OBJECTIVE

To determine any cardiovascular morbidity in the short term with Norplant use by electrocardiography.

METHODS

Prospective observational study of consecutive volunteers. SELLING: Jos Univesity Teaching Hospital, Nigeria.

METHODS

Twenty-one Nigerian women seeking long-term reversible contraception were recruited for this study during a Norplant training programme in our centre in August 1997. The clients had baseline (Pre-insertion) blood pressure checks and electrocardiographic (ECG) tracings. These were repeated at the 3,6 and 12 months follow-up visits and the results were analysed.

METHODS

Heart rate, mean QRS electrical axis, PR and QRS intervals, rhthm assessment, chamber enlargement/hypertrophy.

RESULTS

The mean age of subjects was 32.4 +/- 3.98 years (range 25-38 years). The mean weight at pre-insertion and at the 3, 6 and 12 months follow-up visits were 63.63 +/- 10.43, 60.59 +/- 10.07, 64.08 +/- 12.15 and 62.29 +/- 12.25 kilograms respectively. The differences were not significant. The systolic and diastolic blood pressures did not show any significant changes throughout the period of study. The heart rate and cardiac axis measurements did not show any significant changes during the study period. There was no chamber enlargement or hypertrophy. Rhythm remained generally normal. The PR and QRS intervals remained within normal limits throughout the study period. However, they seemed to be significantly prolonged--mean PR interval (seconds) pre-insertion 0.153 +/- 0.003, and at 12 months 0.173 +/- 0.006 (P = 0.019), mean QRS interval (seconds) pre-insertion 0.056 +/- 0.003 and at 12 months 0.74 +/- 0.002 (P = 0.005)

CONCLUSIONS

There is a tendency to significant prolongation of ECG intervals in Norplant users. This requires longer observation.

Pregnancy rates among adolescents have not decreased over the last 10 years, despite numerous efforts. To solve this important health problem, the major strategy recommended is to encourage contraceptive use among sexually active teenagers. An important means of obtaining this is by promoting methods that are not dependent on daily administration in order to avoid noncompliance. One such method (Norplant) has already shown to be much more effective than the combination pill in preventing pregnancy in adolescent women. The frameless intrauterine implant system (fixed, frameless, and completely flexible) has been studied since 1985 in women between 14 and 50 years of age. The results in young nulligravid women confirm its very high effectiveness (cumulative pregnancy rate at 36 months: 1.4%), its low expulsion rate (cumulative rate at 36 months: 0.9%) and its optimal tolerance (cumulative removal rate for medical reasons at 36 months: 2.4%), resulting in a high acceptance of the implant and a high continued use. The system (GyneFix) offers long-term protection (5 years), and its insertion, with or without anesthetic, is easily accomplished in the office. The GyneFix should therefore be recommended as an excellent alternative for birth control pills for young women with low risk for STDs, especially when compliance is a problem, without an increased risk for complications and without systemic side effects. Removal of the device is accomplished by traction on the tail. It can also be used for emergency contraception and for insertion immediately after termination of pregnancy.

OBJECTIVE

The aim of this study was to determine the prevalence of enlarged follicles, as detected by a single clinical or ultrasonographic examination, among users of levonorgestrel subdermal contraceptive implants (Norplant implants).

METHODS

This was a cross-sectional study of 103 users of Norplant implants and 50 users of the TCu380A intrauterine contraceptive device, all of whom received reproductive health services from PROFAMILIA, Santo Domingo, Dominican Republic. Bimanual pelvic examination and vaginal ultrasonography were performed. Enlarged follicles (>25 mm) were followed up weekly. The chi(2) test was applied to these data.

RESULTS

Enlarged follicles were detected by ultrasonography in 17. 5% of Norplant implants users and 4% of TCu380A intrauterine contraceptive device users, respectively (P <.04). There was no difference according to duration of use. The longest time to involution of the follicles was 4 weeks. Forty percent of the enlarged follicles detected by ultrasonography were also detected by bimanual pelvic examination.

CONCLUSIONS

Enlarged follicles are a frequent finding among women who use Norplant implants, but they are less frequent than described in previous studies, which were based on serial ultrasonographic scans in selected groups of users. Physicians and users should be aware of the transient nature of these enlarged follicles, which do not require intervention.

BACKGROUND

The purpose of this article is to review the experiences of family planning clinic providers in making Norplant available to adolescents. We look specifically at the proportions of women receiving the implant from these providers who are teenagers, the policies adopted regarding implant education and whether or not parental consent is required for minors. Pricing policies and the implications of high method cost for teenagers are discussed. Finally, some of the policies adopted by state agencies related to adolescent use of the implant are reviewed.

METHODS

The data come from two national surveys conducted by the Alan Guttmacher Institute (AGI). The first, a survey of family planning agencies, collected data from 616 family planning providers of clinic services (response rate 69%). The second surveyed the Medicaid, health and welfare agencies in all 51 jurisdictions about policies related to Norplant.

RESULTS

Over one-quarter of all contraceptive implants inserted by family planning agencies were provided to teenagers. Teenagers were routinely informed about the implant in about 85% of those clinics offering implant services. Few state agencies notify women about the implant. Twenty-three percent of all family planning agencies providing implant services report that parental consent must be obtained prior to implant insertion. The Medicaid program has paid for a majority of implant insertions at family planning agencies.

CONCLUSIONS

Teenagers who rely on publicly funded family planning clinics for contraceptive services face a variety of barriers in obtaining Norplant. High method cost, parental consent requirements and issues related to Medicaid eligibility are likely to deter some teenagers who might otherwise choose Norplant.

Norplant contraceptive implants are a relatively new acquisition onto the Kenyan family planning scene. The method seems highly acceptable to a wide cross-section of Kenyan women in government and non-governmental organisations (NGO) clinics. One thousand, six hundred and fifty four clients were recruited into the programme of the largest family planning NGO between 1991 and 1994. Most of the acceptors were young with an average number of 2.6 living children. Half-yearly acceptance rates have been rising. There were minimal serious side effects reported, but 72.0% of the clients complained of some menstrual disruption. Site infection rates were 0.2%, the same as capsule expulsion rates and benign ovarian cyst. Continuation rates were good at 91.0% over the first year and 80.0% over the second year. Client profile and user characteristics are presented. Norplant seems to be a well accepted contraceptive method by young low-parity Kenyan women seeking long-term, continuous yet reversible contraceptive options.

Norplant implant use in Singapore showed a decrease in vitamin K-dependent Factors II, V, VII and reduction in fibrinolytic activity at the end of 5 years of use. Increased platelet numbers and accelerated platelet aggregation were also found throughout the 5 years of Norplant use. It thus appears that unlike the combined pill, prolonged Norplant use does not activate the coagulation system and does not enhance a state of hypercoagulation. On removal of the Norplant implants at the end of 5 years, the significant changes seen in hemostatic function observed with Norplant use remained.

Women using the Norplant-2 rod system in Singapore have been shown to have a change in their hemostatic function. There is a decrease in vitamin K dependent factors II, VII and a tendency toward lowered fibrinolytic activity after use of Norplant-2 rods. There was also an increase in platelet number and accelerated-platelet aggregation. These changes are similar to those seen with the Norplant six-capsule system and it would appear that both systems do not activate the coagulation system or enhance a state of hypercoagulation. On removal of the Norplant-2 rods at the end of 5 years, the significant changes seen in hemoglobin function observed with Norplant-2 rod use remained.

Indonesia's national family planning program constitutes the largest introduction of the NORPLANT® implant in the world. With the first five-year removals occurring in late 1991, the program was at a critical stage. In Fall 1991, the ANEORTA Project conducted a Use-Dynamics Study to look systematically at NORPLANT® implant use in the field. To prepare for that study, and to get early information on program functioning, BKKBN and the Population Council, in conjunction with Andalas University in West Sumatra and BKS-PENFIN in West Java, undertook a diagnostic study of six clinics in each of two provinces, interviewing service providers and examining records. A total of 120 acceptors were visited to determine the feasibility of locating them and whether they were still using implants. About 70 percent of the acceptors had accepted from non-clinical sources, either "safaris" or mobile team visits. The four-year life-table continuation rate was 78 percent. No written information specifically devoted to the NORPLANT® implant was available either to providers or to clients. Available records generally matched official records, although significant gaps were found. All physicians and nurse-midwives, as well as many nurses, had some training, formal or informal in NORPLANT® implant insertion and removal. Contrary to expectation, clinical staff, records, and logistics all seemed generally adequate for five-year removal, although some problems were anticipated.

Norplant is a levonorgestrel-containing contraceptive system that consists of six small capsules (2.4 x 34 mm), which are placed subdermally. Owing to the relative newness of this contraceptive modality, problems with removal of the Norplant implants are just beginning to be reported; these consist primarily of inability to locate and remove all six implant capsules upon discontinuation. Ultrasonographic images of 14 women with the Norplant system in place were obtained in the axial and longitudinal planes. On axial view the capsules consisted of discrete circular individual areas of high echogenicity with prominent posterior shadowing. Capsules scanned in a longitudinal plane demonstrated echogenicity of the superior and inferior capsular walls, giving a tubular appearance. It was possible to demonstrate the depth of capsule placement, spatial relation to surrounding capsules, and orientation in relation to the skin surface. Ultrasonography therefore may provide a useful, noninvasive method for localization of nonpalpable Norplant implants, thus facilitating removal.

Following the approval of the long-acting contraceptive levonorgestrel (the Norplant Contraceptive System) for use by women, government officials have required or proposed uses of levonorgestrel that are problematic. One court ordered a woman convicted of child abuse to use levonorgestrel as a condition of her probation; legislators have proposed that women on welfare be paid to use levonorgestrel. Court-ordered use of long-acting contraceptives because of child abuse raises serious questions about a person's fundamental rights to refuse medical treatment, to be free of cruel and unusual punishment, and to procreate. The state's compelling interest in protecting children from abuse may be served by less intrusive means than imposing contraception on parents who have committed child abuse. If government benefits were based on the use of long-acting contraceptives, individuals would have to assume a potentially serious health risk before receiving their benefits. Government benefits should not be made contingent on the acceptance of a health risk.

A non-comparative study of the Norplant contraceptive subdermal implant system was conducted in Kumasi, Ghana. A total of 100 acceptors were enrolled in the clinical trial, which began in 1987. There were no pregnancies during the first two years of use. Only nine post-insertion medical problems were reported during the first two years of use. One woman in this study requested removal for menstrual pattern changes through two years of use. As assessed through user-satisfaction questionnaires administered at approximately six months of use, there has been an overall positive user experience with Norplant in this study. Although the sample size in this study is small, our results seem to be consistent with other studies and it appears that Norplant offers an effective, safe and acceptable method of contraception for Ghanaian women.

The purpose of this study was to identify factors that explain why women who consulted at the same clinic, went through the same counseling procedure and who had no contraindications for using Norplant decided to use another long-acting method, the IUD. Subjects were women who consulted at the Family Planning Clinic, State University of Campinas Hospital. One hundred Norplant acceptors and 100 IUD acceptors were interviewed at home, by trained interviewers who were not related to the clinic. Four out of five Norplant acceptors and all IUD acceptors had learned about the method chosen before attending the clinic. Results suggest that among IUD users there were more women who did not like the idea of taking a hormone or medicine to prevent pregnancy, while Norplant acceptors were more willing to try new experiences. Half the Norplant acceptors had learned about the method through TV, compared to 12% of IUD acceptors. Counseling at the clinic was not a determining factor, though it is important to clarify clients' doubts.

OBJECTIVE

Norplant's long duration of action may result in users being less motivated than non-users to return for reproductive health care appointments. This study determined compliance with scheduled return appointments among adolescents using Norplant and those using other methods of contraception.

METHODS

We retrospectively reviewed the records of all teenagers (age < or = 18 years) who received Norplant between June 1991 and August 1993, as well as those of a comparison group of adolescents, matched for age and race, using other methods of contraception. Subjects receiving Norplant were given appointments for a two-week and an annual examination. Comparison subjects were given only an appointment for an annual examination. Norplant users not returning within 5 weeks or any subject not presenting within 12 months for an annual examination, were considered non-compliant.

RESULTS

Eighty-eight adolescents received Norplant during the study period and the records of 85 were available for review. Only 48 of the 85 Norplant users returned for scheduled two-week check-up, while 18 of 43 subjects who had Norplant at least 12 months were compliant with annual examinations. The compliance rate with annual examinations among the 89 subjects not using Norplant was 38%, not dissimilar from that of the Norplant group.

CONCLUSIONS

These data demonstrate that compliance with return appointments for reproductive health care among adolescent Norplant users is poor but not significantly worse than that of non-users of Norplant. Strategies promoting the benefits of return visits need to be improved for adolescents receiving contraception.