Fetal Organogenesis in a Pregestational Diabetic Mother Who has Taking an Oral Hypoglycemic Agent in Early Pregnancy

Lee, Chang Beom; Kim, Seung Yong

Abstract

BACKGROUND: Women with diabetes mellitus are not treated with oral hypoglycemic agents because of the concerns about teratogenicity and neonate complication. There is not enough information about the safety of these drugs and especially during the first trimester of pregnancy.
METHODS
Eight type 2 diabetic pregnant women with accidental exposure to an oral hypoglycemic agent during embryogenesis and twenty type 2 diabetic pregnant women who were matched for age, weight, and glycemic control, but they were not exposed to an oral hypoglycemic agent, were compared retrospectively.
RESULTS
1) Three out of the eight neonates (38%) in the oral hypoglycemic agent group had congenital malformations and stillbirth compared with five out of twenty (25%) in the control group (Odds ratio 1.8; range: 0.2~13.8, P >0.05). 2) In the control group, the mean HbA1c of the 5 mothers with anomalistic neonates and stillbirths was higher than that of 15 mothers with normal neonates (8.8% vs. 6.2 %, P = 0.1). The anomalies included three congenital heart diseases (1 ventricular septal defect, 2 patent ductus arteriosus) and one renal agenesis. 3) In the oral hypoglycemic agent group, the mean HbA1c of the 3 mothers with anomalistic neonates and stillbirth was higher than that of the 5 mothers with normal neonates (9.0% vs. 6.3%, P = 0.4). The anomalies included one urachal sinus and one facial palsy that have not been commonly described for diabetic embryopathy. 4) In both groups, the mean HbA1c of 8 mothers with complicated neonates and the 20 mothers with normal neonates was 8.1% and 6.8%, respectively, (P =0.09).
CONCLUSION
We found no obvious indication for therapeutic abortions in patients who have accidentally been treated with an oral hypoglycemic agent during embryogenesis. On the contrary, it seems reasonable to reassure these women with respect to their risk of having a malformed baby, and then to stop treatment with an oral hypoglycemic agent and initiate insulin treatment.