TY - JOUR
T1 - In-utero exposure to metformin for type 2 diabetes or polycystic ovary syndrome
T2 - A prospective comparative observational study
AU - Diav-Citrin, Orna
AU - Steinmetz-Shoob, Salit
AU - Shechtman, Svetlana
AU - Ornoy, Asher
N1 - Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/9
Y1 - 2018/9
N2 - Objective: To evaluate the rate of major anomalies after first trimester (T1)-metformin exposure. Design: Comparative, observational cohort study done at the Israeli Teratology Information Service between 2000 and 2013. Results: 170 T1-metformin-exposed pregnancies [119 for diabetes and 51 for polycystic ovary syndrome (PCOS)] were prospectively followed-up and compared with 93 pregnancies of T1-insulin treated women and 530 non-teratogenic exposed (NTE) pregnancies. The differences in the rate of major anomalies excluding genetic/cytogenetic, and spontaneously resolved cardiovascular anomalies were not significant [4.4% (2/45) – metformin-PCOS, 1.1% (1/90) – metformin-diabetes, 2.5% (2/80) – insulin, and 1.7% (9/519) – NTE; ORadj metformin/NTE 1.77; 95% CI 0.45-7.01; ORadj insulin/NTE 1.69; 95% CI 0.35-8.11]. The rate of Cesarean section was higher in both the metformin-diabetes 51/90 (56.7%) and insulin 45/79 (57.0%) groups compared with the NTE group [138/503 (27.4%)]. Conclusion: Metformin-T1-exposure per se is not associated with an increased risk of major anomalies.
AB - Objective: To evaluate the rate of major anomalies after first trimester (T1)-metformin exposure. Design: Comparative, observational cohort study done at the Israeli Teratology Information Service between 2000 and 2013. Results: 170 T1-metformin-exposed pregnancies [119 for diabetes and 51 for polycystic ovary syndrome (PCOS)] were prospectively followed-up and compared with 93 pregnancies of T1-insulin treated women and 530 non-teratogenic exposed (NTE) pregnancies. The differences in the rate of major anomalies excluding genetic/cytogenetic, and spontaneously resolved cardiovascular anomalies were not significant [4.4% (2/45) – metformin-PCOS, 1.1% (1/90) – metformin-diabetes, 2.5% (2/80) – insulin, and 1.7% (9/519) – NTE; ORadj metformin/NTE 1.77; 95% CI 0.45-7.01; ORadj insulin/NTE 1.69; 95% CI 0.35-8.11]. The rate of Cesarean section was higher in both the metformin-diabetes 51/90 (56.7%) and insulin 45/79 (57.0%) groups compared with the NTE group [138/503 (27.4%)]. Conclusion: Metformin-T1-exposure per se is not associated with an increased risk of major anomalies.
KW - Congenital anomalies
KW - Diabetes mellitus
KW - Metformin
KW - Polycystic ovary syndrome
KW - Pregnancy
UR - http://www.scopus.com/inward/record.url?scp=85047849776&partnerID=8YFLogxK
U2 - 10.1016/j.reprotox.2018.05.007
DO - 10.1016/j.reprotox.2018.05.007
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C2 - 29857030
AN - SCOPUS:85047849776
SN - 0890-6238
VL - 80
SP - 85
EP - 91
JO - Reproductive Toxicology
JF - Reproductive Toxicology
ER -