A randomized double-blind controlled trial of two different doses of self-administered vaginal misoprostol for successful copper intrauterine device insertion

Abstract

Abstract Objective The current study aims to compare the efficacy and safety of 200 mcg versus 400 mcg vaginal misoprostol administered 3 h prior to intrauterine device (IUD) insertion in parous women. Study design A randomized double-blind controlled trial. Setting Women’s Health Hospital, Assiut, Egypt. Materials and methods Two-hundred twelve women were randomized into two groups; group I received 2 misoprostol 400 mcg tablets and group II received one misoprostol 200 mcg and one placebo tablet vaginally three hours before a copper IUD insertion. The primary outcome was the rate of successful IUD insertion in both groups. The secondary outcomes include the rate of adverse effects. Results There was no statistical difference between both groups as regard successful IUD insertion (p = 0.17). Additionally, the satisfaction score reported by the women was not statistically different (p = 0.11). Failure of IUD insertion was present in three cases in the misoprostol 400 mcg group versus four cases in the misoprostol 200 mcg group (p = 0.45). Both groups were similar regarding the duration of insertion (p = 0.85). Abdominal cramping and shivering were the main side effects in both groups, however the rate of their occurrence was significantly higher in the misoprostol 400 mcg group than the other group (30.2% versus 10.4% and 7.5% versus 1.9%, respectively; p = 0.0001). Conclusion Vaginal misoprostol 200 mcg prior to IUD insertion appears to be similar to 400 mcg as regard the success of IUD insertion and procedure duration with significantly lower side effects.