Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach
Abstract Background Most women who give birth will initiate lactation and breast/chestfeeding, with up to 40% of infants globally receiving human milk exclusively for the first 6 months of life. One of the studies indicates that 40% of breastfeeding women had used at least one prescription medicatio...
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BMC
2025-07-01
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| Series: | International Breastfeeding Journal |
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| Online Access: | https://doi.org/10.1186/s13006-025-00743-3 |
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| author | Katarzyna M. Maksym Kinga Kalita-Kurzyńska Diane Spatz Melinda Boss Maria Carmen Collado Anna Gonciarz-Dytman Bei Han Asma Khalil Joanna Kozakiewicz Ernest Kuchar Karolina Morze Rebecca Powell Natalie Shenker Sławomir Wątroba Anna L. David Aleksandra Wesołowska |
| author_facet | Katarzyna M. Maksym Kinga Kalita-Kurzyńska Diane Spatz Melinda Boss Maria Carmen Collado Anna Gonciarz-Dytman Bei Han Asma Khalil Joanna Kozakiewicz Ernest Kuchar Karolina Morze Rebecca Powell Natalie Shenker Sławomir Wątroba Anna L. David Aleksandra Wesołowska |
| author_sort | Katarzyna M. Maksym |
| collection | DOAJ |
| description | Abstract Background Most women who give birth will initiate lactation and breast/chestfeeding, with up to 40% of infants globally receiving human milk exclusively for the first 6 months of life. One of the studies indicates that 40% of breastfeeding women had used at least one prescription medication in the first 3 months postpartum. The lack of information on the safety of medications during lactation may lead to cessation of lactation in favor of treatments, therefore contribute to suboptimal breastfeeding rates. Inadequate terminology to define and grade adverse events for lactation and breast/chestfeeding limits the understanding of potential therapeutic harms. This results in lactating women commonly being excluded from participation in clinical trials, leading to inequitable access to effective treatments. We developed a comprehensive framework with new definitions and grades for breastfeeding Adverse Events (AEs) through consideration of the physiology and pathology of lactation. Methods We performed the Delphi consensus process between January 2021 and November 2023. An international multidisciplinary group of lactation and breast/chestfeeding experts identified a gap in AE terminology and developed definitions and grading of AEs based on the generic Common Regulatory Criteria for Adverse Events (CTCAE) structure. These underwent two rounds of a modified Delphi procedure involving an international multidisciplinary team of experts and patient representatives. The web platform REDCapⓇ was used to collect the results of the Delphi surveys. Results Three new definitions, delayed secretory activation, primary lactation insufficiency, and secondary lactation insufficiency, were developed and mapped to the Medical Dictionary of Regulatory Activities (MedDRA, March 2023). Oversupply of milk and other changes in lactation/feeding patterns were mapped to existing MedDRA terms. Grading for all five definitions was developed and agreed upon through consensus. Conclusions These new definitions and grading of adverse events in lactation and breast/chestfeeding fill the gap in existing classifications and should encourage the inclusion of postpartum individuals into clinical trials. |
| format | Article |
| id | doaj-art-2509a79c596d4fe1b9bcafe0b20e8e98 |
| institution | Kabale University |
| issn | 1746-4358 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | International Breastfeeding Journal |
| spelling | doaj-art-2509a79c596d4fe1b9bcafe0b20e8e982025-08-20T04:01:35ZengBMCInternational Breastfeeding Journal1746-43582025-07-0120111610.1186/s13006-025-00743-3Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approachKatarzyna M. Maksym0Kinga Kalita-Kurzyńska1Diane Spatz2Melinda Boss3Maria Carmen Collado4Anna Gonciarz-Dytman5Bei Han6Asma Khalil7Joanna Kozakiewicz8Ernest Kuchar9Karolina Morze10Rebecca Powell11Natalie Shenker12Sławomir Wątroba13Anna L. David14Aleksandra Wesołowska15Institute for Women’s Health, University College LondonLaboratory of Human Milk and Lactation Research, Regional Human Milk Bank at Holy Family Specialist Hospital, Department of Medical Biology, Medical University of WarsawDepartment of Family and Community Health and the Center for Pediatric Nursing Research and Evidence Based Practice at Children’s Hospital of Philadephia, University of Pennsylvania School of NursingSchool of Allied Health, The University of Western AustraliaInstitute of Agrochemistry and Food Technology – National Research Council (IATA-CSIC)Pfizer Polska Sp. Z O.ODepartment of Nutrition and Food Safety, School of Public Health, Health Science Center of Xi’an Jiaotong University Xi’anSt George’s Hospital, University of LondonIBCLC Private PracticeDepartment of Pediatrics With Clinical Assessment Unit, Medical University of WarsawDepartment of Clinical Pharmacy and Biopharmacy, Poznan University of Medical SciencesDepartment of Medicine, Division of Infectious Diseases, Department of Immunology and Immunotherapy, Icahn School of Medicine at Mount Sinai New YorkDepartment of Surgery and Cancer, Imperial College LondonDepartment of Neonatology and Neonatal Intensive Care, Independent Public Specialist HospitalInstitute for Women’s Health, University College LondonLaboratory of Human Milk and Lactation Research, Regional Human Milk Bank at Holy Family Specialist Hospital, Department of Medical Biology, Medical University of WarsawAbstract Background Most women who give birth will initiate lactation and breast/chestfeeding, with up to 40% of infants globally receiving human milk exclusively for the first 6 months of life. One of the studies indicates that 40% of breastfeeding women had used at least one prescription medication in the first 3 months postpartum. The lack of information on the safety of medications during lactation may lead to cessation of lactation in favor of treatments, therefore contribute to suboptimal breastfeeding rates. Inadequate terminology to define and grade adverse events for lactation and breast/chestfeeding limits the understanding of potential therapeutic harms. This results in lactating women commonly being excluded from participation in clinical trials, leading to inequitable access to effective treatments. We developed a comprehensive framework with new definitions and grades for breastfeeding Adverse Events (AEs) through consideration of the physiology and pathology of lactation. Methods We performed the Delphi consensus process between January 2021 and November 2023. An international multidisciplinary group of lactation and breast/chestfeeding experts identified a gap in AE terminology and developed definitions and grading of AEs based on the generic Common Regulatory Criteria for Adverse Events (CTCAE) structure. These underwent two rounds of a modified Delphi procedure involving an international multidisciplinary team of experts and patient representatives. The web platform REDCapⓇ was used to collect the results of the Delphi surveys. Results Three new definitions, delayed secretory activation, primary lactation insufficiency, and secondary lactation insufficiency, were developed and mapped to the Medical Dictionary of Regulatory Activities (MedDRA, March 2023). Oversupply of milk and other changes in lactation/feeding patterns were mapped to existing MedDRA terms. Grading for all five definitions was developed and agreed upon through consensus. Conclusions These new definitions and grading of adverse events in lactation and breast/chestfeeding fill the gap in existing classifications and should encourage the inclusion of postpartum individuals into clinical trials.https://doi.org/10.1186/s13006-025-00743-3Adverse eventPharmacovigilanceLactationBreastfeedingDefinition |
| spellingShingle | Katarzyna M. Maksym Kinga Kalita-Kurzyńska Diane Spatz Melinda Boss Maria Carmen Collado Anna Gonciarz-Dytman Bei Han Asma Khalil Joanna Kozakiewicz Ernest Kuchar Karolina Morze Rebecca Powell Natalie Shenker Sławomir Wątroba Anna L. David Aleksandra Wesołowska Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach International Breastfeeding Journal Adverse event Pharmacovigilance Lactation Breastfeeding Definition |
| title | Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach |
| title_full | Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach |
| title_fullStr | Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach |
| title_full_unstemmed | Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach |
| title_short | Development of lactation and breast/chestfeeding adverse event terminology (LaBAET) through a Delphi consensus approach |
| title_sort | development of lactation and breast chestfeeding adverse event terminology labaet through a delphi consensus approach |
| topic | Adverse event Pharmacovigilance Lactation Breastfeeding Definition |
| url | https://doi.org/10.1186/s13006-025-00743-3 |
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