Perbandingan keefektifan dan keamanan induksi persalinan dengan misoprostol sublingual vs vaginal

PANGASTUTI, Nuring, Prof.Dr. HM. Sulchan Sofoewan, PhD.,SpOG(K)

2005 | Tesis | PPDS I Obstetri dan Ginekologi

Latar belakang: Misoprostol telah cukup banyak digunakan untuk induksi persalinan..Berbagai cara pemberiannya memberikan lama induksi dan efek samping yang berbeda. Melalui rute sublingual, kadar puncak dalam darah asam misoprostol tercapai lebih cepat dibandingkan melalui vaginal, sehingga lama induksi akan lebih pendek. Tujuan: Penelitian ini bertujuan membandingkan keefektifan dan keamanan induksi persalinan dengan misoprostol sublingual dan vaginal. Rancangan penelitian: Uji klinis secara random. Tempat dan waktu: Penelitian dilakukan di RS Dr Sardjito Jogjakarta dan rumah sakit mitra pendidikan Obstetri dan Ginekologi FK-UGM, sejak tanggal 1 Oktober 2004 sampai dengan 30 April 2005. Bahan dan cara: Subyek penelitian adalah 120 ibu hamil yang memerlukan induksi. Dari randomisasi komputer dihasilkan kelompok uji (sublingual) yang diberi 50 μg misoprostol di bawah lidah, dan kelompok kontrol (vaginal) yang mendapatkan dosis sama di forniks posterior. Misoprostol diberikan tiap 6 jam selama belum masuk dalam persalinan, maksimal 4 kali pemberian. Hasil: Keberhasilan induksi kelompok perlakuan mencapai 88,5 %, sedangkan kelompok kontrol 84,7 % (p=0,54). Lama induksi kelompok perlakuan (6,57±4,99 jam) lebih pendek dibandingkan kelompok kontrol (8,57±5,81 jam, p=0,06). Lama tercapai kala II kelompok perlakuan (8,23±5,28 jam) juga lebih pendek (10,51±6,25 jam, p=0,06) dibandingkan kelompok kontrol. Satu kasus atonia uteri dijumpai pada kelompok perlakuan, satu kasus ruptur uteri pada kelompok kontrol. Efek samping pada kedua kelompok adalah mual, muntah, hiperstimulasi dan gawat janin (p=0,72). Simpulan: Tidak ada perbedaan bermakna dalam hal keberhasilan induksi, lama induksi, serta lama tercapai kala II di antara kedua kelompok. Meskipun tidak ada perbedaan bermakna efek samping obat pada kedua kelompok, terdapat satu kasus atonia uteri pada kelompok sublingual dan satu kasus ruptur uteri pada kelompok vaginal.

Background: Misoprostol has been widely used to induce labor. Recent reports suggest that blood peak level of sublingual administration of misoprostol happens faster than vaginal administration. The duration of labor is then expected to be shorter. Objectives: To compare sublingual administration of misoprostol vs. vaginal for induction of labor in terms of effectiveness and safety. Material and method: A randomized controlled trial was used in this study. A total of 120 eligible pregnant women were randomly assigned to a treated (sublingual) and a control group (vaginal). Fifty micrograms of misoprostol was placed under the tongue (sublingual administration), and the same dose was given by posterior fornix application (vaginal administration). Misoprostol was given 6 hourly as far as the women were not in labor for maximal doses of 200 μg. Results: There was no difference between treated and control group in the rate patients who arrived to an active phase of labor i.e. 88,5 %, vs 84,7 % respectively (p=0,54). The duration from start of induction to 4 cm dilated cervix was shorter in the treated group, but not statistically different (6,57+ 4.99 vs 8,57 + 5,81 hours, p=0,06). The duration from start of induction to fully dilated cervix was shorter in the treated group (8,23±5,28 vs 10,51±6,25 hours, p=0,06), but also not statistically different. One case of uterine atony was found in the treated group, and one uterine rupture in the control group. Nausea, vomiting, hyperstimulation and fetal distress were other side effects encountered in both groups (p=0,72). Conclusion: There was no difference between treated and control group in the rate patients who arrived to an active phase of labor and the duration from the start of induction to fully dilated cervix. No difference in the rate of side effects, but one case of uterine atony was found in the treated group and one uterine rupture in the control group.

Kata Kunci : Induksi Persalinan,Misoprostol,Rute Pemberian, induction of labor, misoprostol, route of administration, side effects