# AFFIRM trial (awareness of fetal movements) Study · id `maternal:affirm-trial` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Pregnancy Browse, care area: The baby before birth ## In plain language 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. ## 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. ## Key facts - 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: 430830 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., snapshot `maternal:ctgov-nct01777022-2026-10-14`, retrieved 2026-10-14); 409175 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, snapshot `maternal:pubmed-30269876-2026-10-14`, retrieved 2026-10-14); 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, snapshot `maternal:pubmed-30269876-2026-10-14`, retrieved 2026-10-14) - Started: 2014-01-01 (actual) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., snapshot `maternal:ctgov-nct01777022-2026-10-14`, retrieved 2026-10-14) - Primary completion: 2016-12-31 (actual) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., snapshot `maternal:ctgov-nct01777022-2026-10-14`, retrieved 2026-10-14) - Completion: 2017-09-30 (actual) (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., snapshot `maternal:ctgov-nct01777022-2026-10-14`, retrieved 2026-10-14) - Countries: Ireland; United Kingdom (Promoting Awareness Fetal Movements to Reduce Fetal Mortality Stillbirth, a Stepped Wedge Cluster Randomised Trial., snapshot `maternal:ctgov-nct01777022-2026-10-14`, retrieved 2026-10-14) - Care setting: Not reported - Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `maternal:ctgov-nct01777022-2026-10-14`, retrieved 2026-10-14) ## Claims, with the population each applies to ## 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 ### 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. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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 - 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 - Source problem: a cited source is corrected. Check the sources before relying on this claim. - Sources: 1. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, BACKGROUND, sentence 2, fragment 1 of 3. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 2. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, BACKGROUND, sentence 2, fragment 2 of 3. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 3. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, BACKGROUND, sentence 2, fragment 3 of 3. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 4. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, METHODS, sentence 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 5. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, METHODS, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 6. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, METHODS, sentence 5. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 7. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, METHODS, sentence 6. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 8. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, METHODS, sentence 7. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 9. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, FINDINGS, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 10. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, FINDINGS, sentence 3, fragment 1 of 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 11. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, FINDINGS, sentence 3, fragment 2 of 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 12. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, FINDINGS, sentence 4, fragment 1 of 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 13. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, FINDINGS, sentence 4, fragment 2 of 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 14. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, INTERPRETATION, sentence 1. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 15. Supports: Awareness of fetal movements and care package to reduce fetal mortality (AFFIRM): a stepped wedge, cluster-randomised trial (Publication, 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.) Locator: Abstract, INTERPRETATION, sentence 2. Retrieved 2026-10-14T18:18:39Z. Source state: Corrected. Snapshot hash: 006e9645dc5dfc95994f53fb1c3790e59ca744c8b7afde854e6ff8ae3ef43bf3. How it applies: PubMed abstract. 16. Background: Department of Error (Publication, edition PMC Open Access subset article (a published correction), full-text XML from NCBI E-utilities, retrieved 2026-10-14.) Locator: Body, paragraph 1, sentence 1, fragment 1 of 2. Retrieved 2026-10-14T18:48:44Z. Source state: Current. Snapshot hash: 896ddf6ee57b629c2c751e7b5ba4a2a691cc9a32a1aae52f4ebc0af3e773c283. How it applies: Frames the population or setting. Source page. 17. Background: Department of Error (Publication, edition PMC Open Access subset article (a published correction), full-text XML from NCBI E-utilities, retrieved 2026-10-14.) Locator: Body, paragraph 1, sentence 1, fragment 2 of 2. Retrieved 2026-10-14T18:48:44Z. Source state: Current. Snapshot hash: 896ddf6ee57b629c2c751e7b5ba4a2a691cc9a32a1aae52f4ebc0af3e773c283. How it applies: Frames the population or setting. Source page. 18. Background: Department of Error (Publication, edition PMC Open Access subset article (a published correction), full-text XML from NCBI E-utilities, retrieved 2026-10-14.) Locator: Body, paragraph 1, sentence 2. Retrieved 2026-10-14T18:48:44Z. Source state: Current. Snapshot hash: 896ddf6ee57b629c2c751e7b5ba4a2a691cc9a32a1aae52f4ebc0af3e773c283. How it applies: Frames the population or setting. Source page. ## Connected pages - Tests a fetal-movement care package against stillbirth: Stillbirth (`maternal:stillbirth`) ## Provenance Content hash: 2b6169ebf9165a88d728848024ac6e6193d4d87024ab9327921720ad81539728 Last substantive edit: 2026-10-14 Evidence last checked: 2026-10-14