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新培训提供者进行宫内节育器插入术的临床结局:ECHO试验经验。

Clinical outcomes of intrauterine device insertions by newly trained providers: The ECHO trial experience.

作者信息

Yacobson Irina, Wanga Valentine, Ahmed Khatija, Chipato Tsungai, Gichangi Peter, Kiarie James, Louw Cheryl, Morrison Susan, Moss Margaret, Mugo Nelly R, Palanee-Phillips Thesla, Pleaner Melanie, Scoville Caitlin W, Thomas Katherine K, Nanda Kavita

机构信息

FHI 360, Durham, NC, United States.

Department of Global Health, University of Washington, Seattle, WA, United States.

出版信息

Contracept X. 2023 Mar 30;5:100092. doi: 10.1016/j.conx.2023.100092. eCollection 2023.

DOI:10.1016/j.conx.2023.100092
PMID:37188149
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10176026/
Abstract

OBJECTIVES

To assess the rates of failed insertion, expulsion, and perforation when intrauterine device (IUD) insertions were done by newly trained clinicians, and to examine factors that may affect these outcomes.

STUDY DESIGN

We evaluated skill-based outcomes following IUD insertion at 12 African sites in a secondary analysis of the Evidence for Contraceptive Options and HIV Outcomes (ECHO) randomized trial. Before trial initiation, we provided competency-based IUD training to clinicians and offered ongoing clinical support. We used Cox proportional hazards regression to examine factors associated with expulsion.

RESULTS

Among 2582 IUD acceptors who underwent first attempted IUD insertion, 141 experienced insertion failure (5.46%) and seven had uterine perforation (0.27%). Perforation was more common among breastfeeding women within three months postpartum (0.65%) compared with non-breastfeeding women (0.22%). We recorded 493 expulsions (15.5 per 100 person-years, 95% confidence interval [CI] 14.1─16.9): 383 partial and 110 complete. The risk of IUD expulsion was lower among women older than 24 years (aHR 0.63, 95% CI 0.50─0.78) and may be higher among nulliparous women. (aHR 1.65, 95% CI 0.97─2.82). Breastfeeding (aHR 0.94, 95% CI 0.72─1.22) had no significant effect on expulsion. IUD expulsion rate was highest during the first three months of the trial.

CONCLUSIONS

IUD insertion failure and uterine perforation rates in our study were comparable to those reported in the literature. These results suggest that training, ongoing support, and opportunities to apply new skills were effective in ensuring good clinical outcomes for women receiving IUD insertion by newly trained providers.

IMPLICATIONS

Data from this study support recommendations to program managers, policymakers, and clinicians that IUDs can be inserted safely in resource-constrained settings when providers receive appropriate training and support.

摘要

目的

评估新培训的临床医生进行宫内节育器(IUD)插入时的插入失败、排出和穿孔率,并检查可能影响这些结果的因素。

研究设计

在避孕选择与HIV结局证据(ECHO)随机试验的二次分析中,我们评估了12个非洲地点IUD插入后的基于技能的结局。在试验开始前,我们为临床医生提供了基于能力的IUD培训,并提供持续的临床支持。我们使用Cox比例风险回归来检查与排出相关的因素。

结果

在2582名首次尝试插入IUD的接受者中,141人经历了插入失败(5.46%),7人发生子宫穿孔(0.27%)。与非哺乳期妇女(0.22%)相比,产后三个月内的哺乳期妇女穿孔更为常见(0.65%)。我们记录了493次排出(每100人年15.5次,95%置信区间[CI]14.1─16.9):383次部分排出和110次完全排出。24岁以上女性的IUD排出风险较低(校正风险比[aHR]0.63,95%CI 0.50─0.78),未生育女性的排出风险可能较高(aHR 1.65,95%CI 0.97─2.82)。母乳喂养(aHR 0.94,95%CI 0.72─1.22)对排出无显著影响。IUD排出率在试验的前三个月最高。

结论

我们研究中的IUD插入失败率和子宫穿孔率与文献报道的相当。这些结果表明,培训、持续支持以及应用新技能的机会对于确保新培训的提供者为接受IUD插入的女性取得良好临床结局是有效的。

启示

本研究的数据支持向项目管理者、政策制定者和临床医生提出的建议,即当提供者接受适当培训和支持时,IUD可在资源有限的环境中安全插入。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4e0/10176026/43dca99ab0f9/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4e0/10176026/2460059c04c7/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4e0/10176026/43dca99ab0f9/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4e0/10176026/2460059c04c7/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d4e0/10176026/43dca99ab0f9/gr2.jpg

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本文引用的文献

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Potential for Improving Intrauterine Device (IUD) Service Delivery Quality: Results from a Secondary Data Analysis.提高宫内节育器(IUD)服务质量的潜力:二次数据分析结果
Gates Open Res. 2020 Mar 4;3:1473. doi: 10.12688/gatesopenres.12997.3. eCollection 2019.
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HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial.肌肉注射长效醋酸甲羟孕酮、含铜宫内节育器或左炔诺孕酮皮下埋植避孕的女性中的艾滋病毒感染发病率:一项随机、多中心、开放性标签试验。
Lancet. 2019 Jul 27;394(10195):303-313. doi: 10.1016/S0140-6736(19)31288-7. Epub 2019 Jun 13.
3
Intrauterine devices and risk of uterine perforation: current perspectives.
宫内节育器与子宫穿孔风险:当前观点
Open Access J Contracept. 2016 Mar 16;7:19-32. doi: 10.2147/OAJC.S85546. eCollection 2016.
4
IUD use among parous women and risk of uterine perforation: a secondary analysis.经产妇使用宫内节育器与子宫穿孔风险:一项二次分析
Contraception. 2017 Jun;95(6):605-607. doi: 10.1016/j.contraception.2017.03.007. Epub 2017 Mar 16.
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A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.一项为期3年的多中心随机对照试验,比较依托孕烯和左炔诺孕酮释放型避孕植入剂,并设有非随机匹配的铜宫内节育器对照组。
Hum Reprod. 2015 Nov;30(11):2527-38. doi: 10.1093/humrep/dev221. Epub 2015 Sep 25.
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Risk of uterine perforation with levonorgestrel-releasing and copper intrauterine devices in the European Active Surveillance Study on Intrauterine Devices.欧洲宫内节育器主动监测研究中左炔诺孕酮宫内节育器和铜宫内节育器导致子宫穿孔的风险
Contraception. 2015 Apr;91(4):274-9. doi: 10.1016/j.contraception.2015.01.007. Epub 2015 Jan 16.
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Association of age and parity with intrauterine device expulsion.年龄和产次与宫内节育器脱落的相关性。
Obstet Gynecol. 2014 Oct;124(4):718-726. doi: 10.1097/AOG.0000000000000475.
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Worldwide use of intrauterine contraception: a review.宫内节育器在全球的使用情况综述
Contraception. 2014 Mar;89(3):162-73. doi: 10.1016/j.contraception.2013.11.011. Epub 2013 Nov 25.
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Failed IUD insertions in community practice: an under-recognized problem?在社区实践中失败的宫内节育器放置术:一个被低估的问题?
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