Postplacental Insertion of Levonorgestrel Intrauterine System Versus Copper Intrauterine Device: A Prospective Study

PurposeTo compare between postplacental insertion of levonorgestrel intrauterine system versus copper intrauterine device regarding expulsion rates, patient satisfaction, complications, and continuation rates.MethodsThis prospective observational study was conducted on 1100 participants divided in to two groups: group (1) CU-IUD group and group (2) LNG-IUS group where women were assigned for postplacental insertion of either CU-IUD or LNG-IUS, respectively. Follow-up at 6 weeks, 3 and 6 months postpartum and data were collected and analyzed to evaluate outcomes.ResultsNo statistical difference between both groups regarding patients’ characteristics, the overall expulsion rate was higher in LNS-IUS group than CU-IUD group; 77 patients (14%) and 50 patients (9%), respectively, (P value < 0.05), odds ratio: 1.63 at CI: (1.12–2.37). No significant difference between the two groups regarding pain intensity, perforation, abnormal uterine bleeding, and clinical endometritis (P > 0.05). Overall satisfaction rate at six months was 478(87%) in the CU-IUD group and 472(85.8%) in the LNS-IUS group (P value > 0.05), odds ratio: 1.1 at CI: (0.78–1.55). Continuation rate at s6 months was comparable between the two groups 485 (88.2%) and 480 (87.3%) in CU-IUD group and LNS-IUS group respectively, (P value < 0.05), odds ratio: 1.09 at CI: (0.76–1.56).ConclusionThe rate of expulsion of LNG-IUS is higher than copper IUD when inserted postplacental, yet the continuation and acceptability rates were comparable between the two groups.     

两种产后立即放置T Cu380A IUD方法的比较——3年随访分析

将产后准备选择ＩＵＤ避孕的３８４例阴道分娩产妇（９８．７０％ 是首次分娩）,随机分为两组,于胎盘娩出后１０ ｍ ｉｎ 内徒手放置（１８９例）或卵园钳放置（１９５例） ＴＣｕ ３８０Ａ ＩＵＤ。以生命表法统计、χ２检验比较这两种不同放置方法放置后６、１２、２４ 和３６ 个月的脱落率和其他停用率。３８４ 例无一发生子宫穿孔、大出血、感染或恶露延长。放置后主要停用原因是脱落。两组６～３６ 个月各项停用指标（脱落、妊娠、因出血／疼痛取出等）的粗累积率均无显著差异（Ｐ＞ ０．０５）。研究认为,不同放置方法对阴道分娩ＩＰＰＩ效果无明显影响;ＴＣｕ ３８０ＡＩＵＤ是适合中国妇女产后立即放置的。本文还对影响ＩＰＰＩ脱落率的因素如哺乳和ＩＵＤ在宫腔内位置等进行了讨论。     

Intrauterine Copper Device (CuT380A) as a Contraceptive Method in the Indian Context: Acceptability,Safety and Efficacy Depending on the Timing of Insertion

Background

Ideal time of Intrauterine copper device (IUCD) insertion either to space or limit births in Indian women should be known to check fertility effectively and safely. We therefore aimed to compare various IUCD related clinical factors to assess its acceptability, safety and efficacy in immediate postpartum vaginal insertion, intra-caesarean insertion, delayed postpartum insertion and interval insertion at a tertiary-care centre in India.

Methods

It was a retrospective analysis of prospectively collected data from July 2013 to July 2014. Data was reviewed about maternal age, socioeconomic status, education, occupation and parity of a total of 1631 eligible mothers and was compared between postpartum group and interval group. Data about spontaneous expulsion rate of IUCD, proportion of patients not able to feel thread, reasons for removal and failure rate of IUCD up to a follow-up period of 6 months was also collected in these women and compared among immediate vaginal insertion, intra-caesarean insertion, delayed postpartum insertion and interval insertion.

Results

Majority of women were between 20 and 35 years of age group, literate, multiparous, unemployed and belonged to middle/lower socio-economic strata in both postpartum and interval groups. Spontaneous expulsion rates were 1.84, 0.84, 2.83 and 1.63%; proportions of patients not able to feel thread were 3.07, 8.73, 4.45 and 1.63%; and removal rates were 7.99, 6.48, 7.69 and 3.47% in immediate vaginal, intra-caesarean, delayed postpartum and interval insertion groups, respectively. Failure was seen in only one case of delayed postpartum insertion.

Conclusion

IUCD was more acceptable among young, literate and multiparous women as a contraceptive method. Immediate postpartum period was the safest and most efficacious time for IUCD insertion with least expulsion rate, maximum continuation rate and no failure and, therefore, should be encouraged by adequate counseling of mothers.

     

两种产后立即放置TCu380A宫内节育器方法的比较——910例12个月随访分析

目的：比较徒手和卵圆钳两种方法对产后立即放置（ＩＰＰＩ）宫内节育器（ＩＵＤ）效果的影响。方法：将９１０例阴道分娩产妇（其中９７．７％是首次分娩）随机分成两组，于胎盘娩出后１０分钟内放置ＴＣｕ３８０ＡＩＵＤ，其中４７０例徒手放置（手放组），４４０例用卵圆钳放置（钳放组）。随访１２个月，以生命表法统计、χ２检验比较两种放置方法的脱落率、妊娠率、因症取出率等。结果：６和１２个月的随访率分别为９５．１６％和９２．６４％。９１０例中未发生子宫穿孔和感染，仅手放组有１例带器妊娠。放置后主要停用原因是脱落，手放组与钳放组１２个月的粗累积脱落率分别为１５．８６／１００妇女和１５．８８／１００妇女，因症（出血、疼痛）取出率分别为２．１１／１００妇女和１．５７／１００妇女，差异无显著性（Ｐ均＞０．０５）。结论：徒手放置或卵圆钳放置对ＩＰＰＩ的效果无明显影响；ＴＣｕ３８０ＡＩＵＤ适合中国妇女产后立即放置。     

Pelvic Actinomycosis Following Insertion of an Intrauterine Contraceptive Device

Summary: A case of actinomycosis following insertion of an intrauterine contraceptive device is reported. The patient was treated successfully by antibiotic therapy and conservative surgery.     

Comparative Efficacy of Vaginal Misoprostol vs Vaginal Dinoprostone Administered 3 Hours Prior to Copper T380A Intrauterine Device Insertion in Nulliparous Women: A Randomized Controlled Trial

Study ObjectiveTo compare the effectiveness of misoprostol and dinoprostone tablets administered vaginally 3 hours before copper intrauterine device (IUD) insertion vs placebo in reducing pain and increasing ease of insertion among nulliparous women.DesignRandomized controlled trial.SettingTertiary referral hospital.ParticipantsA total of 129 nulliparous women requesting a Copper T380A IUD insertion.InterventionsWomen were randomized to receive 200 μg misoprostol or 3 mg dinoprostone or placebo 3 hours before IUD insertion.Main Outcome Measure(s)Primary outcome was patient-reported pain during IUD insertion using a 10-cm visual analog scale (VAS). Secondary outcomes include provider ease of insertion, women satisfaction level, and side effects.ResultsParticipants' baseline characteristics were comparable between the study groups. Mean pain score during IUD insertion was lower with misoprostol than placebo (3.1 ± 2.3 vs 4.4 ± 2.2; P = .02) and dinoprostone compared to placebo (2.4 ± 1.8 vs 4.4 ± 2.2; P < .001). Clinicians reported easier IUD insertion with misoprostol than placebo (2.4 ± 1.7 vs 4.0 ± 2.4; P = .001) and dinoprostone compared to placebo (2.0 ± 1.5 vs 4.0 ± 2.4; P < .001). Women's satisfaction levels were higher with both misoprostol and dinoprostone than placebo (P < .001). Side effects did not differ among the 3 study groups.ConclusionsPremedication with vaginal misoprostol or dinoprostone effectively lowered pain during copper IUD insertion. However, the reduction in pain scores was clinically significant only in women who received dinoprostone. In both the misoprostol and dinoprostone groups, clinicians found the procedure easier, and women were more satisfied with IUD insertion. Side effects and complications were similar in all groups.     

Streptococcal Toxic Shock Syndrome After Insertion of a Levonorgestrel Intrauterine Device

BackgroundThe insertion of intrauterine devices (IUDs) is associated with a small increased risk of pelvic inflammatory disease and ascending infection, particularly in patients with risk factors. However, the risk of sepsis and toxic shock syndrome after insertion of an IUD is a rare event, described only through case reports in the literature.CaseThis report describes the case of a 40-year-old woman who presented with high fever, myalgias, and abdominal pain 2 days following the insertion of a levonorgestrel-releasing IUD. She was found to have group A Streptococcus infection in the vagina that led to a diagnosis of streptococcal toxic shock syndrome and required admission to the intensive care unit.ConclusionToxic shock syndrome is a rare but potentially catastrophic complication after the insertion of an IUD. Health care providers should be conscious of this complication, particularly among patients presenting with fever and sepsis soon after IUD insertion.     

Strategies to Mitigate Anxiety and Pain in Intrauterine Device Insertion: A Systematic Review

One barrier to the use of intrauterine devices (IUDs) as a contraceptive method is the experience of anxiety and pain during the insertion procedure. Previous reviews have focused on pharmacological methods used to relieve pain during IUD insertion; however, few similar reviews have examined non-pharmacological methods to relieve pain or strategies to reduce anxiety. The objectives of this study were to identify and categorize strategies for reducing anxiety and pain with respect to IUD insertion and the ways in which anxiety and pain were assessed. In particular, the study aimed to identify non-pharmacological interventions and studies that included anxiety as a research outcome. A literature search was conducted of all English-language studies between inception and the week of July 29, 2018 from the following online databases: Medline, Embase, Cochrane Library, and PubMed. The search revealed 426 studies after removal of duplicates, 35 of which fulfilled the inclusion criteria. A total of 29 studies were identified as assessing pharmacological interventions for the management of pain, and six studies assessed non-pharmacological interventions. Only one study included a measurement of patient anxiety during the procedure as an outcome measure. Research on non-pharmacological interventions for the management of anxiety and pain during IUD insertion is lacking. This review found that evidence for the studied pharmacological interventions is conflicting, and there is very little evidence on understanding the effectiveness of strategies to manage anxiety during the IUD insertion procedure. Further high-quality research on non-pharmacological pain and anxiety management strategies is warranted.     

产褥期末放置MLcu375SL和Tcu380A比较性研究

目的了解产褥期末放置两种宫内节育器的可接受性和有效性.方法采用随机编码分为MLcμ375SL和Tcu380A两组,计算各种累积停用率和续用率.结论两组宫内节育器的妊娠率均在一个低水平.产褥期末放置宫内节育器是可行的,尤其是MLcu375SL更适合于农村地区妇女使用.     

An evaluation of the TCu 380Ag and the Multiload Cu375

The TCu 380Ag (Outokumpu Oy, Pori, Finland) and the Multiload Cu375 (Multilan, Organon, Oss, The Netherlands) were evaluated in 1477 women in a multicenter clinical trial. The intrauterine devices showed similar, low-event rates. Cumulative life-table pregnancy rates were less than 1.0, and continuation rates were approximately 90 per 100 women at 1 year after insertion. The risk of subsequent hospitalization or pelvic infection was low.     

Migration of an Intrauterine Contraceptive Device during the Course of Pregnancy: A Case Report

Uterine perforation by a contraceptive intrauterine device (IUD) is a relatively rare event. These events may result secondary to mechanical force applied during placement (primary perforation) or migration by uterine contractions or surgical manipulation after placement (secondary perforation). A 33-year-old woman with an IUD placed 9 years before admission visited the emergency department with an early pregnancy and a 3-day history of vaginal bleeding. Vaginal examination revealed IUD strings visible at the cervical os, and transvaginal ultrasound confirmed the presence of an IUD in the lower uterine segment and upper cervix. The IUD migrated spontaneously to the fundal myometrium at 15 weeks’ gestation. Premature rupture of membranes ensued at 20 weeks’ gestation, and, at delivery, the IUD could not be retrieved. Subsequent computed tomography confirmed that the IUD was incompletely embedded in the fundal myometrium and partially extending into the peritoneal cavity. At laparoscopic sterilization 6 weeks later, the IUD had perforated the small bowel, and the device was removed with concomitant bowel repair. This case documents spontaneous migration of a copper IUD from the lower uterine segment through the fundus during early pregnancy and supports removal of asymptomatic ectopic IUDs whenever possible.     

Benefits of Self-administered Vaginal Dinoprostone 12 Hours before Levonorgestrel-releasing Intrauterine Device Insertion in Nulliparous Adolescents and Young Women: A Randomized Controlled Trial

Study ObjectiveTo assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52-mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women.DesignRandomized controlled trial.SettingTertiary referral hospital.ParticipantsNulliparous adolescents and young women aged 18-22 years.InterventionsParticipants were randomly assigned into 2 groups; the dinoprostone group (n = 65) received dinoprostone 3 mg vaginally, and the placebo group (n = 65) received placebo tablets vaginally.Main Outcome MeasuresPrimary outcome was pain scores during LNG-IUD insertion measured using a visual analogue scale. Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, Women's satisfaction score, need for additional analgesics, and side effects.ResultsThe dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement (2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus (3.55 ± 1.71 vs 5.12 ± 1.37) compared with the placebo group (P < .001). No significant differences were found between both groups regarding anticipated pain scores (P = .85), pain during speculum insertion and 20 minutes postinsertion and insertion duration (P = .53). Women's satisfaction, provider reported ease of insertion, and need for additional analgesia were significantly better among dinoprostone users (P < .001, < .001, and .02, respectively). Side effects and procedure complications were similar for the 2 groups.ConclusionSelf-administered dinoprostone 3 mg vaginally 12 hours before a 52-mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.     

Pain Perception during Levonorgestrel-releasing Intrauterine Device Insertion in Nulliparous Women: A Systematic Review

Study Objective

Intrauterine devices (IUDs) still remain underused in adolescents. Pain during insertion might prevent adolescents to opt for a levonorgestrel-releasing IUD. This study aimed to conduct a systematic review, following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, and critically appraise published data with respect to the efficacy of various substances (analgesics or not) in preventing pain during levonorgestrel-releasing IUD insertion in nulliparous women as a proxy for adolescents.

Fertility after Intrauterine Device Removal: A Pilot Study

Abstract

Background Despite high efficacy, only 7.7% of women in the United States currently using contraception use an IUD. There is little published contemporary data about fertility rates after IUD use, especially in nulliparous women and women using the hormonal IUD.

Study Design We recruited sexually active women 18 to 35 years of age enrolled in the Contraceptive CHOICE Project who had discontinued a contraceptive method and desired pregnancy.

Results In this pilot project, we enrolled 69 former IUD users (19 copper and 50 levonorgestrel) and 42 former non-IUD users. Pregnancy rates at 12 months were similar between the two groups; 81% of IUD users became pregnant compared to 70% of non-IUD users (p = 0.18). In the Cox model, there was no difference in the time to pregnancy in IUD users compared to non-IUD users (HR_adj 1.19, 95% CI 0.74–1.92). African American race was the only variable associated with reduced fertility (HR_adj 0.40, 95% CI 0.24–0.67).

Conclusions We found no difference in 12-month pregnancy rates or time to pregnancy between former IUD users and users of other contraceptive methods. However, there was a clinically and statistically significant reduction in fertility in African American women.

Chinese Abstract

摘要：

背景：尽管宫内节育器有效性很高,在美国目前只有7.7%的女性使用宫内节育器避孕。关于当前宫内节育器使用后妊娠率的资料鲜有发表,尤其是有关未产妇和使用含激素宫内节育器的女性的相关资料。

研究设计：我们招募了18- 35岁的性活跃女性参加避孕选择项目,这些女性已经停止避孕,期望妊娠。

结果： 在这项初步研究里,我们招募了69名以前使用宫内节育器的女性（19名使用的是含铜节育器,50名使用的是含左炔诺孕酮节育器）和42名未使用宫内节育器的女性。两组女性12个月后的妊娠率是相似的;使用过宫内节育器的女性和未使用过宫内节育器的女性妊娠率分别为81%和70%（p=0.18）。在Cox模型中,使用过宫内节育器的女性和未使用过宫内节育器的女性妊娠时间没有差异（HR adj 1.19, 95% CI 0.74–1.92）,非洲裔美国人是与生殖力下降相关的唯一变量。

结论：我们发现使用宫内节育器避孕的女性和使用其他避孕方法的女性12个月后的妊娠率及妊娠时间没有差异。然而,非洲裔美国人的生殖力临床上和统计学均显著的下降。     

活性元宫型药铜365宫内节育器体外释放吲哚美辛的研究

目的:建立国产活性元宫型药铜365宫内节育器中吲哚美辛体外释放度测定方法。方法:以模拟宫腔液为释放介质,控制温度(37.0±0.1℃),匀速磁力搅拌,控制速度为70r/min,采用紫外分光光度法测定药物含量及释放量。结果:吲哚美辛的吸收度与浓度呈良好的线性关系,吲哚美辛的释放于d3达到平衡。结论:建立的吲哚美辛释放度测定方法简便、准确,可用于质量控制。