THE SAFETY AND EFFICACY OF USING LETROZOLE PRETREATMENT WITH MISOPROSTOL VERSUS MISOPROSTOL ALONE FOR SUCCESSFUL SECOND-TRIMESTER MEDICAL ABORTION: A RANDOMIZED CONTROLLED TRIAL
Khaled Kholaif, Ahmed H. Attia
Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt
Objective: To compare the safety and efficacy of combined letrozole plus misoprostol regimen versus misoprostol only regimen in increasing the rate of complete abortion in second trimester abortion. Study Design: A prospective randomized double blinded placebo-controlled clinical trial. Patients and Methods: The present study was conducted in obstetrics and gynecology hospital, faculty of medicine, Cairo University, Egypt from January 2019 to October 2019. Two hundred women who were candidate of medical abortion and eligible for legal abortion with gestational age >12 weeks were randomly divided into one of two groups either letrozole plus misoprostol group or misoprostol only group. Letrozole with misoprostol group received daily vaginal dose of 7.5 mg letrozole for three days followed by vaginal misoprostol. In control group the patients received only vaginal misoprostol. The rate of complete abortion, induction-to-abortion time, and side-effects were assessed. Results: Baseline characteristics were not statistically significantly different between the two groups. Women in combined letrozole misoprostol group had significantly higher rate of complete abortions with shorter induction to abortion interval compared to women in misoprostol only group ( p <0.001 and <0.001 respectively). Oxytocin use and the need for surgical evacuation were significantly higher in misoprostol only group than letrozole plus misoprostol group ( p <0.001 and <0.001 respectively). Side effects of study drugs and complications of abortion were not significantly different between the two groups. Conclusion: Letrozole combined with misoprostol resulted in higher rate of complete abortions and shorter induction to abortion interval compared with misoprostol only medical treatment in women with second trimester abortion, the side effects also were tolerable and similar in the two regimens.