Post-marketing surveillance of Norplant((R)) contraceptive implants: II. Non-reproductive health(1)

This controlled cohort study aimed to evaluate the safety and efficacy of Norplant contraceptive implants in developing countries. Women initiating Norplant implants were index subjects and women initiating intrauterine devices (IUDs) or surgical sterilization were controls. Consenting participants at 32 clinics in eight developing countries were admitted and followed-up every 6 months for 5 years. Major and less serious health events during follow-up were recorded. Incidence rate ratios of health events adjusted for clinic were estimated for initial and current method use. This paper reports non-reproductive health events. The study involved 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of sterilization. Five years follow-up was completed for 94.6% of the women. The study accumulated 78,323 woman-years of observation. The initial method chosen accounted for 84.4% or more of observed woman-years in users of Norplant, IUD, or sterilization. Twenty-two of the recorded 34 deaths were due to accidents, suicide or homicide. Few deaths or major health events were due to cancer or acute cardiovascular diseases and were not associated with the contraceptive method used. The incidence rates of major health events were low and with two exceptions, there was no significant excess risk of serious morbidity for Norplant users compared with controls; among Norplant initiators gallbladder disease occurred at an incidence rate of 1.5 per 1,000 woman-years and was weakly associated with use of Norplant (rate ratio 1.52 [95% C.I. 1.02, 2.27]). For current Norplant users compared to controls, the rate ratio of a combined variable of hypertension and borderline hypertension was significantly elevated (1.81, [1.12, 2.92]). The occurrence of less serious health events was also low and several of them were significantly more often reported among Norplant users. Headache-migraine, weight gain, mood disturbances, pruritus, eczema, and acne had incidence rates among Norplant users of 11.5, 4.5, 2.8, 1.5, 1.4, and 0.9 per 1,000 woman-years, respectively, and were significantly higher than in controls. Respiratory health problems, nonspecific symptoms, and several ill-defined conditions were also significantly more often reported for Norplant users, but some of the excess incidence may be attributable to reporting and detection bias. The study confirms the safety with respect to serious disease of Norplant, IUDs, and sterilization.     

WHO 86925 Norplant上市后监测(中国部分)

本课题研究目的是对Norplant皮下埋植剂潜在副作用进行监测,以进一步证实其安全性。对使用Norplant和IUD或绝育术的妇女进行比较随访研究。每半年随访一次,详细记录所有健康情况,共随访5年。随访率达99.9％。结果:Norplant组及对照组IUD和绝育术的5年继续使用率分别为76.25、80.89、98.10/100使用者。Norplant的5年累计妊娠率为0.6/100使用者,远低于IUD的8.11/100使用者,宫外孕发生率为0.46/1000妇女年,低于IUD的1.24/1000妇女年,但宫外孕和妊娠之比在Norplant组为31.6:100,远高于IUD的6.7:100,如发生妊娠,要警惕宫外孕的可能。月经问题是Norplant的主要终止使用原因,但使用5年者,其血红蛋白均值上升,和接收时相比P<0.001,而IUD使用5年者,其血红蛋白均值下降,和接收时相比P<0.01。在观察5年中胆囊炎胆石症、纤维囊性乳腺病在Norplant使用者中的发病率高于对照组,P<0.05～0.001,但未发现重大健康问题。Norplant使用5年是安全的。     

3种常用避孕节育技术对已婚育龄妇女生活质量的影响

目的:分析比较育龄妇女使用元宫铜300宫内节育器(IUD)、复方甲地孕酮避孕针和两根型皮下埋植剂3个月后生活质量的变化情况。方法:2007年7月～2008年12月在我国8个省的20所县级计划生育服务站开展多中心临床研究。以在每所服务站就诊要求使用上述3种避孕方法的健康育龄妇女为研究对象,采用SF-36量表调查妇女使用避孕措施前和使用后3个月时的生活质量状况。结果:20个研究中心共纳入1356例已婚育龄妇女,其中446例使用元宫铜300IUD、610例使用皮下埋植剂、300例使用避孕针避孕。使用避孕措施3个月后,IUD组和避孕针组生活质量总得分较基线得分略增加,而使用皮下埋植剂组生活质量总得分略下降。调整基线得分、所在地区、职业、收入、产次及末次使用避孕方法,使用皮下埋植剂和避孕针组生活质量得分增加值略低于元宫铜组。结论:3种避孕方法对妇女生活质量的影响均较小,使用元宫铜300IUD者生活质量改善情况略优于使用避孕针和皮下埋植剂者。     

Trends in contraceptive patterns and behaviors during a period of fertility transition in China: 1988-2006

BackgroundThis paper explores how contraceptive patterns and behaviors changed during the course of China's population transition and a period of low fertility from 1988 to 2006.Study DesignBased on data from Chinese nationwide surveys of family planning and reproductive health undertaken in 1988, 1997, 2001 and 2006, this study uses a multinomial logit model to analyze changes in, regional differences in and determinants of contraceptive behaviors during this period.ResultsThe overall prevalence of contraceptive use among married women aged 15–49 years changed little during these 20 years, holding steady at about 90%. However, there were notable changes in the method mix: the predominant methods used were the long-term methods of the intrauterine device (IUD) and female sterilization, and contraceptive use gradually shifted from sterilization to IUDs and condoms. There existed a close relationship between contraceptive methods used and sociodemographic characteristics. Hans, rural, old and less educated women are more likely to use sterilization, while minorities, urban, young and educated women are more likely to use IUDs.ConclusionThere are marked changes in the method mix among different demographic groups during the course of China's population transition and a period of low fertility. The findings indicate that future works aimed at promoting reproductive health should be diverse among different populations.     

Copper T IUD use and ectopic pregnancy rates in the United States.

Over a four-year exposure period, the rate of ectopic pregnancy for women using a Copper T IUD was less than 1 per 1000 years of use. The cumulative 4-year probability of having an ectopic pregnancy while using the Copper T was 4 per 1000 women. These results are based on a study of 35,496 women with 38,064 years of use. Data on ectopic pregnancies in the United States provide a basis with which IUD experience may be compared. The National Hospital Discharge Survey shows a doubling in the number of ectopic pregnancies and in the incidence rates between 1965 and 1976. The relative risk of ectopic pregnancy among IUD users as compared with sexually active women not using the pill or sterilization may have been above 1 in 1965. In 1976, the relative risk is estimated to have been below 1. Compared with all woman-years of exposure, including women using contraceptive sterilization and the pill, the relative risk of extopic pregnancy to IUD users in 1976 was about 1. The IUD could not have been a major factor contributing to the recent doubling in the rate of ectopic pregnancy in the U.S.     

Evaluating contraceptive choice through the method-mix approach. An Indian Council of Medical Research (ICMR) task force study

The method-mix approach was used to evaluate informed contraceptive choices in the present study. A total of 8,077 potential clients were given a balanced presentation of all available contraceptive methods in the national program, ie, the CuT 200 intrauterine device (IUD), low-dose combined oral pills (OC), condom, and sterilization (female/male) along with a new method, Norplant(R).(1) The majority of women opted for spacing methods; among them, the IUD was preferred by about 60% of clients, followed by condoms (9%), OC (6%), and Norplant (5%). Sterilization, mainly female, was accepted by about 17% of the women making an informed choice.The economic status of couples did not influence the contraceptive choices, as all the methods were offered free of cost in the present study, which is the current practice in the national program. Illiterate women more often accepted sterilization (about 25%) than did literate women (15%). This is because illiterate women had more children; about 30% of illiterate women had three or more children, as opposed to 16.2% of literate women. However, literacy status did not influence the choice of any specific spacing method. The study also revealed that, by encouraging potential clients to make an informed choice, they could override the provider's bias while accepting a particular type of spacing method. This is evident from the observation that Norplant was the first choice of the provider for 35% of the women, whereas only 5% of women preferred and accepted Norplant. The present study stresses an urgent need to promote the practice of informed choices in the national program with a variety of contraceptive options-especially, spacing methods for improving contraceptive prevalence and reproductive health in the country.     

江苏省农村已婚育龄妇女贫血的发生与避孕方法使用关系的研究

目的明确江苏省已婚育龄妇女中贫血发生的比例,探讨放置宫内节育器对已婚育龄妇女贫血发生的影响。方法采用整群抽样的方法,在避孕药具不良反应监测试点调查已婚育龄妇女生育史、避孕方法应用和副作用发生情况,同时进行相应的健康检查。结果江苏省农村已婚育龄妇女贫血患病率为41.52%,其中苏南地区为28.32%、苏中和苏北地区分别为51.22%和51.98%(P<0.001)。经产次调整后,宫内节育器使用者贫血患病率为42.37%,女性绝育术者贫血患病率为39.30%,避孕药和屏障法贫血的患病率分别为37.80%和35.54%(P<0.001)。宫内节育器使用者贫血的自报率很低,仅1.18%。分地区多因素非条件Logistic回归分析显示,苏南地区使用宫内节育器(OR=1.400,95%CI1.256~1.559)为贫血的主要影响因素;苏北地区多产次(OR=1.333,95%CI1.169~1.520)为贫血的主要影响因素。结论江苏省农村已婚育龄妇女的贫血患病率较高,地区差异明显;不同地区贫血的影响因素不同,使用宫内节育器与妇女贫血发生有关。应做好使用避孕方法前对象的健康筛检;放置宫内节育器后加强随访和血红蛋白监测,及时发现贫血并进行规范治疗,提高妇女的生殖健康水平。     

Effectiveness of IUDs: a review

Large, multicenter, randomized trials of IUDs conducted between 1970 and 1986 encompass more than 50,000 woman-years of experience in the two-year interval following device insertion. Taken singly and collectively, these trials demonstrate that IUD failure rates are strongly affected by the age of participants, notably by the proportion of women under age 25 admitted to the studies. Individual trials and overall comparisons indicate further that: 1. Non-medicated devices such as the Mahua steel ring and Lippes loop D have pregnancy rates above 2 per 100 woman-years. 2. The first approved copper IUDs, the Copper 7 and the TCu 200, do not markedly differ in pregnancy rates from standard plastic devices with rates significantly above 2 per 100 woman-years. 3. Five more recent, widely used copper IUDs have had failure rates significantly below 2 per 100 woman-years in multicenter trials. The point estimate of the failure rate was less than 1 pregnancy per 100 woman-years for three of these IUDs. One copper-bearing device had a failure rate significantly below 1 per 100 woman-years. 4. Devices releasing either 25 mcg/day of progesterone or 2 mcg/day of levonorgestrel have had significantly higher failure rates than the more effective copper-releasing IUDs; however, devices releasing 20 mcg/day of levonorgestrel appear at least as effective as the most effective copper IUDs. Long-term IUD failure rates derived from straight assignment as well as randomized trials indicate 4-year gross cumulative failure rates do not exceed 10 per 100 for any of the standard copper devices or the Lippes loop D. Point estimates of the four-year gross cumulative pregnancy rates have been below 5 per 100 users in studies of the TCu 220C, the Nova T, the TCu 380A, and the MLCu 375.     

Patterns of contraceptive use in China

This article uses demographic and contraceptive use data from China's 1982 census, 1982 national fertility survey, and National Family Planning Commission to examine the country's patterns of reproductive and contraceptive behavior. Although China's fertility is near replacement level, it varies considerably among the country's subregions. One-half of all 15-49-year-old married fecund women who practice contraception are using intrauterine devices (IUDs); this means that about 70 percent of the world's IUD users are in China. Although China and the United States have similar overall contraceptive use rates, pronounced differences exist regarding the types of contraceptive methods used. Among China's subregions, contraceptive use rates vary considerably. The greater the percentage of minority groups in a subregion, the lower its contraceptive prevalence rate. The lower the proportion urban in an area, the greater the use of the IUD, except in areas with large numbers of minorities. Among the subregions, associations between urban/health variables and pill/condom use rates are strongly positive, and associations between urban/health variables and IUD use rates are strongly negative.     

The multiload IUD--a U.S. researcher's evaluation of a European device.

This evaluative review focused on the performance and safety of the Dutch-made Multiload copper IUD, primarily the Multiload-375 (MLCu-375) model which has a longer life expectancy (5 or more years) than the Multiload-250 (MLCu-250) model, usually cited for a life expectancy for three years. This copper-medicated IUD differs from the copper-T IUDs in shape and insertion technique. The review shows that (a) the MLCu-375 IUD seems to be slightly less effective in preventing pregnancies than TCu-380A IUD. Its efficacy is comparable to that of the Nova-T by two to three years of use; (b) the MLCu-250 IUD is similarly effective to TCu-200 but may be slightly less effective than TCu-220C; (c) no consistent differences were detectable in expulsion rates or in removal rates for bleeding/pain between the Multiload IUDs and comparative Copper-T IUDs; (d) the Multiload IUDs may perform better in nulliparous women than the T-shaped devices; (e) no or a very low incidence of uterine perforation is associated with insertions of the Multiload IUD; (f) ectopic pregnancy risks are similarly low in Multiload IUD users as in Copper-T-380A users; and (g) pelvic inflammatory disease (PID) risks are similarly low in Multiload IUD users as in users of T-shaped copper IUDs.     

‘It would have control over me instead of me having control’: intrauterine devices and the meaning of reproductive freedom

In the past decade, enthusiasm for intrauterine devices (IUDs) has rapidly grown in the United States. Messages from health care providers, pharmaceutical advertisements, and public health campaigns extol the freedom that women can experience using a long-term, internal, highly effective contraceptive method. Little research has investigated how young women conceptualize IUDs in terms of freedom and control. We conducted a thematic analysis of in-depth, individual interviews with 37 young Black and Latina women and explored their perspectives on IUDs as promoting and constraining freedom. Participants with favorable views of the IUD (n = 13) appreciated that it would allow them to live their day-to-day lives ‘normally’ without thinking about contraception and with minimal side effects. Four current IUD users found the method empowering because they could pursue their goals without fear of unintended pregnancy. In contrast, nearly two-thirds of participants (n = 24) had predominantly negative views and focused on temporal and physical features of IUD use. They expressed concern that IUDs would impinge on their personal agency by restricting their bodily autonomy since they would not be able to discontinue use without a health care provider; found the idea of a contraceptive method inside their body for years unsettling; and/or desired flexibility over their pregnancy plans. These results highlight a contradiction between IUD promotion discourses and some women’s views about the method and their approaches to pregnancy. Discursive and clinical practices that encourage the use of long-acting contraceptive methods like IUDs over other methods may unintentionally infringe upon reproductive autonomy.     

Effect of shared contraceptive experiences on IUD use at an urban abortion clinic

BackgroundWe studied the effect of contraceptive social networking on postabortion intrauterine device (IUD) uptake. This study explores whether women who have heard personal stories of IUD use are more likely to use an IUD for postabortion contraception.Study DesignWe surveyed 299 women undergoing induced abortion at San Francisco General Hospital's Women's Options Center before and after contraceptive counseling. Both English- and Spanish-speaking women, aged 15 years and older, were surveyed.ResultsFifty percent of women surveyed chose to use an IUD for postabortion contraception. Women choosing IUDs were more likely than women choosing other contraceptives or no contraceptives to be multiparous, Latina and interested in IUDs prior to contraceptive counseling. Disclosure of personal IUD use by a clinic staff member was independently associated with the decision to use an IUD (odds ratio 8.1, 95% confidence interval 3.8–17.2).ConclusionsWomen undergoing abortion in an urban clinic have knowledge and high acceptance of IUDs, and sharing of contraceptive experiences is common among women of all demographics. Controlling for demographics and prior knowledge of IUDs, sharing of personal IUD experiences by providers is significantly associated with IUD use.     

Norplant as a Contraceptive Device in Enugu, Eastern Nigeria

This paper is an evaluation of acceptability and use-experience with the contraceptive device Norplant at the University of Nigeria Teaching Hospital, Enugu, Eastern Nigeria. Over a period of 36 months, 173 women (8% of the clinic population) accepted the implant. Use of Norplant was concentrated among high-parity women, and the proportion of Norplant users was highest among women aged 30–34 years. Comparing Norplant and IUD users, we found Norplant users to be significantly less highly educated with <1% of Norplant users having tertiary education compared to 25% of new IUD users. The continuation rate with Norplant was 89% at three years, suggesting this method has the potential for improving the low contraceptive prevalence in this region.     

Contraceptive practice and ectopic pregnancy

The relationships between contraceptive practice and ectopic pregnancy were examined for users of barrier contraceptives, sterilization, steroidal contraceptives, and IUDs. Clinical studies on the outcome of pregnancy among diaphragm users indicated that they were not at any increased risk of ectopic pregnancy and may be at a reduced risk. Except for diaphragm users, there were insufficient published data to assess the risks of ectopic pregnancy for users of other barrier contraceptives. For all sterilization approaches, the International Fertility Research Program reported 6.9% ectopic pregnancies in over 20,000 voluntary sterilizations. Data provided by the United States Food and Drug Administration regarding rates of ectopic pregnancy for different types of IUDs suggested that copper-bearing IUDs were associated with a lower rate of ectopic pregnancy and that progesterone-releasing IUDs were associated with a higher rate than the non-medicated IUDs. No evidence as yet has demonstrated that IUDs cause ectopic pregnancy. Compared to women who use no contraceptive method, the use of IUDs greatly reduced the probability of intrauterine pregnancy but only somewhat reduced the probability of ectopic pregnancy. Recent data on the association between the duration of IUD use and the risk of ectopic pregnancy provided conflicting results. Women who have discontinued oral contraceptive or barrier contraceptive methods have not appeared to be at any increased risk of ectopic pregnancy.     

A comparison of the clinical performance, contraceptive efficacy, reversibility and acceptability of Norplant implants and Ortho Gynae T380 intrauterine copper contraceptive device

In this comparative study, the five-year continuity rate of 53.7% in the Norplant implants group was comparable to that of 52.7% in the copper IUD group. The difference was not statistically significant. Only one accidental pregnancy occurred during the five years of copper IUD use.Desire for future pregnancy was the main reason for removal in the Norplant implants group (35.9%) while expulsion of the IUD (13.2%) was the main reason for removal of the copper IUD. Menstrual disturbance was not a major side-effect in either group.The post-removal conception rates of 78.6% in the Norplant implants group and 75.0% in the copper IUD were good and comparable.Both the Norplant implants and copper IUD are acceptable and effective contraceptive methods in Singapore.     

Advances in contraception: IUDs from a managed care perspective

Contraceptive use in the United States is virtually universal among women of reproductive age. However, unplanned pregnancies continue to occur and can be largely attributed to the nonuse and misuse of contraception. Reducing unintended pregnancies constitutes a critical goal for managed care and the public. This can be achieved in part with intrauterine devices (IUDs), which are an effective method of contraception that require a one-time insertion and stay in place for 5-10 years. Therefore, compliance issues are largely mitigated, and actual use efficacy is the same as perfect use efficacy. The IUD is also reversible, unlike tubal ligation, and could potentially be the contraceptive of choice in today's environment. Unfortunately, safety concerns surrounding the use of older IUDs have precluded many women from recognizing the benefits of their use. Currently, the only approved IUDs in the United States are ParaGard, the copper IUD, and Mirena, the levonorgestrel-releasing intrauterine system (LNG-IUS). These devices offer superior safety profiles compared with those products that were withdrawn from the market in the 1970s. In addition to a favorable safety and tolerability profile, the LNG-IUS offers an advantage over copper IUDs, demonstrating improved efficacy in preventing intrauterine and ectopic pregnancies. Successful communication between patients and providers regarding the improved safety and efficacy of newer IUDs will ensure an appropriate place in therapy. Thus, greater numbers of women will recognize the IUD as a safe, cost-effective means to contraception, thereby reducing the economic and social burdens associated with unplanned pregnancies.     

吉妮与爱母宫内节育器使用24个月的临床效果观察

目的:比较吉妮与爱母两种宫内节育器(IUD)的临床使用效果。方法:对自愿要求放置IUD避孕而无禁忌证的育龄妇女236例,随机分成两组,分别放置吉妮IUD(117例)和爱母IUD(119例)。结果:两种IUD2年累积带器妊娠率分别为每百妇女年0.86和2.84,差异无统计学意义(P>0.05);2年累积脱落率分别为每百妇女年0.85和9.57,差异有统计学意义(P<0.05);2年累积因症取出率分别为每百妇女年0.00和5.31,差异有统计学意义(P<0.05);2年累积续用率分别为每百妇女年98.29和83.19,差异有统计学意义(P<0.05)。结论:吉妮与爱母两种IUD均具有较好的临床效果,其中吉妮IUD具有较好的有效性和可接受性。     

Five years' experience with levonorgestrel-releasing IUDs

Two levonorgestrel-releasing IUDs and a copper-releasing IUD of the same shape were studied in a randomized comparative study over five years. The levonorgestrel-releasing IUDs released 20 micrograms or 30 micrograms per day. The Pearl index during the 10,600 woman-months of LNG-IUD use was 0.11. The control device releasing copper had a Pearl index of 1.6. The amount and duration of menstrual bleeding was greatly reduced, leading to a high incidence of oligo- or amenorrhea. The continuation rate in this pioneer trial was 53 per 100 users for the levonorgestrel-releasing IUD (LNG-IUDs) and 50 per 100 users for the copper-releasing IUD (Nova T). The removal rates for reasons other than amenorrhea were not significantly different. Discontinuation because of amenorrhea occurred during the first two years, the cumulative termination rate for this reason was 11.6 per 100 users at five years. The LNG-IUDs removed for investigation after five years of use revealed that the devices contained about 40 percent of the original load. The effective lifespan of the device has been demonstrated by this study to be five years; the residual steroid gives an additional safety period of two more years. The LNG-IUD is a highly effective reversible contraceptive method, which strongly reduced the amount and duration of bleeding. During the first two months there is scanty but frequent spotting which, like the high incidence of oligo- and/or amenorrhea, requires counselling of health personnel and women using LNG-IUDs.     

The quality of family planning services in rural China.

This article provides a preliminary analysis of three aspects of service quality in four rural counties in China--the availability of contraceptive methods, information given to users, and provider knowledge about methods. Contraceptive choice and characteristics of contraceptive use by women in the study areas are also examined. The data are derived from a survey carried out by the authors during 1987, under the auspices of China's State Family Planning Commission. The survey was conducted in four rural counties located in Fujian and Heilongjiang provinces. A total of 318 married women of reproductive age were randomly selected and interviewed. All family planning service sites serving the women were visited and a sample of service providers was interviewed. No shortage of contraceptives existed in any of the counties, but variations in community wealth and local procurement practices have resulted in the acquisition of an IUD with high failure rates. Although providers believe they inform women about method choices and side effects, women were poorly informed about the methods they selected. Not all providers who insert IUDs and distribute pills were knowledgeable about contraindications and side effects of the methods. Ever-use of contraception was nearly 100 percent, but most women, especially in Heilongjiang, have only used one method: the IUD or sterilization. Improvements in quality, especially in method mix, providers' level of knowledge, and the quality and quantity of information provided to users will likely improve contraceptive continuation, client satisfaction, and women's health.     

Ovarian function during use of a levonorgestrel-releasing IUD

Ovarian function was studied for two complete menstrual cycles in 9 regularly menstruating women and for 8 weeks in three amenorrhoeic women who had used levonorgestrel-releasing IUDs (LNG-IUD) for more than four years. Nine patients using copper IUDs (Nova-T) were studied for two complete menstrual cycles as controls. According to progesterone levels, 15/17 cycles in women using LNG-IUDs were ovulatory, whereas only 8/17 cycles showed normal follicular growth and rupture as judged by ultrasound. In ovulatory cycles, the peak progesterone levels were lower than in the controls. The preovulatory estradiol and LH peak levels were also lower than in control subjects. SHBG levels were lower in LNG-IUD users than in copper IUD users. It is concluded that, although the dose of levonorgestrel released from the IUD is very low, it probably exerts an effect on the gonadotrophin secretion, which disturbs follicular development in many of the women studied, which in addition to the local effect on the endometrium, contributes to its high contraceptive efficacy.