Table 3.
Adverse events | Metformin (n = 9) n (%) |
Placebo (n = 5) n (%) |
Fisher’s Exact Test | p |
---|---|---|---|---|
Maternal | ||||
Diarrhea / loose stools | 5 (56) | 2 (40) | .37 | 1.00 |
Nausea/Vomiting | 4 (44) | 0 (0) | .13 | .22 |
Either of the above symptoms | 6 (67) | 2 (40) | .28 | .58 |
Abdominal pain/ cramping / bloating | 4 (56) | 3 (60) | .37 | 1.00 |
Headache | 3 (33) | 0 (0) | .23 | .26 |
Other | 2 (22) | 4 (80) | .06 | .09 |
Infant | ||||
Gastric reflux | 3 (33) | 0 (0) | .23 | .26 |
Gas | 2 (22) | 2 (40) | .36 | .58 |
Constipation | 1 (11) | 1 (20) | .49 | 1.00 |
Diarrhea / loose stools | 1 (11) | 2 (40) | .25 | .51 |
Any of the above symptoms | 5 (56) | 4 (80) | .31 | .58 |
Insufficient weight gain | 1 (11) | 0 (0) | .64 | 1.00 |
Runny nose / cold symptoms | 2 (22) | 0 (0) | .40 | .51 |
Irritability | 2 (22) | 0 (0) | .40 | .51 |
Other | 1 (11) | 1 (20) | .49 | 1.00 |
Note. Metformin formulation used in this study was Glucophage XR; n=9 represents only those who took the study drug (the one participant assigned metformin did not take the study drug). Fisher’s Exact Test Table Probability and two-sided p-value.