title: A randomized clinical trial of the effect of intensive versus non-intensive counselling on discontinuation rates due to bleeding disturbances of three long-acting reversible contraceptives.
abstract: OBJECTIVE
  Does intensive counselling before insertion and throughout the first year of use have any influence on discontinuation rates due to unpredictable menstrual bleeding in users of three long-acting reversible contraceptives (LARCs)?
  
  
  CONCLUSIONS
  Intensive counselling had a similar effect to routine counselling in terms of discontinuation rates due to unpredictable menstrual bleeding in new users of the contraceptives.
  
  
  BACKGROUND
  Contraceptive efficacy and satisfaction rates are very high with LARCs, including the etonogestrel (ENG)-releasing implant, the levonorgestrel-releasing intrauterine system (LNG-IUS) and the TCu380A intrauterine device (IUD). However, unpredictable menstrual bleeding constitutes the principal reason for premature discontinuation, particularly in the cases of the ENG-implant and the LNG-IUS.
  
  
  METHODS
  A randomized clinical trial was conducted between 2011 and 2013, and involved 297 women: 98 ENG-implant users, 99 LNG-IUS users and 100 TCu380A IUD users.
  
  
  METHODS
  Women accepting each contraceptive method were randomized into two groups after the women chose their contraceptive method. Group I received routine counselling at the clinic, including information on safety, efficacy and side effects, as well as what to expect regarding bleeding disturbances. Group II received 'intensive counselling'. In addition to the information provided to those in Group I, these women also received leaflets on their chosen method and were seen by the same three professionals, the most experienced at the clinic, throughout the year of follow-up. These three professionals went over all the information provided at each consultation. Women in both groups were instructed to return to the clinic after 45 (±7) days and at 6 and 12 (±1) months after insertion. They were instructed to record all bleeding episodes on a menstrual calendar specifically provided for this purpose. Additionally, satisfaction with the method was evaluated by a questionnaire completed by the women after 12 months of use of the contraceptive method.
  
  
  RESULTS
  There were no significant differences between the intensive and routine counselling groups on the discontinuation rates due to unpredictable menstrual bleeding of the three contraceptives under evaluation. The 1-year cumulative discontinuation rates due to menstrual bleeding irregularities were 2.1, 2.7 and 4.0% and the continuation rates were 82.6, 81.0 and 73.2%, for the ENG-implant, the LNG-IUS or the TCu380A IUD users, respectively. The main reasons for discontinuation of the methods were weight gain in users of the ENG-implant and expulsion of the TCu380A.
  
  
  CONCLUSIONS
  The main limitations are that we cannot assure generalization of the results to another settings and that the routine counselling provided by our counsellors may already be appropriate for the women attending the clinic and so consequently intensive counselling including written leaflets was unable to influence the premature discontinuation rate due to unpredictable menstrual bleeding. Additionally, counselling could discourage some women from using the LARC methods offered in the study and consequently those women may have decided on other contraceptives.
  
  
  CONCLUSIONS
  Routine counselling may be sufficient for many women to help reduce premature discontinuation rates and improve continuation rates and user satisfaction among new users of LARC methods.
  
  
  BACKGROUND
  The trial was registered at clinicaltrials.gov (NCT01392157).
  
  
  BACKGROUND
  The study was partially funded by the Fundação de Apoio a Pesquisa do Estado de São Paulo (FAPESP) grant # 2012/01379-0, the Brazilian National Research Council (CNPq) grant #573747/2008-3 and by Merck (MSD), Brazil under an unrestricted grant. The LNG-IUS were donated by the International Contraceptive Access Foundation (ICA) and the copper IUD by Injeflex, São Paulo, Brazil. L.B. has occasionally served on the Board of MSD, Bayer and Vifor.
authors.forename: Waleska
authors.initials: W
authors.lastname: Modesto
authors.forename: M Valeria
authors.initials: MV
authors.lastname: Bahamondes
authors.forename: Luis
authors.initials: L
authors.lastname: Bahamondes
mesh_terms: D000328:Adult; D015992:Body Mass Index; D003267:Contraception / Q000379:methods*; D003271:Contraceptive Agents, Female / Q000009:adverse effects / Q000627:therapeutic use*; D003376:Counseling / Q000379:methods*; D017135:Desogestrel; D005260:Female; D006470:Hemorrhage; D006801:Humans; D007435:Intrauterine Devices, Copper / Q000009:adverse effects / Q000706:statistics & numerical data*; D007436:Intrauterine Devices, Medicated / Q000009:adverse effects / Q000706:statistics & numerical data*; D016912:Levonorgestrel / Q000009:adverse effects / Q000627:therapeutic use; D008598:Menstruation / Q000187:drug effects*; D015430:Weight Gain / Q000187:drug effects
chemical_list: D003271:Contraceptive Agents, Female; C044815:etonogestrel; D016912:Levonorgestrel; D017135:Desogestrel