Predictors of pregnancy in microbicide trials
Predictors of pregnancy in microbicide trials
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DOI：
10.1016/j.contraception.2010.08.018
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发表时间：
2011-05-01
期刊：
影响因子：
2.9
通讯作者：
Van Damme, Lut
中科院分区：
文献类型：
--
作者：
Halpern, Vera;Lie, Che-Chin;Van Damme, Lut
背景：高妊娠率破坏了艾滋病毒预防试验的实施和解释。我们进行了这项分析，以确定基线参与者的特征与怀孕的风险增加，在最近的阴道杀微生物剂trials.Study设计：我们分析了数据，从四个最近完成的III期临床试验的候选杀微生物剂预防HIV感染。使用考克斯比例风险模型，按研究中嵌套的研究中心分层，确定预测妊娠的基线因素。六千七百四十八名妇女贡献的数据为这个analysis.Results：怀孕被检测到的1826（27.1%）妇女。对于有怀孕史、与男性同居或在入组前一周报告有更多未使用避孕套的性行为的女性，怀孕的风险更高。年龄较大的参与者、受教育年限较长的妇女、在基线访谈时报告有更多性伴侣的妇女、报告使用宫内避孕、植入、绝育或注射的妇女以及报告在最后一次阴道性交时使用避孕套的妇女的怀孕风险较低。我们的数据表明，目前使用或接受宫内避孕，植入，绝育或注射是最有效的方法，以减少怀孕率，并可能是一个有用的资格标准，在未来的艾滋病毒预防试验。(C)2011 Elsevier Inc. All rights reserved.
Background: High pregnancy rates undermine the conduct and interpretation of HIV prevention trials. We performed this analysis to identify baseline participant characteristics associated with increased risk of pregnancy in recent vaginal microbicide trials.Study Design: We analyzed the data from four recently completed Phase III trials of candidate microbicides for prevention of HIV infection. Cox proportional hazard models, stratified by site nested within study, were used to determine the baseline factors that predict pregnancy. Six thousand seven hundred forty-eight women contributed data for this analysis.Results: Pregnancies were detected in a total of 1826 (27.1%) women. The hazard of pregnancy was higher for women who had a history of pregnancy, were living with a man or reported more sexual acts not protected by condoms in the week prior to enrollment. The risk of pregnancy was lower in older participants; in women with more years of education; in women who reported more sexual partners at baseline interview; in women who reported using intrauterine contraception, implants, sterilization or injectables and in women who reported use of a condom during their last act of vaginal intercourse.Conclusions: Our data suggest that current use or acceptance of intrauterine contraception, implants, sterilization or injectables is the most effective approach to reduce pregnancy rates and might be a useful eligibility criterion in future HIV prevention trials. (C) 2011 Elsevier Inc. All rights reserved.