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To refine understanding of the acceptability of Norplant in the US on the basis of different target populations and sources of care, the experiences of four groups of clients who had the implants inserted at University of Colorado Health Sciences Center between April 1991 and September 1992 and could be reached for a postinsertion telephone interview were compared. The 254 women interviewed (61% of total acceptors over this period) were drawn from four clinics: adolescent, resident, certified nurse midwife, and faculty physician. The average length of time since insertion was 13.2 months. As expected, adolescent patients were significantly more likely to be younger, single, less educated, and of lower parity than women in the three other groups. The overall removal rate was 14.6%, with no significant difference among groups or in terms of factors such as age, race, or socioeconomic status; the mean time to removal was 10.2 months. The most common reason for removal (32%) was unacceptable bleeding; however, abnormal bleeding was not significantly associated with the decision to discontinue the method. Weight gain and headache were the only side effects reported significantly more frequently by removers than retainers. Only 150 (59%) women returned for a scheduled postinsertion follow-up visit; compliance was lowest among teens (41%) and highest among patients of faculty (77%). 10 of the 37 women who opted for removal had this procedure performed at another clinic site; this finding suggests that clinic-based studies may underestimate the actual Norplant discontinuation rate.
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PMID:Assessing the acceptability of Norplant contraceptive in four patient populations. 852 14

This paper describes the first two years of Norplant use among 1560 acceptors in two rural counties of Hebei province and two rural counties of Shandong province, China. No pregnancies were reported during Norplant use, with an overall continuation rate of 88.4% after two years. Many women did, however, report side effects, including menstrual problems, headache, dizziness, and nausea among 46.7%, 6.7%, 6.3%, and 3.3% of women, respectively. Menstrual cycle disruption accounted for 77% of all Norplant removals. The majority of removals due to menstrual problems occurred in the second year of use, while most of the removals due to other causes occurred during the first year of use. Clinical performance among the four counties was diverse, with two-year continuation rates of 73.9-95.3%. Factors which may contribute to the diversity among study sites and the overall high continuation rate are discussed in the context of Chinese family planning.
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PMID:Introduction of Norplant implants in four counties of rural China: a two-year evaluation. 874 98

During December 1992 to October 1994, in Texas, clinical researchers conducted a prospective case control study (15 cases receiving Norplant immediately postpartum vs. 6 controls undergoing bilateral tubal ligation immediately postpartum) to determine the safety and efficacy of inserting the contraceptive implant Norplant (6 capsules inserted subdermally, each containing 35 mg levonorgestrel) immediately postpartum. They followed the cases and the controls for three months. The study subjects were 18-35 years old, received prenatal care at one of the Department of Obstetrics and Gynecology's (Texas Tech University Health Sciences Center) community clinics, had an uncomplicated term pregnancy and normal spontaneous vaginal delivery, and did not breast feed. They tended to be poor. During the first week after Norplant insertion, serum levonorgestrel levels peaked at about 2000 pg/ml, then fell abruptly until about the eighth week to about 250 pg/ml. This lower levonorgestrel level concerned the researchers because it is just slightly higher than levels associated with pregnancy. They were also concerned about the possibility of Norplant inducing a hypoestrogenic state in postpartum women. The Norplant group was more likely than the tubal ligation group to experience irregular bleeding (p 0.01), headaches (p 0.01), hair loss (p 0.05), and abdominal discomfort (p 0.05). The various serum metabolic biomarkers, serum electrolytes, and blood components fell into the normal range in both groups. The serum estradiol, progesterone, and urinary steroid biomarkers suggested that the Norplant group experienced very suppressed steroid secretion throughout the three month study period, while the controls had normal postpartum ovarian activity. Thus, ovarian activity was absent in the Norplant group. These findings suggest that postpartum insertion of Norplant is safe and effective. Yet further clinical evaluation is needed to address concerns about the long-term hypoestrogenic state and contraceptive efficacy beyond the three month postpartum period.
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PMID:Immediate postpartum insertion of the norplant contraceptive device. 875 9

During July 1991-July 1993 in Edinburgh, Scotland, 508 women 15-42 years old were inserted with the contraceptive subdermal implant Norplant. Physicians and trained family planning nurses counseled the women, which counseling included a detailed description of Norplant, its advantages and disadvantages (especially bleeding problems), and a description of the insertion and removal procedures. The women chose Norplant as an alternative to sterilization or other contraceptive methods with which they experienced problems. Two women were pregnant at the time of insertion. There were no method failures. 27 (9%) women were lost to follow-up. 71 (25%) women were very satisfied with Norplant, 30 of whom had regular cycles and 14 of whom had amenorrhea. At least 70% of all patients experienced changes in vaginal bleeding patterns. The 12-month and 18-month continuation rates were 84% and 80%, respectively. Leading reasons for removal of Norplant were bleeding problems (43%), weight gain (35%), and mood swings (21%). The combination of weight gain, mood swings, depression, and headache accounted for 56% of all removals. Major problems did not occur with either insertion or removal of Norplant. These findings suggest that Norplant is an effective and acceptable contraceptive method, despite the high incidence of bleeding changes.
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PMID:The introduction of a new contraceptive; two years experience with Norplant. 878 85

The authors present their findings from the study of adolescents' reasons for discontinuing the use of Norplant and Depo-Provera. Their experiences after method discontinuation were also assessed. 35 adolescents of mean gynecologic age 4.7 years and body mass index (BMI) 24.2 who discontinued Depo-Provera, and 31 adolescents of mean gynecologic age 3.4 years and BMI 24.1 who discontinued Norplant were periodically assessed during use of the methods and up to 12 months after discontinuation. The most common reasons for discontinuation of both Norplant and Depo-Provera after mean periods of 21.8 and 9.2 months use, respectively, were irregular menstrual bleeding (64%), weight gain (41%), and increased headaches (30%). The resumption of menstrual regularity and dysmenorrhea was noted sooner after discontinuation of Norplant, compared to Depo-Provera. The increase in BMI noted at the discontinuation of Depo-Provera persisted up to 6 months after discontinuation of either method. 62% of adolescents reported no break in contraceptive practice. The condom was the most popular method (37%) after discontinuation of Depo-Provera, and oral contraceptives (39%) after discontinuation of Norplant. The authors conclude that health care providers should aggressively manage physical problems associated with Depo-Provera and Norplant use, and expedite the transition to new contraceptive methods in an effort to minimize the high pregnancy rates observed after discontinuation of these methods in adolescents.
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PMID:Adolescents' reasons for and experience after discontinuation of the long-acting contraceptives Depo-Provera and Norplant. 886 83

This study examines early contraceptive implant discontinuation among low-income clinic patients in Dallas, New York, and Pittsburgh and the impact of negative media coverage of Norplant in the press. Interviews were conducted among 786 women during 1993-94 at baseline, prior to insertion, and 6 months later. The explanatory logistic model included sociodemographic characteristics of users, motivation to avoid unintended pregnancy, satisfaction with previous contraceptive methods, and negative media coverage of a method of birth control. The sample population included only 55% who had completed high school, 22% who were currently employed, and 94% with at least one prior pregnancy. 70% had had at least one unintended pregnancy. 29% had experienced two or more unintended pregnancies. 8% had had no live births. 60% of the women were adolescents at the time of their first birth. The cumulative life table 6-month discontinuation rate was 7.6% (58 women out of 786). The removal rate was 1.02 during month 2, 1.55 during month 3, and almost 1.50 during months 4-6. 28% had the implant removed due to menstrual side effects, 19% complained of headaches, and 10% had some arm discomfort. 9% experienced weight changes and early removal. 7% discontinued use due to mood changes, and 5% stated hair loss, chest pains, or negative media reports as the reasons. About 75% of discontinuers and continuers reported side effects due to less regular menstrual periods. Discontinuers were more likely than continuers to report headaches, hair loss, weight gain, and the perception of long-term health problems. Discontinuers were more likely to report arm infection. Among the 33% exposed to intense negative media coverage, only 15% discontinued use. Findings suggest that counselors should explore the fertility desires of a woman and her spouse and refrain from promoting a specific method.
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PMID:Determinants of early implant discontinuation among low-income women. 895 15

Although Thailand's National Family Planning Program introduced Norplant contraceptive implants in 1986, few women infected with human immunodeficiency virus (HIV) select this method, and its efficacy, clinical effects, and side effects in this population have not been investigated. To address these issues, a prospective cohort study was conducted during 1993-96 of 41 asymptomatic HIV-infected women who presented to the Family Planning Clinic at Ramathibodi Hospital in Bangkok, Thailand, and voluntarily accepted Norplant implants. All implants were inserted within 4 weeks after delivery or abortion. 63.4% of acceptors had not used any contraceptive method prior to pregnancy. At 6 and 12 months after insertion, 26% and 23%, respectively, reported irregular menstrual periods and 24.4% and 36.6%, respectively, reported amenorrhea. Side effects, reported by 3-10% of women, included headache, acne/chloasma, anorexia, and nausea. There were no significant changes in body weight, blood pressure, and hemoglobin between insertion and the 12-month follow-up. No pregnancies occurred during the study period. These findings suggest that Norplant implants are an effective, appropriate contraceptive method for HIV-infected women who want to avoid pregnancy but are not interested in sterilization.
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PMID:Use of Norplant implants in asymptomatic HIV-1 infected women. 917 51

Field research conducted in 24 rural townships in four counties (Zunhua and Leting in Hebei Province and Boshan and Yiyuan in Shandong Province) in China identified potential local-level obstacles to widespread use of Norplant contraceptive implants. A total of 1556 women received the implants between June 1992 and June 1993. In 1992, Norplant represented 20% of total contraceptive use in the study area; however, in 1993, this statistic dropped to 10% in 3 of the 4 counties. About 49% of Norplant acceptors experienced at least 1 side effect in the first 6 months, primarily menstrual disorders, headache, vertigo, and nausea. The gross discontinuation rate due to menstrual disorder was 1% at 6 months, 3% at 12 months, and 8% at 24 months; the overall discontinuation rates were 2%, 4%, and 10%, respectively. There were only 3 pregnancies due to method failure in the 24-month study period. Despite the high acceptability and effectiveness of this method, family planning workers complained that the required acceptor screening, insertion, follow-up visits, counseling, and treatment of side effects associated with Norplant increased their work loads. The decline in the method's popularity from 1992 to 1993 is presumed due to local program-related factors such as decreased implementation of an informed choice policy, unavailability of daily Norplant insertion services, the slow response of family planning workers to requests for treatment of side effects or capsule removal, and the improved availability of alternative contraceptive choices. However, demand for Norplant remained stable in Yiyuan County, where there was widespread resistance to sterilization and a willingness on the part of family planning workers to accept the increased work load associated with this method.
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PMID:Acceptance, efficacy, and side effects of Norplant implants in four counties in north China. 921 32

Norplant was first introduced in Ethiopia in 1994. This study examines the safety, efficacy, tolerance, and acceptability of Norplant among 364 patients of reproductive age who obtained implants from the Family Planning Department of the Gandhi Memorial Hospital during June-December, 1994. During the study period, 608 patients were provided with information about family planning methods. 110 accepted injectables, and 115 accepted oral pills. 96.7% of patients were married, 84.3% were urbanites, 84.9% were educated, 70.1% were housewives, and 91.5% were Christians. The mean age was 27.9 years. Ages ranged from 17 to 45 years. The mean body weight was 53.5 kg. Blood pressure readings were low for most women. The mean number of living children was 3.1. 70.3% of Norplant patients switched from other family planning methods. The mean duration of contraceptive use was 23.5 months. The average duration of Norplant implants since insertion was 25.3 months. The range was 3-30 months. 33.0% women were lactating at the time of insertion. The mean time of insertion was 12.5 minutes. Times ranged from 5 to 20 minutes. Insertion was made in the medial aspect of the upper left arm for right-handed women. A 2 mm incision was made, and six flexible capsules were inserted in a fan-shaped pattern with the help of a trocar. Insertion was performed under aseptic conditions and local anesthesia. Patients were advised to keep the dressed site clean and dry for a week, at which time dressings were removed and the site was checked for infection. Other check-ups were made at monthly intervals for 3 months. The most frequent complications were irregular bleeding, amenorrhea, headache, weight change, and local pain at the insertion site. The continuation rate was 95.1%. 93.9% rated Norplant highly. Health personnel were the main source of information about Norplant.
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PMID:Norplant implants in Ethiopia. 929 31

Presented in this report are the recommendations of two expert groups, the Technical Guidance/Competence Working Group of the US Agency for International Development's Maximizing Access and Quality Initiative and the World Health Organization's Family Planning and Population Unit, regarding currently available family planning methods. The former group addressed key biomedical questions and formulated recommendations about 11 groups of family planning methods: combined oral contraceptives, progestin-only pills during breast feeding, progestin-only injectables, combined injectable contraceptives, Norplant implants, copper-bearing IUDs, tubal occlusion, vasectomy, lactational amenorrhea method, natural family planning, and barrier methods. A table presents the relative importance, by method, of procedures such as pelvic exam, blood pressure reading, breast exam, and screening for sexually transmitted diseases and cervical cancer. The medical eligibility recommendations for each method are also presented in tabular form, with four categories for temporary methods: 1) no restrictions on use, 2) advantages generally outweigh theoretical or proven risks, 3) theoretical or proven risks usually outweigh the advantages, and 4) unacceptable health risks. Included among the 41 conditions for which eligibility criteria are specified are age, smoking, thromboembolic disorder, headaches, irregular vaginal bleeding, family history of breast cancer, obesity, drug interactions, parity, breast feeding, postpartum, and postabortion. The new guidance presented in this report enables providers to give family planning clients expanded contraceptive choices while ensuring method safety and effectiveness.
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PMID:Family planning methods: new guidance. 934 75


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