A Randomized Clinical Trial of the Effect of Intensive Versus Non-intensive Counseling on Discontinuation Rates Due to Bleeding Disturbances of Three Long-Acting Reversible Contraceptives

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Long-acting reversible contraceptives (LARCs) include the etonogestrel (ENG)–releasing subdermal implant, the levonorgestrel-releasing intrauterine system (LNG-IUS), and the TCu380A intrauterine device (IUD). Despite the high contraceptive efficacy of LARCs, adverse effects may lead to their premature removal, reduce continuation rates, and potentially increase unintended pregnancies. The primary reason for premature discontinuation is unpredictable menstrual bleeding, especially for users of the ENG-implant and the LNG-IUS. Counseling is a well-accepted strategy to improve acceptance, continuation, and satisfaction among contraceptive users and new users.

The aim of this randomized clinical trial was to determine whether intensive counseling before insertion and during the first year of use would reduce discontinuation rates due to unpredictable menstrual bleeding in new users of these 3 LARCs. The study was conducted between 2011 and 2013 at an obstetrics-gynecology clinic in Brazil. Contraceptive efficacy and satisfaction rates were investigated for 98 users of the ENG-releasing implant, 99 users of the LNG-IUS, and 100 users of the TCu380A IUD. Each participant had been allowed to choose any one of these methods. Subjects were randomized to 1 of 2 counseling strategies: Women in group I received routine counseling at the clinic, which included information on safety, efficacy, and adverse effects, especially the likelihood of bleeding. Women in group II received the same information, but in addition were given “intensive counseling,” which included leaflets on their chosen method and counseling throughout 1 year of follow-up by the same 3 professionals, who were the most experienced at the clinic. All subjects were instructed to return to the clinic after 45 (+7) days and at 6 and 12 (+1) months after insertion and to record all bleeding episodes in a menstrual diary specifically provided for this purpose. Satisfaction of the women with each contraceptive method was evaluated 12 months after initial use by a questionnaire.

No significant differences between the groups or between the 3 contraceptives were found for discontinuation rates due to unpredictable menstrual bleeding. Cumulative discontinuation rates at 1 year due to menstrual bleeding irregularities for the ENG implant, the LNG-IUS, and the TCu380A IUD users were 2.1%, 2.7%, and 4.0%, respectively; continuation rates were 82.6%, 81.0%, and 73.2%. The primary reason for discontinuation was weight gain in users of the ENG implant and expulsion in users of the TCu380A.

These data indicate that routine counseling is as effective as intensive counseling in reducing premature discontinuation rates, improving continuation rates, and achieving high satisfaction among new users of LARC methods. However, these findings should be interpreted with caution. The results may not apply to other settings, and premature discontinuation due to menstrual bleeding was already low. Moreover, some women could be discouraged by counseling from using the LARC methods and could decide to use other contraceptives.

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