Pregnancy outcome of women inadvertently exposed to ribostamycin during early pregnancy: a prospective cohort study.
No information is currently available on the safety of the aminoglycoside ribostamycin in pregnancy. We aimed to study the pregnancy outcome of women inadvertently exposed to ribostamycin during the first trimester of pregnancy. In a prospective cohort study, 102 women inadvertently exposed to ribostamycin during the first trimester of pregnancy and an age- and gravidity-matched control group, were enrolled. Study outcomes were gestational age at birth, major and minor malformations, and birth weight. Fetal outcomes were evaluated in 85 women inadvertently exposed to ribostamycin during the first-trimester of pregnancy and in 170 control subjects. Newborns were clinically examined at birth by a neonatologist and by imaging studies if any suspicious abnormalities were noted. There were 4/85 (4.9%) babies born with major malformations in the exposed group and 3/170 (1.8%) in the control group (P=0.7). Gestational age at delivery, rate of minor anomalies, rate of preterm births, and birth weight were not different between groups. In conclusion, similar to what is reported for other aminoglycoside, exposure to ribostamycin during the first-trimester of pregnancy does not appear to increase the risk of adverse fetal outcomes.
Lee
Si Won
SW
Cheil General Hospital & Women's Healthcare Center, Kwandong University College of Medicine, Seoul, South Korea.
Han
Jung Yeol
JY
Choi
June Seek
JS
Chung
Jin Hoon
JH
Kim
Moon Young
MY
Yang
Jae Hyug
JH
Koong
Mi Kyoung
MK
Nava-Ocampo
Alejandro A
AA
Koren
Gideon
G
D000014:Abnormalities, Drug-Induced / Q000209:etiology; D000328:Adult; D000900:Anti-Bacterial Agents / Q000009:adverse effects*; D001724:Birth Weight / Q000187:drug effects; D016022:Case-Control Studies; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D018811:Maternal Exposure; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D012271:Ribostamycin / Q000009:adverse effects*; D018570:Risk Assessment
D000900:Anti-Bacterial Agents; D012271:Ribostamycin