Taufik Rahman Alkaff, Diah Rumekti Hadiati, Risanto Siswosudarmo
Department of Obstetrics and Gynecology
Medical Faculty Gadjah Mada University
Yogyakarta
Abstract
Back ground:IUD is one of most effective and long acting contraceptive, but the rate of its use in Indonesia is still low.As conventional IUD inserter is too short to use for delivering it during immediate postpartum (postplacental) period, then the new inserter, R_inserter, is developped.
Objective:To find out whether the new R_inserter can be used easily to deliver CuT-380A IUD in a standard procedure and to find out its safety.
Design: Phase II clinical trial, post-test observation.
Material and method: The IUD’sused were the conventional CuT-380A with a modification on its inserter namely 9 cm longer, produced by PT Kimia Farma Indonesia. The study was carried out in three hospitals and three community health centers (Puskemas) which were the network of Sardjito teaching hospital, from January 2012 to April 2013. All eligible women needing IUD as their contraceptives were recruited. IUD insertion was carried out by trained obstetric and gynecology resident or midwives. Follow up was done after 1 week, then 1, 3, 6, 9 and 12months after insertion.The ease of insertion, rate of the following events namely expulsion, infection,pain, bleeding, and continuation were main outcomes of interest.
Results:During the study period, a total 142participants were recruited. The mean duration of insertion was 3.89 ± 2.08 minutes (ranged 2 to 10 minutes). No subjective difficulties were perceived by the providers. The cumulative expulsion rate for 1, 3, 6, 9 and 12 months were9.9%, 9.9%, 10.6%, 10.6% and 10.% consecutively. The rate of expulsion if the IUD was inserted during 10 minutes after placental delivery was 6.2% compared to 24.1% if it was inserted after 10 minutes (RR 3.90; 95% CI 1.37-11.2). Infection, pain, and bleeding were relatively small and could be appropriately managed. The continuation rate for 1, 3, 6, 9 and 12 months were 89.4%, 89.4%, 86.6%, 86.6% and 85.9% consecutively. No pregnancy was found during the study period.
Conclussion: The R_inserter could be easily used to deliver a CuT-380A IUD.The rate of expulsion was highest during the first month of insertion and was related to the time of insertion.
Key words:R_ inserter, postpartum IUD,expulsion, infection,continuation rate.