Comparison · NCT02179788-deaths
Standard Care Plus Metformin vs Standard Care Plus Placebo: deaths from any cause
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Standard Care Plus Metformin vs Standard Care Plus Placebo: deaths from any cause. Trial comparisons, record NCT02179788-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02179788-deaths
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.278 | wilson | |
| Risk in group 2 | 0 | 0 | 0.434 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.434 | 0.278 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Standard Care Plus Metformin | 10 stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.~Standard care: Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump.~Metformin: The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~* Days 1-7, one 750 mg capsule with evening meal (750 mg/day)~* Days 8-14, three 500 mg capsule with evening meal (1500 mg/day)~* Days 14-28 (or through completion of post-intervention data collection),four 500 mg capsules with evening meal (2000 mg/day)~The trial duration was28 days (with a +/- 3 day cushion) | 0 | 10 | EG000 |
| Group 2 | Standard Care Plus Placebo | 5 Stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day (Standard Care) and to take the assigned study drug. The placebo arm consumed methylcellulose USP Powder encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:~* Days 1-7, take 1 capsule with evening meal~* Days 8-14, take 3 capsules with evening meal~* Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal~Standard care: Mothers were instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump. | 0 | 5 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- 4 weeks
Source ClinicalTrials.gov
Trial
- Title
- Metformin to Augment Low Milk Supply (MALMS) Study
- NCT number
- NCT02179788
- Phases
- PHASE1, PHASE2
- Conditions
- Low Milk Supply, Pre-diabetes, Insulin Resistance, Suppressed Lactation
- Interventions
- Standard care, Metformin, Placebo
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Results first posted
- 2020-10-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02179788?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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