Orna Diav-Citrin1, Salit Steinmetz-Shoob2, Svetlana Shechtman3, Asher Ornoy4. 1. The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Hebrew University Hadassah Medical School, Jerusalem, Israel. Electronic address: orna.diav-citrin@moh.gov.il. 2. The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel; The Division of Clinical Pharmacy, the Hebrew University of Jerusalem, Israel. 3. The Israeli Teratology Information Service, Israel Ministry of Health, Jerusalem, Israel. 4. The Hebrew University Hadassah Medical School, Jerusalem, Israel.
Abstract
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.
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.
Authors: Kerstin M G Brand; Laura Saarelainen; Jaak Sonajalg; Emmanuelle Boutmy; Caroline Foch; Marja Vääräsmäki; Laure Morin-Papunen; Judith Schlachter; Katja M Hakkarainen; Pasi Korhonen Journal: BMJ Open Diabetes Res Care Date: 2022-01