IUD (Nova-T) insertion following induced abortion

In a prospective study, 86 women who had an IUD (Nova-T) inserted immediately after induced abortion were compared to 95 abortion patients who started another contraception (control I). Additionally, the rate of complications following IUD insertion in a Family Planning Clinic (control II) were studied in 83 non-pregnant women. The overall infection rate for post-abortion patients was 4.4% (5.8% in the study group, 3.2% in control I). No infections were observed in control group II. Confidence limits (95%) for the three groups were overlapping. Among the women in the study group, bleeding and pain were not more frequent, but if one of these complications occurred, it tended to be more serious and the duration was longer. The number of days before resumption of work after abortion was 3-4 days in both abortion groups. After three months, the continuation rate was 83% (71 of 86) in the study group, 76% (72 of 95) in control I and 93% (77 of 83) in control II. Sixty-nine of the 181 women admitted for legal abortion had been admitted for the same reason previously. In this study, the recurrence rate after 12 months was 0% in the study group and 4.2% (4 of 95) in control group I. The insertion of an IUD at the time of abortion seems to be an effective and acceptable solution to the problem of recurrent abortion.     

IUD insertion following induced abortion

In a multicenter survey, women who received an IUD immediately after abortion were compared with abortion patients who started using oral contraception. Additionally, women receiving a Nova T were compared with women receiving a Multiload 250. Follow-up data were gathered after 6 weeks.

Pain was a common phenomenon post-abortum. In the study group of IUD users, complaints about pain were not more frequent than among controls, but if pain was experienced, it was more intense and of longer duration among IUD users. Bleeding immediately following the induced abortion was less frequent among IUD users, but if bleeding occurred, it tended to last longer. The first menstrual period after the induced abortion was heavier and more painful among IUD users. Expulsion of the IUD occurred in 10 cases (3.3%), all of them with the Nova T, none with Multiload.

The study did not generate evidence for an increased risk of PID in women receiving an IUD after an induced abortion.     

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.     

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。     

活性γCu380IUD与TCu380IUD及吉妮330IUD临床效果观察

目的观察比较活性γCu380IUD、TCu380IUD及吉妮330IUD临床避孕效果。方法2003年11月～2005年12月本院选择自愿放置IUD的已婚育龄妇女300例,随机分成三组(各100例),分别放置活性γCu380IUD、TCu380IUD及吉妮330IUD,并于放置后1、3、6、12、24个月进行随访。结果三种IUD放置24个月后比较其脱落率、带器妊娠率、因症取出率及累积续用率均无统计学差异(p>0.05)。结论三种IUD均具有脱落低、带器妊娠率低、因症取出率低及累积续用率较高的优点,其避孕效果良好,可在临床上推广使用。     

去尾丝HCu280型花式IUD临床效果观察

目的:探讨放置去尾丝HCu280型花式宫内节育器(IUD)的临床效果,为推广使用提供科学依据。方法:21~45岁已婚已育且无放置IUD禁忌证妇女中,选择自愿放置去尾丝HCu280型花式IUD妇女200例为观察对象(HCu280IUD组),以选择放置TCu380AIUD妇女198例为对照(TCu380AIUD组),分别于放置后1、3、6和12个月进行随访,比较两组避孕效果、副作用主诉情况。结果:置器12个月HCu280IUD组和TCu380AIUD组带器妊娠率分别为每百妇女年0和0.5(P0.05);脱落率分别为每百妇年0.5和4.2(P0.05);与IUD使用相关终止率分别为每百妇女年3.5和9.6(P0.05);总终止率分别为每百妇女年4.0和10.1(P0.05);续用率分别为每百妇女年96.0和89.9。置器后1、3、6、12个月副作用主诉率,HCu280IUD组低于TCu380AIUD组。结论:HCu280型花式IUD避孕效果好,副作用主诉少,续用率高。     

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.     

元宫药铜环、Tcu环、母体乐三种IUD产生副反应的比较

目的:比较新型宫内节育器(IUD)元宫药铜环和传统的节育器 Tcu380IUD 母体系 MLcu IUD 的避孕效果和副反应.方法:1380 例自愿放置 IUD 的育龄妇女为对象.随机分为3组.分别放置元宫药铜 Tcu380IUD MLcu IUD.结果:元宫药铜 IUD、Tcu380IUD 和 MLeuIUD 使用12月带器妊娠率分别为0.48%、3.75%、0.85%.脱落率分别为 0.93%、2.92%、0.85%.因症取出率分别为2.80%、6.25%、3.81%.续用率分别为 95.8%、87.08%、94.49%.结论:元宫药铜环是一种安全可靠对月经影响小的宫内节育器.     

IUD insertion immediately after incomplete abortion

All women who were admitted to the Felix Bulnes Hospital, Santiaog, Chile, for incomplete abortion between July 1968 and June 1969 were given instruction in family planning and contraceptive services. A total of 584 women chose to have an IUD insertion. Although all the women thought they had received an IUD, 1 group had a Lippes loop D inserted immediately after curettage and the other group had no insertion. The attending doctor had no prior knowledge as to which women were to receive the device nor did the doctor at the follow-up know until after the physical exam had taken place. 30 days after discharge from the hospital, the women returned from check-up and follow-up. At this time the women who had not received an IUD were given an insertion. Differences between the group with insertion and the one without were significant only for the interval between curettage and first menses and for the quantity of flow in relation to previous menstruation. The difference between the 2 groups for duration of menstrual flow was of borderline significance at the .05 significance level. It is concluded from the study that in the absence of psychologi cal bias of the patient to the IUD insertion, and possibly bias in its use by the doctor, there are no serious complications in the first month following immediate postabortal IUD insertion even where the abortion was a septic incomplete one.     

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.     

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.     

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.     

Immediate postplacental IUD insertion: a randomized trial of sutured (Lippes Loop and TCu22OC) and non-sutured (TCu22OC) models

A randomized clinical trial concerning immediate post-placental insertion (IPPI) of the Delta Lippes Loop, Delta TCu22OC, and TCu22OC was undertaken to assess the effect of the addition of catgut strands on IUD performance. A total of 906 devices were inserted and the subjects followed for 20 months, at which time 14,136 woman-months experience had been accumulated. The Delta Loop constantly had inadmissibly high expulsion and pregnancy rates. The two T-IUD models had significantly lower rates of expulsion and pregnancy, and these rates were similar for the sutured and the non-sutured TCu22OC. Immediate postplacental insertion of the three IUD models was totally safe in terms of infection and perforation. Due to the difficulty of insertion and high expellability, the Delta Loop is considered unfit for IPPI. Performance of the TCu22OC was good but the results did not indicate that "suturing" improved the retainability of this IUD model significantly.     

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.     

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。     

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.