[Practice of obstetric medicine in neurological disorders: towards evidence-based shared decision-making (SDM)]

Obstetric medicine is a specialized field providing medical care to women with internal diseases who wish to conceive or whose conditions manifest during pregnancy. It bridges the gap between internal medicine and obstetrics by addressing the medical complexities that arise when the physiological changes of pregnancy unmask or exacerbate pre-existing conditions. In clinical practice, Japanese physicians rely heavily on electronic package inserts, which are notably conservative; approximately 21.6% of drugs are contraindicated for pregnant women in Japan, compared to only 4.3% in Australia. This discrepancy arises because Japanese labeling often prioritizes animal developmental toxicity data over human epidemiological evidence. However, these inserts do not have absolute binding force, and clinical judgment based on medical validity should prevail. Since pre-marketing clinical trials for pregnant women are ethically nonexistent, risk assessment relies on post-marketing observational studies. We present evidence from an integrated database of 12,971 pregnancy cases, encompassing findings on various medications such as domperidone, fluoroquinolones, and triptans, among others. Regarding multiple sclerosis (MS) therapies, recent data from the German MS Pregnancy Registry on S1P receptor modulators indicate no increased risk of major malformations but suggest potential fetal toxicity, such as an increased risk of small-for-gestational-age (SGA) infants. Through the Japan Association of Medical Sciences' TEAM project, cross-cutting guidelines have been developed to support patients' reproductive goals. We aim for a society where patients can make informed, autonomous choices through shared decision-making with healthcare providers regarding their treatment and pregnancy.