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Levonorgestrel concentrations in maternal and infant serum during use of subdermal levonorgestrel contraceptive implants, Norplant, by nursing mothers.

The transfer of levonorgestrel to infants was studied in 42 lactating women in whom the contraceptive subdermal implants, Norplant, were inserted 30 to 40 days postpartum. The women breastfed their infants for one year. Simultaneous mother and infant blood samples were taken once during the year. The levonorgestrel serum concentrations were measured by radioimmunoassay. During the first postinsertion month, the levonorgestrel concentration in the infants serum amounted, on the average, to 5% of the maternal concentration. Thereafter, the ratio ranged from 8 to 13%. The implications of this finding are discussed.

Breast Feeding↗

Contraceptive implant use among inner city teens.

PURPOSES: This study develops a clinical profile of urban teens who selected Norplant for contraception; determines which variables identify the subjects most likely to be compliant with the method; and determines the most common reasons for early termination of use. METHODS: Demographic and health history data and reasons for termination of use were collected prospectively for 122 inner city teens who received Norplant. Life table analysis and the Mantel-Haenszel procedure were used to investigate differences between Norplant retainers and terminators. RESULTS: The sample consisted of black and Hispanic teens between the ages of 13-19 years, the majority of whom had one or more children and were in school. One and two year retention rates were 71% and 62%. The highest removal rates occurred during the 3-6 month interval after insertion. A significant finding was that teens who have experienced induced abortion were more likely to retain Norplant. Common reasons for termination of use included general and social concerns, including pregnancy desire. CONCLUSIONS: Norplant retention rates for this teen sample were greater than the compliance rates reported for other conventional methods. Similar to noncompliance with oral contraceptives, discontinuance of the method was most likely to occur in the first 6 months of use. A history of induced abortion identifies those teens most likely to retain Norplant, suggesting that these teens might evaluate contraceptive risks and benefits differently than those with no abortion history. Pregnancy desire was a common reason for terminating Norplant use.

Adolescent↗

Clinical performance of a new two-rod levonorgestrel contraceptive implant: a three-year randomized study with Norplant implants as controls.

In a randomized three-year clinical trial at seven clinics, the performance of levonorgestrel rod (LNG ROD) implants used by 600 women was compared with that of soft tubing NORPLANT implants used by 598 women. No pregnancies occurred in either group of women and, accordingly, body weight did not affect the efficacy of either type of implant. There were neither statistically significant nor important differences in termination rates for any reason over the three years. Complaint and illness rates during use of either of the two implant types were statistically indistinguishable and were attributable to the same set of conditions. Seventy-one per 100 of the women using each implant regimen continued to the three-year point, for an average annual continuation rate of 89 per 100. Removals of LNG ROD implants were accomplished in about half the time required for removal of Norplant capsule implants (p < 0.001).

Adolescent↗

Correlation of endocrine profiles with bleeding patterns during use of Nestorone contraceptive implants.

The relationship between ovarian hormones and bleeding patterns during continuous progestin contraception was studied in 29 women who used Nestorone (NES) releasing implants. Oestradiol and progesterone were measured in blood samples taken twice a week for 6 consecutive weeks, during months 6, 12, 18 and 24 of implant use. Retrospectively, the association between hormonal concentrations and bleeding patterns was evaluated. Twenty-four short (</= 24 days), 36 normal (25-35 days), 27 long (36-90 days) and nine episodes of amenorrhoea, as well as 28 periods of prolonged bleeding, were identified. Short cycles, periods of prolonged bleeding and amenorrhoea were characterized by low oestradiol concentrations. Bleeding after a normal or long cycle regularly occurred after a rise and fall of oestradiol or oestradiol and progesterone. The duration of bleeding was directly and significantly associated with the highest concentration of oestradiol in the previous 15 days in anovulatory cycles. Luteal activity was associated with shorter duration of bleeding. Periods of prolonged bleeding were usually initiated with a drop in oestradiol and over half ended with an increase in oestradiol. It was concluded that changes in endogenous hormone have a significant influence over the bleeding pattern during use of NES implants.

Adolescent↗

Early post implantation contraceptive effects of a purified fraction of neem (Azadirachta indica) seeds, given orally in rats: possible mechanisms involved.

Neem seed and leaf extracts have immunomodulators that induce cellular immune reactions. These aspects of neem were exploited in earlier studies, where the oral administration of the neem seed extracts in rodents and primates could completely abrogate pregnancy at an early post implantation stage. Complete restoration of fertility was observed in the animals treated in the subsequent cycles. For the purpose of using neem as a long term contraceptive, an activity guided fractionation, followed by identification and characterization of the biologically active fraction from neem seeds was carried out. Sequentially extracted fractions of neem seeds were tested orally at an early post implantation stage in rats. The hexane extract of the neem seeds was found to be biologically active and was the precursor for the final active fraction. The active fraction, identified as a mixture of six components, could completely abrogate pregnancy in rodents up to a concentration of 10%. No apparent toxic effects could be seen following treatment with the fraction. The treatment with the active fraction caused a specific activation of T lymphocyte cells of CD8+ subtype as well as phagocytic cells followed by elevation in cytokines gamma-interferon and TNF. The results of the present study show that a pure active fraction of neem seeds could be obtained for the purpose of early post implantation contraception when given orally, and its mechanism of action seems to be by activating cell mediated immune reactions.

Abortifacient Agents↗

[Continuity of utilization of a levonorgestrel releasing contraceptive implant: prospective study in Belgium].

Since 1988 we inserted 760 sets of a subcutaneous hormonal contraceptive releasing levonorgestrel active for 5 years. The aim of the study was to investigate the continuation rates. We considered our first 612 insertions. The 5-year cumulative pregnancy rate was 3.7%. The continuation rates were high (50% of the implants remained in situ after 3 1/2 years). These rates increased with age, and were better with European than with non-European subjects (mainly Moroccan and Turkish women). Parity didn't influence. The rates increased over time, because more unhappy women soon came back compared to satisfied users. Removals were related to pregnancy wish, irregular blood loss, end of action, and various side effects. In a few cases untrained physicians removed the implants.

Adult↗

Effect of subdermal levonorgestrel contraceptive implants on vaginal candidiasis.

A total of 150 women in 3 equal groups, each using a different contraceptive method (group I used Norplant, group II used the IUD and group III used combined OC pills) were investigated for the presence of vaginal candidiasis before and at various time intervals (3, 6 and 12 months) after starting to use the particular contraceptive method. The incidence of vaginal Candida albicans infection increased significantly among pill and IUD users, but with a much lower intensity among the latter cases. In Norplant users the increase was slight and insignificant. The explanation of these findings within the context of changes in local vaginal milieu is discussed.

Adult↗

Results of a user satisfaction study carried out in women using Uniplant contraceptive implant.

A study of the acceptability of Uniplant, a 12-month single implant of nomegestrol acetate, included 819 women from Africa, Latin America, and China, participating in a clinical trial of Uniplant. A standard, pre-coded questionnaire was specially designed for this purpose and applied at the moment of removal of implant, either at the end of 12 months of use or at the time of discontinuation for whatever reason. The level of satisfaction proved high when users' comparison with their previous contraceptive method, users' recommendation of Uniplant to others, users' intention to use the method in the future, and service satisfaction were taken into consideration. Uniplant was considered easy to use, safe (low risk of pregnancy), and also to cause fewer side effects than other methods. When asked about the least liked feature of Uniplant, almost half the respondents said that there was nothing that they disliked and about one-third mentioned the changes in their menstrual pattern. However, according to the clinical trial, over half of the Uniplant users have bleeding patterns similar to untreated cycles. The majority of respondents did not feel any discomfort during the procedure of insertion and removal of the implant. About 70% of patients in the study stated that they required contraception for more than one year and most of these women said that they did not mind having to change the implant every year.

Adult↗