14-18 岁青少年宫内避孕:左炔诺孕酮宫内缓释系统与 Copper T 380A 比较的多中心随机试点研究。

Intrauterine contraception for adolescents aged 14-18 years: a multicenter randomized pilot study of levonorgestrel-releasing intrauterine system compared to the Copper T 380A.

机构信息

Department of Family Medicine, University of Illinois College of Medicine, Chicago, IL 60612, USA.

出版信息

Contraception. 2010 Feb;81(2):123-7. doi: 10.1016/j.contraception.2009.09.004. Epub 2009 Oct 8.

Abstract

BACKGROUND

Intrauterine contraception can provide adolescents with effective, long-term contraception as well as with other health benefits. In adult populations, intrauterine contraception rates highly in patient satisfaction and safety. It is rarely prescribed to adolescents because of limited data.

STUDY DESIGN

Multicenter, randomized, controlled, participant-blinded pilot study of 14-18-year-old females assigned to the Copper T 380A intrauterine device or the Levonorgestrel Intrauterine System. Participants were followed up for 6 months following insertion.

RESULTS

We enrolled 23 participants; 12 received the Levonorgestrel Intrauterine System, and 11 received the Copper T 380A. At 6 months, the continuation rates were 75% for the Levonorgestrel Intrauterine System users and 45% for the Copper T 380A users (p=.15). Two Copper T 380A users experienced partial expulsion. Heavy bleeding and pelvic pain were the most commonly reported side effects. Participants rated both methods favorably.

CONCLUSIONS

This study shows that at 6 months, though not statistically significant, adolescent continuation rates trended towards being greater with the Levonorgestrel Intrauterine System compared to the Copper T 380A. These pilot data will be helpful in the design of a larger trial of intrauterine contraception use among adolescents.

摘要

背景

宫内节育器可为青少年提供有效、长期的避孕措施,并带来其他健康益处。在成年人群中,宫内节育器的患者满意度和安全性都很高。由于数据有限,很少将其用于青少年。

研究设计

这是一项多中心、随机、对照、参与者盲法的试点研究,研究对象为 14-18 岁的女性,分为铜 T380A 宫内节育器组或左炔诺孕酮宫内节育系统组。参与者在插入后随访 6 个月。

结果

我们共招募了 23 名参与者,其中 12 名接受了左炔诺孕酮宫内节育系统,11 名接受了铜 T380A。6 个月时,左炔诺孕酮宫内节育系统使用者的续用率为 75%,铜 T380A 使用者的续用率为 45%(p=.15)。2 名铜 T380A 使用者出现部分脱落。大量出血和盆腔疼痛是最常报告的副作用。参与者对两种方法的评价都很好。

结论

本研究表明,6 个月时,尽管无统计学意义,但与铜 T380A 相比,左炔诺孕酮宫内节育系统的青少年续用率呈上升趋势。这些初步数据将有助于设计一项更大规模的青少年宫内节育器使用试验。

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