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早期药物流产后左炔诺孕酮宫内节育系统的快速放置与延迟放置——一项随机试验

Fast-track vs. delayed insertion of the levonorgestrel-releasing intrauterine system after early medical abortion - a randomized trial.

作者信息

Korjamo Riina, Mentula Maarit, Heikinheimo Oskari

机构信息

Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.

出版信息

Contraception. 2017 Nov;96(5):344-351. doi: 10.1016/j.contraception.2017.07.008. Epub 2017 Aug 5.

DOI:10.1016/j.contraception.2017.07.008
PMID:28774663
Abstract

OBJECTIVE

To compare levonorgestrel (LNG) 52-mg intrauterine system (IUS) expulsion rates with fast-track (≤3 days) or delayed (2-4 weeks) insertion following mifepristone and misoprostol medical abortion.

STUDY DESIGN

In this pilot trial, we randomized 108 women at ≤63 days' gestation to fast-track (n=55) or delayed (n=53) insertion. Follow-up visits occurred at 2-4 weeks, 3 months and 1 year. We assessed total and partial expulsion at 3 months and 1 year, adverse effects and bleeding profiles.

RESULTS

We had follow-up data at 3 months and 1 year for 41 (74.5%) and 37 (69.8%) women in the fast-track group and 31 (56.4%) and 28 (52.8%) women in the delayed group. By 3 months, expulsion occurred in six (12.5%) women after fast-track and one (2.3%) woman after delayed insertion [risk ratio (RR) 5.50, 95% confidence interval (CI) 0.69-43.90]; most (n=5) of these were partial expulsions in the fast-track group. By 1 year, expulsion had occurred in seven (14.6%) and five (11.5%) women in the fast-track and delayed groups, respectively (RR 1.28, 95% CI 0.44-3.75). We found no differences in rates of vacuum aspiration, residual tissue, infection and bleeding or bleeding patterns within 3 months of insertion.

CONCLUSION

Fast-track insertion of the LNG 52-mg IUS after medical abortion is feasible but may result in higher expulsion rates compared to delayed insertion. Due to lack of statistical power and high lost-to-follow-up rates, we were unable to fully address this question.

IMPLICATIONS

Fast-tract initiation of LNG 52-mg IUS contraception after medical abortion is feasible. It results in higher expulsion rates than delayed insertion but may improve postabortal intrauterine contraception uptake.

摘要

目的

比较米非司酮和米索前列醇药物流产后快速(≤3天)或延迟(2 - 4周)放置左炔诺孕酮(LNG)52毫克宫内节育系统(IUS)的排出率。

研究设计

在这项试点试验中,我们将108名妊娠≤63天的女性随机分为快速放置组(n = 55)或延迟放置组(n = 53)。在2 - 4周、3个月和1年进行随访。我们在3个月和1年时评估完全和部分排出情况、不良反应及出血情况。

结果

快速放置组41名(74.5%)女性和延迟放置组31名(56.4%)女性有3个月的随访数据,快速放置组37名(69.8%)女性和延迟放置组28名(52.8%)女性有1年的随访数据。到3个月时,快速放置后有6名(12.5%)女性发生排出,延迟放置后有1名(2.3%)女性发生排出[风险比(RR)5.50,95%置信区间(CI)0.69 - 43.90];其中大多数(n = 5)是快速放置组的部分排出。到1年时,快速放置组和延迟放置组分别有7名(14.6%)和5名(11.5%)女性发生排出(RR 1.28,95% CI 0.44 - 3.75)。我们发现在放置后3个月内,真空吸引率、残留组织、感染及出血或出血模式方面没有差异。

结论

药物流产后快速放置52毫克LNG - IUS是可行的,但与延迟放置相比,可能导致更高的排出率。由于缺乏统计学效力和高失访率,我们无法完全解决这个问题。

启示

药物流产后快速启动52毫克LNG - IUS避孕是可行的。它导致的排出率高于延迟放置,但可能提高流产后宫内避孕的使用率。

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