Evaluate various clinical aspects of the use of Levonorgestrel intrauterine system 52MG (SIU-LNG)

• Grant number: 21/01160-8
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: March 01, 2021
• End date: October 31, 2021
• Field of knowledge: Health Sciences - Medicine - Maternal and Child Health
• Principal Investigator: Luis Guillermo Bahamondes
• Grantee: Rafael Boava Souza
• Host Institution: Centro de Atenção Integral à Saúde da Mulher (CAISM). Hospital da Mulher Professor Doutor José Aristodemo Pinotti. Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
• Associated research grant: 15/20504-9 - Clinical findings among progestin-only contraceptives' users, AP.TEM

Abstract

Objectives: to evaluate different sociodemographic, clinical and opinion characteristics, including acceptance, satisfaction and continuity in relation to other contraceptives of women already using and new users of the intrauterine system with levonorgestrel 52mg (SIU-LNG),as well as the opinion of doctors from institutions that receive the SIU-LNG provided free of charge from UNICAMP / CEMICAMP. Methods: a prospective cohort study will be conducted on various aspects of using the SIULNG as a contraceptive method. 440 women aged between 18 and 40 years will be included. The women in the study with new users (total of 220 women) will be recruited from those seeking contraceptive methods at the Family Planning Clinic of CAISM-UNICAMP. The data will be obtained through a questionnaire developed for the study with several questions related to: knowledge and opinions of new users about the SIU LNG as well as the contraceptive preference in case the SIU-LNG does not exist on demand at the Clinic. Prior insertion of the method, trained professionals from the outpatient clinic will provide guidance on intrauterine contraceptives available at the Family Planning Clinic of CAISM-UNICAMP. Among women who are already users, we will apply a questionnaire where we will assess the degree of satisfaction of women who have already used the method, how they got to know it, the reasons for use, the reasons for satisfaction, the possibility of recommending the method to friends. The sample size for this component will be 220 women. Also retrospectively, we will compare some sociodemographic characteristics of SIU-LNG users with copper IUDusers before making the SIU-LNG available at the UNICAMP / CEMICAMP family planning clinic, and from the year 2007 when the SIU-LNG was available. This will be doneto find out if the intrauterine contraceptive acceptors are different or similar before the SIULNG is made available and when the copper IUD and the SIU LNG "live together" in the same clinic. We estimate to have data for this component of 31,388 insertions, including around 12,000 SIU-LNG. All participants who are invited and those who accept will be invited to sign the ICF before completing the questionnaire. We will also invite professionals from the 24 centers (04 per center) in Brazil who receive the SIU LNG free of charge from UNICAMP to complete a pre-tested questionnaire where we will obtain their opinion on the use of the SIU LNG, challenges, possible problems and benefits for the women. In total we will invite 96 professionals. Statistical analysis: Data will be presented as mean and SD with 95% confidence intervals. The comparison of the various variables of acceptance and satisfaction between the methods will be evaluated by the Ç 2 test. The level of significance will be 5%.