Othman Kakaire1, Josaphat Kayogoza Byamugisha, Nazarius Mbona Tumwesigye, Kristina Gemzell-Danielsson. 1. Department of Obstetrics and Gynaecology and School of Public Health, Makerere University College of Health Sciences, Old Mulago Hill Kampala, Uganda; and the Division of Obstetrics and Gynaecology, Department of Women's and Children's Health, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
Abstract
OBJECTIVE: To compare discontinuation rates of the levonorgestrel and copper intrauterine devices (IUDs) among women with human immunodeficiency virus. METHODS: A double-masked randomized trial was conducted at Mulago Hospital, Uganda. Women received either a copper or levonorgestrel IUD. The primary outcome was discontinuation of intrauterine contraception within 1 year of placement. The secondary outcomes were incidence of side effects and severe adverse events. To discern a difference of 10% from a copper IUD discontinuation rate of 18%, power of 80%, and 95% confidence interval (CI), a sample size of 351 per arm was estimated. Analysis of the primary outcome was by intension-to-treat principle. RESULTS:From September 2013 to December 2014, 979 were screened and 703 randomized as follows: 349 to the copper group and 354 to the levonorgestrel group. In total, 8.6% (29/338) women in the copper group compared with 8.1% (27/334) in the levonorgestrel group discontinued intrauterine conception within 1 year of placement (incidence rate ratio 1.1 [95% CI 0.64-1.96]). Overall, the incidence of heavy bleeding was higher in the copper group (37% [125/338]) than in the levonorgestrel group (19.5% [65/334]). However, the incidence of amenorrhea, which occurred in 3.3% (11/338) of women, was lower in the copper group than the 19.8% (66/334) of women who reported amenorrhea in the levonorgestrel group. CONCLUSION: There was no difference in discontinuation rates between the copper and levonorgestrel devices. Women in the levonorgestrel group had reduced incidence of heavy bleeding and a higher incidence of amenorrhea compared with those in the copper group. CLINICAL TRIAL REGISTRATION: Pan African Clinical Trial Registry, www.pactr.org, PACTR 201308000561212. LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To compare discontinuation rates of the levonorgestrel and copper intrauterine devices (IUDs) among women with human immunodeficiency virus. METHODS: A double-masked randomized trial was conducted at Mulago Hospital, Uganda. Women received either a copper or levonorgestrel IUD. The primary outcome was discontinuation of intrauterine contraception within 1 year of placement. The secondary outcomes were incidence of side effects and severe adverse events. To discern a difference of 10% from a copper IUD discontinuation rate of 18%, power of 80%, and 95% confidence interval (CI), a sample size of 351 per arm was estimated. Analysis of the primary outcome was by intension-to-treat principle. RESULTS: From September 2013 to December 2014, 979 were screened and 703 randomized as follows: 349 to the copper group and 354 to the levonorgestrel group. In total, 8.6% (29/338) women in the copper group compared with 8.1% (27/334) in the levonorgestrel group discontinued intrauterine conception within 1 year of placement (incidence rate ratio 1.1 [95% CI 0.64-1.96]). Overall, the incidence of heavy bleeding was higher in the copper group (37% [125/338]) than in the levonorgestrel group (19.5% [65/334]). However, the incidence of amenorrhea, which occurred in 3.3% (11/338) of women, was lower in the copper group than the 19.8% (66/334) of women who reported amenorrhea in the levonorgestrel group. CONCLUSION: There was no difference in discontinuation rates between the copper and levonorgestrel devices. Women in the levonorgestrel group had reduced incidence of heavy bleeding and a higher incidence of amenorrhea compared with those in the copper group. CLINICAL TRIAL REGISTRATION: Pan African Clinical Trial Registry, www.pactr.org, PACTR 201308000561212. LEVEL OF EVIDENCE: I.
Authors: Catherine S Todd; Tracy C Anderman; Sarah Long; Landon Myer; Linda-Gail Bekker; Gregory A Petro; Heidi E Jones Journal: Contraception Date: 2018-02-09 Impact factor: 3.375