Trial · NCT02179788
Metformin to Augment Low Milk Supply (MALMS) Study
NCT02179788, Phase 1, Phase 2, Completed, Children's Hospital Medical Center, Cincinnati; results first posted 2020-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metformin to Augment Low Milk Supply (MALMS) Study. Trials, record NCT02179788. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02179788
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metformin to Augment Low Milk Supply (MALMS) Study
- NCT number
- NCT02179788
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Low Milk Supply, Pre-diabetes, Insulin Resistance, Suppressed Lactation
- Interventions
- Standard care, Metformin, Placebo
- First posted
- 2014-07-02
- Last updated
- 2020-10-19
- Results first posted
- 2020-10-19
- Limitations and caveats
Many mothers wanted to delay enrollment until they could trial non-pharmacologic methods. Many mothers were hesitant to use a medication to try to increase milk supply once seeing how low baseline supply was.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Change in Milk Output | baseline and 4 weeks post-intervention | Maximal change in maternal breast milk production (g/24 hours) between baseline and 4 weeks post-intervention in a model adjusted for baseline milk volume, maternal day postpartum of randomization, and baseline fasting plasma glucose. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Change in Milk Output | baseline and 4 weeks post-intervention | milliliters | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Peak Change in Milk Output | Standard Care Plus Metformin | 8 | Inter-Quartile Range -23 to 33 | milliliters | |
| Peak Change in Milk Output | Standard Care Plus Placebo | -58 | Inter-Quartile Range -62 to -1 | milliliters |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Care Plus Metformin | 10 | |
| Overall Study | STARTED | Standard Care Plus Placebo | 5 | |
| Overall Study | COMPLETED | Standard Care Plus Metformin | 10 | |
| Overall Study | COMPLETED | Standard Care Plus Placebo | 5 | |
| Overall Study | NOT COMPLETED | Standard Care Plus Metformin | 0 | |
| Overall Study | NOT COMPLETED | Standard Care Plus Placebo | 0 |
Source ClinicalTrials.gov
Adverse events26
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea, vomiting diarrhea-Mom | Gastrointestinal disorders | Standard Care Plus Metformin | 6 | 20 | 6 |
| other | Nausea, vomiting diarrhea-Mom | Gastrointestinal disorders | Standard Care Plus Placebo | 3 | 10 | 3 |
| other | gas/bloating/cramping-mom | Gastrointestinal disorders | Standard Care Plus Metformin | 4 | 20 | 4 |
| other | gas/bloating/cramping-mom | Gastrointestinal disorders | Standard Care Plus Placebo | 0 | 10 | 0 |
| other | Headache-mom | Nervous system disorders | Standard Care Plus Metformin | 3 | 20 | 3 |
| other | Headache-mom | Nervous system disorders | Standard Care Plus Placebo | 0 | 10 | 0 |
| other | Mom-Breast pain | Reproductive system and breast disorders | Standard Care Plus Metformin | 0 | 20 | 0 |
| other | Mom-Breast pain | Reproductive system and breast disorders | Standard Care Plus Placebo | 1 | 10 | 1 |
| other | gas/diarrhea/constipation/reflux-infant | Gastrointestinal disorders | Standard Care Plus Metformin | 5 | 20 | 5 |
| other | gas/diarrhea/constipation/reflux-infant | Gastrointestinal disorders | Standard Care Plus Placebo | 4 | 10 | 4 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Care Plus Metformin | 0 | 10 |
| Total, all-cause mortality | Standard Care Plus Placebo | 0 | 5 |
| Total, other adverse events | Standard Care Plus Metformin | 13 | 20 |
| Total, other adverse events | Standard Care Plus Placebo | 8 | 10 |
| Total, serious adverse events | Standard Care Plus Metformin | 0 | 20 |
| Total, serious adverse events | Standard Care Plus Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Care Plus Metformin vs Standard Care Plus Placebo: deaths from any cause | Trial comparisons |
| Standard Care Plus Metformin vs Standard Care Plus Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02179788
GET https://conductscience.org/api/trials/v1/NCT02179788/events?page=2