Objective The objective of our study is to assess the impact of triptan exposure on pregnancy outcome. Methods We performed a prospective observational cohort study with 432 pregnant women exposed to triptans and enrolled by the German Embryotox system. Pregnancy outcomes were compared with a migraine and a non-migraine comparison cohort. Primary objectives were major birth defects and spontaneous abortion; secondary endpoints were preterm delivery, birth weight, pregnancy complications and the rate of electively terminated pregnancies. Results Compared to a non-migraine cohort the rates of major birth defects (ORadj 0.84; 95% CI 0.4-1.9), spontaneous abortions (ORadj 1.20; 95% CI 0.9-1.7), preterm delivery (ORadj 1.01; 95% CI 0.7-1.5), and preeclampsia (ORadj 1.33; 95% CI 0.7-2.5) were not increased in triptan-exposed pregnancies. Conclusions Our findings support the evidence that triptans are not major teratogens. When compellingly needed during pregnancy, sumatriptan as the best studied triptan appears an acceptable treatment option. A detailed fetal ultrasound should be offered in cases of first trimester exposure to less well-studied triptans. Trial registration number in German Clinical Trials Register: DRKS00007660.
Keywords: Migraine disorder; birth defects; developmental disorders; drug safety; pregnant women; teratogen.