A comparative randomized study of three different IUDs in nulliparous Mexican women
A comparative randomized study of three different IUDs in nulliparous Mexican women
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DOI：
10.1016/s0010-7824(02)00519-x
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发表时间：
2003-04-01
期刊：
影响因子：
2.9
通讯作者：
Vázquez-Estrada, LA
中科院分区：
文献类型：
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作者：
Otero-Flores, JB;Guerrero-Carreño, FJ;Vázquez-Estrada, LA
为评价专为无产妇女设计的宫内节育器（TCu 380 Nul和ML Cu 375 sl）的临床性能，进行了一项前瞻性随机单盲研究，将其与标准TCu 380 a进行比较。我们纳入了1170名健康的未生育妇女，随机分配接受三种宫内节育器中的任何一种，并进行了1年的随访。延续率和终止率采用总累积生命表分析评估，并采用log-rank检验进行比较。研究结束时，TCu 380 A、TCu 380 Nul和ML Cu 375 sl的持续率（95%置信区间）分别为29.5%（+/ -12.9）、85.9%（+/-5.3）和85.4% (+/-5.8)（p < 0.001）。使用前3个月有6例妊娠，TCu 380 a组失败率为1% (+/-0.6)，TCu 380 Nul组失败率为0.5% (+/-0.3)，ML Cu 375 sl组无妊娠（p < 0.05）。与标准宫内节育器相比，专门为未生育妇女设计的宫内节育器具有更好的临床表现。这可能会提高这一人群对宫内节育器的使用。(C) 2003爱思唯尔科学有限公司版权所有。
With the aim to evaluate the clinical performance of intrauterine devices (IUDs) especially designed for nulliparous women (TCu 380 Nul and ML Cu 375 sl), a prospective randomized, single-blind study comparing them with standard TCu 380 A, was carried out. We included 1170 healthy nulliparous women randomly allocated to receive any of the three types of IUDs and conducted follow-up for 1 year of use. Continuation and termination rates were evaluated by gross cumulative life table analysis and compared by the log-rank test. Continuation rates (95% confidence interval) at the end of the study for TCu 380 A, TCu 380 Nul and ML Cu 375 sl were 29.5% ( +/-12.9), 85.9% (+/-5.3) and 85.4% (+/-5.8), respectively (p < 0.001). There were six pregnancies during the first 3 months of use, for a failure rate of 1% (+/-0.6) in the TCu 380 A group, 0.5% (+/-0.3) in TCu 380 Nul, and no pregnancy in ML Cu 375 sl (p < 0.05). Especially designed IUDs for nulliparous women had a better clinical profile compared with the standard IUD. This may improve the use of IUD in this population. (C) 2003 Elsevier Science Inc. All rights reserved.