The T 380A intrauterine device: a retrospective 5-year evaluation

Background

The undue resistance to intrauterine device (IUD) use seen in several settings does not seem to occur in the Family Planning Unit of UNIFESP-EPM (São Paulo Federal University, Brazil). In fact, the Copper T 380A IUD in this clinic has reached an outstanding importance and this motivated us to present our differing experience. The prevalence of this method in this clinic is as high as 40%. This contrasts to the low use in the rest of the country, where tubal ligation is by far the most used contraceptive method (40%) and where IUD is inexpressive (1.1%).

Study Design

This is a retrospective study of the records of 118 users of Copper T 380A IUD inserted at the clinic and who were followed during 5 years.

Results

The cumulative pregnancy rate was 0.8%. The main cause for discontinuation of the study was loss to follow-up (21.3%). Other reasons for the withdrawal of the device were personal option (13.6%), dislocation (11.7%) and pregnancy wish (3.4%). There was no withdrawal by pelvic inflammatory disease. Bleeding (0.8%) was not an important cause for withdrawal, and there were no withdrawals due to pain. The continuation rate at 5 years was 46.7%.The structured service and an adequate educative program perhaps could explain at least partially the good performance of IUD use in this clinic. There was an amazing prevalence of the components of the metabolic syndrome. This could represent contraindications for hormonal contraception, and, in consequence, it could influence the increased option for and continuation of the IUD.

Conclusion

These data show a good performance of the IUD for long duration, in relation to other studies, and this should be considered as a reliable alternative to the high prevalence of female sterilization in this country.     

Continuation rates and reasons for discontinuing TCu380A IUD use in Tabriz, Iran

PURPOSE: The long-term effectiveness of copper-bearing intrauterine device (IUD) has been documented. This paper reports results from a 60-month study on the use of TCu380A IUD among 401 women in Tabriz, Iran. MATERIALS: In 2003, a 5% sample of women who had had an IUD inserted between May 1997 and May 1999 was taken. Analyses of discontinuation employed Tietze net rate life tables. RESULTS: Continuation of TCu380A IUD use by women at 1 month, 6 month, 1 year, 2 years, 3 years, 4 years and 5 years was 98.2, 89.3, 79.3, 68.3, 57.6, 49.5 and 45.0 per 100, respectively. Among women using the TCu380A IUD, the rate of termination due to pain/bleeding was significantly higher than the rate of termination due to other causes. Overall, two pregnancies were reported within 5 years after insertion. A third pregnancy occurred on Year 6. CONCLUSION: These findings indicate that family planning educators and health care providers should give more emphasis to counseling programs for women desiring IUD insertion and during follow-up.     

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。     

TCu380A、TCu220C和MLCu375宫内节育器系统评估

目的 :评价TCu380A、TCu2 2 0C、MLCu375三种宫内节育器的有效性、副反应和可接受性。方法 :见中国计划生育学杂志“我国常用口服避孕药和宫内节育器系统评估的方法概述”(2 0 0 5年 1期 17页 )。结果 :TCu380AIUD妊娠率及脱落率均低于MLCu375IUD ,副作用发生率高于MLCu375IUD ,续用率等同或高于MLCu375IUD ,临床综合效能与MLCu375IUD相近 ;TCu380AIUD妊娠率低于TCu2 2 0CIUD ,脱落率及安全性与TCu2 2 0CIUD相似 ,放置满 5年后续用率高于TCu2 2 0CIUD ;MLCu375IUD妊娠率略低于TCu2 2 0CIUD ,脱落率低于或等同于TCu2 2 0CIUD ,二者的副反应发生率相似 ,临床综合效能优于TCu2 2 0CIUD。建议 :可以继续使用TCu380AIUD、MLCu375IUD和TCu2 2 0CIUD ,并且加大TCu380AIUD和MLCu375IUD的使用份额。在总体上应优先考虑提供铜表面积≥ 30 0mm2 的宫内节育器     

Menstrual problems and side effects associated with long-term TCu 380A IUD use in perimenopausal women

The study assessing menstrual problems and side effects associated with long-term TCu 380A intrauterine device (IUD) use in perimenopausal women is reported. Fifty perimenopausal TCu 380A IUD acceptors who had IUD inserted after age 40 and used IUD at least 36 months were recruited. The mean age of acceptors at time of insertion was 44.2 years with an average parity of two live births. The mean body weight at insertion was 62.13 kg. Most of the bleeding patterns were regular cycles. Intermenstrual bleeding and pelvic pain were the side effects most often reported. No pregnancies, pelvic inflammatory disease, or IUD expulsions occurred during the follow-up period. This study suggests that the use of TCu 380A IUD in perimenopausal women is safe and effective.     

MCu IUD放置8年多中心临床比较性研究

目的:观察MCu IUD的临床效果及安全性。方法:国内6个临床中心按统一标准选择1100例要求使用IUD避孕的妇女,随机放置MCu IUD与TCu380A IUD各550例,定期随访观察96个月。结果:放置满96个月时,MCu组与TCu380A组的继续使用率分别为每百妇女年77.09,72.18(P>0.05);带器妊娠率分别为每百妇女年2.50,3.42(P>0.05);脱落率分别为每百妇女年1.07,5.73,差异有极显著性意义(P<0.001);因出血/疼痛取出率分别为每百妇女年5.66,7.77(P>0.05);有副反应主诉分别为每百妇女年4.48,5.54(P<0.05);因计划妊娠取器后足月妊娠分娩两组分别为82.5%,81.08%,总妊娠率均在90%以上。结论:MCu IUD脱落率低、避孕效果和可逆性好,是比较理想的IUD。     

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.     

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.     

The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women

The objective of this paper was to compare the efficacy, acceptability, safety, and bleeding patterns of TCu 380A intrauterine device (IUD) and progesterone-releasing vaginal ring used by breastfeeding women. The study population included 97 breastfeeding women using IUD and 100 women using vaginal ring. Of the IUD users, no insertion failure, perforation, or accidental pregnancy occurred in 12 months. There was one IUD expulsion. There were no discontinuations of IUD due to medical reasons other than expulsion. The total discontinuation rate was 2.3%. In the ring group, no accidental pregnancy occurred. The major reasons for discontinuation were ring use-related problems and vaginal problems. The total discontinuation rate was 65.4% within 1 year. The frequency of any one complaint among the ring users was higher than that among the IUD users. There were no differences in the proportion of women having no sexual activity and in the weight of their babies between the two groups. Compared with the IUD users, the median number of bleeding/spotting (B/S) episodes and B/S days of the vaginal ring users were fewer; consequently, the mean length of B/S-free interval was longer in all four reference periods; the mean length of B/S episode and segment were the same; the occurrence of amenorrhea was more frequent; in contrast, the proportions of normal bleeding patterns were fewer. The frequencies of prolonged bleeding, frequent bleeding, and infrequent bleeding patterns did not differ between the two groups. The percentage of irregular bleeding was fewer only in the first two reference periods. It is concluded that the TCu 380A IUD and progesterone-releasing vaginal ring used by breastfeeding women are safe and effective. The higher discontinuation rate of the ring users was mainly because of use-related problems. Breastfeeding women with TCu 380A IUD had better tolerance and acceptability. The TCu 380A IUD does not, but the progesterone-releasing vaginal ring does, suppress the recovery of ovarian function. However, once return of menstruation occurred, there were no differences in bleeding patterns between the two contraceptive methods.     

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。     

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。     

宫内节育器不同铜表面积对月经血量的影响

对健康妇女随机放置TCu380A和TCu220C IUD后的月经血量变化进行观察,放器前TCu380A和TCu220C组平均月经血量(MBL)为45.3±13.4ml和42.6±11.5ml,放器后1、3、6、12周期平均MBL分别为72.4±41.6ml和73.2+38.3ml;77.0±42.9ml和82.9±46.9ml;73.2±31.2ml和74.5±30.5ml及64.5±18.9ml和68.2±14.4ml;放置两种IUD后MBL较放器前明显增多(P<0.001),但两种IUD间比较,放器后各周期平均MBL无显著差别(P>0.05),提示在一定范围内增加铜的表面积对放器后MBL的增加程度并无显著影响。     

TCu220C与TCu380A IUD体外细胞毒性研究

目的:评价两种含铜宫内节育器体外细胞毒性。方法:采用TCu220C和TCu380A,10%FBS-DMEM浸提后,与L929细胞接触培养,通过倒置相差显微镜观察其形态,采取MTT(四唑盐)比色法量化细胞毒性,计算相对增值率(RGR),并进行毒性评价。结果:TCu220C表现出轻度的细胞毒性(1～2级),TCu380A表现出明显的细胞毒性(4级)。结论:相同形状的两种含铜宫内节育器因含铜面积不同,其表现出来的细胞毒性也不同,含铜面积越大,细胞毒性越大。     

TCu220C与TCu380AIVD体外细胞毒性研究

目的:评价两种含铜宫内节育器体外细胞毒性.方法:采用TCu220C和TCu380A,10?S-DMEM浸提后,与L929细胞接触培养,通过倒置相差显微镜观察其形态,采取MTT(四唑盐)比色法量化细胞毒性,计算相对增值率(RGR),并进行毒性评价.结果:TCu220C表现出轻度的细胞毒性(1～2级),TCu380A表现出明显的细胞毒性(4级).结论:相同形状的两种含铜宫内节育器因含铜面积不同,其表现出来的细胞毒性也不同,含铜面积越大,细胞毒性越大.     

MCu110和TCu220C、TCu380A宫内节育器比较的系统评估

目的：评价MCu110功能性宫内节育器的有效性、副反应和可接受性。方法：通过电子和手工检索查阅2000年1月～2008年12月国内外发表的相关文献,并依照循证医学的方法对纳入评估的文献进行筛选、评价和分析。结果：共获得合格文献10篇,均为随机对照临床试验且正式发表。评估结果显示,置器后12月和24月,MCu110的临床综合效果优于TCu220C;脱落率略低于TCu380A,可接受性略优于TCu380A,副反应各项指标二者互有优劣,而带器妊娠率差别未发现有统计学意义。结论：与TCu380A相比,能够证实MCu110有效性、副反应和可接受性的多中心随机对照试验并不多,尤其是长期随访研究;建议由非MCu110研制单位组织开展多中心随机对照试验,观察年限不少于5年。     

GyneFix330和TCu220C、TCu380A宫内节育器比较的系统评估

目的:评价GyneFix330与TCu220C、TCu380A宫内节育器(IUD)的有效性、副反应和续用情况。方法:电子和手工检索1990年1月~2009年11月中英文发表的相关文献,按循证医学方法对纳入文献进行分析评价。结果:纳入26篇正式发表的随机对照临床试验文献。与TCu220C IUD相比,GyneFix330IUD的12个月和24个月带器妊娠率和脱落率较低;6个月、12个月和24个月的经期延长、经量增多、腰腹痛和不规则出血发生率较低;12个月因症取出率较低,续用率则较高。GyneFix330和TCu380A IUD12个月、24个月、36个月和9年的带器妊娠率均低于2.50/100妇女。两组6个月、12个月、24个月和36个月的月经量增多、白带增多和不规则出血发生率互有优劣。与TCu380A IUD相比,Gyne-Fix330IUD12个月和24个月的因症取出率接近,续用率略高。结论:GyneFix330IUD临床应用效果优于TCu220C IUD,与TCu380A IUD相差不大,仍需长期大样本临床观察予以确证。     

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。     

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.     

Intrauterine contraceptive insertion postabortion: a systematic review

Background

This review was conducted to evaluate the evidence regarding the safety and effectiveness of intrauterine device (IUD) insertion immediately following spontaneous or induced abortion.

Study Design

We searched MEDLINE databases for all articles (in all languages) published in peer-reviewed journals from January 1966 through March 2010 for evidence comparing immediate postabortion IUD insertion with either no IUD insertion, insertion at a different time, insertion following first-trimester compared with second-trimester abortion or copper IUD insertion compared with hormone-releasing IUD insertion postabortion. We used standard abstraction forms to summarize and assess the quality of the evidence.

Results

The search strategy identified a total of 990 articles, of which 19 met our inclusion criteria for this review. Studies comparing immediate postabortion IUD insertion with no IUD insertion found that both groups experienced similar rates of pain and infection and a similar number of bleeding days, but one study reported that women with copper IUD insertion experienced a greater amount of bleeding than women without IUD insertion after abortion. Results from studies comparing immediate postabortion IUD insertion and insertion at a time not associated with pregnancy did not report differences between the two groups in the duration of bleeding, pain, expulsions or pelvic inflammatory disease (PID). One study however reported a greater amount of bleeding and another reported more removals for medical reasons among women with postabortion IUD insertion. Evidence from studies that examined immediate vs. delayed postabortion insertion reported minimal differences in bleeding, pain, expulsion and PID between groups. Studies comparing immediate IUD insertion after first- vs. second-trimester abortion reported no difference in removals for pain and bleeding, and an increased risk of expulsion among those women who had insertions after second-trimester abortion. In addition, women with insertions immediately after abortions occurring later in the first trimester had higher expulsion rates than those with insertions after early first-trimester abortions. Studies examining women using a copper IUD compared with a hormone-releasing IUD reported inconsistent results, with one paper reporting more bleeding days in the copper IUD group and another finding higher rates of removal for bleeding in the progesterone-releasing IUD group.

Conclusion

Intrauterine device insertion immediately after abortion is not associated with an increased risk of adverse outcomes compared with use of other contraceptive methods or with no IUD insertion after abortion and compared with IUD insertion at times other than immediately after abortion. Intrauterine device expulsion rates, while generally low, were higher with insertions that occurred after later first-trimester abortion compared with after early first-trimester abortion and higher with IUD insertion after second-trimester abortion compared with after first-trimester abortion.     

Blood copper levels in Mexican users of the T380A IUD

OBJECTIVE: Copper T380A is one of the most commonly prescribed intrauterine devices (IUDs). However, there are few reports of its systemic health effects. This study evaluates the association between the use of T380A IUD and blood Cu levels in a group of Mexican users. METHODS: Eighty-six T380A users and eight nonusers were recruited. Blood Cu levels were measured using an atomic absorption spectrophotometic technique. RESULTS: In IUD users, mean blood Cu level was significantly higher than in nonusers, 216.63 vs. 107.47 microg/dL (p相似文献