{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T06:09:21Z","timestamp":1789193361029,"version":"build-2803163510"},"reference-count":28,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T00:00:00Z","timestamp":1789084800000},"content-version":"unspecified","delay-in-days":10,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","award":["INV-062675"],"award-info":[{"award-number":["INV-062675"]}],"id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,8,19]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the \u2018Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening\u2019 (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>\n                      This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11\n                      <jats:sup>+0<\/jats:sup>\n                      to 13\n                      <jats:sup>+6<\/jats:sup>\n                      weeks\u2019 gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14\n                      <jats:sup>+0<\/jats:sup>\n                      and 27\n                      <jats:sup>+6<\/jats:sup>\n                      weeks\u2019 gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11\n                      <jats:sup>+0<\/jats:sup>\n                      to 13\n                      <jats:sup>+6<\/jats:sup>\n                      weeks\u2019).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024\u201328489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727\/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002\/01\/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC\/01\/MISC\/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138\/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-118330","type":"journal-article","created":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T05:15:37Z","timestamp":1789190137000},"page":"e118330","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Prospective accuracy study on an artificial intelligence-based ultrasound system for gestational age estimation among pregnant women in Ghana, Kenya and South Africa: protocol"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9686-1187","authenticated-orcid":false,"given":"Alim","family":"Swarray Deen","sequence":"first","affiliation":[{"name":"Obstetrics and Gynaecology, University of Ghana, Accra, Ghana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1182-6679","authenticated-orcid":false,"given":"Annie Rene Alison","family":"McDougall","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosa","family":"Chemway","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Craik","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Skandarupan","family":"Jayaratnam","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naima","family":"Joseph","sequence":"additional","affiliation":[{"name":"Division of Maternal-Fetal Medicine, Boston University School of Medicine, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3643-923X","authenticated-orcid":false,"given":"Robert","family":"Mahar","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology and Biostatistics Unit, Murdoch Children\u2019s Research Institute, Parkville, Victoria, Australia"},{"name":"Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia"},{"name":"The University of Melbourne School of Population and Global Health, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8442-3048","authenticated-orcid":false,"given":"Digsu","family":"Koye","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology and Biostatistics Unit, Murdoch Children\u2019s Research Institute, Parkville, Victoria, Australia"},{"name":"Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3519-8275","authenticated-orcid":false,"given":"Long","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Simpson","sequence":"additional","affiliation":[{"name":"Clinical Epidemiology and Biostatistics Unit, Murdoch Children\u2019s Research Institute, Parkville, Victoria, Australia"},{"name":"Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Gwako","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4020-8933","authenticated-orcid":false,"given":"Ruth Lorna","family":"Hadebe","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Cape Town, Rondebosch, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edmund Tetteh","family":"Nartey","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynaecology, University of Ghana, Accra, Ghana"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Minckas","sequence":"additional","affiliation":[{"name":"The University of Melbourne Nossal Institute for Global Health, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4674-0998","authenticated-orcid":false,"given":"Ahmet Metin","family":"G\u00fclmezoglu","sequence":"additional","affiliation":[{"name":"Concept Foundation, Geneva, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3214-7096","authenticated-orcid":false,"given":"Joshua Peter","family":"Vogel","sequence":"additional","affiliation":[{"name":"Burnet Institute, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayesha","family":"Osman","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology, University of Cape Town, Rondebosch, South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,11]]},"reference":[{"key":"2026091122151970000_16.9.e118330.1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(24)00560-6"},{"key":"2026091122151970000_16.9.e118330.2","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1038\/s41572-023-00417-6","article-title":"Pre-eclampsia","volume":"9","author":"Dimitriadis","year":"2023","journal-title":"Nat Rev Dis Primers"},{"key":"2026091122151970000_16.9.e118330.3","unstructured":"World Health Organization . WHO recommendations on antiplatelet agents for prevention of pre-eclampsia. Geneva World Health Organization; 2021."},{"key":"2026091122151970000_16.9.e118330.4","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1186\/s12978-025-02156-1","article-title":"Protocol for a prospective cohort study on pre-eclampsia risk prediction in Ghana, Kenya and South Africa","volume":"22","author":"Blackburn","year":"2025","journal-title":"Reprod Health"},{"key":"2026091122151970000_16.9.e118330.5","doi-asserted-by":"crossref","DOI":"10.1186\/s12978-025-01980-9","article-title":"Formative research to optimize pre-eclampsia risk-screening and prevention (PEARLS): study protocol","volume":"22","author":"Minckas","year":"2025","journal-title":"Reprod Health"},{"key":"2026091122151970000_16.9.e118330.6","unstructured":"Risk assessment: Assessment of risk for preeclampsia (PE), 2023. Available: https:\/\/www.fetalmedicine.org\/research\/assess\/preeclampsia\/first-trimester"},{"key":"2026091122151970000_16.9.e118330.7","doi-asserted-by":"publisher","DOI":"10.1002\/uog.19112"},{"key":"2026091122151970000_16.9.e118330.8","doi-asserted-by":"crossref","first-page":"592","DOI":"10.1002\/uog.27490","article-title":"Externally validated prediction models for pre\u2010eclampsia: systematic review and meta\u2010analysis","volume":"63","author":"Tiruneh","year":"2024","journal-title":"Ultrasound in Obstet & Gyne"},{"key":"2026091122151970000_16.9.e118330.9","doi-asserted-by":"crossref","DOI":"10.1186\/s12884-021-04283-6","article-title":"Performance of Fetal Medicine Foundation algorithm for first trimester preeclampsia screening in an indigenous south Asian population","volume":"21","author":"Prasad","year":"2021","journal-title":"BMC Pregnancy Childbirth"},{"key":"2026091122151970000_16.9.e118330.10","unstructured":"WHO . WHO recommendations on antenatal care for a positive pregnancy experience. Geneva; Switzerland WHO; 2016."},{"key":"2026091122151970000_16.9.e118330.11","unstructured":"WHO antenatal care recommendations for a positive pregnancy experience . Maternal and fetal assessment update: imaging ultrasound before 24 weeks of pregnancy. Geneva World Health Organization; 2022."},{"key":"2026091122151970000_16.9.e118330.12","doi-asserted-by":"crossref","DOI":"10.1186\/s12978-018-0571-y","article-title":"Obstetric ultrasound use in low and middle income countries: a narrative review","volume":"15","author":"Kim","year":"2018","journal-title":"Reprod Health"},{"key":"2026091122151970000_16.9.e118330.13","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgh-2022-011170","article-title":"Strengthening antenatal care services for all: implementing imaging ultrasound before 24 weeks of pregnancy","volume":"8","author":"Noguchi","year":"2023","journal-title":"BMJ Glob Health"},{"key":"2026091122151970000_16.9.e118330.14","doi-asserted-by":"crossref","DOI":"10.1136\/bmjopen-2022-065181","article-title":"Portable ultrasound technologies for estimating gestational age in pregnant women: a scoping review and analysis of commercially available models","volume":"12","author":"Eggleston","year":"2022","journal-title":"BMJ Open"},{"key":"2026091122151970000_16.9.e118330.15","doi-asserted-by":"crossref","DOI":"10.1038\/s43856-022-00194-5","article-title":"A mobile-optimized artificial intelligence system for gestational age and fetal malpresentation assessment","volume":"2","author":"Gomes","year":"2022","journal-title":"Commun Med (Lond)"},{"key":"2026091122151970000_16.9.e118330.16","doi-asserted-by":"crossref","first-page":"1273","DOI":"10.3233\/THC-231482","article-title":"Artificial intelligence as a new answer to old challenges in maternal-fetal medicine and obstetrics","volume":"32","author":"Medjedovic","year":"2023","journal-title":"THC"},{"key":"2026091122151970000_16.9.e118330.17","doi-asserted-by":"crossref","unstructured":"Pokaprakarn T , Prieto JC , Price JT , et al . AI Estimation of Gestational Age from Blind Ultrasound Sweeps in Low-Resource Settings. NEJM Evid 2022;1. doi:10.1056\/evidoa2100058","DOI":"10.1056\/EVIDoa2100058"},{"key":"2026091122151970000_16.9.e118330.18","doi-asserted-by":"crossref","DOI":"10.1038\/s41746-025-02024-z","article-title":"Fetal gestational age estimation using artificial intelligence on non-targeted ultrasound images and video","volume":"8","author":"Benson","year":"2025","journal-title":"NPJ Digit Med"},{"key":"2026091122151970000_16.9.e118330.19","doi-asserted-by":"crossref","first-page":"127","DOI":"10.1002\/uog.26106","article-title":"ISUOG Practice Guidelines (updated): performance of 11\u201314\u2010week ultrasound scan","volume":"61","author":"Bilardo","year":"2023","journal-title":"Ultrasound in Obstet & Gyne"},{"key":"2026091122151970000_16.9.e118330.20","doi-asserted-by":"crossref","first-page":"840","DOI":"10.1002\/uog.24888","article-title":"ISUOG Practice Guidelines (updated): performance of the routine mid\u2010trimester fetal ultrasound scan","volume":"59","author":"Salomon","year":"2022","journal-title":"Ultrasound in Obstet & Gyne"},{"key":"2026091122151970000_16.9.e118330.21","unstructured":"GE HealthCare . Vscan air(tm) portable ultrasound system. 2024. Available: https:\/\/www.gehealthcare.com.au\/products\/ultrasound\/handheld-ultrasound?utm_source=google&utm_medium=paid-search&utm_campaign=ANZ-ULT-POC-VSCAN_PAID_ADS_CAMPAIGN-IS2.0-COV-AD-24-06&utm_content=brand-generic&gad_source=1&gclid=EAIaIQobChMIxv36vNqHigMVwKZmAh126g76EAAYASAAEgJdPvD_BwE [Accessed 2 Dec 2024]."},{"key":"2026091122151970000_16.9.e118330.22","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1002\/uog.13376","article-title":"Image-scoring system for crown-rump length measurement","volume":"44","author":"Wanyonyi","year":"2014","journal-title":"Ultrasound Obstet Gynecol"},{"key":"2026091122151970000_16.9.e118330.23","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)61490-2"},{"key":"2026091122151970000_16.9.e118330.24","doi-asserted-by":"crossref","DOI":"10.1002\/bimj.202300279","article-title":"A Bayesian model-based reduced major axis regression","volume":"66","author":"Ma","year":"2024","journal-title":"Biom J"},{"key":"2026091122151970000_16.9.e118330.25","doi-asserted-by":"crossref","DOI":"10.1186\/s12884-025-08261-0","article-title":"Facilitators and barriers to implementation of obstetric ultrasound scanning intervention by midwives within maternal and child health departments of the selected healthcare facilities in four districts of Zambia: experiences of healthcare workers","volume":"26","author":"Hangulu","year":"2026","journal-title":"BMC Pregnancy Childbirth"},{"key":"2026091122151970000_16.9.e118330.26","doi-asserted-by":"crossref","DOI":"10.1186\/s12884-022-04609-y","article-title":"Enablers and barriers to introduction of obstetrics ultrasound service at primary care facilities in a resource-limited setting: a qualitative study in four regions of Ethiopia","volume":"22","author":"Roro","year":"2022","journal-title":"BMC Pregnancy Childbirth"},{"key":"2026091122151970000_16.9.e118330.27","doi-asserted-by":"crossref","DOI":"10.2196\/34823","article-title":"Acceptability and Feasibility of a Low-Cost Device for Gestational Age Assessment in a Low-Resource Setting: Qualitative Study","volume":"9","author":"Koech","year":"2022","journal-title":"JMIR Hum Factors"},{"key":"2026091122151970000_16.9.e118330.28","doi-asserted-by":"crossref","DOI":"10.1080\/16549716.2020.1770967","article-title":"Implementation of the INTERGROWTH-21st gestational dating and fetal and newborn growth standards in Nairobi, Kenya: women\u2019s experiences with ultrasound and newborn assessment: Women\u2019s experiences with ultrasound and newborn assessment in peri-urban Kenya","volume":"13","author":"Jones","year":"2020","journal-title":"Glob Health Action"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-118330","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T05:15:44Z","timestamp":1789190144000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-118330"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":28,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9,11]]},"published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1136\/bmjopen-2026-118330"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-118330","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]}}}