Performance of the Frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women

The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was significantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD.Both Frameless IUD and TCu380A are highly effective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is significantly more effective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.     

B超监测下放置吉妮IN IUD的临床效果观察

目的:观察B超监测放置吉妮IN IUD宫内节育器的临床效果。方法:多中心随机分组在B超监测下放置吉妮IN IUD289例,TCu380A IUD 303例,分别于术后1、3、6、12、24、36个月行妇科及B超随访,以生命表方法统计结果并行显著性检验。结果:①术后疼痛TCu380A组明显高于吉妮IN组(P<0.05);术后6~36月,月经紊乱以TCu380A组为高(P<0.05)。②两组带器妊娠率均较低(吉妮IN组1.04/100妇女,TCu380A组1.32/100妇女,P>0.05);脱落率TCu380A组(6.60/100妇女)高于吉妮IN组(4.84/100妇女,P<0.05);吉妮IN组因出血和疼痛的终止率(2.77/100妇女)较TCu380A组(5.61/100妇女)低(P<0.05)。结论:吉妮INIUD具有与TCu380A IUD同样高的避孕效率,其在降低脱落率、因症取出率及副反应发生率方面优于TCu380A IUD。     

B超监测下吉妮和TCu 380 A宫内节育器592例临床分析

目的:①多中心观察B超监测下放置吉妮和TCu380A宫内节育器(IUD)并随访12月的临床效果;②探讨吉妮IUD近期脱落的原因。方法:随机分组并在B超监测下放置吉妮IUD289例,TCu380AIUD303例,术后1、3、6、12月定期妇科及B超随访,记录受试对象病史、术时和术后情况,用SPSS10.0软件包进行数据处理,以生命表方法统计结果并行显著性检验。结果:①术后疼痛症状发生情况TCu380AIUD组明显高于吉妮IUD组,差异有显著性(P<0.05);术后6、12月随访月经紊乱以TCu380AIUD组为高,差异有显著性(P<0.05)。②术后6月、12月生命表结果提示吉妮IUD组因出血和疼痛的终止率较TCu380AIUD组低,差异有显著性(P<0.05)。③子宫后位者易发生带器妊娠,脱落与月经量及置器医生放置IUD质量有关。结论:吉妮IUD的避孕效果与国际推荐使用的TCu380AIUD一致,置器后出血和疼痛副反应少于后者。引入B超监测IUD放置过程对杜绝放置的不安全隐患有重要作用,也是在监控和验证放置IUD质量、年轻医生的培训过程及基层推广应用中必须注意的问题。     

3种宫内节育器临床避孕效果随访1年观察

目的观察GyneFix IN IUD、MCu IUD、TCu220C IUD的临床避孕效果。方法2003年6月~2006年6月本院采用对比性研究,以随机方法放置3种IUD635例,其中GyneFix IN IUD 212例,MCu IUD213例,TCu220C IUD 210例,于放置后1、3、6、12个月进行随访。结果3种IUD12个月的带器妊娠率、脱落率、因症取出率和累积续用率分别为GyneFix IN IUD0.47%,0.94%,0.47%,98.11%;MCu IUD0.94%,0.94%,1.41%,96.24%;TCu220C IUD0.95%,5.71%,4.29%,88.10%。3种IUD带器妊娠率比较,差异无显著性意义(P>0.05);GyneFix IN IUD和MCu IUD的脱落率低于TCu220C IUD,差异有非常显著性意义(P<0.01);GyneFix IN IUD和MCu IUD的因症取出率低于TCu220C IUD,差异有显著性意义(P<0.05);GyneFix IN IUD和MCu IUD的12个月的累积续用率高于TCu220C IUD,差异有非常显著性意义(P<0.01)。结论GyneFix IN IUD和MCuIUD具有脱落率低、因症取出率低、累积续用率高的优点,值得临床应用。根据对象的自身条件,选择合适的IUD,可提高避孕效果,减少副反应的发生。     

The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial

Background

Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared.

Study Design

Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years.

Results

Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI: 4.4-6.4) per 100 and 2.5 (95% CI: 1.9-3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9-2.0) and 0.5 (95% CI: 0.3-0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI: 0.7-1.9) and 2.5 (95% CI: 1.8-3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different.

Conclusions

The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.     

Comparison of the performances of TCu380A and TCu380S IUDs up to five years

A modification of the TCu380A IUD to create the model TCu380S was introduced many years ago. The TCu380S utilizes copper sleeves that are flush in the plastic and are set at both ends of the horizontal arm. The objective of this study is to compare the clinical performance of the TCu380A and the TCu380S IUDs, especially regarding contraceptive performance and expulsion, in a cohort of women who had one of these two devices inserted at random. This paper presents the results up to 5 years of use. A total of 1568 women were enrolled: 806 women received a TCu380A and 762 women received a TCu380S IUD. The performance was evaluated by life-table analysis and significance between rates was tested by the method of log-rank. The cumulative pregnancy rate was low in users of both models of IUD but lower in users of the TCu380S model through the 5 years of use, without statistical significance. Expulsion was significantly higher in users of the TCu380S model during the five years of use. The other reasons for discontinuation were similar for both devices and did not show statistical significance. The continuation rate was significantly lower in users of the TCu380S model in the first and second years of use. Both devices presented a very low pregnancy rate and TCu380S presented a lower pregnancy rate than the TCu380A, although without statistical significance.     

两种新型含铜IUD对宫颈沙眼衣原体阳性率影响的研究

本文报道了同期放置的TCu380A及GyneFix两种新型含铜宫内节育器在放置1年及2年时与对照组宫颈砂眼衣原体(CT)阳性率的比较。TCu380A组放置1年时阳性率为5.63％,2年时为4.92％;GyneFix组放置1年时阳性率为4.62％,2年时为5.08％,两组含铜IUD放置1年及2年时各组比较差别均无显著意义(P>0.05);对照组CT阳性率为15.18％,与上述各组比较差别均有显著意义(P<0.05)。本文结论认为含铜IUD对宫颈CT感染有抑制作用。     

TCu220 IUD、吉妮柔式IUD使用12个月临床效果观察

目的:评价TCu220、吉妮柔式两种宫内节育器(IUD)使用效果,为推广新型IUD提供依据。方法:采用整群抽样方法,选择本市13个县、市区在2006年1月~2007年1月放置TCu220、吉妮柔式IUD的所有已婚育龄妇女,随访1年,观察两种IUD使用效果及副反应发生情况。结果:放置TCu220IUD高孕次(>5次)妇女副反应发生率增加(P<0.05),放置吉妮柔式IUD妇女各孕次段副反应发生率比较差异均无统计学意义(P>0.05)。TCu220及吉妮柔式IUD使用满1年的妊娠率、脱落率、因症取出率、总终止率和续用率分别为每百妇女0.96、7.44、7.43、15.73、84.27及0.85、3.00、4.98、11.47、88.53,吉妮柔式IUD脱落率、因症取出率和总终止率明显低于TCu220IUD,差异均有统计学意义(P<0.05,P<0.01,P<0.01)。结论:两种IUD避孕效果可靠,孕次影响TCu220 IUD副反应的发生,吉妮柔式IDU在脱落和因症取出方面明显优于TCu220 IUD。     

剖宫产妇女放置两种IUD临床效果观察

目的 :观察剖宫产妇女放置新型GyneFixIN宫内节育器 (IUD)的临床效果。方法 :采用随机对照临床研究方法 ,对 195例有剖宫产史的健康妇女于月经后或人工流产术毕即时放置GyneFixINIUD 99例 (吉妮组 )及TCu2 2 0CIUD 96例 (TCu2 2 0C组 ) ,于放器后 1、3、6、12和 2 4个月随访 ,以生命表法统计两种IUD的终止情况。结果 :吉妮组使用 2年脱落率和因症取出率分别为每百妇女 1.0 1和 2 .0 2 ,明显低于TCu2 2 0C组的每百妇女 10 .4 2和 8.33(P <0 0 1)。结论 :GyneFixINIUD无支架 ,铜表面积大并固定于子宫底 ,更适合有剖宫产史妇女放置     

4种新型宫内节育器使用5年临床效果评价

为较好掌握新型 IUD 的优点和特征,便于医务人员根据不同育龄妇女身体状况选择适当的 IUD 类型,本课题对2400例育龄妇女随机放置 TCu380A、三球头 TCu220C、MLCu375SL 和含药宫铜4种新型 IUD 使用5年间的终止原因进行临床多中心研究分析。结果表明:第二代活性 IUD具有安全、高效、长效的优点,其中尤以 TCu380A 具有较高续用率(78.1/100妇女),其妊娠率(带器妊娠及意外妊娠)为4.9/100妇女,脱落率也最低,为6.9/100妇女(P<0.05);MLCu375SL 城市组使用效果明显优于农村组,其5年续用率分别为80.54/100妇女和66.89/100妇女(P<0.05);农村组脱落率最高,为14.6/100妇女(P<0.05);含药宫铜 IUD 置器后月经量增加的症状明显减少,因症取出率最低,5年末为3.7/100妇女(P<0.01);;三球头 TCu220C 具有低因症取出率和低脱落率的优点,但带器妊娠率最高,为8.4/100妇女(P<0.01)。结果提示:T 铜 IUD 的脱落率相对较低;三球头 TCu220C 的球头和含药宫铜 IUD 所含的消炎痛在减少副反应方面有一定的作用;ML-Cu375SL 适合城市妇女使用。     

TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age

OBJECTIVE: The objective of the study was to evaluate the performance of the TCu 380A IUD in women who had been using the device for more than 10 years and who were 35 years of age or more on completion of the 10th year of IUD use. METHODS: A total of 228 women who had an IUD inserted between 1987 and 1992 were included in the study. The cutoff date for analysis was January 31, 2004. Clinical performance was evaluated by life-table analysis. The mean age of women at 10 years of use was 38.8+/-0.4 years and mean parity was 2.2+/-0.08 (mean+/-SD). The duration of follow-up beyond 10 years ranged from 1 to 72 months. No pregnancy was observed in 366 woman-years of observation beyond 10 years of use. The main reason for discontinuation was removal of the device because the clients had previously been informed that the IUD was not approved for use beyond 10 years. This reason accounted for a gross cumulative 6 years discontinuation rate of 42.5 per 100 women beyond 10 years. The other main reasons for discontinuation beyond 10 years of use were surgical sterilization, menopause and expulsion with gross cumulative 6-year termination rates of 19.2, 11.0 and 21.2 per 100 women, respectively. The cumulative continuation rate beyond 10 years was 67.0 at the end of the first year of follow-up and 21.2 at the end of the sixth year. CONCLUSION: We found no evidence that the TCu 380A IUD loses its effectiveness after 10 years of use. RESULTS: The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained.     

Long-term reversible contraception: Twelve years of experience with the TCu380A and TCu220C

Few data on the long-term efficacy of intrauterine devies (IUD) are available, and this article reports on the final 12-year experience with the TCu220C and TCu380A devices from two randomized, multicenter trials conducted in 24 centers. A total of 3,277 and 1,396 women, respectively, were recruited for use of each device between 1981 and 1986 and followed at 3, 6, and 12 months after insertion and yearly thereafter. At the end of 12 years, a total of 17,098 women-years of experience had been accumulated for the TCu220C and 7,159 women-years for the TCu380A. The cumulative 12-year intrauterine pregnancy rates were 7.0 (standard error [SE] 0.6) per 100 women for the TCu220C and 1.9 (SE 0.5) for the TCu380A (p < 0.001). Pregnancy rates were highest in the first years after insertion; the TCu220C had a consistently higher annual pregnancy rate than did the TCu380A at all intervals since insertion. No pregnancies were reported with the TCu380A after 8 years of use. Total medical removals were approximately 6% in the first year and dropped to approximately 4% per year for each device for up to 12 years of use (cumulative 12 year rates were 37.3 [SE 1.3] and 40.2 [SE 2.1] per 100 women for the TCu220C and TCu380A devices, respectively). The overall continuation rate at all intervals since insertion was higher with the TCu220C device, mainly due to higher removal rates for nonmedical reasons with the TCu380A. The cumulative ectopic pregnancy rates were 0.7 and 0.4 for the TCu220C and TCu380A, respectively. Pregnancy rates were higher in the Chinese compared with the non-Chinese centers for both devices, though the greater efficacy of the TCu380A was apparent in both groups of centers. The total medical and nonmedical removal rates were lower in the Chinese compared with the non-Chinese centers, and did not show any substantial differences between the devices. We conclude that both devices are safe and effective for at least 12 years of use and the low pregnancy rate with the TCu380A is comparable with that reported in the United States among women who had undergone tubal sterilization. The very high efficacy of the TCu380A makes it the IUD of choice, and it can be considered as a potentially reversible, nonsurgical alternative to sterilization for women requiring very long-term pregnancy protection.     

MCuⅡIUD与TCu380A IUD放置60个月临床效果对比研究

目的:观察放置MCuⅡ功能性宫内节育器(MCuⅡIUD)的临床效果及安全性。方法:国内多中心统一标准,选择2000例要求放置IUD避孕的妇女,随机放置MCuⅡIUD与TCu380A IUD各1000例,定期随访观察60个月。结果:放置满60个月,MCuⅡIUD与380ATCu IUD的带器妊娠率分别为1.83/百妇女年、2.10/百妇女年,差异无统计学意义(P>0.05);脱落率分别为0.72/百妇女年、3.03/百妇女年,差异有统计学意义(P<0.05);因出血/疼痛取出分别为4.54/百妇女年、6.12/百妇女年,副作用发生率分别为3.50%、3.80%,差异均无统计学意义(P>0.05);计划妊娠取器后两组妊娠率分别为86.6%、91.7%,差异无统计学意义(P>0.05)。结论:MCuⅡIUD避孕效应高,脱落率低,放置后出现副作用发生率低,可逆性好,是比较理想的IUD。     

四种宫内节育器的对比研究

本研究用实验流行病学方法,按随机分配原则对比了TCu380A、TCu220三球头、MLCu375SL、含药宫铜IUD四种宫内节育器(以下简称IUD)在江苏省育龄妇女中的使用效果。从1991年10月至1992年3月随机放置四种IUD,其中:TCu380A 593例,TCu220三球头606例,MLCu375SL 600例,含药宫铜IUD601例,共计2400例,农村、城市受试对象各为1200例。置器24个月时四种IUD累积续用率分别为:TCu380A 87.34/百妇女年,TCu220三球头88.41/百妇女年,MLCu375SL 87.32/百妇女年,含药宫铜型88.18/百妇女年,组间比较无显著差异(P>0.05);因妊娠、脱落、出血/疼痛终止率,四种IUD间均无显著差异;含药宫铜IUD明显降低出血副反应的发生率;按城、乡分组在24个月时农村组续用率较高,对此结果进行了探讨。     

3种宫内节育器临床使用12个月避孕效果比较分析

目的:比较育龄妇女月经间期放置3种宫内节育器(IUD)的使用效果.方法:对2008年1月～2010年5月在本中心、青海红十字医院和乐都县计划生育服务站放置GyneFix330、TCu380A和MLCu375IUD共799例妇女进行1年随访,比较使用1年的临床效果和副反应.结果:GyneFix330、TCu380A和ML...     

Arandomized multicentre trial of the Multiload 375 and TCu380A lUDs in parous women: three-year results

Two copper IUDs—the Multiload 375 and TCu380A—are being studied in a randomized multicentre study in parous women involving nineteen centres in nine countries. There have been 1,832 insertions of the Multiload 375 and 1,823 of the TCu380A. After three years of use, the Multiload 375 had a pregnancy rate that was significantly higher than the TCu380A (2.9 ± 0.4 vs. 1.6 ± 0.3 per 100 women). There were no differences at one, two and three years of use in the expulsion rates. It is concluded that the Multiload 375 shows no clinical advantages over the TCu380A and its extra cost should be an important consideration in the choice of the most appropriate IUD.     

月经间期放置MYCu宫内节育器临床效果的比较性研究

目的:了解第三代爱母宫内节育器(MYCu IUD)在月经间期放置的临床效果、副作用及对生活质量的影响。方法:对要求放置IUD避孕的育龄妇女,在月经间期随机放置MYCu IUD(MYCu组,368例)与TCu 380AIUD(TCu380A组,369例),放置后1、3、6、12个月随访观察,记录使用情况。结果:置器后12个月MYCu组与TCu 380A组随访率分别为99.45%、100.00%;置器12个月累积续用率分别为每百妇女年94.02、91.87(P0.05);带器妊娠率分别为每百妇女年0.56、0.00(P=0.1703);脱落率分别为每百妇女年0.57、1.95(P=0.0947);无因IUD下移而停用者;因症终止率分别为每百妇女年3.01、6.03(P=0.0849)。置器后1、3、6个月副作用发生率MYCu组明显低于TCu380A组(P0.05)。两组对象相关生活质量均得到改善。结论:放置MYCu IUD较TCu 380AIUD疼痛和出血的副作用少,续用率、避孕效果与TCu 380AIUD相当,是一种临床效果好、副作用发生率较低的新型IUD。     

不同分娩方式妇女放置三种IUD的术时评价

目的:研究不同分娩方式妇女放置三种新型含铜宫内节育器(CulUD)的术时评价。方法:将观察对象按经阴道和经剖宫产的不同分娩方式分为两组,每组均随机放置CyneFix IN IUD、MCu功能性IUD和TCu380A IUD,记录两组放置不同种IUD的扩宫情况、置器疼痛反应和置器时间。结果:放置GyneFix IN IUD和TCu380A IUD在不同分娩方式组中扩宫率、痛觉评分、置器时间无显著差异(P>0.05)。放置MCu功能性IUD在剖宫产分娩组扩宫率为92.5％,显著高于阴道分娩组的33.3％(P<0.05);痛觉评分为8.62±0.82分,显著高于阴道分娩组(P<0.01);置器时间为(9.62±3.15)min,较另两种IUD置器时间显著延长(P<0.05)。结论:GyneFix IN IUD和TCu380A IUD置器术时扩宫率低、费时少,疼痛反应轻,不受分娩方式影响。     

吉妮致美IUD对月经出血模式影响及特殊时期使用的系统评价

目的:系统评价吉妮致美与其他吉妮系列产品对月经出血模式的影响,以及吉妮致美在特殊情况下使用的效果。方法:计算机检索CNKI(1979~2014)、CBMdisc(1978~2014)、万方(1982~2014)、维普(1989~2014)数据库,并结合手工检索相关杂志。根据纳入、排除标准筛选文献,并经质量评价后,采用RevMan 5.0软件进行meta分析。结果:文献检索共检到580篇文献,根据纳入排除标准,最终纳入7篇已发表研究。分析结果显示:1在经量增多发生率、经期延长发生率、点滴出血发生率方面,吉妮致美普遍低于吉妮IN和吉妮柔适;2在人工流产后即时放置吉妮致美和宫铜200宫内节育器(IUD)的比较中,吉妮致美具有更低的脱落相关终止率和因症取出率;3在有剖宫产史的妇女中,带器妊娠率、脱落相关终止率、因症取出率方面,吉妮致美均低于元宫Cu220IUD或TCu220CIUD,在脱落相关终止率、因症取出率方面,吉妮致美均低于TCu380AIUD。结论:吉妮致美可以有效改善月经出血模式,同时在人工流产后即时放置或者有剖宫产史的妇女中放置时,可以有效预防妊娠、降低IUD脱落率并减少因症取出率,进而提高续用率,值得推广应用。     

Safety and efficacy in parous women of a 52-mg levonorgestrel-medicated intrauterine device: a 7-year randomized comparative study with the TCu380A

ObjectivesTo compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) levonorgestrel IUD (LNG-IUD) or the copper T 380 A (TCu380A) intrauterine device.Study designThis was an open-label 7-year randomized controlled trial in 20 centres, 11 of which in China. Data on 1884 women with interval insertion of the LNG-IUD and 1871 of the TCu380A were analysed using life tables with 30-day intervals and Cox proportional hazards models.ResultsThe cumulative 7-year pregnancy rate of the LNG-IUD was 0.5 (standard error 0.2) per 100, significantly lower than 2.5 (0.4) per 100 of the TCu380A, cumulative method discontinuation rates at 7 years were 70.6 (1.2) and 40.8 (1.3) per 100, respectively. Dominant reasons for discontinuing the LNG-IUD were amenorrhea (26.1 [1.3] per 100) and reduced bleeding (12.5 [1.1] per 100), particularly in Chinese women and, for the TCu380A, increased bleeding (9.9 [0.9] per 100), especially among non-Chinese women. Removal rates for pain were similar for the two intrauterine devices (IUDs). Cumulative rates of removal for symptoms compatible with hormonal side effects were 5.7 (0.7) and 0.4 (0.2) per 100 for the LNG-IUD and TCu380A, respectively, and cumulative losses to follow-up at 7 years were 26.0 (1.4) and 36.9 (1.3) per 100, respectively.ConclusionThe LNG-IUD and the TCu380A have very high contraceptive efficacy, with the LNG-IUD significantly higher than the TCu380A. Overall rates of IUD removals were higher among LNG-IUD users than TCu380A users. Removals for amenorrhea appeared culturally associated.ImplicationsThe 52-mg LNG-IUD and the TCu380A have very high contraceptive efficacy through 7 years. As an IUD, the unique side effects of the LNG-IUD are reduced bleeding, amenorrhea and symptoms compatible with hormonal contraceptives.