THE USE OF NEW INSERTER (R_INSERTER) FOR DELIVERING CuT-380A IUD DURING POSTPARTUM PERIOD PHASE II CLINICAL TRIAL

Abstract

THE USE OF NEW INSERTER (R_INSERTER) FOR DELIVERING CuT-380A IUD DURING POSTPARTUM PERIOD PHASE II CLINICAL TRIAL

Risanto Siswosudarmo¹, Kadek Kurniawan², Herdhana Suwartono³, Taufik Rahman Alkaff⁴, and Maria Anggraeni⁵

ABSTRAK

Latar Belakang: IUD adalah salah satu alat kontrasepsi jangka panjang yang efektif, tetapi penggunaan di Indonesia masih rendah. Karena inserter IUD yang biasa di pakai terlalu pendek untuk pemasangan segera pascasalin maka bentuk inserter baru (R_inseter) telah dikembangkan.

Tujuan: Untuk mengetahui apakah R_inserter dapat digunakan dengan mudah sesuai standard pemasangan IUD dan untuk mengetahui keamanannya.

Metode: Uji klinis fase II, post test observation.

Bahan dan cara: IUD yang dipasang adalah TCu380A dengan modifikasi pada inserternya (R_inserter) buatan PT Kimia Farma. Penelitian ini dilakukan di 3 Rumah Sakit dan 3 Puskesmas yang merupakan afiliasi rumah sakit pendidikan Dr Sardjito dari bulan Januari 2012 sampai April 2013. Semua klien yang memenuhi kriteria inklusi dan eksklusi dimasukkan dalam penelitian ini. Pemasangan dilakukan oleh Residen atau Bidan yang telah mendapatkan pelatihan. Follow up dilakukan setelah 1 minggu, 1, 3, 6, 9 dan 12 bulan pascapasang. Kemudahan, angka ekspulsi, infeksi, nyeri, perdarahan, dan angka kelangsungan merupakan hasil utama yang diobservasi.

Hasil dan Pembahasan: Selama kurun waktu tersebut telah direkrut sebanyak 142 klien yang memenuhi kriteria kelayakan. Lama pemasangan rata-rata adalah 3,89 ± 2,08 menit dengan minimum 2 menit dan maksimum 10 menit. Tidak ada kesulitan yang dirasakan. Secara kumulatif kejadian dalam 1, 3, 6, 9 dan 12 bulan untuk ekspulsi masing-masing adalah 9,9%, 9,9%, 10,6%, 10,6% dan 10%. Angka ekspulsi jika IUD dipasang dalam 10 menit pertama setelah plasenta lahir adalah 6,2% dibanding 24,1% bila pemasangan dilakukan setelah 10 menit (RR 3,90; 95%CI 1,37-11,2). Kejadian seperti infeksi, nyeri dan perdarahan relatif kecil dan dapat diatasi. Angka kelangsungan selama 1, 3, 6, 9 dan 12 bulan berturut turut adalah 89,4%, 89,4%, 86,6% 86,6% dan 85,9%. Tidak dijumpai kehamilan pada penelitian ini.

Kesimpulan: R_inserter dapat dipakai untuk memasang IUD CuT-380A dengan mudah dan aman. Angka kejadian ekspulsi tertinggi terjadi dalam satu bulan pertama pascapasang dan berhubungan dengan saat pemasangan.

Kata kunci: R_inserter, IUD pascasalin, ekspulsi, infeksi, angka kelangsungan.

ABSTRACT

Background: IUD is one of the most effective and long acting contraception, but the rate of its use in Indonesia is still low. As conventional IUD inserter is too short to deliver it during immediate postpartum (postplacental) period, then the new inserter, R_inserter, is developped.

Objective:To find out whether the R_inserter can be used easily to deliver CuT-380A IUD during postpartum period in a standard procedure and to find out its safety.

Method: Phase II clinical trial, post-test observation.

Materials and Method: The IUD’s used 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 contraception 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 and Discussion: During the study period, a total 142 participants 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 were 9.9%, 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.

Keywords:  R_ inserter, postpartum IUD, expulsion, infection, continuation rate.

1,2,3,4 Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Gadjah Mada/ Sardjito Hospital Yogyakarta

5 National Family Planning Board, Jakarta