Levonorgestrel Intrauterine Device Use in Overweight and Obese Women

The levonorgestrel intrauterine device (LNG-IUD) is a safe, effective, long-acting, reversible contraceptive that reduces unintended pregnancy and decreases heavy menstrual bleeding. Many procedures such as IUD insertion are more challenging in overweight and obese women. The objective of this study was to describe LNG-IUD insertion, continuation, and complications in overweight and obese women in an ethnically diverse population in Hawai‘i. A retrospective cohort study of women who had a LNG-IUD inserted at the University of Hawai‘i, Department of Obstetrics and Gynecology Resident and Faculty practice sites between January 2009 and December 2010 was performed. A total of 149 women were followed. The most commonly reported races were Asian (32%), Native Hawaiian (26%), and non-Hawaiian Pacific Islander (20%). The mean BMI of the study population was 28.4 (standard deviation 7.2) with 37% classified as normal weight, 30% as overweight, and 33% as obese. Overall, 76% of women continued the LNG-IUD 12 months after insertion. No statistically significant difference emerged in 12-month IUD continuation between the BMI groups. Difficult (5%) and failed (3%) IUD insertions were rare for all BMI groups. IUD complications occurred in 9% of women and included expulsion and self-removal. In this diverse population, the majority of women continued to use the LNG-IUD one year after insertion with low rates of difficult insertions and complications.     

Intrauterine device use among women with uterine fibroids: a systematic review

Background

There are concerns that intrauterine device (IUD) use by women with uterine fibroids might increase their uterine bleeding or risk for device expulsion. The objective of this systematic review was to evaluate evidence concerning the safety and effectiveness of IUD use among women with uterine fibroids. Key questions included whether IUD use is associated with increased risk for uterine bleeding among women with uterine fibroids and whether the presence of uterine fibroids is associated with an increased risk for device expulsion among IUD users.

Study Design

We searched the PubMed database for peer-reviewed articles relevant to IUD (copper or levonorgestrel-releasing) use and uterine fibroids published in any language from database inception through June 2009. We used standard abstract forms and a grading system to summarize and assess the quality of the evidence.

Results

From 202 articles found in the database search, we identified 11 studies that met our inclusion criteria, all of which examined outcomes among users of the levonorgestrel-releasing IUD (LNG-IUD). Evidence from 10 of 11 noncomparative studies (Level II-3, fair) suggests that LNG-IUD use among women with fibroids does not increase menstrual bleeding, and results from all 11 showed that menstrual blood loss decreased among women who continued to use the LNG-IUD through the end of the study period. Overall, serum levels of hemoglobin, hematocrit and ferritin increased among LNG-IUD users in studies that assessed these outcomes. Several studies reported some occurrences of irregular bleeding. Findings from two cohort studies (Level II-2, fair to poor) showed rates of LNG-IUD expulsion to be higher among women with uterine fibroids (11% in each) than among women without uterine fibroids (0% and 3%); however, in one study the difference was not statistically significant, and in the other significance testing was not conducted. Six prospective noncomparative studies reported expulsion rates of 0-20% among women with uterine fibroids.

Conclusions

Most women with uterine fibroids are likely to have less menstrual blood loss and higher serum levels of hemoglobin, hematocrit and ferritin after insertion of an LNG-IUD, despite some occurrences of irregular bleeding. LNG-IUD users with uterine fibroids may have higher rates of expulsion than those without fibroids.     

Phase III-clinical trial with NORPLANT-2 (covered rods). Report of a 24-month study

In a phase III multicentre clinical trial, the subdermal implant Norplant^R-2 was studied for its clinical use effectiveness, safety and bleeding pattern. A total of 1466 healthy volunteers, with no contraindication to steroid use, were observed for 29,669 woman-months of use. One method failure was reported at 18 months of Norplant^R -2 use. The method was associated with altered menstrual pattern with a trend towards reduced blood loss.

The continuation rates were 88.1 and 73.5 per 100 users at 12 and 24 months of use, respectively. Menstrual disturbance, mainly prolonged bleeding, accounted for the majority of the discontinuations. Removal of Norplant^R -2 due to local infection was rare (0.4 per 100 users at 24 months). In similar clinical trial conditions, the continuation rate with Norplant^R-2 is significantly higher than those observed with LNG IUD and injectable contraceptives, norethisterone oenanthate 200 mg given every 60 ± 5 days, and is comparable to that of CUT 200 IUD.     

人工流产后和月经间期放置活性γ型宫内节育器的临床效果观察

目的:比较人工流产后和月经间期放置活性γ型宫内节育器(IUD)的临床效果。方法:采用多中心临床对照试验的方法,在全国10个省市的27家计划生育服务和医疗机构,对符合本研究纳入标准的观察对象,分别在月经间期、人工流产后即时放置活性γ型IUD,比较其避孕效果。结果:共接收观察对象1 300例,月经间期放置IUD 824例(月经间期组),人工流产后即时放置IUD 476例(人流后组)。随访12个月时,月经间期组和人流后组带器妊娠率均较低(≤0.12/百妇女年),脱落相关终止率分别为1.53/百妇女年、2.20/百妇女年,脱落相关终止原因中两组均以下移为主,医疗原因取出率分别为1.74/百妇女年、1.06/百妇女年,人流后组所有的医疗原因取出均发生在放置后3个月内。人流后组置器后前3个月IUD相关终止率一直高于月经间期组,但放置12个月时终止率基本相等。两组间差异均无统计学意义(P0.05)。结论:人工流产后和月经间期放置活性γ型IUD均安全可靠。     

Return to fertility after removal of a levonorgestrel-releasing intrauterine device and Nova-T

In a European randomized multicenter study, the efficacy and safety of an intrauterine contraceptive device releasing 20 microgram levonorgestrel/24 hours (LNG-IUD) have been evaluated and compared to the Nova-T. Because the LNG-IUD has a strongly suppressive effect on the endometrium and in some women affects ovarian function, the return to fertility after removal of the IUD was studied. Two-hundred-nine women (71 in the Nova-T and 138 in the LNG-IUD group), who had their IUDs removed because of planning pregnancy, were followed at least 24 months or until termination of pregnancy. For the Nova-T, the cumulative conception gross rate was 71.2/100 women after 12 months (79.7 after 24 months) and for the LNG-IUD 79.1 (86.6 after 24 months). The difference between the devices is not statistically significant, and in spite of the endometrial suppression during use of LNG-IUD, there is no delay of return to fertility and in both groups 96% of the pregnancies occurred during the first year after removal of the device. Eighty-four % of the pregnancies in the Nova-T group and eighty-six % in the LNG-IUD group ended in live births. The results suggest that the endometrium recovers quickly, normal ovulations are established and the fertility seems to be unaffected after use of an LNG-IUD.     

Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up

OBJECTIVE: This study aimed to compare immediate postplacental (IPP) and early postpartum (EP) intrauterine device (IUD) insertions with interval (INT) IUD insertions with respect to efficacy and complications. METHODS: The study group consisted of 268 women in whom the following TCu 380A IUD insertions were performed: 84 IPP (less than 10 min), 46 EP (10 min to 72 h) and 138 INT (more than 6 weeks). The women were followed up 8 weeks, 6 months and 12 months after insertion. Complications and pregnancies encountered at the end of 1 year following IPP, EP and INT insertions were compared. The chi-square test and Fisher's Exact Test were used for the evaluation of the data. RESULTS: Complications developed in 40.4% of the women in the IPP group, in 74.4% of the women in the EP group and in 19.2% of the women in the INT group (p<.001). Although no statistically significant difference was found between the groups for uterine perforation and infection (p>.001), there was a statistically significant difference between the groups in the incidence of complete and partial expulsion according to the time of IUD insertion. The overall cumulative pregnancy rate and frequency of pregnancy were found to be higher (p>.05 for both), which are both insignificant for the EP group (2 of 43 women), as compared with the INT (4 of 130 women) and IPP groups (2 of 84 women), and pregnancy rates at 1 year for all groups was 3.1% (8 of 257 women). CONCLUSION: IPP and EP insertion of the TCu 380A IUD is an effective and convenient procedure, and expulsion rates in these groups are higher than in the INT group. Further studies are necessary to determine the cause of the higher expulsion rates and to find ways to reduce such rates.     

Immediate postabortal insertion of a levonorgestrel-releasing IUD

Experimental IUDs releasing only 10 μg levonorgestrel per day and established copper-releasing IUDs (Nova-T) were inserted in 60 women in connection with legal first-trimester abortion. Bleeding and spotting and other events were recorded during the first year. Restoration of the menstrual cycle was studied. Blood samples were collected twice a week over a three-month period from five women receiving a levonorgestrel-releasing IUD to determine plasma levels of estradiol, progesterone, levonorgestrel, LH and FSH. FSH showed an increase approximately ten days (range 4–19) after abortion. LH/hCG concentrations reached a plateau approximately 24 days (range 9–42) after abortion. Initially, levonorgestrel concentrations were two-fold compared with concentrations of 90 pg/ml after four weeks. After four weeks the plasma levonorgestrel concentrations were stable. All five women had an ovulatory menstrual cycle. The first periods occurred 35 days after operation in the levonorgestrel-IUD group and 30 days after operation in the Nova-T group. The median duration of bleeding and spotting after the insertion was 12 days (range 3–26) in the Nova-T group and 12.5 days (range 3–93) in the levonorgestrel-IUD group. The difference was not statistically significant. From the second month on, menses-like bleeding was more common in the copper-releasing IUD group than in the levonorgestrel-IUD group. The difference was statistically significant (p < 0.001). After one year 75 percent of the patients continued with their IUDs in both groups. One pregnancy occurred in the experimental levonorgestrel-IUD group. One total expulsion was noticed in both groups, and one partial expulsion in the levonorgestrel-IUD group. Two levonorgestrel-IUDs and four Nova-Ts were removed because of bleeding and/or pain. One infection was noticed in the whole group six days after the operation. In the levonorgestrel-IUD group 74 percent of the women had a regular cycle after one year, while all Nova-T patients had a regular cycle. Twelve percent (7 women) were lost to follow-up at one year. The results of this study suggest that a levonorgestrel-releasing IUD can be inserted after legal first-trimester abortion and the results are comparable with those of previous studies that have been made using copper-releasing IUDs.     

Postplacental insertion of the levonorgestrel intrauterine device after cesarean delivery vs. delayed insertion: a randomized controlled trial

Objective

This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4–8 weeks after delivery.

Study design

This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4–8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery.

Results

Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment.

Conclusions

Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion.

Implications

Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis.     

子宫内膜息肉不孕患者宫腔镜下不同治疗方式的疗效观察

目的:比较宫腔镜下微型剪刀剪除息肉加电凝术与宫腔镜下子宫内膜息肉电切除术治疗子宫内膜息肉不孕症患者的疗效。方法:78例异常子宫出血的不孕症患者经B超联合宫腔镜检查诊断为子宫内膜息肉,用随机表法分为两组:A组38例行宫腔镜下微型剪刀剪除息肉加电凝术,B组40例行宫腔镜下子宫内膜息肉电切除术。比较两组患者手术情况、术后1年月经量的情况、随访1年妊娠和复发情况。结果:手术时间、出血量及并发症,两组比较无统计学差异(P>0.05)。A组治疗后半年内月经量明显减少(P<0.05),1年时月经量无明显减少(P>0.05);B组治疗后半年内、1年时月经量较治疗前明显减少(P<0.05)。半年内两组妊娠率比较无统计学差异(P>0.05),1年时两组妊娠率差异有统计学意义(P<0.05)。半年内两组复发率比较无统计学差异(P>0.05),但1年时两组复发率比较有统计学差异(P<0.05)。结论:宫腔镜下微型剪刀剪除息肉加电凝术疗效主要见于治疗后半年内,而宫腔镜下子宫内膜息肉电切除术在术后1年仍保持良好疗效。     

阴道分娩月经恢复后放置3种宫内节育器的临床效果观察

目的:评价阴道分娩妇女在月经恢复后放置3种宫内节育器(IUD)的有效性,为育龄妇女知情选择IUD提供参考依据。方法:阴道分娩妇女在月经恢复后知情选择分别放置吉妮IUD(吉妮组148例)、爱母IUD(爱母组223例)和花式IUD(花式组232例),并进行1年随访,比较3种IUD的临床效果。结果:放置术中和观察期间未发现子宫穿孔。放置1年时吉妮组和爱母组均无妊娠发生,花式组4例带器妊娠,3组间差异有统计学意义(P=0.0399)。花式IUD的脱落率最高(2.2/百妇女年),因症取出率以爱母组最高(2.27/百妇女年),与IUD相关的终止率以吉妮组最低(2.75/百妇女年),爱母组为3.60/百妇女年,花式组为5.65/百妇女年,但组间差异无统计学意义。结论:本观察的3种IUD均适合在阴道分娩月经恢复后放置。     

剖宫产术后放置GeneFiex、TCu220C及活性165宫内节育器的临床效果比较

目的:观察剖宫产术后放置吉妮致美(GeneFiexIN)、TCu220C、活性165宫内节育器的临床效果。方法:对646例有剖宫产史的受术者,随机放置吉妮致美及TCu220C、活性165宫内节育器,随访1年后,观察效果。结果:放置吉妮致美随访一年后,带器妊娠为0.99/百妇女年,脱落率为0.98/百妇女年,因症取出率为2.93/百妇女年;TCu200c带器妊娠为5.36/百妇女年,脱落率为3.95/百妇女年,因症取出率为12.09/百妇女年;活性165带器妊娠为5.99/百妇女年,脱落率为3.68/百妇女年,因症取出率为11.06/百妇女年。结论:放置吉妮致美宫内节育器具有出血少,腹痛率低,脱落率低等优点,续用率及避孕效果均高于TCu220C及活性165宫内节育器,是剖宫产术后放置宫内节育器的首选。     

Comparative study on contraceptive efficacy and clinical performance of the copper/low-density polyethylene nanocomposite IUD and the copper T220C IUD

BACKGROUND: The study was conducted to compare the antifertility effectiveness and side effects of the copper/low-density polyethylene nanocomposite IUD (experimental group) and the copper T220C IUD (control group). STUDY DESIGN: One hundred females were randomly divided into two groups (experimental group and control group, n = 50 in each group). Clinical observation and comparative study were performed on the two groups for 12 months. RESULTS: Follow-up rate was 100% at the 12th month. In the experimental group and control group, the cumulative continuation rates were both 92.0 per 100 women at the 12th month and there was no difference between them (p > .05). The pregnancy rate, removal rate and expulsion rate were low with the difference being not statistically significant (p>.05). The most common side effects were excessive menstrual bleeding, spotting and pain. The rates of side effects were lower in the experimental group than in control group, especially during the initial 3 months after insertion with the differences being statistically significant (p < .05). CONCLUSION: The new design of the copper/low-density polyethylene nanocomposite IUD showed low pregnancy rate, high contraceptive efficacy and satisfactory acceptability. The study suggested that the TCu220C IUD also had high contraceptive efficacy, but had relatively more side effects.     

Intrauterine contraception with Nova-T and Copper-T-200 during three years

A randomized comparative trial on the clinical performance of two copper-releasing IUDs (Nova-T and Copper-T-200) was performed simultaneously in Denmark, Finland and Sweden. After three years the cumulative pregnancy rate was 1.9 for Nova-T and 5.0 for Copper-T. This difference in efficacy was statistically significant (p < 0.001). Copper-T had a lower expulsion rate (p < 0.05) in the total series but not in postmenstrual insertions. Differences between the two devices in other termination rates were not statistically significant. Analysis according to age and parity demonstrated that the pregnancy rate of Nova-T was lower than that of Copper-T in every age and parity group. The pregnancy rate of Nova-T was not affected by age or parity whereas the pregnancy rate and the expulsion rate of Copper-T decreased with increasing age and parity. The removal rate because of infection decreased markedly after the first year of use for both devices. The cumulative rate of removals for infection during the three years of use was not significantly correlated to age and there was no correlation to parity. The continuation rates increased with age and parity. The continuation rates of nulli- and primiparous women were almost identical with both devices and lower than continuation rates of women with 2 or three or more children. Only 11% of the women were lost to follow-up during 36 months. Nova-T had superior effectiveness in preventing undesired pregnancies when compared with Copper-T. The performance of Nova-T is less affected by age and parity than the performance of Copper-T. The silver core in copper wire gives a prolongation of the life-span for Nova-T. For these reasons, Nova-T appears to meet the requirements for an ideal IUD.     

放置元宫铜300、TCu380A及活性165 IUD 12个月效果观察

目的:观察元宫铜300、TCu380A和活性165宫内节育器(IUD)使用效果,探讨改善其使用价值的途径。方法:采用多中心随机比较性临床研究方法,自2007年7月3日~2008年11月21日,在全国6个省22家计划生育服务机构,对符合条件的健康育龄期妇女,随机分别放置元宫铜300、TCu380A或活性165IUD,比较避孕效果、失败率和不良反应的发生情况。结果:共接收观察对象3299例,放置元宫铜300、TCu380A和活性165IUD分别为1104、1104和1091例。12个月末失访率为0.24%(8/3299)。观察期间无子宫穿孔和盆腔感染发生。在IUD使用失败的各种原因中,3种IUD带器妊娠、下移取出终止率比较,差异均无统计学意义(P0.05);完全脱落以活性165最高(终止率为2.09/百妇女年),与元宫铜300(终止率为0.84/百妇女年)和TCu380AIUD(终止率为0.75/百妇女年)分别比较,差异均有统计学意义(P0.05);放置活性165IUD有4例发生意外妊娠(终止率为0.38/百妇女年),其他两种IUD各有1例(终止率均为0.11/百妇女年)。3种IUD中因出血和(或)疼痛的终止率以元宫铜300IUD最高,TCu380AIUD次之,活性165IUD最低,差异有统计学意义(P0.05)。结论:3种IUD各有优缺点,应综合考虑适用对象与IUD的特点,以提高IUD的实际使用价值。     

Cervical mucus granulocyte macrophage colony stimulating factor and interleukin-2 soluble receptor in women using copper intrauterine contraceptive devices

The objectives of this study were to evaluate the bleeding patterns and clinical performance during the first 2 years of use of an intrauterine system releasing 20 microg/day of levonorgestrel (LNG-IUS, Mirena). Two-hundred-fifty-six women accepted use of Mirena from April 1998 through September 1998. The gross cumulative discontinuation rate due to pregnancy and expulsion were significantly higher in women who used the device because of heavy bleeding. There was one pregnancy at the 15th month of use after an inadvertent expulsion of the device. The continuation rate was 66.2 at the end of the second year. Forty-four percent of women reported amenorrhea at the 6th month of use. This rate maintained stability at 50% after 12 and 24 months of use. Spotting was present in 25% of the users at 6 months, decreasing to 8% and 11% at 18 and 24 months, respectively. Oligomenorrhea was described by one-quarter of women and was similar at each observation period. Removals due to menstrual bleeding problems were concentrated in the first 6 months of use and mostly due to amenorrhea or menorrhagia. In conclusion, LNG-IUS showed a high contraceptive efficacy and a good continuation rate up to 2 years. In addition, a reduction of blood loss was observed a few months after insertion.     

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。     

The efficacy and acceptability of a low-dose levonorgestrel intravaginal ring for contraception in a UK cohort

The efficacy and acceptability of a levonorgestrel-releasing intravaginal ring (IVR) for contraception was assessed in a British cohort studied as part of a multicentre, multinational clinical trial performed under the auspices of the World Health Organisation. One-hundred-and-fifty women took part in the study in two UK centres and completed 1417.5 months of method use. Fifty-nine women discontinued use of the IVR before the end of one year giving an overall discontinuation rate of 39.9 per 100 woman-years. The discontinuation for pregnancy with the ring in situ, was 3.0 per 100 woman-years (life table analysis). Menstrual disturbance, vaginal problems and involuntary expulsion resulted in discontinuation rates of 8.9, 8.4 and 1.6 per 100 woman-years, respectively. This method is an acceptable and effective method of contraception for women.     

剖宫产术后1年内行人工流产妇女术后放置IUD的避孕效果观察

目的 探讨剖宫产术后1年内行人工流产患者术后立即放置宫内节育器(IUD)的避孕效果.方法 选取2015年8月至2016年7月于安徽省马鞍市妇幼保健院就诊的人工流产术后立即放置IUD妇女480例,根据患者有无剖宫产史及剖宫产术后时间将所有患者分为A、B、C三组,剖宫产术后12个月内为A组,剖宫产术后12个月以上为B组,无剖宫产史的患者为C组.对比分析所有人工流产患者术后立即放置IUD的避孕效果和副作用.结果 置入IUD后1个月中,A组患者经期延长、经量增加、腰腹痛、不规则出血和白带增多的发生率高于其他两组,但差异无统计学意义(χ2值分别为0.28、0.01、0.14、0.01、0.07,均P>0.05).三组患者在3个月及以后时间点发生经期延长、经量增加、腰腹痛、不规则出血和白带增多的发生率比较,差异无统计学意义(χ2值分别为0.16、0.05、0.07、0.01、0.23,均P>0.05).所有患者在随访期间无出现闭经(宫腔粘连)的情况.三组患者置入IUD后,术后6个月时因疼痛或因出血取出率最高,三组之间比较差异无统计学意义(χ2=0.02,P>0.05).在随访期间,所有患者均未出现带器妊娠0.置入IUD后,B组在术后3个月内完全脱落2例,其余患者未发生完全脱落及部分脱落情况.至术后12个月时,三组患者累计续用率比较差异无统计学意义(χ2=0.92,P>0.05).结论 剖宫产术后1年内行人工流产的患者术后立即放置IUD是安全、可行的.     

Microdose intravaginal levonorgestrel contraception: a multicentre clinical trial. I. Contraceptive efficacy and side effects. World Health Organization. Task Force on Long-Acting Systemic Agents for Fertility Regulation

A multicentre clinical trial, including 19 centres in 13 countries, assessed the contraceptive efficacy and clinical acceptability of a Silastic 382 vaginal ring releasing 20 micrograms of levonorgestrel for at least 90 days. A total of 1005 women entered the study and 8176.74 woman-months of experience was gathered. The rate of intrauterine pregnancy at one year of use was 3.6 per 100 women (95% confidence interval 2.2-5.0), and of ectopic pregnancy, 0.2% (one case). The principal reasons for discontinuation were menstrual disturbances (17.2% at one year), vaginal symptoms (6.0%) and repeated expulsion of the ring (7.1%). The pregnancy rate with this 20 micrograms levonorgestrel-releasing vaginal ring compares favourably with that of a low estrogen combination oral contraceptive tested by WHO and is less than half that of a progestogen-only oral contraceptive in a WHO randomized study. It is concluded that the WHO intravaginal ring releasing an average of 20 micrograms of levonorgestrel per 24 hours is an effective method of contraception for at least one year of use.     

Effect of prior pregnancy and combined oral contraceptives on baseline menstrual blood loss and bleeding response to intrauterine devices.

No effect of pregnancy was found on baseline menstrual blood loss (MBL) in women within one year of parturition or abortion. The increased bleeding response of women to intrauterine devices (IUDs) was found to be independent of pregnancy status during the year preceding IUD sertion. Women pregnant within a year of insertion had no different MBL than those pregnant more than a year prior to insertion. MBL quantified in subjects within three months of discontinuing combined oral contraceptives (OCs) was significantly lower than in prior non-OC users. Furthermore, MBL was significantly reduced in the former group during the first three menses following IUD insertion. At the sixth and twelfth menses post-insertion, MBL was still lower in prior OC users, but the difference between users and non-users was less and no longer statistically significant.