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J Korean Soc Matern Child Health > Volume 22(3); 2018 > Article
Journal of The Korean Society of Maternal and Child Health 2018;22(3):125-130.
DOI: https://doi.org/10.21896/jksmch.2018.22.3.125    Published online September 30, 2018.
Suggestion for Guidelines of Pregnancy Exposure Registry
Eui Sun Seong1, Hye Jin Youn1, Jin Hoon Chung1, June Seek Choi1, Jung Yeol Han1, Geum Joon Cho2, Jung Mi Oh3
1Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, Korea
2Department of Obstetrics and Gynecolog , Korea University College of Medicine, Seoul, Republic of Korea
3College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Korea
국내 임신부(난임 임신부 포함) 약물 등록 체계 구축을 위한 제언
성의선1, 윤혜진1, 정진훈1, 최준식1, 한정열1, 조금준2, 오정미3
1단국대학교 의과대학 제일병원 산부인과
2고려대학교 산부인과
3서울대학교 약학대학 약학과
Correspondence:  Jung Yeol Han,
Email: hanjungyeol055@gmail.com
Abstract
About 40% of pregnant women are exposed to one or more kinds of medications including multivitamins during their early pregnancy period. And some of those medications are essential for the mother’s health throughout full time of pregnancy. But most of clinical trial for the medicine cannot include the pregnant women because of its uncertain effect on fetus. In this circumstances, the medication can be researched by retrospective study through establishing pregnancy exposure registries. In this study, we aimed to make evidence of fetal safety and risk of many biopharmaceutical products that can help clinician & pregnant women. It is important to enroll the pregnant women who had medication exposure in her early pregnancy without any selective biases. And It should include enough population size and proper data. In addition, pregnancy outcome including the major & minor anomalies of fetus following the exposure of medications in pregnancy must be evaluated by regulated standard guideline. USA & European Union had already published the registry of pregnant women and it really helpful for safe prescription in pregnant women. So It is strongly suggested that this registry will have a great influence on determining the safety and risk of many medications in Korean pregnant women.
Key Words: pregnancy, medications, registry
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