Midtrimester pregnancy termination with prostaglandin E1 Misoprostol compared with physician-chosen combination method; A prospective randomized trial / 대한산부인과학회잡지

ABSTRACT

OBJECTIVE: The purpose of this study was to determine the effectiveness and safety of misoprostol in termination of pregnancy. MATERIALS & METHODS: 38 women who presented with indication for termination of pregnancy were assigned randomly to receive either 200 microgram of misoprostol orally every 4 hours as needed, or medication according to the our established protocol (physician-chosen combinations of Sulprostone infusion every 6 hours with vaginal PGE2 or Laminaria). Exclusion criteria were history of asthma, glaucoma, cardiac or hepatic disease, or chorioamnionitis. Unless delivery had occurred or was imminent after 24 hours with medication, the case was considered to have failed. The induction to delivery time and influencing factors were analyzed in both group using t-test, chi-square test or Fisher`s exact test, Kaplan-Meier and Cox regression. RESULTS: The success rate of termination of pregnancy within 12 hours and 24 hours were 67% and 93% with misoprostol (n=15) versus 5% and 43% with physician-chosen combination (n=21) (p<0.05). Among 3 cases failed with misoprostol within 24 hours, two cases crossed to the alternative method after 24 hours of misoprostol, so, the 2 cases were excluded. The mean dosage and frequency of misoprostol was 540 microgram and 2.8 times. The mean induction to delivery time ( mean +/- standard deviation) with oral misoprostol (n=15) was 640+/-590 minutes versus 1670+/-750 minutes with physician-chosen combination (n=21) (p<0.001). Reanalyzed in selected cases of Bishop score time with misoprostol (n=13) was 728+/-586 minutes versus 1748+/-678 minutes with physician-chosen combination (n=20) (p<0.001). The side effects (nausea, vomiting, diarrhea, mild fever, and chest tightness) were 47% in misoprostol group and 28% in physician-chosen combination group, but they were mild and had no clinical significance. By Cox regression analysis, the Bishop score method of termination (p<0.05) are most significant factors to influence the induction to delivery time.

CONCLUSIONS:

Compared to the routine physician-chosen combination method for termination of pregnancy, oral misoprostol results in shorter induction to delivery time and is easy to use without significant maternal side effects.