StillbirthSPiRENCT03231007
Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
An observational study of Stillbirth, run by University of Manchester at 20 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stillbirth
- What is being tested?
- Questionnaire
- How many people
- 4,952 participants
- Where
- 20 sitesUnited Kingdom
- Study dates
- 10 Jul 2017to 5 Jul 2018
- 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
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
- Staff who were employed after the care bundle was implemented
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United Kingdom20 sites
Barnsley Hospital NHS Foundation Trust
Barnsley
Royal United Hospitals Bath NHS Foundation Trust
Bath
Birmingham Women's and Children's NHS Foundation Trust
Birmingham
North Bristol NHS Trust
Bristol
North Cumbria University Hospitals NHS Trust
Carlisle
Countess of Chester Hospital NHS Foundation Trust
Chester
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Doncaster
Royal Devon & Exeter NHS Foundation Trust
Exeter
Gateshead Health NHS Foundation Trust
Gateshead
Oxford University Hospitals NHS Trust
Headington
Hull and East Yorkshire Hospital NHS Trust
Hull
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal
Liverpool Women's NHS Foundation Trust
Liverpool
Central Manchester University Hospitals NHS Foundation Trust
Manchester
Plymouth Hospital NHS Trust
Plymouth
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield
Taunton and Somerset NHS Foundation Trust
Taunton
The Mid Yorkshire Hospitals NHS Trust
Wakefield
York Teaching Hospital NHS Foundation Trust
York
About this study
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.
Read the detailed 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.
- Conditions
- Stillbirth
- Being tested
- Questionnaire
- Medical subject headings
- Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Innovators | Maternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'. Receives: 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'. Receives: 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'. Receives: 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'. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1st April 2012-1st October 2017
Secondary outcomes (13)
Term, normally formed singleton stillbirths (antepartum and intrapartum).
This excludes issues of preterm birth and major mortality and morbidity associated with congenital anomalies.
Measured: 1st April 2012-1st October 2017
Preterm births
Measured: 1st April 2012-1st October 2017
Babies' gestation
Measured: 1st April 2012-1st October 2017
Number of reported incidents
Measured: 1st April 2012-1st October 2017
Admission to NICU
Measured: 1st April 2012-1st October 2017
Antenatal triage numbers
Measured: 1st April 2012-1st October 2017
Emergency caesarean deliveries
Measured: 1st April 2012-1st October 2017
Induced deliveries
Measured: 1st April 2012-1st October 2017
Birthweight
Measured: 1st April 2012-1st October 2017
Birthweight centile
Using GROW-Centile software
Measured: 1st April 2012-1st October 2017
Spontaneous deliveries
Measured: 1st April 2012-1st October 2017
Caesarean deliveries
Measured: 1st April 2012-1st October 2017
Instrumental deliveries
Measured: 1st April 2012-1st October 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start10 Jul 2017
- Primary completion28 Feb 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for StillbirthStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,952 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Somerset NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, University Hospital Plymouth NHS Trust, Royal United Hospital Bath NHS Trust, North Bristol NHS Trust, Liverpool Women's NHS Foundation Trust, St Helens & Knowsley Teaching Hospitals NHS Trust, Countess of Chester NHS Foundation Trust, University Hospitals of Morecambe Bay NHS Trust, Barnsley Hospital NHS Foundation Trust, Doncaster And Bassetlaw Hospitals NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, Mid Yorkshire Teaching NHS Trust, Oxford University Hospitals NHS Trust, Gateshead Health NHS Foundation Trust, North Cumbria University Hospitals NHS Trust, Sherwood Forest Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Birmingham Women's NHS Foundation Trust
- Responsible party
- Principal investigator, Dr Alexander Heazell, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231007
- Sponsor's protocol ID
- R04666
- Acronym
- SPiRE
- Status last verified
- Dec 2018
- First submitted
- 6 Jul 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Office of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.
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.
PubMed 26794070Manktelow 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.
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.
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.
PubMed 33872334Gardosi 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.
PubMed 23349424Marufu 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.
PubMed 25885887RCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.
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.
PubMed 16856111Widdows 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.
PubMed 29378526
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saving Babies' Lives Project Impact and Results Evaluation: a Mixed Methodology Study
- ClinicalTrials.gov ID
- NCT03231007
- Acronym / sponsor ID
- SPiRE / R04666
- Conditions
- Stillbirth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,952 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Somerset NHS Foundation Trust, Royal Devon and Exeter NHS Foundation Trust, University Hospital Plymouth NHS Trust, Royal United Hospital Bath NHS Trust, North Bristol NHS Trust, Liverpool Women's NHS Foundation Trust, St Helens & Knowsley Teaching Hospitals NHS Trust, Countess of Chester NHS Foundation Trust, University Hospitals of Morecambe Bay NHS Trust, Barnsley Hospital NHS Foundation Trust, Doncaster And Bassetlaw Hospitals NHS Foundation Trust, York Teaching Hospitals NHS Foundation Trust, Hull University Teaching Hospitals NHS Trust, Mid Yorkshire Teaching NHS Trust, Oxford University Hospitals NHS Trust, Gateshead Health NHS Foundation Trust, North Cumbria University Hospitals NHS Trust, Sherwood Forest Hospitals NHS Foundation Trust, Manchester University NHS Foundation Trust, Birmingham Women's NHS Foundation Trust
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 27 Jul 2017 (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 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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Innovators | – | Other: QuestionnaireMaternity units that implemented the Care Bundle to the highest level (according to an NHS survey in 2015) are categorised as 'Innovators'. |
| Early Adopters | – | Other: QuestionnaireMaternity units that implemented the Care Bundle to the second-highest level (according to an NHS survey in 2015) are categorised as 'Early Adopters'. |
| Late Adopters | – | Other: QuestionnaireMaternity units that implemented the Care Bundle to the third-highest level (according to an NHS survey in 2015) are categorised as 'Late Adopters'. |
| Low Adopters | – | Other: QuestionnaireMaternity units that implemented the Care Bundle to the fourth-highest level (according to an NHS survey in 2015) are categorised as 'Low Adopters'. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireA 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). | Other | Early Adopters, Innovators, Late Adopters, Low Adopters |
Primary outcome
Stillbirths
Time frame: 1st April 2012-1st October 2017
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.
13 secondary outcomes
Term, normally formed singleton stillbirths (antepartum and intrapartum).
Time frame: 1st April 2012-1st October 2017
Preterm births
Time frame: 1st April 2012-1st October 2017
Babies' gestation
Time frame: 1st April 2012-1st October 2017
Number of reported incidents
Time frame: 1st April 2012-1st October 2017
Admission to NICU
Time frame: 1st April 2012-1st October 2017
Antenatal triage numbers
Time frame: 1st April 2012-1st October 2017
Emergency caesarean deliveries
Time frame: 1st April 2012-1st October 2017
Induced deliveries
Time frame: 1st April 2012-1st October 2017
Birthweight
Time frame: 1st April 2012-1st October 2017
Birthweight centile
Time frame: 1st April 2012-1st October 2017
Spontaneous deliveries
Time frame: 1st April 2012-1st October 2017
Caesarean deliveries
Time frame: 1st April 2012-1st October 2017
Instrumental deliveries
Time frame: 1st April 2012-1st October 2017
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 4 Dec 2018.
- BackgroundOffice of National Statistics. Characteristics of birth 1, England and Wales, 2013. London: ONS, 2014.
- Background: PubMed 26794070Flenady 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.
- BackgroundManktelow 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.
- BackgroundDraper 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: PubMed 33872334Widdows 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.
- Background: PubMed 23349424Gardosi 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.
- Background: PubMed 25885887Marufu 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.
- BackgroundRCOG Green-Top Guideline 31: The Investigation and Management of the Small-for-Gestational Ages Fetus. Royal College of Obstetricians and Gynaecologists, 2013.
- Background: PubMed 16856111Alfirevic 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.
- Derived from this study: PubMed 29378526Widdows 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stillbirth, run by University of Manchester at 20 sites 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 8 inclusion and 6 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 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Stillbirths (time frame: 1st April 2012-1st October 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231007, which also lists 10 linked publications.
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 4 Dec 2018.