Intrauterine Devices

宫内节育器
  • 文章类型: Journal Article
    背景:在大多数西方国家,医疗保健费用的上涨是一个主要问题。替代医疗保健是一种战略方法,旨在降低成本,同时在患者住所附近提供医疗服务。一个说明性实例涉及将门诊医院护理迁移到初级护理设置。值得注意的是,在初级保健环境中可以安全地插入宫内节育器(IUD).为了建立宫内节育器替代率的务实目标,我们对与插入宫内节育器有关的医疗替代的地区差异进行了评估.此外,我们调查了一级和二级医疗保健环境在随访超声和宫内节育器再插入方面的差异.
    方法:所有在2016年1月1日至2020年12月31日期间在荷兰初级保健(由全科医生和助产士)和二级保健(由医院医生)接受宫内节育器插入的妇女纳入研究。主要结果指标是按护理环境在区域一级按病例混合调整的IUD插入率,以及需要在三个月内进行随访超声和IUD重新插入的比例。
    结果:在840,766个IUD放置中,74%的人被安置在初级保健中,26%被安置在二级保健中。初级保健的比例从2016年的70%增加到2020年的77%。在区域之间观察到的替代率范围为58%至82%。与初级保健专业人员相比,那些接受二级保健的人进行了更多的超声检查以验证宫内节育器的放置(23%与3%;p值<0.01)和三个月内更多的宫内节育器重插(6%vs.2%;p值<0.01)。
    结论:宫内节育器越来越多地插入荷兰的初级保健中,区域IUD插入护理替代率峰值≥80%。IUD插入护理替代初级保健似乎与在三个月内进行超声随访或IUD重新插入的妇女人数显着减少有关。
    BACKGROUND: Rising health care costs are a major concern in most Western countries. The substitution of healthcare stands as a strategic approach aimed at mitigating costs while offering medical services in proximity to patients\' residences. An illustrative instance involves the migration of outpatient hospital care to primary care settings. Notably, the insertion of intrauterine devices (IUDs) can be safely executed within primary care contexts. In order to establish a pragmatic objective for the rate of IUD substitution, we conducted an evaluation of regional disparities in healthcare substitution pertaining to the insertion of intrauterine devices. Furthermore, we investigated disparities in the follow-up ultrasound and reinsertion of IUDs between primary and secondary healthcare environments.
    METHODS: All women who underwent IUD insertion in Dutch primary care (by general practitioners and midwives) and secondary care (by hospital physicians) between January 1, 2016, and December 31, 2020 were included. The main outcome measures were the case-mix adjusted IUD insertion rates at the regional level by care setting and the proportions requiring follow-up ultrasound and IUD reinsertion within three months.
    RESULTS: Of the 840,766 IUD placements, 74% were inserted in primary care and 26% in secondary care. The proportion inserted in primary care increased from 70% in 2016 to 77% in 2020. The observed substitution rate ranged from 58 to 82% between regions. Compared with health care professionals in primary care, those in secondary care performed more ultrasounds to verify IUD placement (23% vs. 3%; p-value < 0.01) and more IUD reinsertions within three months (6% vs. 2%; p-value < 0.01).
    CONCLUSIONS: IUDs are increasingly being inserted in Dutch primary care, with peak regional IUD insertion care substitution rates at ≥ 80%. IUD insertion care substitution to primary care appears to be associated with significantly fewer women having follow-up ultrasound or IUD reinsertion within three months.
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  • 文章类型: Journal Article
    背景:COVID-19大流行影响了全球获得卫生服务的机会,包括避孕。我们试图探索大流行对南非和赞比亚计划生育(FP)服务提供和使用的影响,包括植入和宫内节育器(IUD)用户的愿望和能力获得移除。方法:在2020年8月至2021年4月之间,我们对537名参与正在进行的纵向避孕延续研究的妇女进行了调查。我们还对参与FP提供的39名调查参与者和36名关键线人进行了深入访谈。我们对调查答复进行了描述性分析,对访谈进行了主题分析。结果:随着COVID-19的出现,该样本中避孕药具的使用变化最小。自流行病开始以来,不到一半的妇女(n=220)报告试图使用FP,其中绝大多数使用短效方法。在那些寻求服务的人中,95%获得了他们首选的方法。在赞比亚,在大流行开始之前和之后不使用一种方法的妇女比例没有变化(31%);在南非,比例从8%上升到10%。在这两个国家中,不到7%的植入物或宫内节育器使用者报告想要移除。在寻求驱逐的人中(n=22),91%(n=10)在赞比亚和55%(n=6)在南非胜利获得去除。在定性采访中,有挑战获得FP服务的女性提到排长队,取消避孕服务的优先次序,缺乏交通,缺货,以及担心在设施感染COVID-19。关键线人报告了缺货,尤其是注射剂,和员工短缺作为障碍。结论:在该样本中,我们没有发现COVID-19对避孕方法的实质性影响;然而,提供者和其他参与提供服务的人发现了护理连续性的风险。随着COVID-19大流行的减弱,它仍然是重要的监测人们的能力,以获得他们的首选避孕方法。
    Background: The COVID-19 pandemic affected global access to health services, including contraception. We sought to explore effects of the pandemic on family planning (FP) service provision and use in South Africa and Zambia, including on implant and intrauterine device (IUD) users\' desire and ability to obtain removal. Methods: Between August 2020 and April 2021, we conducted surveys with 537 women participating in an ongoing longitudinal contraceptive continuation study. We also carried out in-depth interviews with 39 of the survey participants and 36 key informants involved in FP provision. We conducted descriptive analysis of survey responses and thematic analysis of interviews. Results: Contraceptive use changed minimally in this sample with the emergence of COVID-19. Fewer than half of women (n=220) reported attempting to access FP since the start of the pandemic, the vast majority of whom were using short-acting methods. Among those who sought services, 95% obtained their preferred method. The proportion of women not using a method before and after pandemic start did not change in Zambia (31%); in South Africa, the proportion increased from 8% to 10%. Less than 7% of implant or IUD users in either country reported wanting removal. Among those who sought removal (n=22), 91% (n=10) in Zambia and 55% (n=6) in South Africa successfully obtained removal. In qualitative interviews, women with challenges accessing FP services mentioned long queues, deprioritization of contraceptive services, lack of transportation, stock-outs, and fear of contracting COVID-19 at a facility. Key informants reported stock-outs, especially of injectables, and staff shortages as barriers. Conclusions: We did not find a substantial impact of COVID-19 on contraceptive access among this sample; however, providers and others involved in service provision identified risks to continuity of care. As the COVID-19 pandemic wanes, it continues to be important to monitor people\'s ability to access their preferred contraceptive methods.
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  • 文章类型: Journal Article
    目的:为了比较去除时间,技术,以及将IUD错位到未错位的IUD的成功。
    方法:我们在2014年7月至2017年7月期间在一个医疗系统内对宫内节育器使用者进行了一项回顾性队列研究。我们使用Fisher精确和Wilcoxon秩和检验来比较IUD错位和非错位患者的临床特征和IUD移除细节。
    结果:在报告存在宫内节育器的1,759次超声报告中,436描述了宫内节育器错位。其中,150将宫内节育器描述为嵌入式,16将其描述为部分穿孔。与非错位宫内节育器相比,错位的患者更有可能被移除和更快地移除宫内节育器(281/436vs.545/1323,p<0.001,中位数为17天从指数超声检查236天,p<0.001)。大多数宫内节育器,错位和非错位,在第一次尝试时被移除(82%,85%),由通才OBGYN(75%,70%),使用环形镊子(73%,65%)。大多数嵌入和部分穿孔的宫内节育器被移除(68%,69%),使用环形镊子(59%,67%),第一次尝试(84%,91%)。
    结论:与未定位的宫内节育器相比,定位错误的宫内节育器更有可能被移除和更快地移除。大多数宫内节育器,甚至是标记为部分穿孔或嵌入的宫内节育器,被一个通才OBGYN带走了,使用环形镊子,第一次尝试。
    结论:宫内节育器错位的超声发现与难以取出宫内节育器无关。
    OBJECTIVE: This study aimed to compare removal timing, techniques, and success of malpositioned intrauterine device (IUDs) to nonmalpositioned IUDs.
    METHODS: We performed a retrospective cohort study of IUD users with ultrasound performed between July 2014 and July 2017 within one medical system. We used Fisher exact and Wilcoxon rank-sum tests to compare clinical characteristics and IUD removal details between patients with malpositioned and nonmalpositioned IUDs.
    RESULTS: Of 1759 ultrasounds reporting the presence of an IUD, 436 described IUD malposition. Of these, 150 described the IUD as embedded and 16 as partially perforated. IUDs were more likely to be removed and removed sooner for patients with malpositioned compared with nonmalpositioned IUDs (281/436 vs 545/1323, p < 0.001 and median 17 days vs 236 days from the index ultrasound, p < 0.001). Most IUDs, malpositioned and nonmalpositioned, were removed on the first attempt (82%, 85%), by a generalist obstetrician and gynecologist (75%, 70%), using a ring forceps (73%, 65%). Most embedded and partially perforated IUDs were removed (68%, 69%), using a ring forceps (59%, 67%), on the first attempt (84%, 91%).
    CONCLUSIONS: Malpositioned IUDs were more likely to be removed and removed sooner than nonmalpositioned IUDs. Most IUDs, even IUDs labeled as partially perforated or embedded, were removed by a generalist obstetrician and gynecologist, using ring forceps, on first attempt.
    CONCLUSIONS: Ultrasound findings of IUD malposition are not associated with difficult IUD removal.
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  • 文章类型: Journal Article
    目的:评估产后6周时宫内节育器(PPIUD)的延续率,在资源不足的情况下,在现有计划中的6个月和1年,并确定终止的决定因素,驱逐和驱逐。
    方法:我们使用了前瞻性队列设计,并在奥里萨邦和恰蒂斯加尔邦的100个公共医疗机构中招募了最近的PPIUD采用者妇女,印度。我们收集了他们的社会人口统计信息,并在六周内对他们进行了电话跟踪,6个月和1年为并发症和延续状态。我们评估了PPIUD的延续率和与PPIUD停药相关的因素,移除,并使用Cox比例风险模型进行驱逐。
    结果:我们招募了916名参与者(来自奥里萨邦的579名(63.2%)和来自恰蒂斯加尔邦的337名(36.8%))。PPIUD在第6周的延续率为88.7%,6个月为74.8%,一年为60.1%。一旦停产,不选择任何计划生育方法的机会很高(高达81.2%)。接受6至12级教育的参与者和那些经历并发症的人(疼痛的腹部,每次阴道出血和排出)更有可能取出宫内节育器,调整后的风险比分别为1.82(95%CI:1.18-2.79)和4.39(95%CI:3.25-5.93)。对于驱逐,我们没有发现任何有统计学意义的因素.
    结论:PPIUD延续率在最初6周后显著下降。必须加强管理并发症的辅导及跟进服务,特别是在PPIUD插入的前6周,以增强和维持方案影响。
    结论:我们的研究结果强调需要加强客户咨询和随访以管理并发症,尤其是在插入PPIUDs的前6周。正在进行的计划需要解决这方面的全面能力建设工作。
    OBJECTIVE: To estimate continuation rates for postpartum intrauterine contraceptive device (PPIUD) at 6 weeks, 6 months and 1-year within existing programs in an under-resourced setting, and to identify determinants of discontinuation, removal and expulsion.
    METHODS: We used a prospective cohort design and enrolled recent PPIUD adopter women across 100 public healthcare facilities in Odisha and Chhattisgarh, India. We collected their socio-demographic information and followed them up telephonically at 6 weeks, 6 months and 1 year for complications and continuation status. We assessed PPIUD continuation rates and factors associated with PPIUD discontinuation, removal, and expulsion using Cox proportional hazards modelling.
    RESULTS: We enrolled 916 participants (579 (63.2%) from Odisha and 337 (36.8%) from Chhattisgarh). The continuation rate of PPIUD was 88.7% at 6 weeks, 74.8% at 6 months 60.1% at one year. Once discontinued, chances of not opting for any family planning method was high (up to 81.2%). Participants with education of 6th to 12th class and those experiencing complications (pain abdomen, bleeding and discharge per vaginum) were more likely to remove the IUD with adjusted hazard ratio of 1.82 (95% CI: 1.18-2.79) and 4.39 (95% CI: 3.25-5.93) respectively. For expulsion, we did not find any factor that was statistically significant.
    CONCLUSIONS: PPIUD continuation rates declined considerably after the initial 6 weeks. Counselling and follow-up services for managing complications must be strengthened, especially in the first 6 weeks of PPIUD insertion, to enhance and sustain programmatic impact.
    CONCLUSIONS: Our findings emphasize on the need to strengthen client counseling and follow-up for management of complications, especially in the first 6 weeks of insertion of PPIUDs. Ongoing programs need to address comprehensive capacity building efforts in this regard.
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  • 文章类型: Journal Article
    背景:对宫内节育器放置相关疼痛的恐惧已被认为是采用长效可逆避孕的重要障碍,降低了最有效的可逆避孕方法的利用率。
    目的:评估宫内节育器置入前宫内滴注甲哌卡因是否比安慰剂更有效地减轻疼痛。
    方法:我们进行了多中心,双盲,随机化,安慰剂对照试验涉及接受宫内节育器置入术的未产妇女。在放置宫内节育器前2分钟,通过水超声导管滴注10mL20mg/mL甲哌卡因或0.9mg/mL氯化钠。在预先指定的时间点使用100mm视觉模拟量表评估疼痛评分。主要结果测量了宫内节育器放置期间干预组和安慰剂组之间视觉模拟量表疼痛评分的差异。次要结果包括滴注时和放置后10分钟的视觉模拟量表疼痛评分,放置疼痛的耐受性,以及镇痛方法的可接受性。
    结果:我们招募了151名参与者,76人分配到甲哌卡因组,75人分配到安慰剂组。IUD放置期间平均VAS疼痛评分差异为13.3mm(95%CI5.75-20.87;P<.001):甲哌卡因组平均为53.9mm(SD22.8),而安慰剂组的平均值为67.2mm(SD22.4)。在针对每个提供者的影响进行调整后,平均疼痛评分差异仍有统计学意义(12.2mm95%CI4.85-19.62;P<.001).干预组中有更高比例的女性在放置期间报告了可忍受的疼痛,其中70/75参与者(93.3%),而安慰剂组中有53/66参与者(80.3%)(P=.021)。
    结论:子宫内滴注甲哌卡因可显著降低未产妇女在放置宫内节育器期间的疼痛评分。尽管这种疼痛减轻方法的确切临床影响仍不确定,观察到的疼痛评分降低导致报告可耐受疼痛的女性比例更高.因此,这一发现和作为减轻疼痛方法的高度接受表明了临床相关性。子宫内滴注甲哌卡因是增加宫内节育器利用率的可能策略,特别是在意外怀孕高风险的未产妇中。
    BACKGROUND: Fear of pain associated with intrauterine device (IUD) placement has been identified as a significant barrier to the adoption of long-acting reversible contraception, contributing to lower utilization of the most effective reversible contraceptive methods.
    OBJECTIVE: To assess whether instillation of intrauterine mepivacaine before IUD placement alleviates pain more effectively than a placebo.
    METHODS: We conducted a multicenter, double-blind, randomized, placebo-controlled trial involving nulliparous women undergoing IUD placement. An intrauterine instillation of 10 mL of 20 mg/mL mepivacaine or 0.9 mg/mL sodium chloride was administrated through a hydrosonography catheter 2 minutes prior to IUD placement. Pain scores were assessed using a 100 mm visual analog scale (VAS) at prespecified time points. Primary outcome measured the difference in VAS pain scores between the intervention group and the placebo group during IUD placement. Secondary outcomes included VAS pain scores at instillation and 10 minutes after placement, tolerability of the placement pain, as well as acceptability of the analgesia method.
    RESULTS: We enrolled 151 participants, with 76 assigned to the mepivacaine group and 75 to the placebo group. The mean VAS pain score during IUD placement showed a difference of 13.3 mm (95% confidence interval (CI) 5.75-20.87; P<.001): the mepivacaine group had a mean of 53.9 mm (standard deviation [SD] 22.8), while the placebo group had a mean of 67.2 mm (SD 22.4). After adjusting for each individual provider\'s impact, the difference in mean pain scores remained statistically significant (12.2 mm 95% CI 4.85-19.62; P<.001). A greater proportion of women in the intervention group reported tolerable pain during placement with 70/75 participants (93.3%) compared to 53/66 participants (80.3%) in the placebo group (P=.021).
    CONCLUSIONS: The intrauterine instillation of mepivacaine results in statistically significant reduction in pain score among nulliparous women during IUD placement. Although the precise clinical impact of this pain reduction method remains uncertain, the observed reduction in pain score result in a higher proportion of women reporting tolerable pain. This finding and the high acceptance as a pain reduction method thereby suggests clinical relevance. Intrauterine instillation of mepivacaine is a possible strategy to increase IUD utilization, particularly among nulliparous women who are at high risk of unintended pregnancy.
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  • 文章类型: Journal Article
    背景:对COVID-19大流行的程度知之甚少,以及对卫生服务的相关限制和中断,影响了澳大利亚境内激素长效可逆避孕(LARC)设备的可及性。这里,我们探索了澳大利亚避孕植入物和激素宫内节育器(IUD)的纵向分配模式,在COVID-19大流行之前和期间。
    方法:基于人群的队列研究;对国家药品福利计划分配数据的10%随机样本进行分析,对于15-49岁的女性,在2017年2月至2021年11月之间分配了激素LARC设备。
    结果:中断的时间序列分析表明,在2020年4月澳大利亚大流行爆发后,激素LARC的每月分配率没有显着差异,趋势没有随后的变化。然而,当按LARC类型分层时,在大流行期间(2020年4月至2021年11月),每月的激素宫内节育器配药率显着增加(0.20/1000095%CI0.01至0.38)),与植入物的减少相比(-0.08/10000(95%CI-0.16至0.01))。大流行期间,荷尔蒙宫内节育器配药的增加对20-24岁的人群最为明显,新用户,那些没有英联邦优惠卡的人,在维多利亚州。
    结论:在定义的大流行期间,在澳大利亚,使用激素LARC设备没有受到负面影响.相反,激素宫内节育器的分配明显增加。
    BACKGROUND: Little is known about the degree to which the COVID-19 pandemic, and associated restrictions and disruptions to health services, impacted the accessibility of hormonal long-acting reversible contraception (LARC) devices within Australia. Here, we explore longitudinal patterns of dispensing of the contraceptive implant and hormonal intrauterine devices (IUDs) within Australia, before and during the COVID-19 pandemic.
    METHODS: Population-based cohort study; analysis of 10% random sample of national Pharmaceutical Benefits Scheme dispensing data, for females aged 15-49 years dispensed a hormonal LARC device between February 2017 and November 2021.
    RESULTS: Interrupted time-series analysis demonstrated overall that there were no significant differences in monthly dispensing rates of hormonal LARC following the Australian onset of the pandemic in April 2020, with no subsequent change in the trend. However, when stratified by LARC type, a significant increase was evident during the pandemic period (April 2020-November 2021) in the rate of hormonal IUD dispensing per month (0.20 per 10 000 95% CI 0.01 to 0.38)), compared with a decrease for the implant (-0.08 per 10 000 (95% CI -0.16 to 0.01)). Increases in hormonal IUD dispensing during the pandemic were most pronounced for those aged 20-24 years, new users, those without a Commonwealth concession card, and in the State of Victoria.
    CONCLUSIONS: Within Australia in the defined pandemic period, access to hormonal LARC devices was not negatively impacted. Rather a significant increase in dispensing of hormonal IUDs was evident.
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  • 文章类型: Journal Article
    目的:评估妇女产后即刻的避孕偏好,并确定六个月后与使用所需避孕方法相关的因素。
    方法:这项前瞻性队列研究包括在巴西一家公立医院分娩后≤48小时的女性。妇女的访谈发生在出院前(面对面访谈)和分娩后六个月(通过电话联系)的两个不同时刻。对于数据收集和管理,我们使用了REDCap电子工具。使用单变量和多变量分析(未调整和调整的赔率比和95%置信区间)来确定与分娩后六个月使用较高的避孕方法相关的因素。
    结果:共纳入294名妇女(166名青少年)。最初的避孕偏好尤其是宫内节育器(IUD)(39.1%),植入物(33.0%)和可注射激素避孕药(17.0%)。六个月后,42.5%(n=125)使用所需的避孕方法。年龄更小,白种人和出院前开始使用避孕药与6个月时使用所需的避孕药有关.
    结论:长效可逆避孕(LARC)方法是分娩后妇女最需要的避孕药。在从分娩单元出院之前提供和开始免费避孕对于使用它们所需的方法是重要的。
    OBJECTIVE: To assess women\'s contraceptive preferences in the immediate postpartum period and identify factors associated with use of their desired contraceptive method six months later.
    METHODS: This prospective cohort study included women ≤48 h after delivery at a single public Brazilian hospital. The women\'s interview took place in two different momentsbefore hospital discharge (in-person interview) and six months after delivery (by telephone contact). For data collection and management, we used the REDCap electronic tool. Univariate and multivariate analyses (unadjusted and adjusted Odds Ratio and 95 % confidence intervals) were used to identify factors associated with higher use of their desired contraceptive method six months after delivery.
    RESULTS: A total of 294 women (166 adolescents) were included. Initial contraceptive preferences were especially intrauterine devices (IUDs) (39.1 %), implants (33.0 %) and injectable hormonal contraceptives (17.0 %). Six months later, 42.5 % (n = 125) were using their desired contraceptive method. Younger age, white race and contraceptive initiation prior to hospital discharge were associated with use of their desired contraceptive at six months.
    CONCLUSIONS: Long-acting reversible contraception (LARC) methods were the most desired contraceptives among women after delivery. Providing and initiating free contraception prior to discharge from a birthing unit is important with regard to use of their desired method.
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  • 文章类型: Journal Article
    为了检查高危型人乳头瘤病毒(HPV)感染和宫颈发育不良的患病率,和HPV感染的清除率,在不同类型的宫内节育器(宫内节育器)和其他避孕方法的使用者中。
    一项基于注册的横断面研究,包括2017-2018年在瑞典县参加宫颈癌筛查计划的16,181名30-49岁女性。来自筛查记录的避孕数据与HPV检测结果配对,细胞学和组织学随访试验以及随后的HPV检测。
    HPV阳性的风险没有差异,或组织学HSIL+,含铜宫内节育器使用者与未报告使用避孕药具的妇女之间的关系。使用左炔诺孕酮宫内系统和激素避孕与年龄校正模型(aOR1.21;95%CI1.04-1.41和aOR1.41;95%CI1.22-1.63)和HSIL+(aOR1.45;95%CI1.02-2.06和aOR1.56;95%CI1.13-2.16)的HPV感染几率较高。HPV清除率无显著差异。
    报告使用左炔诺孕酮宫内节育系统和激素避孕,但不使用铜宫内节育器,与未报告使用避孕药相比,HPV感染和组织学HSIL+的患病率更高。
    在横断面研究中,使用铜宫内节育器的妇女与未使用避孕药的妇女相比,HPV或宫颈发育不良的患病率没有差异。
    UNASSIGNED: To examine the prevalence of infections with high-risk human papillomavirus (HPV) and cervical dysplasia, and the clearance rate of HPV infections, in users of different kinds of intrauterine devices (IUDs) and other contraceptive methods.
    UNASSIGNED: A cross-sectional register-based study including 16,181 women aged 30-49 years participating in the screening programme for cervical cancer in a Swedish County in 2017-2018. Data on contraception from screening records was paired with the HPV test results, cytological and histological follow-up tests and subsequent HPV test.
    UNASSIGNED: There was no difference in the risk of being HPV positive, or histological HSIL+, between users of copper-containing IUDs and women with no reported use of contraception. Use of levonorgestrel intrauterine system and hormonal contraception were associated with higher odds for HPV infection in age-adjusted models (aOR 1.21; 95% CI 1.04-1.41, and aOR 1.41; 95% CI 1.22-1.63, respectively) and for HSIL+ (aOR 1.45; 95% CI 1.02-2.06, and aOR 1.56; 95% CI 1.13-2.16, respectively). No significant differences were found in HPV clearance rates.
    UNASSIGNED: Reported use of levonorgestrel intrauterine system and hormonal contraception, but not use of copper IUD, was associated with a higher prevalence of HPV infections and histological HSIL + compared to no reported use of contraception.
    Women using copper IUD showed no difference in prevalence of HPV or cervical dysplasia compared to women not using contraception in cross-sectional study.
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  • 文章类型: Journal Article
    目的:评价宫腔球囊和宫内节育器对中重度宫腔粘连不孕患者宫腔镜下粘连松解术后粘连重建的预防效果及妊娠结局。
    方法:前瞻性,随机化,对照试验研究。
    方法:某三级大学医院。
    方法:共纳入130例中度(美国生育学会[AFS]评分5-8分)和重度(AFS评分9-12分)宫腔粘连患者。
    方法:将86例患者平均分为使用IUD治疗1个月的组和使用IUD治疗2个月的组。44名患者被分配到使用Foley导管球囊治疗的组。(宫内节育器:元宫宫内节育器)。
    结果:主要结局指标是AFS评分,子宫内膜厚度,和妊娠结局。宫腔镜检查后,AFS评分明显下降(P<0.05),而子宫内膜厚度在三组间显著增加(P<0.001).值得注意的是,球囊组AFS评分下降幅度大于IUD-1个月组和IUD-2个月组(P<0.01),IUD组之间无显著差异(P=0.298)。最后,此外,3组子宫内膜厚度增加程度(P=0.502)和妊娠结局(P=0.803)无显著差异。
    结论:插入球囊或放置宫内节育器一两个月可以有效降低粘连复发的风险,并恢复子宫腔的形状。虽然球囊的治疗效果优于宫内节育器,1个月和2个月IUD组无显著差异.
    背景:这项研究已在中国临床试验注册中心注册(http://www.chictr.org.cn/enIndex。aspx);临床试验注册标识号:ChiCTR-IOR-17,011,943(http://www.chictr.org.cn/showprojen.aspx?proj=17979)。试用登记日期:2017年7月11日。
    OBJECTIVE: To evaluate the efficacy and pregnancy outcomes of intrauterine balloon and intrauterine contraceptive devices in the prevention of adhesion reformation following hysteroscopic adhesiolysis in infertile women with moderate to severe intrauterine adhesion.
    METHODS: A prospective, randomized, controlled trial study.
    METHODS: A tertiary university hospital.
    METHODS: A total of 130 patients with moderate (American Fertility Society [AFS] score of 5-8) and severe (AFS score of 9-12) intrauterine adhesions were recruited.
    METHODS: 86 patients were evenly allocated to group treated with an IUD for 1 month and group treated with an IUD for 2 months. 44 patients were allocated to group treated with a Foley catheter balloon.(IUD: Yuangong IUD).
    RESULTS: The primary outcome measures were the AFS score, endometrial thickness, and pregnancy outcome. After hysteroscopy, the AFS score was significantly decreased(P<0.05), whereas endometrial thickness was significantly increased across the three groups(P<0.001). Notably, the decline in the AFS score in the balloon group was greater than that in the IUD-1-month group and IUD-2-month group(P<0.01), with no significant difference between the IUD groups(P = 0.298). Lastly, In addition, the extent of the increase in endometrial thickness(P = 0.502) and the pregnancy outcomes(P = 0.803) in the three groups were not significantly different.
    CONCLUSIONS: Inserting a balloon or placing an IUD for one or two months can effectively lower the risk of adhesion recurrence and restore the shape of the uterine cavity. While the therapeutic effect of the balloon was superior to that of the IUD, no significant differences were observed in the one-month and two-month IUD groups.
    BACKGROUND: This research was registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/enIndex.aspx ); Clinical trial registry identification number: ChiCTR-IOR-17,011,943 ( http://www.chictr.org.cn/showprojen.aspx?proj=17979 ). Date of trial registration: July 11, 2017.
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  • 文章类型: Journal Article
    目的:中国大多数插入的宫内节育器(IUD)是无尾的,需要宫内手术切除并引起疼痛。这项研究旨在研究利多卡因注射到新型一次性可注射宫颈扩张器中用于IUD取出程序的镇痛效果。
    方法:双盲,安慰剂对照,我们对年龄在18~65岁之间的女性进行了随机临床试验,要求在门诊取出宫内节育器.该研究将参与者随机分配到利多卡因(将5ml的2%利多卡因注射到可注射的宫颈扩张器中)或安慰剂(将5ml的生理盐水注射到装置中)组。所有参与者都接受了标准化的宫颈旁阻滞。主要结果是在100mm视觉模拟量表(VAS)上报告的IUD取出过程中的疼痛。进行意向治疗以评估将利多卡因注射到可注射的宫颈扩张器中的镇痛效果。
    结果:我们招募了74名符合条件的参与者(利多卡因组37名,安慰剂组37名)。结果显示,利多卡因组的术中VAS评分中位数低于安慰剂组(30.0mm[IQR20.0-46.0,n=37]vs46.0mm[IQR30.0-55.0,n=37],P=0.01。在亚组分析中,在取出宫内节育器和没有子宫操作和额外程序的参与者中,利多卡因组和安慰剂组之间的术中VAS评分无统计学差异(15.0mm[IQR10.0-27.5,n=8]vs20.0mm[IQR20.0-40.0,n=6]),p=0.28)。在需要进行宫内节育器取出且无需额外程序的参与者中,与安慰剂组(46.0mm[IQR38.5-50.0,n=23])相比,利多卡因组(25.0mm[IQR15.0-40.5,n=17])的术中VAS评分较低,p<0.01。在除取出宫内节育器外还需要额外程序的参与者中,利多卡因组和安慰剂组之间的术中VAS评分无统计学差异(41.0mm[IQR32.5-57.5,n=12]vs45.0mm[IQR22.5-69.0,n=8]),p=0.97)。
    结论:将利多卡因注射到用于宫颈扩张的新型一次性可注射宫颈扩张器中,可以显着减轻IUD取出过程中的疼痛,特别是在IUD取出期间需要宫内操作的患者。
    结论:当我们必须进行宫内手术以取出宫内节育器时,手术疼痛和颈管狭窄无疑影响手术的实施。将利多卡因注入可注射的宫颈扩张器可在扩张宫颈的同时实现局部麻醉,并可能减少宫内节育器取出的全身麻醉选择。
    OBJECTIVE: The majority of intrauterine devices (IUDs) inserted in China are tailless, requiring intrauterine manipulations for removal and causing pain. This study aimed to investigate the analgesic efficacy of lidocaine injection into a novel disposable injectable cervical dilator for IUD removal procedures.
    METHODS: A double-blinded, placebo-controlled, randomized clinical trial was conducted with women aged 18-65 years old requesting outpatient IUD removal. The study randomly assigned participants to either lidocaine (injecting 5 ml of 2% lidocaine into the injectable cervical dilator) or placebo (injecting 5 ml of normal saline into the device) group. All participants received a standardized paracervical block. The primary outcome was pain reported during IUD removal on a 100 mm Visual Analog Scale (VAS). Intention-to-treat were conducted to evaluate the analgesic effectiveness of injecting lidocaine into the injectable cervical dilators.
    RESULTS: We enrolled seventy-four eligible participants (37 in lidocaine group and 37 in placebo group). The results showed that the median intraoperative VAS score in the lidocaine group was lower than the placebo group (30.0 mm [IQR 20.0-46.0, n = 37] vs 46.0 mm [IQR 30.0-55.0, n = 37], p = 0.01. In subgroup analyses, among participants with IUD removal and without uterine manipulation and additional procedures, there was no statistically significant disparity observed in intraoperative VAS scores between the lidocaine and placebo group (15.0 mm [IQR 10.0-27.5, n = 8] vs 20.0 mm [IQR 20.0-40.0, n = 6]), p = 0.28). Among participants with an IUD removal necessitating intrauterine manipulations and without additional procedures, showing lower intraoperative VAS scores in lidocaine group (25.0 mm [IQR 15.0-40.5, n = 17]) compared to placebo group (46.0 mm [IQR 38.5-50.0, n = 23]), p < 0.01. Among participants with additional procedures in addition to IUD removal, there was no statistically significant disparity observed in intraoperative VAS scores between the lidocaine and placebo group (41.0 mm [IQR 32.5-57.5, n = 12] vs 45.0 mm [IQR 22.5-69.0, n = 8]), p = 0.97).
    CONCLUSIONS: Injecting lidocaine into the novel disposable injectable cervical dilator for cervix dilation can significantly reduce pain during an IUD removal, particularly in patients necessitating intrauterine manipulations during IUD removal.
    CONCLUSIONS: When we have to perform intrauterine manipulations to remove an IUD, surgical pain and narrow cervical canal undoubtedly affect the implementation of the procedure. Injecting lidocaine into the injectable cervical dilator can achieve local anesthesia while dilating the cervix, and might reduce the choice of general anesthesia for IUD removal.
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