| Number | Authors | Author study type | Data collection | Malformation described |
| 22 | Vanky et al., 2012 [22] | CO (RCT with placebo) | P | No description. | 25 | Khattab et al., 2011 [25] | CO | P | No miscarriages or neonatal loss occurred in either group. One baby girl born with major birth defect (tracheoesophageal fistula). | 26 | Vanky et al., 2010 [26] | CO (RCT with placebo) | P | Metformin group: one postpartum pulmonary embolism, one postpartum circulatory shock, one peripartum cardiomyopathy, and one sudden infant death. Placebo group: three spontaneous abortions, ileus in one patient with former gastric bypass operation, and one perinatal infant death caused by serious asphyxia. | 27 |
Nawaz and Rizvi, 2010 [27] | CC | P | No description. | 28 | Begum et al., 2009 [28] | CO | P | No description. | 29 | Nawaz et al., 2008 [29] | CC | P | No stillbirths, perinatal deaths, or major birth defects. One baby in group A had polydactyl. | 30 | Fougner et al., 2008 [30] | CO (RCT with placebo) | P | No description. | 31 | Glueck et al., 2008 [31] | CO (self as control) | P | No maternal lactic acidosis and no maternal or neonatal hypoglycemia. Of the 180 live births to the 142 nondiabetic women with PCOS, there was one major birth defect (sacrococcygeal teratoma), as determined by pediatricians without knowledge of metformin dose or duration. | 32 | Vanky et al., 2004 [32] | CO (RCT with placebo) | P | No description. | 33 |
Glueck et al., 2004 [33] | CO (self as control) | P | No maternal lactic acidosis or maternal hypoglycemia; no major birth defects; there have been no congenital defects or evidence of intrauterine growth. Seventy of the 84 fetuses have had a favourable outcome; no cases of neonatal hypoglycemia. | 34 |
Glueck et al., 2002 [34] | CO | P and R | None developed lactic acidosis. Intermittent diarrhea or gastritis was common in the first 3 weeks of metformin therapy but resolved spontaneously and was not limiting factors. No major fetal malformations or fetal hypoglycemia occurred. | 35 | Salvesen et al., 2007 [35] | CO (RCT with placebo) |
P | No description. | 36 | Hameed et al., 2011 [36] | CO | P | delivered spontaneously at 33 weeks gestation with neonatal asphyxia due to respiratory distress syndrome and died 2 days later. |
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