Clinical performance of a levonorgestrel-releasing intrauterine system and oral contraceptives in young nulliparous women: a comparative study

This 1-year randomized study was carried out at family-planning clinics of two university hospitals to compare the safety and acceptability of a levonorgestrel-releasing intrauterine system (LNG IUS) and oral contraceptives (OCs) in young nulliparous women. The study population consisted of 200 women aged 18-25 years seeking contraception. Ninety-four women entered the LNG IUS group and 99 entered the OC group. Continuation rates, reasons leading to discontinuation, adverse events, menstrual questionnaires, subjective well-being and sexual behavior were evaluated. Nineteen women (20%) in the LNG IUS group discontinued the study during the 1-year observation period, and 27 discontinued (27%) in the OC group. The most common reason (31%) for discontinuation in the IUS group was pain. In the OC group, hormonal side effects were the predominant medical reason for study termination. The safety and acceptability of the LNG IUS for contraception was observed to be as good as with OCs, with a high continuation rate.     

Global survey of healthcare practitioners’ beliefs and practices around intrauterine contraceptive method use in nulliparous women

Background

Despite the efficacy and safety of intrauterine contraceptive methods (IUCs), healthcare providers (HCPs) are sometimes reluctant to recommend their use, particularly in nulliparous women. This study sought to understand the global practitioner perceived impediments to IUC provision.

Study Design

We developed an online survey for HCPs administered across 4 regions comprising 15 countries. We sought their attitudes to IUC provision; their perceived barriers to IUC use, particularly in nulliparous women; as well as their knowledge of the World Health Organization Medical Eligibility Criteria (WHO MEC) for contraceptive use.

Results

We received 1862 responses from HCPs in 15 countries grouped into 4 regions, with an average country response rate of 18%. For analysis, the results were grouped into these regions: Latin America, 402 (21.6%); USA, 156 (8.4%); Europe and Canada, 1103 (59.2%); and Australia, 201 (10.8%). The two most frequently identified perceived barriers to IUC use in nulliparous women were difficulty of insertion (56.6%) and pelvic inflammatory disease (PID) (49.2%), but responses differed by region and HCP type. Only 49.7% recognized the correct WHO MEC category for IUC use in nulliparous women.

Discussion

The results of this survey confirm that, across the four regions, the two main barriers to IUC provision for nulliparous women are concern about the difficulty of insertion and PID. Providers’ knowledge of the WHO MEC was lacking universally. A global effort is required to improve understanding of the evidence and knowledge of available guidelines for IUC use.     

A survey of provider experience with misoprostol to facilitate intrauterine device insertion in nulliparous women

Background

There is a significant need for research on treatments that provide pain relief during intrauterine device (IUD) insertion. Misoprostol is frequently used before IUD insertion but is not always necessary and its use may increase pain and side effects. This survey evaluated how providers who perform IUD insertion in nulliparous women report using misoprostol to facilitate the procedure.

Study Design

An anonymous Internet-based survey was distributed to members of three professional organizations with family planning providers.

Results

Of 2211 survey respondents, 1905 (86%) reported providing IUDs to nulliparous women. Of those providing IUDs to nulliparous women, 947/1905 (49.7%) reported using misoprostol, and 380 (40%) of 947 of misoprostol users reported using the treatment empirically with all nulliparous IUD insertions. There was wide variation reported in dose, route and timing of misoprostol administration. Providers most commonly reported learning of misoprostol use for IUD insertion by word of mouth rather than through the literature.

Conclusions

Despite conflicting published data, nearly half of survey respondents use misoprostol before IUD insertion. Considerable variation in the timing of misoprostol use may explain differences in perception of its effectiveness. Evidence-based information about misoprostol for IUD insertion in nulliparous women, including pharmacokinetics, efficacy and optimal dosing, is needed.     

Self-administration of misoprostol prior to intrauterine device insertion among nulliparous women: a randomized controlled trial

Background

Barriers to intrauterine device (IUD) use in nulliparous women include fear of pain with insertion and provider perception of difficulty with insertion. The goal of this study was to evaluate whether misoprostol prior to IUD insertion in nulliparous women eased insertion and decreased pain.

Study Design

This was a double-blinded, randomized, controlled trial. Nulliparous women requesting an IUD were randomized to buccal placement of 400-mcg misoprostol or placebo. Provider ease of insertion and patient-reported pain were measured using a 100-mm visual analogue scale.

Results

Seventy-three subjects completed the study. Baseline characteristics were similar between groups. Provider perception of ease of insertion was not different between study and control groups (28.97 mm, 22.33 mm, p=.18). Pain immediately prior to IUD insertion (10.84 vs. 2.11; p=.003) and after IUD insertion (46.50 vs. 35.14; p=.040) was higher for those in the study group compared to the control group.

Conclusion

This study demonstrates that it is not helpful to provide misoprostol for cervical ripening prior to insertion of IUDs as it does not improve ease of insertion for provider or decrease reported pain for the woman, and it may increase women's pain experience with insertion.

Implication Statement

Our study demonstrates that providers do not perceive nulliparous IUD insertion as difficult; women do experience pain with insertion but find the experience acceptable. The addition of misoprostol for cervical ripening prior to insertion does not ease insertion for providers and increases the pain level experienced by women.     

Effects of prophylactic misoprostol administration prior to intrauterine device insertion in nulliparous women

Background

This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device (IUD) placement in nulliparous women.

Study Design

Nulliparous, reproductive-aged women desiring an IUD for contraception were randomized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion. Subjects completed a series of 100-mm visual analogue scales (VAS, anchors: 0=none, 100 mm=worst imaginable) to measure their perceived pain at several times points (anticipated pain, leg positioning, speculum placement, tenaculum placement, IUD insertion, equipment removal and 5 min postinsertion). Secondary outcomes included provider “ease of placement” (100-mm VAS, anchors: 0=easy, 100 mm=extremely difficult), side effects and retention of the IUD after 1 month (self-report or clinic visit). The study had 80% power (α=0.05, one-sided) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34.

Results

A total of 40 subjects were randomized to receive either misoprostol or placebo, and 35 completed the study. Five subjects withdrew (four prior to receiving study medication and one declined IUD). Baseline characteristics were similar between groups. There were no significant differences in patient-reported pain with IUD placement [misoprostol 65 mm (SD 21), placebo 55 mm (SD 21), p=.83] or at any other time point. Moreover, the misoprostol group reported significantly more preinsertion nausea (29% vs. 5%, p=.05) and cramping (47% vs. 16%, p=.04) than the placebo group. While provider-reported ease of insertion was not significantly different between groups, three placebo patients required additional dilation vs. none in the misoprostol group. All 35 subjects underwent follow-up at least 1 month postinsertion, and no expulsions were reported.

Conclusion

Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain, but it did appear to increase preinsertion side effects.     

哺乳期妇女放置宫形Cu300IUD初步临床观察

为观察宫形Cu300IUD在哺乳期妇女中的临床使用效果,接收经阴道分娩42天后,剖宫产6个月后的健康妇女690例,采用内藏式放置器放置宫形Cu300IUD,随访12个月,随访率99.9％。结果显示在使用12个月时累积妊娠率0.74/百妇女,脱落率0.89/百妇女,因出血取出率1.17/百妇女,无术后近期因出血取出者,继续使用率为97.22/百妇女。结论:宫形Cu300IUD作为一种哺乳期避孕工具是安全、有效和可接受的。当月经恢复后,宫形Cu300IUD仍能适应子宫变化,继续存放,不需取出。     

Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study

Background

The study was conducted to determine the feasibility of levonorgestrel–intrauterine system (LNG-IUS) insertion at three different times postpartum.

Study Design

From August 2009 to January 2010, all women desiring LNG-IUS for postpartum contraception were offered enrollment into our study and randomized to three insertion times: immediate (within 10 min of placenta delivery), early (10 min to 48 h postpartum) or interval (≥6 weeks postpartum).

Results

Forty-six women met inclusion criteria and were analyzed. There was no difference in utilization rates at 3 and 6 months between groups (p=.931). Expulsion rates were significantly higher and pain during insertion was significantly lower in the immediate and early groups (p<.001) when compared to the interval group.

Conclusion

Insertion of LNG-IUS ≤48 h postpartum is feasible in our institution and may be associated with similar utilization at 6 months, increased expulsion rates and decreased pain at insertion when compared to placement after 6 weeks.     

不同避孕方法与育龄妇女贫血关系的现况研究

目的 了解江苏省农村育龄妇女的贫血状况并探讨不同避孕方法与贫血的关系。方法 资料来源于江苏省避孕药具不良反应监测点的基线调查，用非条件Logistic回归模型分析贫血的影响因素。结果 (1)江苏省农村育龄妇女的贫血患病率为42．54％。(2)贫血的危险因素为经济欠发达地区、年龄≥35岁(OR=1．125，95％CI：1．019～1．242)、月经周期≤24d(OR=1．489，95％CI：1．198～1．850)、多产次(OR=1．230，95％CI：1．125～1．346)、使用宫内节育器(OR=1．153，95％CI：1．047～1．269)；贫血的保护因素为：体重指数≥25kg／m^2(OR=0．693，95％CI：0．624～0．770)、非农民职业(OR=0．862，95％CI：0．776～0．957)、月经量少(OR=0．805，95％CI：0．744～0．871)。结论 农村育龄妇女的贫血患病率较高，已经成为严重的公共卫生问题；使用宫内节育器为贫血的影响因素．使用前应进行对象筛检。     

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.     

Experience with GyneFIX insertions in Spain: favorable acceptance of the intrauterine contraceptive implant with some limitations

This study evaluates the incidents associated with GyneFIX insertion and first-year expulsion and continuity rates within the usual intrauterine contraceptive practice of a working group of Spanish professionals (GESEG), formed specifically with this aim. It is a prospective, multicenter, observational study of GyneFIX insertion in 1684 women. Data were prospectively collected on a structured form and processed centrally. Interest was focused on difficulties encountered during the insertion procedure and symptoms experienced during insertion. All terms were defined by consensus. Among the total, 18.6% of the women were nulliparous. GyneFIX insertion was rated easy in 92%, with more difficulty in nulliparous women, who showed significantly more symptoms during insertion of the device. First-year expulsion and continuity rates were 5.6 and 88 per 100 women, respectively. The pregnancy rate was 0.3 per 100 women/years. The GyneFIX system is an interesting alternative to standard IUDs for intrauterine contraception with copper, particularly in women who have experienced expulsion of other types of IUDs. Experienced professionals in IUD insertion quickly acquire familiarity with the GyneFIX insertion system, but proper implantation does not completely eliminate the risk of expulsion. Thus, the insertion system should be further modified to achieve a simpler, safer technique.     

A randomized comparative study of the TCu380A and Cu-Safe 300 IUDs

The Cu-Safe 300 is one of the latest additions to the array of available IUDs. It was specifically designed to decrease unwanted side-effects (e.g bleeding, pain and expulsion) while providing simplicity of insertion, ease of removal and fair contraceptive protection. For comparison, the TCu380A was chosen. Both types were inserted at random in 600 recipients by a group of independent physicians with a long standing experience in intrauterine contraception. Life table analysis was used for comparison over a period of three years.The Cu-Safe 300 produced a slightly but not statistically significant higher pregnancy rate and more expulsions. Removals for bleeding and pain, however, were significantly less frequent. All inserting physicians agreed that insertion and removal of this new device was remarkably easy.

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Resumen El Cu-Safe 300 es una de las adiciones más recientes a la variedad de dispositivos, intrauterinos disponibles. Fue diseñado específicamente para reducir efectos secundarios indeseables (por ejemplo, sangrado, dolor y expulsión), proporcionando al mismo tiempo colocación sencilla, retiro simple y buena protección anticonceptiva. A efectos de comparación se eligió el TCu380A. Los dos tipos fueron colocados al azar en 600 mujeres por un grupo de médicos independientes de larga experiencia en materia de anticonceptivos intrauterinos. Se utilizó el análisis de tablas de vida para efectuar comparaciones en un período de tres años.El Cu-Safe ocasionó una tasa ligeramente mayor, pero no estadísticamente significativa, de embarazos y más expulsiones. Sin embargo, los retiros ocasionados por sangrado y dolor fueron significativamente menos frequentes. Todos los médicos que realizaron las colocaciones convinicron en que la colocación y el retiro de este nuevo dispositivo eran notablemente sencillos.

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Resumé Le Cu-Safe 300 est une des, dernières acquisitions dans la panoplie des DIU. Il a été dessiné spécialement afin de diminuer les effects secondaires (hémorragies, crampes et expulsion) tout en offrant une insertion et un retrait facile en plus d'une protection contraceptive efficace. A titre comparatif le TCu380A fut choisi. Les deux types de DIU ont été insérés de facon randomisée auprès de 600 femmes par un groupe de practiciens ayant une longue expérience en contraception intrautérine. Les deux groupes ont été suivis durant trois ans. Le Cu-Safe 300 produit un chiffre de grossesse plus élévé mais, statistiquement non significant en comparison avec le TCu380. Il est expulsé plus fréquemment mais donne lieu à moins de retraits pour hémorragies et crampes. Tous les practiciens concernés étaient d'accord que le nouveau DIU s'insère et se retire avec une aisance remarquable.

     

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。     

Prophylactic vaginal dinoprostone administration six hours prior to copper-T380A intrauterine device insertion in nulliparous women: A randomized controlled trial

ObjectiveTo determine the effectiveness of 3 mg vaginal dinoprostone administered six hours prior to copper intrauterine device (IUD) insertion compared to placebo in increasing ease of insertion and reducing insertion pain among nulliparous women. Study design. This was a single-center double-blinded randomized controlled trial (RCT). We randomly divided the two hundred nulliparous women requesting a copper T380A IUD to receive 3 mg vaginal dinoprostone or placebo six hours before IUD insertion. The primary outcome was provider ease of insertion. Patients reported their perceived insertion pain using a 10 cm visual analog scale (VAS). We also reported number of failed IUD insertions.ResultsBaseline characteristics were similar between groups. Ease of insertion score was lower in dinoprostone group than placebo group (3.6 ± 2.5 vs. 5.4 ± 2.8; p < 0.01) denoting easier insertion for clinicians in dinoprostone group. Mean pain score during copper IUD insertion was lower in dinoprostone group (3.7 ± 2.3 vs. 5.0 ± 2.8; p < 0.01). Failed IUD insertion occurred in two cases of dinoprostone group (2%) versus four cases in control group (4%) (p-value; 0.68).ConclusionsAlthough vaginal dinoprostone administration six hours prior to copper IUD insertion in nulliparous women leads to an easy IUD insertion, we do not routinely advise it as the reduction in IUD insertion pain scores with vaginal dinoprostone lacked clinical significance.ImplicationsIn settings where it is feasible to provide dinoprostone vaginally six hours before copper IUD insertion, clinicians will find insertion easier, and nulliparous women may experience somewhat less pain during the procedure. Where waiting six hours is practical, this may prove to be useful.     

Improving slow-transit constipation with transcutaneous electrical stimulation in women: A randomized,comparative study

The purpose of this study was to investigate the effect of transcutaneous electrical stimulation (TES) in women with slow-transit constipation. Twenty-eight women with slow-transit constipation were randomly assigned to a treatment group (14 women) or a control group (14 women). Data collection was conducted from March 7, 2014 to May 2, 2014. TES and sham TES were performed for 20 minutes, three times per week, for 4 weeks for the treatment and control groups, respectively. The results of the tests before and after treatment, including the Constipation Assessment Scale (CAS), abdominal pain, and number of defecations per week, were assessed. A significant decrease in CAS score and in abdominal pain (p < .05), and a significant increase in evacuation frequency per week (p < .05) were observed in the treatment group. In addition, a significant decrease in CAS score and in abdominal pain (p < .05) was observed in the control group. However, no noticeable change was observed in evacuation frequency per week in the control group. Based on these results, TES may have a beneficial effect in women with slow-transit constipation, and could be used to reduce the symptoms of constipation.     

Use of the Mirena™ LNG-IUS and Paragard™ CuT380A intrauterine devices in nulliparous women: Release date 15 December 2009 SFP Guideline 20092

Two intrauterine devices (IUDs) are available in the United States, the levonorgestrel-bearing intrauterine system (Mirena™) and the copper-bearing T380A (Paragard™). These devices have very low typical-use failure rates but are used by only a minority of women. In particular, there is concern about their use in nulliparous women. We review the available data to address common concerns about using IUDs in this population and show that nulliparous women desiring effective contraception should be considered candidates for IUDs.     

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。     

A randomized comparative study on mifepristone alone and in combination with tamoxifen for emergency contraception

The purpose of the clinical study was to compare the efficacy and side effects of 10 mg of mifepristone alone (Group 1) and with 20 mg of tamoxifen (Group 2) for emergency contraception, especially as used within 72-120 h after coitus. Four-hundred female volunteers with one act of unprotected intercourse or contraception failure (200 cases in each group) were recruited and completed the study. There were 198 women treated < 72 h after coitus (100 in Group 1 and 98 in Group 2), whereas the remaining 202 patients were treated between 72-120 h (100 in Group 1 and 102 in Group 2). In total, four pregnancies occurred; one treated < 72 h in each group, two between 72-120 h in Group 1. Efficacy for prevention of unwanted pregnancy by Trussell method is 84% for Group 1, and 95% for Group 2, and which is not significantly different between the two groups and even subgroups. The side effects (15.5% for Group 1 and 14.5% for Group 2) and changes in menstruation were infrequent and mild in both groups. Further studies should be conducted to determine whether tamoxifen combined with mifepristone for emergency contraception is more effective as compared with mifepristone alone.     

The effect of nitroglycerin on the IUD insertion experience in nulliparous women: a pilot study

Objective

Concern about pain during placement of an intrauterine device (IUD) represents a barrier to use, especially among nulliparous women. We hypothesized that nitroglycerin gel applied vaginally 30 min prior to IUD placement would reduce insertion-related pain.

Study design

We designed a randomized, double-blinded, placebo-controlled pilot study to evaluate the efficacy and tolerability of 0.5-mg nitroglycerin gel (1 mL) or identical placebo gel applied vaginally in nulliparous women 30 min prior to IUD placement. The study was limited to women who opted for the levonorgestrel-releasing intrauterine system. Subjects completed a series of 100-mm visual analogue scales at several time points. The primary outcome was subject-reported pain with passage of the IUD through the cervix. Secondary outcomes included subject-reported pain at other time points, provider-reported ease of insertion, side effects, adverse events and need for additional dilation.

Results

A total of 24 women were randomized. Baseline characteristics were similar between groups. The mean pain score with IUD deployment was 55.0 mm [standard deviation (SD) = 29.7 mm] in the placebo group and 57.4 mm (SD 22.1 mm) in the nitroglycerin group (p=.82). There was no difference in ease of insertion reported by providers. Two subjects required dilation, one in each group.

Conclusion

Vaginal administration of 0.5-mg nitroglycerin gel 30 min prior to IUD placement does not appear to decrease patient-reported procedural pain among nulliparous women or ease of insertion for providers.