Decreased Fetal Movements Affecting Care of MotherAFFIRMNCT01777022
Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
A study testing A package of interventions in people with Decreased Fetal Movements Affecting Care of Mother and Pregnancy, run by University of Edinburgh at 29 sites in 2 countries.
Trial summary
Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Decreased Fetal Movements Affecting Care of Mother, Pregnancy, Stillbirth
- What is being tested?
- A package of interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430,830 participants
- Where
- 29 sitesin 2 countries
- Study dates
- 1 Jan 2014to 30 Sep 2017
- Phase
- Interventional
- 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 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The study will include all women delivering at one of the maternity units involved in for the duration of the study.
Who cannot join
- Women delivering in the "washout" period in each unit.
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
United Kingdom27 sites
NHS Grampian
Aberdeen
Neville Hall hospital
Abergavenny
Betsi Cadwaladr University Heath board (Ysbyty Gwynnedd Hospital)
Bangor
Royal Jubilee Hospital
Belfast
Birmingham Women's Hospital
Birmingham, West Midlands
Blackpool Victoria Hospital
Blackpool
St. Richards Hospital
Chichester, West Sussex, PO19 6SE
NHS Dumfries and Galloway
Dumfries
NHS Tayside
Dundee
NHS Lothian
Edinburgh, Lothian, EH54
NHS Greater Glasgow
Glasgow
NHS Highland
Inverness
NHS Ayrshire and Arran
Kilmarnock
NHS Fife
Kirkcaldy
NHS Forth Valley
Larbert
Leeds Teaching Hospital NHS Trust
Leeds, Yorkshire
St Georges Hospital
London
Saint Mary's hospital
Manchester, Lancashire, M13 9WL
NHS Borders
Melrose
Royal Gwent Hospital
Newport, Gwent, NP20 2UB
Lancashire Teaching Hospitals NHS Foundation Trust
Preston
Betsi Cadwaladr University Heath board (Glan Clwyd)
Rhyl
Stepping Hill Hospital
Stockport, Cheshire, SK2 7JE
Royal Albert Edward Infirmary, Wigan
Wigan
NHS Lanarkshire
Wishaw
Worthing Hospital
Worthing, West Sussex
Betsi Cadwaladr University Heath board (Wrexham Maelor)
Wrexham
About this study
Official title: Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth.
The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial.
The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).
- Being tested
- A package of interventions
- Keywords
- Education, Stillbirth, Prevention, Management
- Medical subject headings
- Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A package of interventionsOther
A package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth
| Study group | Role | What they receive |
|---|---|---|
| Current treatment | No intervention | Current education and management protocols will be followed |
| A package of interventions | Other | A package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth Receives: Other: A package of interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of stillbirth
Measured: 36 months
Secondary outcomes (4)
Rates of caesarean section
Measured: 36 months
Rates of induction of labour
Measured: 36 Months
Rates of admission to the neonatal intensive care unit
Measured: 36 Months
Proportion of women with fetal growth restriction
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study start1 Jan 2014
- Primary completion31 Dec 2016
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Decreased Fetal Movements Affecting Care of MotherStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 430,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- Jane E Norman, MD, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777022
- Sponsor's protocol ID
- AFFIRM
- Acronym
- AFFIRM
- Status last verified
- Feb 2018
- First submitted
- 15 Jan 2013
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Camacho EM, Whyte S, Stock SJ, Weir CJ, Norman JE, Heazell AEP. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a trial-based and model-based cost-effectiveness analysis from a stepped wedge, cluster-randomised trial. BMC Pregnancy Childbirth. 2022 Mar 22;22(1):235. doi: 10.1186/s12884-022-04563-9.
PubMed 35317772Norman JE, Heazell AEP, Rodriguez A, Weir CJ, Stock SJE, Calderwood CJ, Cunningham Burley S, Froen JF, Geary M, Breathnach F, Hunter A, McAuliffe FM, Higgins MF, Murdoch E, Ross-Davie M, Scott J, Whyte S; AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018 Nov 3;392(10158):1629-1638. doi: 10.1016/S0140-6736(18)31543-5. Epub 2018 Sep 27.
PubMed 30269876Heazell AEP, Weir CJ, Stock SJE, Calderwood CJ, Burley SC, Froen JF, Geary M, Hunter A, McAuliffe FM, Murdoch E, Rodriguez A, Ross-Davie M, Scott J, Whyte S, Norman JE. Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM). BMJ Open. 2017 Aug 11;7(8):e014813. doi: 10.1136/bmjopen-2016-014813.
PubMed 28801392
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Awareness Fetal Movements and Focussing Interventions Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial.
- ClinicalTrials.gov ID
- NCT01777022
- Acronym / sponsor ID
- AFFIRM / AFFIRM
- Keywords
- Education, Stillbirth, Prevention, Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430,830 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 28 Jan 2013 (estimated)
- 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.
Rates of stillbirth in Scotland are among the highest in resource rich countries. The majority of stillbirths occur in normally formed infants, with (retrospective) evidence of placental insufficiency being the commonest clinical finding. Maternal perception of decreased fetal movements appears to be an early biomarker both of placental insufficiency and subsequent stillbirth.
The study proposed here will test the hypothesis that rates of stillbirth will be reduced by introduction of a package of care consisting of strategies for increasing pregnant women's awareness of the need for prompt reporting of decreased fetal movements, followed by a management plan for identification of placental insufficiency with timely delivery in confirmed cases. The odds of stillbirth fell by 30% after the introduction of a similar package of care in Norway but the efficacy of this intervention (and possible adverse effects and implications for service delivery) have not been tested in a randomized trial.
The investigators plan a stepped wedge cluster design trial, in which hospitals in Scotland and Ireland will be randomized to the timing of introduction of the care package. Outcomes (including the primary outcome of stillbirth) will be derived from Scotland and Ireland's detailed routinely collected maternity data, allowing the investigators to robustly test the hypothesis. A nested qualitative study will examine the acceptability of the intervention to patients and health care providers and identify process issues (barriers to implementation).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current treatment | No intervention | –Current education and management protocols will be followed |
| A package of interventions | Other | Other: A package of interventionsA package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study will include all women delivering at one of the maternity units involved in for the duration of the study.
Key exclusion criteria (1 listed)
- Women delivering in the "washout" period in each unit.
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 |
|---|---|---|
| A package of interventionsA package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the "at risk" fetus in such women, will reduce rates of stillbirth | Other | A package of interventions |
Primary outcome
Rates of stillbirth
Time frame: 36 months
4 secondary outcomes
Rates of caesarean section
Time frame: 36 months
Rates of induction of labour
Time frame: 36 Months
Rates of admission to the neonatal intensive care unit
Time frame: 36 Months
Proportion of women with fetal growth restriction
Time frame: 36 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 8 Feb 2018.
- Derived from this study: PubMed 35317772Camacho EM, Whyte S, Stock SJ, Weir CJ, Norman JE, Heazell AEP. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a trial-based and model-based cost-effectiveness analysis from a stepped wedge, cluster-randomised trial. BMC Pregnancy Childbirth. 2022 Mar 22;22(1):235. doi: 10.1186/s12884-022-04563-9.
- Derived from this study: PubMed 30269876Norman JE, Heazell AEP, Rodriguez A, Weir CJ, Stock SJE, Calderwood CJ, Cunningham Burley S, Froen JF, Geary M, Breathnach F, Hunter A, McAuliffe FM, Higgins MF, Murdoch E, Ross-Davie M, Scott J, Whyte S; AFFIRM investigators. Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial. Lancet. 2018 Nov 3;392(10158):1629-1638. doi: 10.1016/S0140-6736(18)31543-5. Epub 2018 Sep 27.
- Derived from this study: PubMed 28801392Heazell AEP, Weir CJ, Stock SJE, Calderwood CJ, Burley SC, Froen JF, Geary M, Hunter A, McAuliffe FM, Murdoch E, Rodriguez A, Ross-Davie M, Scott J, Whyte S, Norman JE. Can promoting awareness of fetal movements and focusing interventions reduce fetal mortality? A stepped-wedge cluster randomised trial (AFFIRM). BMJ Open. 2017 Aug 11;7(8):e014813. doi: 10.1136/bmjopen-2016-014813.
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.
Jane E Norman, MD study chair
University of Edinburgh
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A package of interventions in people with Decreased Fetal Movements Affecting Care of Mother and Pregnancy, run by University of Edinburgh at 29 sites in 2 countries.
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 1 inclusion and 1 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United Kingdom, Ireland. 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?
Rates of stillbirth (time frame: 36 months). 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 NCT01777022, which also lists 3 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 8 Feb 2018.