Objective: The use of oral hypoglycemic drugs in pregnant women has been limited and therefore there is scanty information on their safety. Concern about possible adverse effects of these drugs on the fetus led us to collect the cases of unintentional fetal exposure to oral antidiabetic agent during embryogenesis for comparision with an appropriately matched control group from the same clinic population.
Methods: Eight type 2 diabetic pregnant women with accidental exposure to oral antidiabetic agent during early pregnancy and 20 type 2 diabetic pregnant women matched for age, weight, and glycemic control but not exposed to oral antidiabetic agent were studied retrospectively.
Results: Three neonates (38%) in the exposed group had congenital malformations and still birth, compared with 5 (25%) in the control group (Odds ratio 1.8 (0.2-13.8), P>0.05). In the control group, the mean of HbA1c of 5 mothers of neonates with anomalies and stillbirth were higher than that of 15 mothers of neonates without anomaly (8.8% vs 6.2%, p=0.1) and the anomalies were major congenital malformation including three congenital heart diseases (1 ventricular septal defect, 2 patent ductus arteriosus) and one renal agenesis. In the exposed group, the mean of HbA1c of 3 mothers of neonates with anomalies and stillbirth were higher than that of 5 mothers of neonates without anomaly (9.0% vs 6.3%, p=0.4) and the anomlies were urachal sinus and facial palsy which was not commonly described in diabetic embryopathy.
Conclusion: Although this study, due to the limited number of pregnancies examined, does not exclude an association between treatment with oral antidiabetic agent at the time of embryogenesis and congenital malformations in the offspring, the risk of our results is lower than that of others. The final answer will demand a much larger number of pregnancies studied prospectively.
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