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电子生育指标Ladycomp/Babycomp避孕效果的回顾性临床试验。

Retrospective clinical trial of contraceptive effectiveness of the electronic fertility indicator Ladycomp/Babycomp.

作者信息

Freundl G, Frank-Herrmann P, Godehardt E, Klemm R, Bachhofer M

机构信息

Frauenklinik Staedt. Krankenhaus Düsseldorf-Benrath, Teaching Hospital of the H.H. University of Düsseldorf, Germany.

出版信息

Adv Contracept. 1998 Jun;14(2):97-108. doi: 10.1023/a:1006534632583.

Abstract

The Babycomp/Ladycomp (Valley Electronics Ltd., Eschenlohe, Germany) is an electronic device that combines the temperature method and calendar method for planning and preventing pregnancy by identifying the fertile and infertile phases of the menstrual cycle. In a retrospective clinical trial, the system was tested as a contraceptive aid. A total of 648 women from Germany and Switzerland have participated: 597 women with 10,275 months of use used the device for contraception. Thirty-three unplanned pregnancies were identified, giving a total pregnancy rate of 3.8 use effectiveness according to the Pearl Index. Six method-related pregnancies occurred, producing a method Pearl Index of 0.7. Calculating the cumulative pregnancy rates by life-table analysis, it was found that, after about one year of exposure, the probability of an unintended pregnancy was 5.3% (0.053), after 2 years it was 6.8% (0.068) and after about 3 years of exposure it was 8.2% (0.082). The mean length of the identified fertile period was 14.3 days with a standard deviation of 4.6 days in all cycles reported. The acceptance of the device by the woman and her partner was good. In fact, 21 of the 33 women who became pregnant would still recommend the device for further use (63.6%).

摘要

Babycomp/Ladycomp(德国埃申洛厄的山谷电子有限公司)是一种电子设备,它通过识别月经周期的易孕期和非易孕期,结合体温法和日历法来计划和预防怀孕。在一项回顾性临床试验中,该系统作为一种避孕辅助工具进行了测试。共有来自德国和瑞士的648名女性参与:597名女性使用该设备避孕,使用时长共计10275个月。共确认了33例意外怀孕,根据 Pearl 指数计算,总妊娠率为3.8%。发生了6例与方法相关的妊娠,方法 Pearl 指数为0.7。通过生命表分析计算累积妊娠率,发现暴露约一年后,意外怀孕的概率为5.3%(0.053),两年后为6.8%(0.068),暴露约三年后为8.2%(0.082)。在所有报告的周期中,确认的易孕期平均长度为14.3天,标准差为4.6天。该设备在女性及其伴侣中的接受度良好。事实上,在33例怀孕的女性中,有21例仍会推荐该设备以供进一步使用(63.6%)。

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