Abstract
Purpose This study aimed at investigating the efficacy and safety of dinoprostone 3 mg vaginally prior to levonorgestrel-releasing intrauterine system (LNG-IUS) insertion in women undergoing elective cesarean delivery (CD). Methods We conducted a prospective, randomized, double-blinded, placebo-controlled trial at family planning clinic of Cairo University hospitals from August 2019 to January 2020. We included 200 women aged >= 18 years who previously delivered by elective CD willing to receive LNG-IUS. Women were randomly assigned with a 1:1 allocation ratio to receive 3 mg vaginal dinoprostone or placebo tablets two hours before LNG-IUS insertion. Our main outcomes were patient-reported pain during insertion and 30 min post-procedure, ease of insertion, satisfaction, duration of insertion, and different side effects. Results Patient-perceived pain during LNG-IUS insertion was significantly reduced in dinoprostone compared to placebo (4.1 +/- 1.7 vs 6.4 +/- 1.3; p < 0.001). Dinoprostone reduced pain scores 30 min post-procedure compared to placebo, but the difference was not statistically significant (3.5 +/- 1.1 vs 3.7 +/- 1.6; p = 0.25). Satisfaction score was higher in dinoprostone compared to placebo (7.9 +/- 1.0 vs 5.9 +/- 0.8; p < 0.001). The insertion was significantly easier and shorter in dinoprostone than placebo (3.9 +/- 1.1 vs 5.9 +/- 1.1; p < 0.001) and (5.6 +/- 0.9 vs 7.2 +/- 0.8; p < 0.001), respectively. Adverse events were not significantly different between both groups. Conclusion Dinoprostone administration 2 h before LNG-IUS insertion in women delivered by elective CD effectively reduced pain during insertion and 30 min post-procedure. Women received dinoprostone had easier and shorter insertion and were more satisfied with tolerable side effects.