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Feasibility and Acceptability of Metformin to Augment Low Milk Supply: A Pilot Randomized Controlled Trial
| Content Provider | SAGE Publishing |
|---|---|
| Author | Nommsen-Rivers, Laurie Thompson, Amy Riddle, Sarah Ward, Laura Wagner, Erin King, Eileen |
| Copyright Year | 2018 |
| Abstract | Metformin improves insulin action, but feasibility in treating low milk supply is unknown.Research aim:To determine the feasibility of a metformin-versus-placebo definitive randomized clinical trial in women with low milk production and signs of insulin resistance.Methods: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.Results: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 = 10) to placebo (n = 5), 70% versus 80% continued to day 28; peak median change in milk output was +8 versus –58 mL/24 hr (p = .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 = 8) versus –58 mL/24 hr (placebo + non-completers, n = 7, p = .07). At baseline assessment, median milk production was significantly lower in those with (n = 31), versus those without (n = 15) signs of insulin resistance (p = .002).Conclusions: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. Registered at ClinicalTrials.gov (NCT02179788) on 02/JUL/2014. |
| Related Links | https://journals.sagepub.com/doi/pdf/10.1177/0890334418819465?download=true |
| Starting Page | 261 |
| Ending Page | 271 |
| Page Count | 11 |
| ISSN | 08903344 |
| Issue Number | 2 |
| Volume Number | 35 |
| Journal | Journal of Human Lactation (JHL) |
| e-ISSN | 15525732 |
| DOI | 10.1177/0890334418819465 |
| Language | English |
| Publisher | Sage Publications CA |
| Publisher Date | 2019-01-10 |
| Publisher Place | Los Angeles |
| Access Restriction | Open |
| Rights Holder | © The Author(s) 2018 |
| Subject Keyword | human milk production lactation insufficient milk Breastfeeding maternal health Randomized Controlled Trials |
| Content Type | Text |
| Resource Type | Article |
| Subject | Obstetrics and Gynecology |
