nct_id>
  </id_info>
  <brief_title>Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study</brief_title>
  <acronym>SPiRE</acronym>
  <official_title>Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Somerset NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Devon and Exeter NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Plymouth NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal United Hospital Bath NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Bristol NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Liverpool Women's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>St Helens &amp; Knowsley Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Countess of Chester NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospitals of Morecambe Bay NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Barnsley Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Doncaster And Bassetlaw Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>York Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hull University Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mid Yorkshire Teaching NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gateshead Health NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Cumbria University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sherwood Forest Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Manchester University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Birmingham Women's NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a multicentre evaluation of maternity care delivered through the Saving Babies'&#xD;
      Lives care bundle using both quantitative and qualitative methodologies. The study will be&#xD;
      conducted in twenty NHS Hospital Trusts from six NHS Strategic Clinical Networks totalling&#xD;
      approximately 100,000 births. It involves participation by both service users and care&#xD;
      providers.&#xD;
&#xD;
      To determine the impact of the care bundle on pregnancy outcomes, birth data and other&#xD;
      clinical measures will be extracted from maternity databases and case-note audit from before&#xD;
      and after implementation. Additionally, this study will employ questionnaires with&#xD;
      organisational leads and review clinical guidelines to assess how resources, leadership and&#xD;
      governance may affect implementation in diverse hospital settings. The cost of implementing&#xD;
      the care bundle, and the cost per stillbirth avoided, will also be estimated as part of a&#xD;
      health economic analysis. The views and experiences of service users and service providers&#xD;
      towards maternity care in relation to the care bundle will be also be sought using&#xD;
      questionnaires.&#xD;
&#xD;
      This study will provide practice-based evidence to advance knowledge about the processes that&#xD;
      underpin successful implementation of the care bundle so that it can be further developed and&#xD;
      refined. This has the potential to translate into substantial improvements in the rate of&#xD;
      late stillbirth in the UK should the care bundle be proved effective.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reducing stillbirth and early neonatal death is a national priority. Best practice and key&#xD;
      evidence indicates this is potentially achievable through application of four key&#xD;
      interventions within routine maternity care delivered as NHS England's Saving Babies' Lives&#xD;
      care bundle. However, adoption of the care bundle by UK maternity services is still in its&#xD;
      infancy and there is significant variation in the degree of implementation between and within&#xD;
      units. The effectiveness of the care bundle, when implemented as a package, in reducing&#xD;
      stillbirth and service delivery has not yet been evaluated. This study aims to evaluate the&#xD;
      impact of implementing the care bundle on UK maternity services and perinatal outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Actual">July 5, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Stillbirths</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Term, normally formed singleton stillbirths (antepartum and intrapartum).</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
    <description>This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm births</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Babies' gestation</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of reported incidents</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Admission to NICU</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antenatal triage numbers</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency caesarean deliveries</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Induced deliveries</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birthweight</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birthweight centile</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
    <description>Using GROW-Centile software</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous deliveries</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caesarean deliveries</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Instrumental deliveries</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women ceasing smoking between booking and delivery</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation with a positive CO test</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA singletons detected prior to delivery</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of all singletons with growth charts in notes</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with estimated fetal weight (EFW) plotted on growth chart</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with symphysis fundal height (SFH) plotted on growth chart</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with EFW correctly plotted on growth chart</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of babies identified as SGA during pregnancy that were appropriate for gestation age (AGA) at birth (false positives)</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of babies identified as AGA during pregnancy that were SGA at birth (false negatives)</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of pregnancies with customised growth chart</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Birthweight centile at last scan (by EFW measurement)</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans</measure>
    <time_frame>1st April 2012-1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women receiving RFM leaflet</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM managed</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of triage women presenting with RFM on at least one occasion</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had scan</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had FH monitoring</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Gestation of baby at RFM episodes</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of growth scans due to RFM</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Time to scan from reporting RFM</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of RFM episodes per pregnancy according to checklist</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of deliveries where both buddy and stickers used</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of staff completing annual CTG training</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of pregnancies where escalation protocol was used</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled</measure>
    <time_frame>1st April 2012 until 1st October 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Equipment required</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
    <description>(e.g. CO test kits)</description>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Staff time required</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
    <description>(e.g. to conduct additional scans)</description>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Antenatal triage numbers</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Number of triage women presenting with RFM on at least one occasion</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Emergency caesarean deliveries</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Induced deliveries</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Caesarean deliveries</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Number of third trimester growth scans</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Number of growth scans due to RFM</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Number of antenatal CTGs due to RFM</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Length of stay in NICU</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Economic Outcome - Length of stay in hospital</measure>
    <time_frame>10th July 2017-31st August 2017</time_frame>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">4952</enrollment>
  <condition>Stillbirth</condition>
  <arm_group>
    <arm_group_label>Innovators</arm_group_label>
    <description>Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Adopters</arm_group_label>
    <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'.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Late Adopters</arm_group_label>
    <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'.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Adopters</arm_group_label>
    <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'.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>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).</description>
    <arm_group_label>Early Adopters</arm_group_label>
    <arm_group_label>Innovators</arm_group_label>
    <arm_group_label>Late Adopters</arm_group_label>
    <arm_group_label>Low Adopters</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Postnatal service users who have received antenatal care and given birth in one of the 20&#xD;
        study sites.&#xD;
&#xD;
        Healthcare professionals who are involved in delivering maternity care in one of the 20&#xD;
        study sites.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Maternity Service Users:&#xD;
&#xD;
          -  Women who received their antenatal care, delivered and were discharged from the same&#xD;
             maternity unit&#xD;
&#xD;
          -  Women who have given birth after 28 weeks of gestation&#xD;
&#xD;
        Exclusion Criteria for Maternity Service Users:&#xD;
&#xD;
          -  Maternal age ≤ 16 years&#xD;
&#xD;
          -  Individuals who cannot understand/not fluent in English (to enable consent without&#xD;
             interpreter)&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Fetuses known to have any congenital or severe structural abnormalities&#xD;
&#xD;
          -  Home births&#xD;
&#xD;
        Inclusion Criteria for Maternity Healthcare Professionals:&#xD;
&#xD;
          -  Midwives working before and after implementation of the care bundle (including&#xD;
             antenatal ward, antenatal clinic, community-based staff, antenatal assessment unit and&#xD;
             labour ward)&#xD;
&#xD;
          -  Community midwives working before and after implementation of the care bundle&#xD;
&#xD;
          -  Sonographers working before and after implementation of the care bundle&#xD;
&#xD;
          -  Junior doctors working before and after implementation of the care bundle&#xD;
&#xD;
          -  Consultant obstetricians working before and after implementation of the care bundle&#xD;
&#xD;
          -  Clinical Directors and Heads of Midwifery working before and after implementation of&#xD;
             the care bundle&#xD;
&#xD;
        Exclusion Criteria for Maternity Healthcare Professionals:&#xD;
&#xD;
        - Staff who were employed after the care bundle was implemented&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Barnsley Hospital NHS Foundation Trust</name>
      <address>
        <city>Barnsley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospitals Bath NHS Foundation Trust</name>
      <address>
        <city>Bath</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Women's and Children's NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Bristol NHS Trust</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Cumbria University Hospitals NHS Trust</name>
      <address>
        <city>Carlisle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Countess of Chester Hospital NHS Foundation Trust</name>
      <address>
        <city>Chester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doncaster and Bassetlaw Hospitals NHS Foundation Trust</name>
      <address>
        <city>Doncaster</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Devon &amp; Exeter NHS Foundation Trust</name>
      <address>
        <city>Exeter</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gateshead Health NHS Foundation Trust</name>
      <address>
        <city>Gateshead</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals NHS Trust</name>
      <address>
        <city>Headington</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hull and East Yorkshire Hospital NHS Trust</name>
      <address>
        <city>Hull</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Morecambe Bay NHS Foundation Trust</name>
      <address>
        <city>Kendal</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Women's NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospital NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Helens and Knowsley Teaching Hospitals NHS Trust</name>
      <address>
        <city>Prescot</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sherwood Forest Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sutton in Ashfield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taunton and Somerset NHS Foundation Trust</name>
      <address>
        <city>Taunton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Mid Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Wakefield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>York Teaching Hospital NHS Foundation Trust</name>
      <address>
        <city>York</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.</citation>
  </reference>
  <reference>
    <citation>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. Erratum In: Lancet. 2021 Sep 25;398(10306):1132.</citation>
    <PMID>26794070</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>33872334</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23349424</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25885887</PMID>
  </reference>
  <reference>
    <citation>RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16856111</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 6, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Dr Alexander Heazell</investigator_full_name>
    <investigator_title>Professor of Obstetrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stillbirth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03231007/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03231007
org study id: R04666
nct id: NCT03231007
lead sponsor: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
measure: Stillbirths
time frame: 1st April 2012-1st October 2017
description: 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.
measure: Term, normally formed singleton stillbirths (antepartum and intrapartum).
time frame: 1st April 2012-1st October 2017
description: This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.
measure: Preterm births
time frame: 1st April 2012-1st October 2017
measure: Babies' gestation
time frame: 1st April 2012-1st October 2017
measure: Number of reported incidents
time frame: 1st April 2012-1st October 2017
measure: Admission to NICU
time frame: 1st April 2012-1st October 2017
measure: Antenatal triage numbers
time frame: 1st April 2012-1st October 2017
measure: Emergency caesarean deliveries
time frame: 1st April 2012-1st October 2017
measure: Induced deliveries
time frame: 1st April 2012-1st October 2017
measure: Birthweight
time frame: 1st April 2012-1st October 2017
measure: Birthweight centile
time frame: 1st April 2012-1st October 2017
description: Using GROW-Centile software
measure: Spontaneous deliveries
time frame: 1st April 2012-1st October 2017
measure: Caesarean deliveries
time frame: 1st April 2012-1st October 2017
measure: Instrumental deliveries
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women smoking at delivery
time frame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women offered carbon monoxide (CO) test
time frame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women accepting CO test
time frame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation
time frame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women ceasing smoking between booking and delivery
time frame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 1 (Smoking in Pregnancy): Proportion of women referred to smoking cessation with a positive CO test
time frame: 10th July 2017-31st August 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA singletons detected prior to delivery
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of all singletons with growth charts in notes
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with estimated fetal weight (EFW) plotted on growth chart
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with symphysis fundal height (SFH) plotted on growth chart
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of SGA pregnancies with EFW correctly plotted on growth chart
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of babies identified as SGA during pregnancy that were appropriate for gestation age (AGA) at birth (false positives)
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of babies identified as AGA during pregnancy that were SGA at birth (false negatives)
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Proportion of pregnancies with customised growth chart
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Birthweight centile at last scan (by EFW measurement)
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 2 (Small for Gestational Age Detection): Number of third trimester growth scans
time frame: 1st April 2012-1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women receiving RFM leaflet
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM managed
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of triage women presenting with RFM on at least one occasion
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had scan
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Proportion of women with RFM who had FH monitoring
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Gestation of baby at RFM episodes
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of growth scans due to RFM
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Time to scan from reporting RFM
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 3 (Patient Information Provision and Reduced Fetal Movements Management): Number of RFM episodes per pregnancy according to checklist
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of deliveries where both buddy and stickers used
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of staff completing annual CTG training
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Proportion of pregnancies where escalation protocol was used
time frame: 1st April 2012 until 1st October 2017
measure: Process Outcome - Care Bundle Element 4 (Effective Fetal Monitoring During Labour): Number of babies therapeutically cooled
time frame: 1st April 2012 until 1st October 2017
measure: Economic Outcome - Equipment required
time frame: 10th July 2017-31st August 2017
description: (e.g. CO test kits)
measure: Economic Outcome - Staff time required
time frame: 10th July 2017-31st August 2017
description: (e.g. to conduct additional scans)
measure: Economic Outcome - Antenatal triage numbers
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of triage women presenting with RFM on at least one occasion
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Emergency caesarean deliveries
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Induced deliveries
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Caesarean deliveries
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of third trimester growth scans
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of growth scans due to RFM
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Number of antenatal CTGs due to RFM
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Length of stay in NICU
time frame: 10th July 2017-31st August 2017
measure: Economic Outcome - Length of stay in hospital
time frame: 10th July 2017-31st August 2017
arm group label: Innovators
description: Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'.
arm group label: 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'.
arm group label: 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'.
arm group label: 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'.
intervention type: Other
intervention name: Questionnaire
description: 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).
arm group label: Early Adopters
arm group label: Innovators
arm group label: Late Adopters
arm group label: Low Adopters
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
facility: 
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country: United Kingdom
citation: Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.
citation: 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. Erratum In: Lancet. 2021 Sep 25;398(10306):1132.
PMID: 26794070
citation: 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.
citation: 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.
citation: 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
citation: 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
citation: 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
citation: RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.
citation: 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
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Dr Alexander Heazell
investigator title: Professor of Obstetrics
mesh term: Stillbirth
sharing ipd: No
provided document: 