{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T20:42:14Z","timestamp":1790023334411,"version":"4.0.1"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T00:00:00Z","timestamp":1751587200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"},{"start":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T00:00:00Z","timestamp":1751587200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0"}],"funder":[{"DOI":"10.13039\/501100014434","name":"Narodowa Agencja Wymiany Akademickiej","doi-asserted-by":"publisher","award":["BPN\/GIN\/2021\/1\/00040\/U\/00001"],"award-info":[{"award-number":["BPN\/GIN\/2021\/1\/00040\/U\/00001"]}],"id":[{"id":"10.13039\/501100014434","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int Breastfeed J"],"DOI":"10.1186\/s13006-025-00743-3","type":"journal-article","created":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T16:58:41Z","timestamp":1751648321000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Development of lactation and breast\/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach"],"prefix":"10.1186","volume":"20","author":[{"given":"Katarzyna M.","family":"Maksym","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kinga","family":"Kalita-Kurzy\u0144ska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane","family":"Spatz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melinda","family":"Boss","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Carmen","family":"Collado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Gonciarz-Dytman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bei","family":"Han","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asma","family":"Khalil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Kozakiewicz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ernest","family":"Kuchar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karolina","family":"Morze","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Powell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalie","family":"Shenker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S\u0142awomir","family":"W\u0105troba","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna L.","family":"David","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleksandra","family":"Weso\u0142owska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,7,4]]},"reference":[{"key":"743_CR1","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1080\/07399339009515912","volume":"11","author":"EJ Saunders","year":"1990","unstructured":"Saunders EJ, Saunders JA. Drug therapy in pregnancy: the lessons of diethylstilbestrol, thalidomide, and Bendectin. Health Care Women Int. 1990;11:423\u201332.","journal-title":"Health Care Women Int"},{"key":"743_CR2","unstructured":"Eunice Kennedy Shriver National Institute of Child Health and Human Development. Task force on research specific to pregnant women and lactating women. 2018. Available from: \nhttps:\/\/www.nichd.nih.gov\/sites\/default\/files\/2018-09\/PRGLAC_Report.pdf. Cited 2024 Apr 3."},{"key":"743_CR3","doi-asserted-by":"publisher","first-page":"e2015094","DOI":"10.1001\/jamanetworkopen.2020.15094","volume":"3","author":"JJ Byrne","year":"2020","unstructured":"Byrne JJ, Saucedo AM, Spong CY. Evaluation of drug labels following the 2015 pregnancy and lactation labeling rule. JAMA Netw Open. 2020;3:e2015094.","journal-title":"JAMA Netw Open"},{"key":"743_CR4","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/j.clinthera.2021.11.017","volume":"44","author":"K North","year":"2022","unstructured":"North K, Gao M, Allen G, Lee AC. Breastfeeding in a global context: epidemiology, impact, and future directions. Clin Ther. 2022;44:228\u201344.","journal-title":"Clin Ther"},{"key":"743_CR5","unstructured":"UNICEF Data. Breastfeeding. 2023 Available from: \nhttps:\/\/data.unicef.org\/topic\/nutrition\/breastfeeding\/.\u00a0Cited 2024 Apr 8."},{"key":"743_CR6","first-page":"292","volume":"6","author":"L Radulescu","year":"2013","unstructured":"Radulescu L, Munteanu O, Popa F, Cirstoiu M. The implications and consequences of maternal obesity on fetal intrauterine growth restriction. J Med Life. 2013;6:292\u20138.","journal-title":"J Med Life"},{"key":"743_CR7","doi-asserted-by":"publisher","first-page":"e0186287","DOI":"10.1371\/journal.pone.0186287","volume":"12","author":"SC Lean","year":"2017","unstructured":"Lean SC, Derricott H, Jones RL, Heazell AEP. Advanced maternal age and adverse pregnancy outcomes: a systematic review and meta-analysis. PLoS ONE. 2017;12:e0186287.","journal-title":"PLoS ONE"},{"key":"743_CR8","doi-asserted-by":"publisher","first-page":"852","DOI":"10.1007\/s10995-016-2177-8","volume":"21","author":"CA Robledo","year":"2017","unstructured":"Robledo CA, Yeung EH, Mendola P, Sundaram R, Boghossian NS, Bell EM, et al. Examining the prevalence rates of preexisting maternal medical conditions and pregnancy complications by source: evidence to inform maternal and child research. Matern Child Health J. 2017;21:852\u201362.","journal-title":"Matern Child Health J"},{"key":"743_CR9","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1186\/s13006-024-00628-x","volume":"19","author":"Y Soliman","year":"2024","unstructured":"Soliman Y, Yakandawala U, Leong C, Garlock ES, Brinkman FSL, Winsor GL, et al. The use of prescription medications and non-prescription medications during lactation in a prospective Canadian cohort study. Int Breastfeed J. 2024;19:23.","journal-title":"Int Breastfeed J"},{"key":"743_CR10","doi-asserted-by":"publisher","first-page":"1073","DOI":"10.1097\/00003081-198012000-00010","volume":"23","author":"WA Bowes","year":"1980","unstructured":"Bowes WA. The effect of medications on the lactating mother and her infant. Clin Obstet and Gynecol. 1980;23:1073\u201380.","journal-title":"Clin Obstet and Gynecol"},{"key":"743_CR11","unstructured":"Eunice Kennedy Shriver National Institute of Child Health and Human Development. List of recommendations from the task force on research specific to pregnant women and lactating women (PRGLAC). 2019. Available from: \nhttps:\/\/www.nichd.nih.gov\/about\/advisory\/PRGLAC\/recommendations. Cited 2024 Apr 3."},{"key":"#cr-split#-743_CR12.1","unstructured":"Committee on Developing a Framework to Address Legal, Ethical, Regulatory, and Policy Issues for Research Specific to Pregnant and Lactating Persons, Board on Health Sciences Policy, Health and Medicine Division, National Academies of Sciences, Engineering, and Medicine. Advancing clinical research with pregnant and lactating populations: overcoming real and perceived liability risks. Riley MF, Helman A, March A, editors. Washington, D.C.: National Academies Press; 2024. p. 27595. Available from:"},{"key":"#cr-split#-743_CR12.2","unstructured":"https:\/\/www.nap.edu\/catalog\/27595. Cited 2024 May 2."},{"key":"743_CR13","unstructured":"Global egulators envision paradigm shift toward inclusion of pregnant and breastfeeding women in clinical research for medicines and vaccines. Available from: \nhttps:\/\/www.fda.gov\/news-events\/fda-voices\/global-regulators-envision-paradigm-shift-toward-inclusion-pregnant-and-breastfeeding-women-clinical."},{"key":"743_CR14","first-page":"2104019","volume":"18","author":"TA Manca","year":"2022","unstructured":"Manca TA, Sadarangani M, Halperin SA, Langley JM, McClymont E, MacDonald SE, et al. Vaccine regulation should require and enforce the inclusion of pregnant and breastfeeding women in prelicensure clinical trials. Hum VaccinImmunother. 2022;18:2104019.","journal-title":"Hum VaccinImmunother"},{"key":"743_CR15","doi-asserted-by":"publisher","first-page":"1289","DOI":"10.3390\/vaccines11081289","volume":"11","author":"V Gianfredi","year":"2023","unstructured":"Gianfredi V, Stefanizzi P, Berti A, D\u2019Amico M, De Lorenzo V, Lorenzo AD, et al. A systematic review of population-based studies assessing knowledge, attitudes, acceptance, and hesitancy of pregnant and breastfeeding women towards the COVID-19 vaccine. Vaccines. 2023;11:1289.","journal-title":"Vaccines"},{"key":"743_CR16","doi-asserted-by":"publisher","first-page":"1113557","DOI":"10.3389\/fphar.2023.1113557","volume":"14","author":"L Sportiello","year":"2023","unstructured":"Sportiello L, Capuano A. It is the time to change the paradigms of pregnant and breastfeeding women in clinical research! Front Pharmacol. 2023;14:1113557.","journal-title":"Front Pharmacol"},{"key":"743_CR17","doi-asserted-by":"publisher","first-page":"917","DOI":"10.1136\/bmj.p917","volume":"381","author":"JK Aronson","year":"2023","unstructured":"Aronson JK. When I use a word \u2026 Medical definitions: adverse events, effects, and reactions. BMJ. 2023;381:917.","journal-title":"BMJ"},{"key":"743_CR18","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1002\/ca.22165","volume":"26","author":"F Hassiotou","year":"2013","unstructured":"Hassiotou F, Geddes D. Anatomy of the human mammary gland: current status of knowledge. Clin Anat. 2013;26:29\u201348.","journal-title":"Clin Anat"},{"key":"743_CR19","doi-asserted-by":"publisher","first-page":"211","DOI":"10.1007\/s10911-007-9054-4","volume":"12","author":"WW Pang","year":"2007","unstructured":"Pang WW, Hartmann PE. Initiation of human lactation: secretory differentiation and secretory activation. J Mammary Gland Biol Neoplasia. 2007;12:211\u201321.","journal-title":"J Mammary Gland Biol Neoplasia"},{"key":"743_CR20","unstructured":"U.S. Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. 2017."},{"key":"743_CR21","unstructured":"MEDRA. What\u2019s new MedDRA version 25.0. 2022."},{"key":"743_CR22","unstructured":"World Health Organization. International statistical classification of diseases and related health problems (ICD). Available from: \nhttps:\/\/www.who.int\/standards\/classifications\/classification-of-diseases."},{"key":"743_CR23","doi-asserted-by":"publisher","first-page":"5993","DOI":"10.1016\/j.vaccine.2016.07.006","volume":"34","author":"J Bonhoeffer","year":"2016","unstructured":"Bonhoeffer J, Kochhar S, Hirschfeld S, Heath PT, Jones CE, Bauwens J, et al. Global alignment of immunization safety assessment in pregnancy \u2013 The GAIA project. Vaccine. 2016;34:5993\u20137.","journal-title":"Vaccine"},{"key":"743_CR24","unstructured":"Division of AIDS table for grading the severity of adult and pediatric adverse events. Available from: \nhttps:\/\/www.mtnstopshiv.org\/sites\/default\/files\/attachments\/DAIDS_AE_GradingTable_ClarificationAug2009_Final_%5B1%5D.pdf."},{"key":"743_CR25","doi-asserted-by":"publisher","first-page":"1167","DOI":"10.1136\/archdischild-2019-317399","volume":"104","author":"T Salaets","year":"2019","unstructured":"Salaets T, Turner MA, Short M, Ward RM, Hokuto I, Ariagno RL, et al. Development of a neonatal adverse event severity scale through a Delphi consensus approach. Arch Dis Child. 2019;104:1167\u201373.","journal-title":"Arch Dis Child"},{"key":"743_CR26","unstructured":"World Health Organization. International classification of functioning, disability and health (ICF). Available from: \nhttps:\/\/www.who.int\/standards\/classifications\/international-classification-of-functioning-disability-and-health."},{"key":"743_CR27","unstructured":"Common Terminology Criteria for Adverse Events (CTCAE). Available from: \nhttps:\/\/ctep.cancer.gov\/protocolDevelopment\/electronic_applications\/ctc.htm."},{"key":"743_CR28","unstructured":"Boss M, Hartmann P, Frauenfeld (CH): Family Larsson-Rosenquist Foundation. LactaResearch Group. LactaPedia. 2018. Available from: \nhttps:\/\/www.lactapedia.com. Cited 2021 Dec 1."},{"key":"743_CR29","unstructured":"CTCAE dictionary. Available from: \nhttps:\/\/safetyprofiler-ctep.nci.nih.gov\/safety-profiler\/static\/#\/home\/(body:ctcDictionary)?version=5.0.\u00a0Cited 2024 Sep 4."},{"key":"743_CR30","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1002\/pd.6047","volume":"42","author":"RN Spencer","year":"2022","unstructured":"Spencer RN, Hecher K, Norman G, Marsal K, Deprest J, Flake A, et al. Development of standard definitions and grading for maternal and fetal adverse event terminology. Prenat Diagn. 2022;42:15\u201326.","journal-title":"Prenat Diagn"},{"key":"743_CR31","unstructured":"INC Terminology Files. Available from: \nhttps:\/\/evs.nci.nih.gov\/ftp1\/Pediatric_Terminologies\/INC\/About.html."},{"key":"743_CR32","doi-asserted-by":"publisher","first-page":"103208","DOI":"10.1016\/j.jbi.2019.103208","volume":"95","author":"PA Harris","year":"2019","unstructured":"Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O\u2019Neal L, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019;95:103208.","journal-title":"J Biomed Inform"},{"key":"743_CR33","doi-asserted-by":"publisher","first-page":"377","DOI":"10.1016\/j.jbi.2008.08.010","volume":"42","author":"PA Harris","year":"2009","unstructured":"Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)\u2014a metadata-driven methodology and workflow process for providing translational research informatics support. J of Biomed Inform. 2009;42:377\u201381.","journal-title":"J of Biomed Inform"},{"key":"743_CR34","doi-asserted-by":"crossref","unstructured":"Boss M, Gardner H, Hartmann P. Normal human lactation: closing the gap. F1000Res. 2018;7:801.","DOI":"10.12688\/f1000research.14452.1"},{"key":"743_CR35","doi-asserted-by":"publisher","first-page":"657","DOI":"10.1001\/archinternmed.2007.124","volume":"168","author":"SR Majumdar","year":"2008","unstructured":"Majumdar SR. Better outcomes for oatients treated at hospitals that participate in clinical trials. Arch Intern Med. 2008;168:657.","journal-title":"Arch Intern Med"},{"key":"743_CR36","doi-asserted-by":"publisher","first-page":"175","DOI":"10.1136\/qshc.2004.011478","volume":"14","author":"J West","year":"2005","unstructured":"West J. Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol. Qual Saf Health Care. 2005;14:175\u20138.","journal-title":"Qual Saf Health Care"},{"key":"743_CR37","doi-asserted-by":"publisher","first-page":"863","DOI":"10.1111\/1471-0528.14528","volume":"124","author":"S Nijjar","year":"2017","unstructured":"Nijjar S, D\u2019Amico M, Wimalaweera N, Cooper N, Zamora J, Khan K. Participation in clinical trials improves outcomes in women\u2019s health: a systematic review and meta-analysis. BJOG. 2017;124:863\u201371.","journal-title":"BJOG"},{"key":"743_CR38","doi-asserted-by":"publisher","first-page":"100492","DOI":"10.1016\/j.ajogmf.2021.100492","volume":"4","author":"O Nir","year":"2022","unstructured":"Nir O, Schwartz A, Toussia-Cohen S, Leibovitch L, Strauss T, Asraf K, et al. Maternal-neonatal transfer of SARS-CoV-2 immunoglobulin G antibodies among parturient women treated with BNT162b2 messenger RNA vaccine during pregnancy. Am J of Obstet Gynecol MFM. 2022;4:100492.","journal-title":"Am J of Obstet Gynecol MFM"},{"key":"743_CR39","doi-asserted-by":"publisher","first-page":"1340607","DOI":"10.3389\/fped.2023.1340607","volume":"11","author":"K Allegaert","year":"2024","unstructured":"Allegaert K, Salaets T, Wade K, Short MA, Ward R, Singh K, et al. The neonatal adverse event severity scale: current status, a stakeholders\u2019 assessment, and future perspectives. Front Pediatr. 2024;11:1340607.","journal-title":"Front Pediatr"}],"container-title":["International Breastfeeding Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13006-025-00743-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13006-025-00743-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13006-025-00743-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T16:58:44Z","timestamp":1751648324000},"score":1,"resource":{"primary":{"URL":"https:\/\/internationalbreastfeedingjournal.biomedcentral.com\/articles\/10.1186\/s13006-025-00743-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,7,4]]},"references-count":40,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2025,12]]}},"alternative-id":["743"],"URL":"https:\/\/doi.org\/10.1186\/s13006-025-00743-3","relation":{},"ISSN":["1746-4358"],"issn-type":[{"value":"1746-4358","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,7,4]]},"assertion":[{"value":"9 February 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 June 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 July 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The survey was performed in compliance with the principles outlined in the Declaration of Helsinki. The Bioethical Committee of the Medical University of Warsaw in Warsaw, Poland has taken note of the information about the investigation and has raised no objections (number of decision: AKBE\/177\/2023).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"53"}}