{"doi":"10.1177/0890334418819465","title":"Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial","abstract":"<jats:sec>\n                    <jats:title>Background:</jats:title>\n                    <jats:p>Metformin improves insulin action, but feasibility in treating low milk supply is unknown.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Research aim:</jats:title>\n                    <jats:p>\n                      To determine the feasibility of a metformin-\n                      <jats:italic>versus</jats:italic>\n                      -placebo definitive randomized clinical trial in women with low milk production and signs of insulin resistance.\n                    </jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:</jats:title>\n                    <jats:p>Pilot trial criteria included: Mother 1–8 weeks postpartum (ideally 1–2 weeks), low milk production, and ≥1 insulin resistance sign; and singleton, healthy, term infant. Eligible mothers were randomly assigned 2:1 (metformin:placebo) and instructed in frequent milk removal for 28 days with option to stop at 14 days.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:</jats:title>\n                    <jats:p>\n                      From 02/2015 through 06/2016, we screened 114 women, completed baseline assessments on 46, and trialed 15 (median, 36 days postpartum). Comparing metformin-assigned (\n                      <jats:italic>n</jats:italic>\n                      = 10) to placebo (\n                      <jats:italic>n</jats:italic>\n                      = 5), 70% versus 80% continued to day 28; peak median change in milk output was +8 versus –58 mL/24 hr (\n                      <jats:italic>p</jats:italic>\n                      = .31) and 80% peaked at Day 14 for both groups; 0% versus 20% desired to continue assigned drug after study completion; 44% versus 0% reported nausea/vomiting. Post-hoc, median peak change in milk output was +22 (metformin completers,\n                      <jats:italic>n</jats:italic>\n                      = 8) versus –58 mL/24 hr (placebo + non-completers,\n                      <jats:italic>n</jats:italic>\n                      = 7,\n                      <jats:italic>p</jats:italic>\n                      = .07). At baseline assessment, median milk production was significantly lower in those with (\n                      <jats:italic>n</jats:italic>\n                      = 31), versus those without (\n                      <jats:italic>n</jats:italic>\n                      = 15) signs of insulin resistance (\n                      <jats:italic>p</jats:italic>\n                      = .002).\n                    </jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:</jats:title>\n                    <jats:p>\n                      Although results trend toward hypothesized direction, trial feasibility concerns include late enrollment and only 20% of metformin-assigned participants sustaining improved milk output to Day 28, with none perceiving metformin worthwhile. Better tools are needed to identify and treat metabolically-driven low milk production.\n                      <jats:italic>Registered at ClinicalTrials.gov (NCT02179788) on 02/JUL/2014.</jats:italic>\n                    </jats:p>\n                  </jats:sec>","journal":"Journal of Human Lactation","year":2019,"id":645585,"datarank":0.5289540786924243,"base_score":3.5263605246161616,"endowment":3.5263605246161616,"self_citation_contribution":0.5289540786924243,"citation_network_contribution":0.0,"self_endowment_contribution":0.5289540786924243,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":33,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1681093,"name":"Amy Thompson","orcid":null,"position":1,"is_corresponding":false},{"id":875570,"name":"Sarah Riddle","orcid":null,"position":2,"is_corresponding":false},{"id":330186,"name":"Laura Ward","orcid":null,"position":3,"is_corresponding":false},{"id":707181,"name":"Erin Wagner","orcid":null,"position":4,"is_corresponding":false},{"id":384210,"name":"Eileen King","orcid":null,"position":5,"is_corresponding":false},{"id":874908,"name":"Laurie Nommsen‐Rivers","orcid":"0000-0003-3213-7186","position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial","abstract":"<jats:sec>\n                    <jats:title>Background:</jats:title>\n                    <jats:p>Metformin improves insulin action, but feasibility in treating low milk supply is unknown.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Research aim:</jats:title>\n                    <jats:p>\n                      To determine the feasibility of a metformin-\n                      <jats:italic>versus</jats:italic>\n                      -placebo definitive randomized clinical trial in women with low milk production and signs of insulin resistance.\n                    </jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:</jats:title>\n                    <jats:p>Pilot trial criteria included: Mother 1–8 weeks postpartum (ideally 1–2 weeks), low milk production, and ≥1 insulin resistance sign; and singleton, healthy, term infant. Eligible mothers were randomly assigned 2:1 (metformin:placebo) and instructed in frequent milk removal for 28 days with option to stop at 14 days.</jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:</jats:title>\n                    <jats:p>\n                      From 02/2015 through 06/2016, we screened 114 women, completed baseline assessments on 46, and trialed 15 (median, 36 days postpartum). Comparing metformin-assigned (\n                      <jats:italic>n</jats:italic>\n                      = 10) to placebo (\n                      <jats:italic>n</jats:italic>\n                      = 5), 70% versus 80% continued to day 28; peak median change in milk output was +8 versus –58 mL/24 hr (\n                      <jats:italic>p</jats:italic>\n                      = .31) and 80% peaked at Day 14 for both groups; 0% versus 20% desired to continue assigned drug after study completion; 44% versus 0% reported nausea/vomiting. Post-hoc, median peak change in milk output was +22 (metformin completers,\n                      <jats:italic>n</jats:italic>\n                      = 8) versus –58 mL/24 hr (placebo + non-completers,\n                      <jats:italic>n</jats:italic>\n                      = 7,\n                      <jats:italic>p</jats:italic>\n                      = .07). At baseline assessment, median milk production was significantly lower in those with (\n                      <jats:italic>n</jats:italic>\n                      = 31), versus those without (\n                      <jats:italic>n</jats:italic>\n                      = 15) signs of insulin resistance (\n                      <jats:italic>p</jats:italic>\n                      = .002).\n                    </jats:p>\n                  </jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:</jats:title>\n                    <jats:p>\n                      Although results trend toward hypothesized direction, trial feasibility concerns include late enrollment and only 20% of metformin-assigned participants sustaining improved milk output to Day 28, with none perceiving metformin worthwhile. Better tools are needed to identify and treat metabolically-driven low milk production.\n                      <jats:italic>Registered at ClinicalTrials.gov (NCT02179788) on 02/JUL/2014.</jats:italic>\n                    </jats:p>\n                  </jats:sec>","is_dataset_classified":null,"base_score":3.5263605246161616,"endowment":3.5263605246161616,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"30629889","pmcid":"PMC8992687","openalex_id":"https://openalex.org/W2911064396","authors":[],"funders":[{"funder_name":"National Institutes of Health","grant_id":"NIH 5 K12 HD051953","title":null},{"funder_name":"National Institutes of Health","grant_id":"NIH 5UL1TR001425-03","title":null},{"funder_name":"NCATS NIH HHS","grant_id":"UL1 TR001425","title":null},{"funder_name":"NICHD NIH HHS","grant_id":"K12 HD051953","title":null},{"funder_name":"National Institutes of Health","grant_id":"5UL1TR001425-03","title":"Cincinnati Center for Clinical and Translational Sciences and Training"},{"funder_name":"National Institutes of Health","grant_id":"5K12HD051953-02","title":"Cincinnati Interdisciplinary Womens Health Research Career Training Grant"}],"total_grants":6,"fwci":2.0555,"citation_percentile":0.86425805,"influential_citations":0,"citation_trend":[{"year":2019,"count":1},{"year":2020,"count":3},{"year":2021,"count":1},{"year":2022,"count":9},{"year":2023,"count":4},{"year":2024,"count":8},{"year":2025,"count":6},{"year":2026,"count":1}],"oa_status":"bronze","license":"https://journals.sagepub.com/page/policies/text-and-data-mining-license","oa_locations":[{"url":"https://journals.sagepub.com/doi/pdf/10.1177/0890334418819465","host_type":"journal"},{"url":"https://journals.sagepub.com/doi/pdf/10.1177/0890334418819465","host_type":"publisher"},{"url":"https://journals.sagepub.com/doi/full-xml/10.1177/0890334418819465","host_type":"publisher"},{"url":"https://doi.org/10.1177/0890334418819465","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/30629889","host_type":"repository"},{"url":"https://escholarship.org/uc/item/8wc6p7bj","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/8992687","host_type":"repository"},{"url":"https://dx.doi.org/10.1177/0890334418819465","host_type":""},{"url":"https://escholarship.org/content/qt8wc6p7bj/qt8wc6p7bj.pdf","host_type":""},{"url":"https://doi.org/https://doi.org/10.1177/0890334418819465","host_type":""}],"fields_of_study":["Breastfeeding Practices and Influences","Infant Nutrition and Health","Gestational Diabetes Research and Management","03 medical and health sciences","0302 clinical medicine","Adult","Breast Feeding","Feasibility Studies","Female","Humans","Hypoglycemic Agents","Infant, Newborn","Insulin Resistance","Lactation","Metformin","Pilot Projects","Postnatal Care","Treatment Outcome","Young Adult"],"mesh_terms":["Adult","Breast Feeding","Feasibility Studies","Female","Humans","Hypoglycemic Agents","Infant, Newborn","Insulin Resistance","Lactation","Metformin","Pilot Projects","Postnatal Care","Treatment Outcome","Young Adult"],"keywords":["Medicine","Metformin","Placebo","Nausea","Randomized controlled trial","Insulin resistance","Vomiting","Insulin","Type 2 diabetes","Breastfeeding","Internal medicine","Diabetes mellitus","Endocrinology","Pediatrics","Lactation","Insufficient Milk","Human Milk Production","Maternal Health Randomized Controlled Trials","Adult","Postnatal Care","Infant, Newborn","Infant","Pilot Projects","Newborn","Young Adult","Breast Feeding","Treatment Outcome","Feasibility Studies","Humans","Hypoglycemic Agents","Female"],"sdg_mappings":[{"sdg_number":3,"sdg_label":"3. 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