Study protocol to compare the influence of the use of Contraceptive Injection in the levels of C Reactive Protein and Oxidized Low-density Lipoprotein

Abstract

Introduction: Women broadly use hormonal contraceptives to avoid an unintended pregnancy. Nevertheless, researchers suggest that its continued use can cause adverse effects, as a variation in the lipid profile and levels of C-reactive Protein (CRP), which lead to subclinical inflammation and, consequently, higher cardiovascular risk. Objective: Test the hypothesis that the continuous use of contraceptive injection (CI) affects C-reactive Protein levels and Oxidized Low-density Lipoprotein of apparently healthy women.  Methods: Comparative observational cross-sectional study, which will include women that have made (and have not made) use of contraceptive injection for at least six months. These women will be recruited by invitations on social networks, doctors’ offices, and health care units. There will be collected anthropometric and blood to analyze criteria for exclusion and blood collection to measure C-reactive Protein (CRP) and Oxidized Low-density Lipoprotein (Ox-LDL). The Term of Free and Informed Consent will be given to the volunteers. A pilot study was held with 14 participants, and the calculation of sample sufficiency was done for the primary outcome CRP, in which it was considered an alpha of 0,05 and beta 0,80 for the relationship between samples 1:1 and, then, the number of 82 participants had been estimated. The Project was submitted to the Committee of Ethics in Research with the Certificate of Presentation for Ethical Consideration (CPEC): 37695620.5.0000.0042.

Estimated Results: This study may suggest a redirection of health workers’ decision making, regarding the use of contraceptives in women with cardiovascular risk.