Potential barriers to the removal of Norplant among family planning clinic patients.

OBJECTIVES: This study examined the prevalence and effects of potential barriers to removal of levonorgestrel implants (Norplant) among low-income women. METHODS: A sample of 687 women who received Norplant at hospital-based family planning clinics were interviewed before Norplant insertion and 6 months after Norplant insertion (or at Norplant removal if removal occurred earlier). Those who continued to use Norplant were reinterviewed at 2 years or at removal. RESULTS: In a multivariate analysis, only 1 of the 4 potential barriers--cost--significantly impeded Norplant discontinuation. CONCLUSIONS: Family planning clinics need to make clear that they follow a policy of Norplant removal on demand, regardless of the patient's ability to pay.     

A multicenter comparative study on the efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant and Norplant-II

In order to assess efficacy, safety, and acceptability of the contraceptive subdermal implants Norplant^® and Norplant^®-II in Mexican women, a comparative phase III clinical trial was undertaken in eight clinics across the country. The study involved 1052 women who were followed-up trimonthly for three years. Cumulative pregnancy rates were 0.29% and 0.34% for Norplant and Norplant-II implants, respectively. Similar overall cumulative discontinuation rates were observed at three years: 50.38% for Norplant capsules, and 50.44% for Norplant-II rods. The main method-related reason for termination was endometrial bleeding irregularity which led to discontinuation rates of 11.94% and 11.62% for Norplant and Norplant-II contraceptive systems, respectively. In 15,279 woman-months of experience accumulated with Norplant implants and 14,092 with Norplant-II implants, there were few adverse events reported. No difference was found between the two groups in either difficulty for implants placement and removal or women's discomfort, even though the time required for insertion and removal of Norplant capsules was longer than for Norplant-II rods. It is concluded that during the first three years of use, both implants systems are equally effective, safe, and acceptable.     

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。     

Norplant contraceptive implants: a new contraceptive for women

This article summarizes current knowledge on the mechanism of action, side effects, and effectiveness of Norplant contraceptive implants. The most common side effect of the implant method is its disruption of the menstrual cycle, especially in the 1st few months of use. Long intervals without frank bleeding may occur and be misinterpreted as pregnancy in women who have not been counseled about this possibility. The average annual continuation rate was 84/100 in a study of 324 women from several countries who were followed for 5 years after Norplant implantation. The net cumulative pregnancy rate for the 5-year study period was 0.6/100. Reasons for method termination included menstrual problems, other medical problems (headache, depression, fatique), planning pregnancy, and other personal reasons (change in marital status, change in residence). To provide training for doctors, nurses, and counselors, the Population Council has established a network of 5 training institutions. Within the next few years, drug regulatory agencies are expected to approve use of Norplant implants in many countries. Although at present the method is available only in Finland and Sweden, Thailand and Indonesia are considering the method and clinical trials are underway in India, China, Brazil, and the US. A consulting committee of the World Health Organization has concluded that Norplant implants are a suitable contraceptive method for use in family planning programs.     

Effect of Norplant contraceptive on the bones of Nigerian women as assessed by quantitative ultrasound and serum markers of bone turnover

Levonorgestrel is a commonly used progestin-only contraceptive that is available as subdermal (Norplant) and intrauterine implants. Other progestin-only contraceptives such as injectable medroxyprogeterone acetate have been shown to decrease bone mineral density in long-term users. We used calcaneal ultrasound to compare the bone quality of Nigerian women between 25 and 50 years of age who had Norplant implants for 1-4 years to that of women who were not using any form of hormonal contraceptive. The mean stiffness index of women who had Norplant implants for as long as 4 years was not significantly different from that of controls. However, serum markers of bone turnover were significantly decreased in women with Norplant implants compared to age-matched controls. Serum bone-specific alkaline phosphatase was significantly decreased in subjects with Norplant implants for 1 year (13.7+/-6.0 vs. 23.0 U/L for controls, p = .001) and serum NTx was significantly decreased in subjects with implants for 3 years (10.6+/-4.9 vs. 17.6+/-7.7 bone collagen equivalents per liter for controls, p < .001). We conclude that although levonorgestrel contraceptive decreased overall bone turnover, it had no deleterious effect on the bone quality of women using Norplant implants for up to 4 years.     

Family planning clinic services in the United States: patterns and trends in the late 1990s.

CONTEXT: Publicly funded family planning clinics are a vital source of contraceptive and reproductive health care for millions of U.S. women. It is important periodically to assess the number and type of clinics and the number of contraceptive clients they serve. METHODS: Service data were requested for agencies and clinics providing publicly funded family planning services in the United States in 1997. The numbers of agencies, clinics and female contraceptive clients were tabulated according to various characteristics and were compared with similar data for 1994. Finally, county data were tabulated according to the presence of family planning clinics and private physicians likely to provide family planning care and according to the number of female contraceptive clients served compared with the number of women needing publicly funded care. RESULTS: In 1997, 3,117 agencies offered publicly funded contraceptive services at 7,206 clinic sites. Forty percent of clinics were run by health departments, 21% by community health centers, 13% by Planned Parenthood affiliates and 26% by hospitals or other agencies. Overall, 59% of clinics received Title X funding. Agencies operated an average of 2.3 clinics, and clinics served an average of 910 contraceptive clients per year. Altogether, clinics provided contraceptive services to 6.6 million women-approximately two of every five women estimated to need publicly funded contraceptive care. The total number of providers and the total number of women served remained stable between 1994 and 1997; at the local level, however, clinic turnover was high. Some 85% of all US counties had one or more publicly funded family planning clinics; 36% had one or more clinics, but no private obstetrician-gynecologist. CONCLUSIONS: Publicly funded family planning clinics are distributed widely throughout the United States and continue to provide contraceptive care to millions of US women. Clinics are sometimes the only source of specialized family planning care available to women in rural counties. However, the high rate of clinic tumover and the lack of significant growth in clinic numbers suggest that limited funding and rising costs have hindered the further expansion and outreach of the clinic network to new geographic areas and hard-to-reach populations.     

Public or private providers? U.S. women's use of reproductive health services

CONTEXT: U.S. women receive contraceptive and reproductive health services from a wide range of publicly funded and private providers. Information on trends in and on patterns of service use can help policymakers and program planners assess the adequacy of current services and plan for future improvements. METHODS: Women who reported in the 1995 National Survey of Family Growth that they had obtained any contraceptive or other reproductive health service in the past year were classified by their primary source of care, and the services they received, their characteristics and their primary source of care were analyzed. Logistic regression was used to test which factors predict women's use of publicly subsidized family planning clinics and of specific types of services. RESULTS: The percentage of women of reproductive age who obtained family planning services increased slightly between 1988 and 1995, primarily among women aged 30 and older. Nearly one in four women who received any contraceptive care visited a publicly funded family planning clinic, as did one in three who received contraceptive counseling or sexually transmitted disease (STD) testing and treatment. Women whose primary source of reproductive care was a publicly funded family planning clinic received a wider range of services than women who visited private providers; moreover, the former were significantly more likely to report obtaining contraceptive care or STD-related care, even after the effects of their background characteristics were controlled. Young, unmarried, minority, less-educated and poor women were more likely than others to depend on publicly subsidized family planning clinics. Source of health insurance was one of the most important predictors of the use of public family planning clinics: Medicaid recipients and uninsured women were 3-4 times as likely as women with private insurance to obtain clinic care. CONCLUSIONS: Publicly funded family planning clinics are an important source of contraceptive and other reproductive health care, providing millions of U.S. women with a wide range of services. Since women's need for reproductive care and for publicly subsidized care is not likely to diminish, clinics may be financially challenged in their efforts to continue delivering this broad package of services to growing numbers of uninsured or disenfranchised women.     

Five-year experience with Norplant

At Klinik Raden Saleh, Department of Obstetrics and Gynaecology, University of Indonesia, from 1 May until 31 August, 1981, Norplant contraceptive implants were inserted into 437 Indonesian women. The continuation rates of Norplant at first, second, third, fourth and fifth year were, respectively, 96%, 92%, 88%, 82% and 78%. Bleeding problems were the most common cause for removal. The cumulative five-year net pregnancy rate for Norplant was 1.8 per 100 women. The Norplant contraceptive system is thus seen to combine the highest acceptability as measured by its continuation rate with the highest long-term effectiveness among the available temporary contraceptive methods.     

NorplantR contraceptive subdermal implants: Two-year experience in Singapore

Norplant contraceptive implants are Silastic containing levonorgestrel implants. This study describes our two-year experience with 100 acceptors of Norplant implants in Singapore. No pregnancies occurred during the first two years of use. Desire for planned pregnancy and disruption of menstrual rhythm were the two main reasons for twenty implant removals during the two years. The continuation rate at the end of two years was 79%. The post-removal conception rate in women desiring pregnancy was 90% at the end of one year. It thus appears that the Norplant contraceptive system offers a highly effective, acceptable, reversible and safe method of contraception.     

Contraceptive implants and lactation

The safety and efficacy of four contraceptive implants, plant, Implanon, Nestorone and Elcometrine, have been evaluated during use in the postpartum period by lactating women. These implants provide highly effective contraceptive protection with no negative effect on breastfeeding or infant growth and development. Breastfeeding women initiating Norplant use in the second postpartum month experience significantly longer periods of amenorrhea than do untreated women or intrauterine device users. After weaning, the bleeding pattern is similar to that observed in non-nursing women. Norplant use does not affect bone turnover and density during lactation. Norplant and Implanon release orally active progestins while Nestorone and Elcometrine implants release an orally inactive progestin, which represents an advantage since the infant should be free of steroidal effects. The infant's daily intake of steroids (estimated from concentrations in maternal milk during the first month of use) range from 90 to 100 ng of levonorgestrel (Norplant), 75-120 ng of etonogestrel (Implanon), and 50 ng and 110 ng of Nestorone (Nestorone and Elcometrine implants, respectively). Nursing women needing contraception may use progestin-only implants when nonhormonal methods are not available or acceptable. Implants that deliver orally active steroids should only be used after 6 weeks postpartum to avoid transferring of steroids to the newborn.     

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.     

Specialized Family Planning Clinics in the United States: Why Women Choose Them and Their Role in Meeting Women's Health Care Needs

BackgroundPublicly funded family planning clinics provide contraceptive care to millions of poor and low-income women every year. To inform the design of services that will best meet the contraceptive and reproductive health needs of women, we conducted a targeted survey of family planning clinic clients, asking women about services received in the past year and about their reasons for visiting a specialized family planning clinic.MethodsWe surveyed 2,094 women receiving services from 22 family planning clinics in 13 states; all sites included in the survey were clinics that specialize in contraceptive and reproductive health services and were located in communities with comprehensive primary care providers.ResultsSix in 10 (59%) respondents had made a health care visit to another provider in the past year, but chose the family planning clinic for contraceptive care. Four in 10 (41%) respondents relied on the family planning clinic as their only recent source for health care. The four most common reasons for choosing a specialized family planning clinic, reported by at least 80% of respondents, were respectful staff, confidential care, free or low-cost services, and staff who are knowledgeable about women's health.ConclusionsSpecialized family planning clinics play an important role as part of the health care safety net in the United States. Collaborations between such clinics and comprehensive primary care providers, such as federally qualified health centers, may be one model for ensuring women on-going access to the full range of care they need.     

The availability and use of publicly funded family planning clinics: U.S. trends, 1994-2001

CONTEXT: It is important to monitor trends among publicly funded family planning clinics to determine where clinics are successfully meeting the contraceptive service needs of low-income women and where more effort is needed.
METHODS: Service data for all U.S. agencies and clinics providing subsidized family planning services were collected for 2001 and compared with similar data collected for 1997 and 1994. Trends reflecting clinic structure and capacity were analyzed at the national and state levels. Client numbers were compared with numbers of women needing publicly funded contraceptive services to create a measure of met need for states and groups of states, according to Medic-aid family planning waiver status.
RESULTS: In 2001, some 7,683 publicly funded family planning clinics provided contraceptive services to 6.7 million women–representing an 8% rise in clinics and a 2% increase in clients since 1994. Change varied by type of provider and clinic location. Health departments and Planned Parenthood affiliates served more clients at fewer sites; community health centers served fewer clients at more sites. One-third of states experienced growth in clinic capacity, with 5–65% increases in met need. In another third of states, met need declined by 5% or more. States with income-based Medicaid family planning waivers served 24% more clients, with met need increasing from 40% to 50%.
CONCLUSIONS: Among states, there has been tremendous variation in the ability of publicly funded family planning clinics to serve women. Implementation of income-based Medicaid family planning waivers in some states was associated with clinics' serving greater numbers of women. Further efforts are needed to ensure access to family planning services for low-income women in every state.     

Post-marketing surveillance of Norplant contraceptive implants: I. Contraceptive efficacy and reproductive health

The subject of this study to examine the safety and contraceptive efficacy of Norplant, we undertook a 5-year study of follow-up of women initiating use of Norplant, intrauterine device (IUD) or sterilization in eight developing countries. Women attending family clinics were enrolled if they consented and were medically eligible to use Norplant, IUD, or female sterilization. Women who chose to initiate use of IUDs or surgical sterilization served as controls and were frequency matched in 5-year age-bands with women who chose to use Norplant. At admission women had a physical examination, and their medical histories, demographic, and socio-economic characteristics were recorded. Follow-up visits were scheduled in the first 6 weeks after admission and semi-annually thereafter for 5 years irrespective of change of contraceptive method. Incidence rate ratios of health events were estimated for initial and current contraceptive method use. This paper reports reproductive health events and contraceptive efficacy. Altogether, 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of surgical sterilization were admitted. Their mean ages at initiation were 28.5, 28.5, and 29.6 years, respectively. More than 99% were married or cohabiting, and parous. Five-year follow-up was completed by 94.6% of the women. By the end of 5 years, the mean duration of first segment use per initiator was 4.16 years for Norplant, 4.10 years for IUDs, and 4.96 years for sterilization accounting for 39,337 woman-years for Norplant, 31,915 for IUDs, and 7,071 for sterilization. The study accumulated 78,323 woman-years of observation. Pearl pregnancy rates for Norplant, copper IUDs and female sterilization were 0.27, 0.88, and 0.17 per 100 woman-years, respectively. Users of Norplant, copper IUDs, and sterilization had rates of ectopic pregnancy of 0.30, 0.68, and 0.13 per 1,000 woman-years, respectively. Major health events related to the reproductive system were rare. Rates of acute PID were significantly lower among Norplant users than IUD users (p = 0.004). The rate of ovarian enlargement was significantly higher in Norplant users than controls (p <0.001), but not rates of hospitalization for this condition. Vaginitis and vaginal discharge, and low abdominal pain were significantly less frequent in Norplant users than in the other groups. Bleeding disturbances were more frequent among Norplant users than controls but not anemia. The study confirms the high contraceptive efficacy of Norplant, copper IUDs, and female sterilization. The incidence rates of major reproductive health problems were low. There was no significant excess of serious reproductive morbidity among users of Norplant compared to users of IUDs and sterilization.     

Norplant selection and satisfaction among low-income women.

OBJECTIVES: This study examined correlates of Norplant selection and satisfaction among low-income women. METHODS: Interviews were completed in family planning clinics in 4 Florida counties with 1152 Norplant users and 1268 nonusers, with follow-up interviews with a subsample up to 1 year later. Logistic regression models estimated the associations of socio-demographic and medical characteristics with Norplant selection and method satisfaction. RESULTS: Odds ratios for Norplant selection were significantly greater among women who planned to have children in 5 or more years, those who were "offered" Norplant, those who lived in Palm Beach County, those who were using drugs, and those who were Medicaid clients. Women younger than 17 and those who learned about Norplant from a friend were twice as likely as others to select Norplant. Ninety-two percent of Norplant users were satisfied with the method; women with side effects and those who felt pressure to select a method were significantly less likely than others to be satisfied. CONCLUSIONS: Norplant provides an acceptable and satisfying method of birth control for many low-income women. Proper counseling about all methods of birth control and about Norplant's side effects remains critical to the appropriate delivery of this method.     

Family planning clinic services in U.S. counties, 1983

Organized family planning clinics are a major source of contraceptive services for low-income women, who are less likely than higher income women to be using a contraceptive method. A 1983 study estimated that 9.5 million U.S. women with family incomes below 150 percent of poverty were at risk of unintended pregnancy, and identified a network of 5,106 clinics providing them with services. Seventy-six percent of all counties in the United States have organized clinics that offer family planning services; almost all of those without services are nonmetropolitan counties. An estimated 52 percent of low-income women at risk of unintended pregnancy were served by organized family planning clinics in 1983, while the rest either went unserved or sought care elsewhere. Ten percent of low-income women not served by clinics live in counties that have no family planning clinics, but 67 percent live in counties where existing clinics reach fewer than half of potential low-income patients. More sites may be needed, particularly in counties without clinics, to effectively serve low-income women at risk of unintended pregnancy. However, since the majority of unserved women live in counties where at least one clinic exists, coverage might be improved through increased accessibility and outreach.     

Transition from Norplant to Jadelle in a clinic with extensive experience providing contraceptive implants

OBJECTIVE: The purpose of this study was to understand the transition process from providing Norplant, the six-capsule first contraceptive implant system, to providing Jadelle, the two-rod second-generation system, in a clinical setting with extensive experience providing Norplant implants. MATERIALS AND METHODS: Two hundred forty-nine women requesting contraceptive implants from the PROFAMILIA clinic (Santo Domingo, Dominican Republic) were provided with information regarding the differences and similarities between the two implant systems being studied, including the easier insertion and removal procedures and the possible shorter use life associated with Jadelle. A questionnaire evaluating their preference and the reason why they chose either system was provided. The health care providers' opinions about the two systems were also studied. RESULTS: Fifty-three percent of the women preferred Jadelle over Norplant. The main reason behind their preference for Jadelle was its reduced number of implants with easier insertion and removal and less visibility in the arm, whereas that for Norplant was greater familiarity. Providers overwhelmingly preferred Jadelle. A 1-h presentation was sufficient training for providers experienced with Norplant. None had any problem with the management of Jadelle. CONCLUSION: The inclusion of Jadelle in a clinic with extensive experience with Norplant was easy and uneventful, but both methods should be available during a transition period of several months while confidence in the new method is being acquired by the community.     

Contraceptive introduction reconsidered: a new methodology for policy and program development

Although new contraceptive technology has the potential for providing women with expanded options for fertility control, the historical record of international family planning shows that, in practice, introduction of new methods has not always broadened reproductive choice. Using the example of introduction of intrauterine devices into the Indian family planning program in the 1960s, we show that an exclusive focus on the technology itself is problematic and argue that methodologies are needed that relate introduction of new methods to user needs and program capacities. We summarize key findings from the Indonesian experience with Norplant introduction. Although an effort was made to address problems with previous approaches, major deficiencies in both the technical and interpersonal dimensions of care arose when the implants were made broadly available within the program. We subsequently present a methodology for contraceptive introduction developed by the World Health Organization. This methodology emphasizes the social and institutional context in which technology is used and suggests a participatory and research-based approach to program and policy development. We illustrate results from this new approach in its implementation in Vietnam and suggest areas for further evaluation.     

Pregnancy after removal of Norplant implants contraceptive

Many concerns have been expressed regarding the introduction of a new contraceptive method into family planning programmes. One of the concerns is the return of fertility after discontinuing the method. To evaluate the subsequent fertility status of the Indonesian women after removal of Norplant, a prospective longitudinal study was undertaken in Klinik Radeb Saleh, Jakarta. Fifty-one women whose Norplant were removed because of their wish to become pregnant were followed-up for a period of two years or until pregnancy occurred, whichever was earlier. Two groups of women who had Lippes C IUD removed or discontinued the use of DMPA for planning pregnancy served as control and were followed-up for equal length of time. The cumulative conception rate for ex-Norplant users, ex-IUD users and ex-DMPA users at one year was 76.5, 74.7 and 70.2 per 100 women, respectively. There was no significant difference between the groups (p greater than 0.05). The present study, along with other studies, indicate that the prolonged use of Norplant do not impair the return of fertility.