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AFFIRM trial (awareness of fetal movements)

A trial in 33 maternity hospitals in the UK and Ireland that tested a package to make pregnant women more aware of the need to report reduced baby movements quickly, and to standardise what staff do next. The package did not reduce stillbirths, and the authors say its benefit remains unproven.

  • Study
  • In this atlas

Overview

Design
Stepped wedge, cluster-randomised trial. Maternity hospitals were grouped and randomised to one of nine intervention implementation dates at 3-month intervals; each hospital had a control period from 1 January 2014, a washout period of 2 months and an intervention period to 31 December 2016. Treatment allocation was not concealed from women and caregivers. Intention-to-treat analysis of births by period.
Phase
Not applicable
Enrolled
  • 430,830 participants (registry enrollment, type ACTUAL; the registry gives no unit) (enrolled count) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., retrieved )
  • 409,175 pregnancies (data collected, report abstract) (unknown count) (Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial, retrieved )
  • 33 hospitals (randomly assigned to an implementation date) (randomized count) (Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT01777022
Started
(actual) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., retrieved )
Primary completion
(actual) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., retrieved )
Completion
(actual) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., retrieved )
Countries
Ireland, United Kingdom (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Stepped wedge, cluster-randomised trial (Lancet 2018; ClinicalTrials.gov NCT01777022, lead sponsor University of Edinburgh). 33 hospitals were randomised to one of nine implementation dates; 409,175 pregnancies in the report (registry count 430,830). Stillbirth 4.40 per 1000 births in the control period and 4.06 in the intervention period, adjusted odds ratio 0.90 (95% CI 0.75 to 1.07). Funded by the Chief Scientist Office (Scottish Government), Tommy's and Sands (PubMed abstract). Only the abstract and the registry record were read.

Arms

  • Current treatment (control period)

    Intervention None named

    Current education and management protocols followed.

  • Reduced fetal movement care package (intervention period)

    Intervention None named

    A package of interventions to raise women's awareness of the need to report reduced fetal movements promptly, followed by a management plan for identifying and delivering the at-risk fetus.

Findings

No findings are published for this study.

Claims and evidence

Context Births in 33 UK and Irish maternity hospitals, 2014 to 2016 (AFFIRM)

Recipient
Fetal
Population
Fetuses and babies in 409,175 pregnancies delivered in 33 maternity hospitals in the UK and Ireland. The care package was aimed at pregnant women and clinicians (awareness of reduced fetal movements and standardised management), but the outcome, stillbirth, is counted per birth.
Care setting
33 maternity hospitals, randomly assigned to one of nine implementation dates at 3-month intervals
Geography
United Kingdom and Ireland
Life stage
Pregnancy and birth, 1 January 2014 to 31 December 2016; the correction to the report defines stillbirths in its table legend as at 22 weeks of gestation or later
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Stillbirth incidence per 1000 births in the control, washout and intervention periods
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Births in participating maternity hospitals during the control and intervention periods
Excluded
  • Not stated in the parts of the source that were read.

  • Effect Interventional Certainty not assessed

    AFFIRM was a stepped wedge, cluster-randomised trial in the UK and Ireland of a care package for reduced fetal movements: it raised women's awareness of the need to report reduced movements promptly and standardised management, including timely delivery. 33 maternity hospitals were randomly assigned to one of nine implementation dates at 3-month intervals. Data from 409,175 pregnancies between 1 January 2014 and 31 December 2016 were collected (157,692 deliveries in the control period, 23,623 in the washout period and 227,860 in the intervention period). Stillbirth incidence was 4.40 per 1000 births in the control period and 4.06 per 1000 births in the intervention period (adjusted odds ratio 0.90, 95% CI 0.75 to 1.07; p=0.23). The authors conclude that the care package did not reduce the risk of stillbirth and that the benefit of a policy promoting awareness of reduced fetal movements remains unproven.

    Source problem. A cited source is corrected. Check the sources before relying on this claim.

    Applies to Fetal
    • Fetuses and babies in 409,175 pregnancies delivered in 33 maternity hospitals in the UK and Ireland. The care package was aimed at pregnant women and clinicians (awareness of reduced fetal movements and standardised management), but the outcome, stillbirth, is counted per birth.
    • 33 maternity hospitals, randomly assigned to one of nine implementation dates at 3-month intervals
    • United Kingdom and Ireland
    • Pregnancy and birth, 1 January 2014 to 31 December 2016; the correction to the report defines stillbirths in its table legend as at 22 weeks of gestation or later
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Stillbirth incidence per 1000 births in the control, washout and intervention periods
    Certainty method
    Not assessed
    Limitations
    Allocation was not concealed from women and caregivers, and the data were derived from observational maternity data. The confidence interval (0.75 to 1.07) includes both a reduction of about a quarter and a small increase, so a modest effect is neither shown nor excluded. The registry count (430,830) and the report count (409,175 pregnancies) are different figures and are not reconciled here. The linked correction (PMID 34338212) was read: it amends some perinatal mortality data in Table 2, clarifies the table legend to define stillbirths at 22 weeks or later, and says the reported primary outcome data, summary and conclusions are unaffected; the stillbirth rates quoted here are the primary outcome. Only the abstract was read.
    Last checked
    2026-10-14
    Next evidence check due
    Not scheduled
    Sources and citations (18)

    1. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, BACKGROUND, sentence 2, fragment 1 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, BACKGROUND, sentence 2, fragment 2 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, BACKGROUND, sentence 2, fragment 3 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, METHODS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    5. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, METHODS, sentence 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    6. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, METHODS, sentence 5
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    7. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, METHODS, sentence 6
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    8. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, METHODS, sentence 7
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    9. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, FINDINGS, sentence 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    10. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, FINDINGS, sentence 3, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    11. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, FINDINGS, sentence 3, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    12. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, FINDINGS, sentence 4, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    13. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, FINDINGS, sentence 4, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    14. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, INTERPRETATION, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    15. Supports Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial

      Publication · Lancet (London, England) · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities, retrieved 2026-10-14. The full text and the version of record were not read. · Published 2018-11-03 · DOI: 10.1016/S0140-6736(18)31543-5 · PMID: 30269876

      Locator
      Abstract, INTERPRETATION, sentence 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Corrected
      Snapshot hash
      006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    16. Background Department of Error

      Publication · Lancet (London, England) · Edition PMC Open Access subset article (a published correction), full-text XML from NCBI E-utilities, retrieved 2026-10-14. · PMCID: PMC7658309 · PMID: 34338212 · DOI: 10.1016/S0140-6736(20)31973-5

      Locator
      Body, paragraph 1, sentence 1, fragment 1 of 2
      How it applies
      Frames the population or setting. Source page.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      896ddf6ee57b629c2c751e7b5ba4a2a691cc9a32a1aae52f4ebc0af3e773c283
      Reuse basis
      PMC Open Access subset article under https://creativecommons.org/licenses/by/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/mf-pmc-PMC7658309.xml.

    17. Background Department of Error

      Publication · Lancet (London, England) · Edition PMC Open Access subset article (a published correction), full-text XML from NCBI E-utilities, retrieved 2026-10-14. · PMCID: PMC7658309 · PMID: 34338212 · DOI: 10.1016/S0140-6736(20)31973-5

      Locator
      Body, paragraph 1, sentence 1, fragment 2 of 2
      How it applies
      Frames the population or setting. Source page.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      896ddf6ee57b629c2c751e7b5ba4a2a691cc9a32a1aae52f4ebc0af3e773c283
      Reuse basis
      PMC Open Access subset article under https://creativecommons.org/licenses/by/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/mf-pmc-PMC7658309.xml.

    18. Background Department of Error

      Publication · Lancet (London, England) · Edition PMC Open Access subset article (a published correction), full-text XML from NCBI E-utilities, retrieved 2026-10-14. · PMCID: PMC7658309 · PMID: 34338212 · DOI: 10.1016/S0140-6736(20)31973-5

      Locator
      Body, paragraph 1, sentence 2
      How it applies
      Frames the population or setting. Source page.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      896ddf6ee57b629c2c751e7b5ba4a2a691cc9a32a1aae52f4ebc0af3e773c283
      Reuse basis
      PMC Open Access subset article under https://creativecommons.org/licenses/by/4.0/. The article's own <permissions> states the licence. The XML is committed unaltered, with the citation and licence kept in the file. The raw file is committed at research/snapshots/mf-pmc-PMC7658309.xml.

Record details

Record id
maternal:affirm-trial
Content hash
2b6169ebf9165a88d728848024ac6e6193d4d87024ab9327921720ad81539728