First-Trimester Itraconazole Exposure and Pregnancy Outcome A Prospective Cohort Study of Women Contacting Teratology Information Services in Italy

被引:34
作者
De Santis, Marco [1 ]
Di Gianantonio, Elena [2 ]
Cesari, Elena [1 ]
Ambrosini, Guido [2 ]
Straface, Gianluca [1 ]
Clementi, Maurizio [2 ]
机构
[1] Univ Cattolica Sacro Cuore, Dept Obstet & Gynecol, Telefono RossoTeratol Informat Serv, I-00168 Rome, Italy
[2] Univ Padua, Dept Pediat, Genet Clin, CEPIG, Padua, Italy
关键词
OBSERVATIONAL COHORT; MALFORMATIONS; FLUCONAZOLE; DRUGS;
D O I
10.2165/00002018-200932030-00006
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Background: Itraconazole is an effective fungal treatment; however, there are few human data on prenatal exposure. Objectives: To evaluate the major malformation rate in itraconazole pre-natally exposed infants. The secondary objective includes evaluation of the pregnancy outcome. Methods: A prospective cohort study was conducted from January 2002 to October 2006 in women who called two Italian Teratology Information Services (TIS). Pregnant women who were exposed to itraconazole during the first trimester and gave informed consent were matched with a contemporary group of pregnant women who contacted the TIS because they had undergone a non-teratogenic drug exposure during the first trimester. Information was obtained via a structured questionnaire at the time of the initial call to the TIS and no earlier than 1 month after delivery. A trained operator conducted the interview. The main outcome measure was information about major congenital anomalies, type of delivery, birth weight, and any pregnancy or neonatal complications. Results: Data were collected on 206 women who called the TIS because of first-trimester exposure to itraconazole, and 207 controls. There were no significant differences in terms of major congenital anomalies in the exposed group versus the control group (3/163 [1.8%] vs 4/190 [2.1%], respectively). There was no statistical difference in the rate of vaginal delivery between the exposed and control groups (101/162 [62.3%] vs 102/190 [53.8%]), premature birth (11/162 [6.8%] vs 15/190 [7.9%]), low birth weight (1/152 [0.7%] vs 4/175 [2.3%]) and high birth weight (10/152 [6.5%] vs 7/175 [4.0%], respectively). The rates of live births (163/206 [79.1%] vs 190/207 [91.8%]), spontaneous abortion (23/206 [11.2%] vs 10/207 [4.8%]) and termination of pregnancy (19/206 [9.2%] vs 7/207 [3.4%] in the exposed and control groups, respectively) were significantly different (p < 0.05). Conclusion: First-trimester itraconazole-exposed infants were not at increased risk of major congenital anomalies, but the rates of spontaneous and induced abortion were higher in the exposed group versus the control group. Larger studies are warranted to confirm these observations.
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收藏
页码:239 / 244
页数:6
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