First trimester diclofenac exposure and pregnancy outcome

被引：22

作者：

Cassina, Matteo ^{[1
]}

De Santis, Marco ^{[2
]}

Cesari, Elena ^{[2
]}

van Eijkeren, Marion ^{[3
]}

Berkovitch, Matitiahu ^{[4
]}

Eleftheriou, Giorgio ^{[5
]}

Raffagnato, Francesco ^{[1
]}

Di Gianantonio, Elena ^{[1
]}

Clementi, Maurizio ^{[1
]}

机构：

[1] Univ Padua, Dept Pediat, Genet Clin, Serv Informaz Teratol, I-35128 Padua, Italy

[2] Univ Cattolica Sacro Cuore, Dept Obstet & Gynecol, Telefono Rossoteratol Informat Serv, I-00168 Rome, Italy

[3] Natl Inst Publ Hlth & Environm, Teratol Informat Serv, NL-3720 BA Bilthoven, Netherlands

[4] Assaf Harofeh Teratogen Informat Ctr, Zerifin, Israel

[5] Poison Control Ctr, Dept Clin Pharmacol, Bergamo, Italy

来源：

REPRODUCTIVE TOXICOLOGY | 2010年 / 30卷 / 03期

关键词：

Pregnancy; Diclofenac; Teratogenicity; Fetal outcome; Birth defects; NONSTEROIDAL ANTIINFLAMMATORY DRUGS; FETAL DUCTUS-ARTERIOSUS; MATERNAL MEDICATION USE; PULMONARY-HYPERTENSION; CONGENITAL-ANOMALIES; GESTATIONAL-AGE; PRETERM LABOR; INDOMETHACIN; GASTROSCHISIS; RISK;

D O I：

10.1016/j.reprotox.2010.04.010

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

Objective: To assess the safety of diclofenac during pregnancy. Methods: A prospective observational cohort study, evaluating follow-up data of women who contacted Teratology Information Services to get counseling. The exposed group included 145 pregnant women who were exposed to diclofenac between the 5th and the 14th gestational week. A contemporary control group (501 women) was randomly selected from among patients who contacted Teratology Information Services with regard to exposures to agents known not to be teratogenic during a similar period of pregnancy. Results: Major birth malformations were not more common in the study group than in the control group (p = 0.07). Conclusion: Our study suggests that the use of diclofenac is relatively safe during the first trimester of pregnancy and the studied sample size makes it possible to exclude a risk of congenital malformation higher than 3.3, with a power of 80%. (C) 2010 Elsevier Inc. All rights reserved.

引用

页码：401 / 404

页数：4

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