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Objective: To compare the safety and effectiveness of CuT 380A IUD use inserted by R-inserter compared with those inserted by ring forceps during the postpartum period. Methods: The study was conducted in three puskesmas (community health centre) as affi liated of Sardjito Hospital. Subjects meeting the inclusion and exclusion criteria were recruited to get a 10% proportion expulsion rate difference, type one error 0.05 and type two error 0.20. Insertion using R-inserter was treated while using ring forceps belonged to the control groups. Follow up was carried out one week after the insertion, one month and then monthly for 12months. Rate of the following events i.e.infection, expulsion, pain, bleeding, removal and continuation of use were primary outcomes of interest. Results: A total of 208 eligible subjects were recruited, consisting of 104 subjects using R-inserter and 104 subjects using ring forceps. Cumulative event rates during 12 months follow up were 1%, 4.3%, 3.4%, 10.1% and 4.8% each for infection, expulsion, bleeding, pain, and removal respectively. There was no difference in the rate of infection between the two groups, i.e. 1,0% for each group. There was one pregnancy over 208 subjects giving the overall failure rate of 0.5%. The overall results showed that there were no differences among those events rates (pain, bleeding, removal and continuation) between R-inserter and ring forceps groups. Continuations rate were 93.7%, 93.2%, 90.8%, and 90.8% each for three, six, nine and 12 months follow up respectively. Conclusions: There were no differences in terms of event rates between the use of CuT 380A IUD inserted by R-inserter and ring forceps.

CuT 380A IUD Inserted by R-Inserter and Ring Forceps during Postpartum Period A Randomized Clinical Trial, Twelve Months Follow Up