置器质量对宫内IUD避孕效果的影响

目的:通过B超实时监测,把IUD置入子宫内膜腔的宫底部位,并追踪其避孕效果,评估置器质量对宫内IUD避孕效果的影响。方法:在B超实时监测,把IUD置入子宫内膜腔的宫底部位,其定量标准:宫内IUD上缘距宫底外缘距离(简称S-S)≤14mm或宫内IUD上缘距宫底外缘距离与宫底厚度之差(简称IUD差值)不超过2mm。研究前对参加项目人员进行技术培训统一标准,研究共接收健康育龄妇女1071名,置器术后即时B超监测子宫内膜腔内IUD位置,对未达到设定宫底部位者实时在床边B超监测下重新放置,术后定期随访,各项数据填入统一表格。结果:通过培训后的置IUD从业人员把IUD置入子宫内膜腔宫底部位占96.55%(1029/1071例),仅3.45%(37/1071例)的IUD没能被置入子宫内膜腔宫底部位,需进行重置干预。术后定期随访宫内Tcu-M型IUD18个月的脱落、带器妊娠、因症取出、他因取出和总停用避孕效果寿命表率(每百名妇女,s)分别是(4.46±0.72)%、(1.07±0.47)%、(5.32±0.93)%、(2.87±0.76)%、(13.08±1.34)%。单因素分析:宫内IUD位置和妇女生育数量是影响Tcu-M型IUD粗累积脱落率的危险因素(P<0.05),有人流、人流加上环、上取环手术史对象宫内Tcu-M型IUD粗累积他因取出率低无宫腔手术史者(P<0.05),其他协变量均不是影响Tcu-M型IUD粗累积寿命表避孕效果的重要因素。结论:用B超实时监测下置器,并对宫内节育器位置进行干预,可以提高置器质量,降低Tcu-M粗累积脱落率和带器妊娠率,提高Tcu-M型IUD避孕效果;宫内IUD越靠近宫底位置,Tcu-M型IUD粗累积脱落率越低;在研究IUD避孕性能中,如果置IUD从业人员均能把IUD置入子宫内膜腔的宫底部位,排除置器质量因素干扰,能更真实反映IUD的避孕效果。     

B超干预下放置IUD的临床效果研究

目的:评价在B超干预下放置IUD的临床效果。方法:将1 455例志愿放置IUD的育龄妇女随机分成两组,均在B超监测下放置Tcu-M型IUD。其中干预组985例,置器后IUD顶端与子宫外缘的距离(S-S)≤14 mm,如超过此范围需马上重置;对照组470例,只记录置器后的实际参数,不作干预。全部观察对象均于术后1、3、6、12个月进行随访,观察临床使用效果。结果:放置满12个月时,对照组和干预组的带器妊娠率分别为36/470、5/985,二者之间比较差异有统计学意义(P<0.01);脱落率分别为23/470、28/985,差异有统计学意义(P<0.05);因症取出率分别为3/470、44/985,累积续用率分别为67/470、93/985,差异无统计学意义(P>0.05)。结论:在B超干预下放置IUD具有脱落率低、带器妊娠率低等优点,值得临床推广。     

3种含铜宫内节育器的临床效果及影响因素

目的:前瞻性研究3种含铜宫内节育器(IUD)临床效果及相关因素。方法:采用随机抽样方法将研究对象分为3组,分别放置TCu380A型IUD、MLCu375型IUD和元宫-365型IUD,置器后1、3、6、12个月分别进行随访。以3种IUD的妊娠率、脱落率、因症取出率和总停用率作为指标进行临床效果评估。结果:共纳入研究对象2283例,其中放置TCu380A型IUD773例、MLCu375型IUD738例和元宫-365型IUD772例。3种IUD的脱落率、因症取出率和总停用率差异有统计学意义(P=0.000)。3种IUD放置1年,累计非意愿妊娠率均<1%。怀孕1次组的非意愿妊娠、脱落、因症取出、总停用、医学原因终止等发生率大于怀孕2次以上组。以元宫-365型IUD为对照,MLCu375型与TCu380A型在上述情况中均有更大的发生风险。脱落率、医学原因终止率还与置器地区有关(P=0.000)。月经量多者比月经量少者停用风险更大(OR=2.513,95%CI1.037～6.092);IUD失败后再次使用组比首次使用组有更高的停用风险(OR=1.649,95%CI1.224～2.221);B超扫描IUD顶部与宫底距离越大,停用风险越大(OR=1.197,95%CI1.052～2.130)。结论:元宫-365型、TCu380A型与MLCu375型3种含铜IUD避孕效果确切,其中元宫-365型IUD在3种含铜IUD中不良停用率最低。IUD使用者的孕次、宫腔深度、B超扫描IUD顶部与宫底的距离、月经量、是否曾有IUD失败史、所放置的IUD种类以及不同置器地区等因素影响其临床效果。     

广东省置器从业人员置器质量现状调查

目的:评估广东省计划生育系统各级置宫内节育器(IUD)从业人员的置器质量,分析研究置器妇女的社会生物学特征等因素对置器质量的影响。方法:采用分层整群抽样方法,选择9个市(县)计划生育服务中心(站)及11个服务所的全体置器从业人员,每人现场置器10-15例。置器后B超测量IUD上缘至宫底外缘的距离。结果:从业人员所在单位级别(中心、站、所)对置器平均距离无影响;从业人员学历、职称、工作年限对置器质量有明显影响;受术者子宫位置对置器平均距离有影响。结论:置器从业人员距“把节育器置入宫底部位”的要求尚有差距;应把置器质量进行定量,制定相应的指标。     

放置两种吉妮IUD 18个月临床效果分析

目的:观察吉妮致美与吉妮宫内节育器(IUD)使用18月的临床效果。方法:随机分组分别放置吉妮致美IUD517例,吉妮IUD508例,分别于置器后1、3、6、18个月进行随访,记录病史、放置IUD手术时间及术后随访情况,对数据进行生命表分析和Logistic多因素分析。结果:①随访18个月吉妮致美和吉妮IUD的带器妊娠率分别为0.60/100妇女年和0.61/100妇女年(P>0.05);②置器后6月内月经周期缩短、经量增多、月经期延长情况吉妮致美组低于吉妮组(P<0.05),因出血终止使用的吉妮致美组(1.2/100妇女年)明显低于吉妮组(6.69/100妇女年),P<0.05;③两组均无因疼痛所致的终止。④带器妊娠的危险因素为子宫内口至子宫底外缘距离大和子宫后屈;⑤脱落的危险因素则为体力劳动和哺乳期置器者。结论:吉妮和吉妮致美IUD避孕效率高;吉妮致美IUD对减少置器后近期出血及因出血所致终止率有明显效果,为吉妮IUD系列的扩大应用提供了更多的选择。     

纵隔子宫放置两只吉妮IUD2例

目的:观察吉妮致美与吉妮宫内节育器(IUD)使用18月的临床效果.方法:随机分组分别放置吉妮致美IUD517例,吉妮IUD508例,分别于置器后1、3、6、18个月进行随访,记录病史、放置IUD手术时间及术后随访情况,对数据进行生命表分析和Logistic多因素分析.结果:①随访18个月吉妮致美和吉妮IUD的带器妊娠率分别为0.60/100妇女年和0.61/100妇女年(P>0.05);②置器后6月内月经周期缩短、经量增多、月经期延长情况吉妮致美组低于吉妮组(P<0.05),因出血终止使用的吉妮致美组(1.2/100妇女年)明显低于吉妮组(6.69/100妇女年),P<0.05;③两组均无因疼痛所致的终止.④带器妊娠的危险因素为子宫内口至子宫底外缘距离大和子宫后屈;⑤脱落的危险因素则为体力劳动和哺乳期置器者.结论:吉妮和吉妮致美IUD避孕效率高;吉妮致美IUD对减少置器后近期出血及因出血所致终止率有明显效果,为吉妮IUD系列的扩大应用提供了更多的选择.     

阴式B超监测不同分娩方式妇女放置IUD的临床观察

目的探讨阴式B超监测不同分娩方式妇女放置宫内节育器(IUD)的临床效果。方法在阴式B超监测下放置I-UD371例(其中256例为经阴道分娩,115例剖宫产分娩)为观察组;选择同期在传统盲视下放置IUD357例(其中245例为经阴道分娩,112例剖宫产分娩)为对照组,于放置后1、3、6、12个月进行随访。结果观察组的剖宫产组的置器时间明显短于对照组的置器时间,差异具有非常显著性(P<0.01);观察组的阴道分娩组的置器时间稍短于对照组的置器时间,但无显著性差异(P>0.05);2组置器时间比较有显著性差异(P<0.05)。使用IUD6个月:观察组的带器妊娠率、脱落率、因症取出率和续用率分别为0、0.27%、0.27%和98.10%;对照组分别为0.58%、2.05%、1.17%和94.15%。2组比较有显著性差异(P<0.05)。使用IUD12个月,观察组的续用率为94.05%,对照组为91.86%,2组比较有显著性差异(P<0.05)。结论阴式B超监测下放置IUD具有脱落率低、续用率高、副反应小的优点,值得临床推广。     

功能性宫内节育器MCuⅡ与MCu的多中心随机对照临床研究

目的观察MCuⅡ功能性宫内节育器(intrauterine contraceptive device,IUD)的妊娠率、脱落率、因不良反应取出率和不良反应发生率。方法采用多中心随机对照的研究方法,对MCuⅡIUD与MCuIUD作临床效果比较。常规放置IUD,在置器后第1、3、6、12、24个月进行随访,观察临床效果和不良反应。结果共接纳对象1 000例,放置MCuⅡIUD与MCuIUD各500例,置器满24个月带器妊娠率分别为0.63%、1.45%;脱落率分别为0.42%、0.21%;因不良反应取出率分别为3.44%、3.03%;置器后各阶段不良反应(主诉)发生率及两组取出后5～12月间妊娠率的各项组间差异比较均无统计学意义(P>0.05)。MCuⅡIUD取出时探针探测IUD金属摩擦感比MCu IUD清楚(P<0.05),因此取出手术操作容易。结论 MCuⅡIUD与MCu IUD是带器妊娠率低、脱落率低、因不良反应取出率低和不良反应发生率低的IUD。MCuⅡIUD在MCuIUD基础上铜表面积增加至225mm2,符合国家标准;铜表面积增加了而不良反应未增加;取出时操作容易,证实产品改进是成功的,是值得推广的新型IUD。     

育龄妇女宫内节育器位置下移影响因素分析

目的:观察使用IUD避孕的育龄妇女中各类不同因素对IUD下移程度的影响并分析IUD发生下移的主要危险因素和降低风险的主要措施。方法:对使用IUD避孕的108例妇女采用结构式问卷进行访谈并行妇科及B超检查,测定IUD上缘到子宫底外缘的距离以>20 mm者确定为IUD下移,记录相关因素数据。结果:B超诊断15例IUD下移,下移率为13.89%,痛经、妊娠次数、上取环次数、置环后不良反应为IUD下移的危险因素;妇科炎症经有效治疗、置环后合理用药为保护性因素;后位子宫、产后哺乳期放置IUD、基层计生站放置IUD下移发生率低。结论:放置IUD术前认真询问病史、做好妇科体检、治疗痛经及妇科炎症,术后合理用药、减少不良反应,可使IUD下移的危险性降低;基层计生服务放置IUD质量较好,应重视和加强以便更好高效地为育龄妇女服务。     

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。     

T-shaped IUDs accommodate in their position during the first 3 months after insertion

The objective of this study was to observe the position dynamics of the T-shaped intrauterine device (IUD) in the uterine cavity, from insertion to 90 days of use. IUD position was evaluated in 214 women by vaginal ultrasound, measuring the IUD-endometrium, IUD-myometrium, and IUD-fundus distances. The 90th percentile of the IUD-endometrium distance was 5, 6, and 8 mm at time of insertion, 30 and 90 days of use; 7, 9, and 10 mm for IUD-myometrium distance; and 23, 24, and 27 mm for IUD-fundus distance, respectively. Seventeen IUDs were classified as misplaced at insertion by using the 90th percentile of the IUD-myometrium distance as standard. Of these, only 6 remained misplaced after 90 days of use. On the other hand, 21 IUDs were beyond the 90th percentile at the 90-day observation, only 6 of which were considered misplaced at insertion. We conclude that the T-shaped IUD accommodates its position in the uterine cavity during the first 3 months following insertion, and that ultrasound evaluation of its position is not a good predictor of future evaluation.     

Can ultrasound predict IUD expulsion after medical abortion?

Objectives

Our randomized trial compared early and delayed intrauterine device (IUD) insertion following medical abortion. In this planned substudy, we explore if endometrial thickness and initial IUD position were associated with IUD expulsion. We also describe IUD movement within the uterus during the 6 months after insertion.

Study design

We recruited women undergoing medical abortion and choosing the copper IUD for contraception (n = 156). Participants were randomly assigned to early insertion 1 week after mifepristone or delayed insertion 4–6 weeks later. We measured endometrial thickness by transvaginal sonogram 1 week after abortion and IUD distance from the fundal aspect of the endometrial cavity three times: at insertion, 6–8 weeks later and at 6 months.

Results

We analyzed endometrial thickness in 113 women, baseline IUD position in 114 women and IUD movement in 65 women. Women who expelled IUDs (n = 15) had slightly thicker endometria (p = .007) and slightly lower baseline IUD positions (p = .03) than those who retained IUDs, but no clear cutoffs emerged in the receiver operating characteristic curve analysis. Retained IUDs commonly moved up and down throughout the 6 months (from 14 mm towards the fundus to 32 mm towards the cervix). Overall, retained IUDs moved a median of 2 mm towards the cervix between insertion and exit (p < .0001).

Conclusions

After medical abortion, the risk of IUD expulsion increases with thicker endometria and lower baseline position. Since no clear cutoffs emerged in the analysis and expulsion remained uncommon even with thicker endometria, we do not recommend restricting IUD insertion based on ultrasound data.

Implication

Copper T IUDs often move within the uterus without expelling. Expulsion is uncommon, and we do not recommend restricting IUD insertion based on ultrasound data.     

Immediate postpartum insertion of IUDs

The literature concerning immediate postpartum insertion of IUDs does not give the general impression that IUDs inserted immediately postpartum are well retained by the involuting uterus. Despite unfavorable expulsion rates, the procedure was not found to be dangerous in terms of uterine perforation, pyrexia, and infection or delayed uterine involution. With the goal of improving retention rates, new devices have been bio-engineered, and inserters have been lengthened in the effort to place the IUD high in the uterine fundus. The Multiload IUD (MLCu250) was evaluated for immediate post-placental insertions, and the results of a straight trial have shown a low expulsion rate. In order to determine whether the physical characteristics of the MLCu250 were responsible for its performance after insertion during the 4th stage of labor, this IUD was randomly compared with the Tcu200. It was found that at 2 years the cumulative expulsion rates of both IUDs were quite acceptable and did not differ significantly. Because the reason for discrepancy between these findings and the overall results in the literature are not evident, it seems relevant to focus on some technical details of the procedure. The standard technique used in this study is reported. Regarding criteria of ideal postplacental insertion, the IUDs should be completely safe and effective and not able to be expelled. The question that arises is how do present IUDs fulfill these criteria. The safety of the procedure has generally been found adequate, but inversion of stemmed devices theoretically remains a risk. Tolerance of the IUD models assessed for immediate postplacent insertion has been generally satisfactory. Effectiveness and expulsion of an IUD are not strictly related phenomena. The real problem continues to be the early diagnosis of expulsion.     

Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women

This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.     

Anchored IUDs. A new development in intrauterine contraception

The need for IUD removal due to bleeding could be reduced by reducing the size of the device, which could be done if the frame were replaced by threading copper tubules on a nonresorbable string anchored in the fundus of the uterus. Such devices have been designed since 1977, but the most successful one was a temporary device designed in 1984 by D. Wildemeersch to insert a postpartum IUD during the period of uterine involution. A similar device for permanent attachment, the Cu-Fix 390 IUD, consists of 6 copper tubules, each 5 mm long and 2.2 mm in diameter threaded on a polypropylene filament. A knot at the distal end serves as a retention body attached by a loop embedded in the uterine fundus. Insertion is accomplished by a tube and a plunger which carries a stylet for embedding the loop. Between 1985 and 1988, 382 devices were inserted, 38.5% in nulliparas and 53.7% in women under 30. The only problem encountered was some spotting. For postpartum insertion the Gyne-T 380 PP IUD, which is an ordinary T Cu 380 IUD provided with a loop of catgut between 2 knots, is inserted by a tube and plunger device with a pin to insert the knots into the fundus to anchor the IUD. This device may solve the problem of enhanced IUD expulsion after postplacental insertion.     

Five years private practice experience of nulliparous women using copper IUD's

This is a study of 296 nulliparous women who used Copper IUD's as their method of contraception. At the time of first insertion the women had an average age of 21.6 years. The gross cumulative pregnancy rate rose to 11.8 over 5 years. The gross cumulative expulsion rate rose to 13.6 over 5 years and the removal rate for bleeding and pain to 20.4. The net rates were lower over 5 years (pregnancy 8.6, expulsion 11.2 and bleeding and pain 17.3). 29 women expelled their IUD's, of whom 20 underwent reinsertion. 43 women requested removal of their IUD's because of bleeding and pain, of whom 6 requested a reinsertion at a later date. Taking reinsertions into account, the continuation rate over 5 years was 55.2. Inability to insert the IUD was encountered in 28 women (8.6%). In 20 of the women cervical stenosis precluded the insertion of the IUD without local anesthetic, and in the other 8, the pain and/or syncope encountered during sounding the uterus precluded the continuation of the procedure. Insertion problems were encountered in 31 women (10.5%). Syncope occurred in 4 women and one of the women developed a ‘grand mal’ seizure. Clinically significant pelvic infection occurred within 30 days of insertion in 5 women (approximately 1% of insertions), and one woman developed pelvic infection from gonorrhoea.     

含吲哚美辛MYCu宫内节育器多中心临床研究

目的:探讨放置MYCu宫内节育器(IUD)的临床效果。方法:在我国不同地域选择8个省的49个中心放置MYCuIUD5200例,放置后1、3、6、12个月随访。结果:放置满12个月者纳入统计分析共4998例,累积带器妊娠率0.29/百妇女年,累积脱落率0.24/百妇女年,因出血/疼痛累积终止率1.56/百妇女年,与使用IUD有关的累积终止率2.08/百妇女年;8个省因与使用IUD有关的累积终止率3.51/百妇女年～1.00/百妇女年,差异无统计学意义(P﹥0.05);放置后不良反应主要为月经异常、不规则出血、腰腹疼痛和白带增多,随放置时间延长而逐渐缓解。结论:MY-CuIUD避孕效果可靠,脱落率低,不良反应发生率低,是比较理想的IUD。     

Development of a new method of insertion of IUD's

In order to improve the efficiency and to lower the rate of expulsion of the stainless steel ring type of IUD a study of the uterine geometry of 200 cases of repeated expulsion of the IUD was done. A new home-made uterine metrology device which was capable of accurately measuring the longitudinal as well as the transverse diameter of the endometrial cavity at the fundus was used. A group of women of similar age wearing an IUD successfully more than 3 years, but not longer than 15 years, served as controls. Ten women from the group of repeated expulsions of the IUD and 10 women from the control group were examined with X-ray hysterograms. The geometry of the endometrial cavity in the expulsion group was of the dystonia type, similar to a cloth pocket with great depth and loose mouth, while in the control group it was mostly of the triangular type or globular and the tension of the cervix was good. In cases where the transverse diameter of the endometrial cavity at the fundus was too narrow or the longitudinal length of the endometral cavity was too short, the rate of expulsion appeared high. In order to improve the effectiveness of the IUD, the circle of the ring should be tangentially fitted to the inner surface of the endometrial cavity. This may be calculated according to the following formula: $\text{r =}\text{c}\text{h}\text{(√c}{}^2\text{+ h}{}^2\text{? c)}$. A table for selection of size of the IUD according to the new formula is suggested.