임신 제 1삼분기 이부프로펜에 노출된 임신부에서의 태아 기형 및 임신결과에 관한 연구 = Clinical Studies : Fetal Anomaly and Pregnancy Outcomes after Exposure to Ibuprofen in First Trimester of Pregnancy

다국어 초록 (Multilingual Abstract)

Purpose: Ibuprofen is a non steroidal anti-inflammatory drug used for treating fever and pain including headache, arthralgia, and back pain. There is scarce information on the safety of ibuprofen associated with fetal anomaly when used early in pregnancy. Epidemiology studies have suggested that use of NSAIDs, including ibuprofen, during pregnancy may increase the risk of cardiac defects and gastroschisis. The aim of the study was to evaluate fetal outcomes among pregnant women who were unintentionally exposed to ibuprofen in early pregnancy. Methods: Total 381 pregnant women who were unintentionally exposed to ibuprofen during early pregnancy were prospectively followed up. In addition, 643 age and gravity matched pregnant women not exposed to any potential teratogenic agent during pregnancy were recruited as controls. Patients were followed-up until delivery or loss to follow-up. Newborns were examined in order to identify any major congenital malformation. Results: Mean age of exposed women was 31.2±3.4 years, with a mean number of previous pregnancies of 2.3±1.2 and mean gestational weeks at exposure of 4.4±2.2. All gestations were confirmed by ultrasonography. Of exposed women, 17 (5.6%) had spontaneous abortions, 16 were on-going pregnancies, 1 had an intra-uterine fetal death, 21 artificial abortion and 55 cases were lost to follow-up. Therefore, 271 pregnancies unintentionally exposed to ibuprofen were evaluated, each delivering a singleton baby. Three babies had congenital anomalies: one had unilateral hydronephrosis, another baby was born with a unilateral inguinal hernia. The last baby was born with unilateral kidney dysplasia with megaureter. In the control group, 6 babies were born with major malformations [1.11% vs. 1.31% (P=0.552, OR: 0.841, 95% CI: 0.2 to 3.4)]. Conclusion: These preliminary results suggest that the ibuprofen may not be a major human teratogen.