The Safety of Metoclopramide Use in the First Trimester of Pregnancy
The Safety of Metoclopramide Use in the First Trimester of Pregnancy
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DOI：
10.1056/nejmoa0807154
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发表时间：
2009-06-11
影响因子：
158.5
通讯作者：
Levy, Amalia
中科院分区：
文献类型：
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作者：
Matok, Ilan;Gorodischer, Rafael;Levy, Amalia
在许多国家，甲氧氯普胺是孕妇首选的止吐药物，但关于其妊娠安全性的信息不足。方法：通过将1998年1月1日至2007年3月31日期间在以色列南区Clalit卫生服务中心登记的所有妇女的药品计算机数据库与该地区医院同期母婴医院记录的计算机数据库连接起来，调查妊娠早期使用甲氧氯普胺的安全性。我们评估了妊娠期使用甲氧氯普胺与胎儿不良结局之间的关系，调整了胎次、产妇年龄、种族、产妇是否患有糖尿病、吸烟状况以及是否存在围产期发烧。结果研究期间共发生单胎分娩113612例。总共有81,703名婴儿（71.9%）是在Clalit保健服务机构登记的妇女所生；其中3458人（4.2%）在妊娠前三个月暴露于甲氧氯普胺。与未暴露于甲氧氯普胺相比，暴露于甲氧氯普胺与主要先天性畸形（分别为5.3%和4.9%；优势比为1.04；95%可信区间[CI]为0.89至1.21）、低出生体重（8.5%和8.3%；优势比为1.01；95% CI为0.89至1.14）、早产（6.3%和5.9%；优势比为1.15；95% CI为0.99至1.34）或围产期死亡（1.5%和2.2%；优势比为0.87；95% CI为0.55至1.38）的风险增加无关。当暴露和未暴露胎儿的治疗性流产纳入分析时，结果基本不变。结论：在这个庞大的婴儿队列中，妊娠早期暴露于甲氧氯普胺与任何不良结局的风险显著增加无关。这些发现为孕妇服用甲氧氯普胺缓解妊娠期恶心和呕吐的安全性提供了保证。
BACKGROUNDIn various countries, metoclopramide is the antiemetic drug of choice in pregnant women, but insufficient information exists regarding its safety in pregnancy.METHODSWe investigated the safety of metoclopramide use during the first trimester of pregnancy by linking a computerized database of medications dispensed between January 1, 1998, and March 31, 2007, to all women registered in the Clalit Health Services, southern district of Israel, with computerized databases containing maternal and infant hospital records from the district hospital during the same period. We assessed associations between the use of metoclopramide in pregnancy and adverse outcomes for the fetus, adjusting for parity, maternal age, ethnic group, presence or absence of maternal diabetes, smoking status, and presence or absence of peripartum fever.RESULTSThere were 113,612 singleton births during the study period. A total of 81,703 of the infants (71.9%) were born to women registered in Clalit Health Services; 3458 of them (4.2%) were exposed to metoclopramide during the first trimester of pregnancy. Exposure to metoclopramide, as compared with no exposure to the drug, was not associated with significantly increased risks of major congenital malformations (5.3% and 4.9%, respectively; odds ratio, 1.04; 95% confidence interval [CI], 0.89 to 1.21), low birth weight (8.5% and 8.3%; odds ratio, 1.01; 95% CI, 0.89 to 1.14), pre-term delivery (6.3% and 5.9%; odds ratio, 1.15; 95% CI, 0.99 to 1.34), or perinatal death (1.5% and 2.2%; odds ratio, 0.87; 95% CI, 0.55 to 1.38). The results were materially unchanged when therapeutic abortions of exposed and unexposed fetuses were included in the analysis.CONCLUSIONSIn this large cohort of infants, exposure to metoclopramide in the first trimester was not associated with significantly increased risks of any of several adverse outcomes. These findings provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy.