研究参与者和临床医生对新型低剂量镍钛诺框架宫内节育器在未分娩和已分娩参与者中的放置经验[ID: 1374840]

D. Turok, M. Hou, Colleen P McNicholas, Anita Nelson, K. Peters, Andrea Roe
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引用次数: 0

摘要

临床医生可能会认为子宫内节育器(IUD)的放置对未分娩的用户比有分娩的用户更具挑战性。本研究评估了未分娩与已分娩研究参与者和临床医生放置新型低剂量铜(175 mm2)柔性镍钛合金框架宫内节育器的经验。方法:这项单臂、irb批准的3期临床试验在42个美国中心招募了17-45岁的有妊娠能力的人。我们比较了未产和已产的参与者首次尝试放置宫内节育器的经历,包括放置成功,参与者报告的疼痛(11分数值疼痛量表),研究者报告的宫内节育器放置的难易程度(5分李克特量表),需要机械宫颈扩张和子宫穿孔。结果:在入组的1620名参与者中,973名(60.1%)报告了零胎次,647名(39.9%)报告了胎次。929例(96.0%)未生育者第一次尝试放置宫内节育器成功,625例(96.6%)已生育者第一次尝试放置宫内节育器成功。包括第二次尝试在内,有1,601名(98.8%)参与者成功安置。未分娩的参与者报告的平均疼痛评分为5.6(±2.19),而已分娩的参与者报告的平均疼痛评分为4.0(±2.55)(P<.001),研究人员更频繁地报告了81名(8.4%)未分娩的参与者和22名(3.4%)已分娩的参与者放置硬或非常硬的宫内节育器(P<.001)。在未分娩的参与者中,203人(21.2%)报告了与放置相关的疼痛相关不良事件,而已分娩的参与者中有65人(10.1%)报告了与放置相关的疼痛相关不良事件(P< 0.001)。202例(20.8%)未产者需要机械扩张术,79例(12.2%)已产者需要机械扩张术(P< 0.001)。1例未产者(0.10%)和1例已产者(0.15%)发生子宫穿孔。结论:尽管与已分娩的参与者相比,未分娩的参与者经历了更具有挑战性的宫内节育器放置,但使用这种新型低剂量铜宫内节育器的参与者经历了相似的宫内节育器放置成功。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Study Participants' and Clinicians' Experiences With Placement of a Novel Low-Dose Copper Intrauterine Device With a Nitinol Frame in Nulliparous Versus Parous Participants [ID: 1374840]
INTRODUCTION: Clinicians may perceive intrauterine device (IUD) placement to be more challenging for nulliparous versus parous users. This study assesses nulliparous versus parous study participants' and clinicians' experiences with placement of a novel, low-dose copper (175 mm2) IUD with a flexible nitinol frame. METHODS: This single-arm, IRB-approved, phase 3 clinical trial recruited pregnancy-capable people aged 17–45 at 42 U.S. centers. We compared nulliparous and parous participants' experiences for first IUD placement attempt including successful placement, participant-reported pain (on an 11-point numeric pain rating scale), investigator-reported ease of IUD placement (on a 5-point Likert scale), need for mechanical cervical dilation, and uterine perforation. RESULTS: Of 1,620 participants enrolled, 973 (60.1%) reported nulliparity and 647 (39.9%) parity. Successful IUD placement occurred at first attempt for 929 (96.0%) nulliparous versus 625 (96.6%) parous participants. Including second attempts, successful placement occurred for 1,601 (98.8%) participants. Nulliparous participants reported a mean pain score of 5.6 (±2.19) versus 4.0 (±2.55) for parous participants (P<.001), and investigators more frequently reported hard or very hard IUD placement in 81 (8.4%) nulliparous versus 22 (3.4%) parous participants (P<.001). Among nulliparous participants, 203 (21.2%) reported pain-related adverse events associated with placement versus 65 (10.1%) in parous participants (P<.001). Mechanical dilation was required for 202 (20.8%) nulliparous versus 79 (12.2%) parous participants (P<.001). Uterine perforation occurred in 1 nulliparous (0.10%) and 1 parous participant (0.15%). CONCLUSION: Despite experiencing more challenging IUD placements than parous participants, nulliparous trial participants experienced similar IUD placement success with this novel, low-dose copper IUD.
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