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产后早期放置宫内节育器时的疼痛

Pain With Early Postpartum Intrauterine Device Placement.

作者信息

Berkley Holly H, Lutgendorf Monica A, Kully Gennifer, Raiciulescu Sorana, Stortz Sharon K, Hinz Erica, Hofler Lisa G, Averbach Sarah

机构信息

Department of Gynecologic Surgery and Obstetrics, Naval Medical Center San Diego, San Diego, and the Division of Complex Family Planning, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Diego, La Jolla, California; the Division of Maternal Fetal Medicine, Department of Gynecologic Surgery and Obstetrics, and the Department of Preventative Medicine and Biostatistics, Uniformed Services University, Bethesda, Maryland; the Division of Complex Family Planning, Department of Obstetrics and Gynecology, University of Illinois at Chicago, Chicago, Illinois; and the Division of Complex Family Planning, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico.

出版信息

O G Open. 2025 Jun 12;2(3):e088. doi: 10.1097/og9.0000000000000088. eCollection 2025 Jun.

Abstract

OBJECTIVE

To compare pain between early and interval postpartum intrauterine device (IUD) placement.

METHODS

This is a planned secondary outcome analysis of a randomized trial among 404 participants randomized to early (14-28 days) or interval (42-56 days) postpartum IUD placement. Participants reported pain using a 100-mm visual analog scale at three times during IUD placement (bimanual examination, speculum placement, and IUD placement). We estimated that 112 participants would be required to achieve 80% power with an α of 5% to detect a 15-mm difference in pain with IUD placement. We used linear mixed models adjusting for demographic differences to compare mean pain scores between groups and per-protocol sensitivity analyses to account for crossover.

RESULTS

We enrolled 404 participants between March 2018 and July 2021; 325 received IUDs and were included in the analysis of pain with placement. Mean pain scores reported were not different between the early and interval groups: bimanual (9.2 mm vs 6.95 mm, mean difference 2.25 mm [95% CI, -2.68 to7.17], =.37, respectively); speculum (16.95 mm vs 15.86 mm, mean difference 1.09 mm [95% CI, -3.38 to 6.0], =.66); and IUD placement (18.43 mm vs 20.9 mm, mean difference -2.47 mm [95% CI, -7.39 to 2.44], =.32). In the per-protocol analysis, pain scores were not meaningfully different from those in the primary intention-to-treat analysis.

CONCLUSION

Pain reported is not different among people who are postpartum having early and interval IUD placement. Understanding the experience of pain with early and interval placement may help clinicians support patients in making informed choices about the timing of IUD placement.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT03462758.

摘要

目的

比较产后早期和间隔期放置宫内节育器(IUD)时的疼痛情况。

方法

这是一项对404名参与者进行的随机试验的计划二次结果分析,这些参与者被随机分配至产后早期(14 - 28天)或间隔期(42 - 56天)放置IUD。参与者在放置IUD的三个阶段(双合诊检查、放置窥器和放置IUD)使用100毫米视觉模拟量表报告疼痛程度。我们估计需要112名参与者,在α为5%的情况下达到80%的检验效能,以检测放置IUD时疼痛程度有15毫米的差异。我们使用线性混合模型调整人口统计学差异,以比较两组之间的平均疼痛评分,并进行符合方案敏感性分析以考虑交叉情况。

结果

在2018年3月至2021年7月期间,我们招募了404名参与者;325名接受了IUD放置,并被纳入放置时疼痛情况的分析。早期组和间隔期组报告的平均疼痛评分没有差异:双合诊检查时(9.2毫米对6.95毫米,平均差异2.25毫米[95%CI,-2.68至7.17],P = 0.37);放置窥器时(16.95毫米对15.86毫米,平均差异1.09毫米[95%CI,-3.38至6.0],P = 0.66);放置IUD时(18.43毫米对20.9毫米,平均差异-2.47毫米[95%CI,-7.39至2.44],P = 0.32)。在符合方案分析中,疼痛评分与主要意向性分析中的评分没有显著差异。

结论

产后早期和间隔期放置IUD的人群报告的疼痛情况没有差异。了解早期和间隔期放置IUD时的疼痛体验,可能有助于临床医生帮助患者做出关于IUD放置时间的明智选择。

临床试验注册

ClinicalTrials.gov,NCT03462758。

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