Original Article

A prospective cohort study of fetal and neonatal outcomes in women taking medicinally Ramulus Cinnamomi during pregnancy


So Yun Kim1, Jin Ha Kim2, Jung Yeol Han3, Gideon Koren4, June Seek Choi5,

1Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, MizMedi Hospital GangSeo, Seoul, Korea
2Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
3Department of Obstetrics and Gynecology, Ilsan Paik Hospital, University of Inje, College of Medicine, Goyang City, Gyunggi Do, Korea
4Department of Physiology and Pharmacology, Western University, Ontario, Canada
5Department of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University School of Medicine, Seoul, Korea


Abstract


Background: Ramulus Cinnamomi has been used as a traditional herbal supplement. According to the Food and Drug Administration, Ramulus Cinnamomi is safe during pregnancy when consumed in amounts commonly found in food. However, only a few studies have evaluated the safety of Ramulus Cinnamomi during pregnancy as a medicine.
Methods: All 1,284 patients in the Korean Motherisk Program participated in this prospective cohort study.
Results: 241 pregnant women were exposed to Ramulus Cinnamomi and 1,043 in an unexposed group were exposed to another substance known to be non-teratogenic. The route of exposure was exclusively oral and the most common indication for use was a functional gastrointestinal disorder. Nulliparity was statistically more common in the exposed group than in the unexposed group. Other characteristics were similar between the two groups. Neonatal outcomes were also similar. One infant with a major malformation (0.6%) was born in the exposed group, with 3 (0.6%) in the unexposed group (OR: 1.0, 95% CI=0.11-9.81, p=1.00). Other fetal and neonatal outcomes were not significantly different between the two groups.
Conclusions: Our findings suggest that Ramulus Cinnamomi is not a major teratogen and that it has no significant effect on neonatal malformations. However, further confirmation in a larger study is required.

Keywords: pregnancy, Ramulus Cinnamomi, women