Comparison of the Intrauterine Enabler Device Technique and Conventional Method for Inserting Copper 380 mm² Intrauterine Device: A Pilot Randomized Controlled Trial

Background This pilot study compared the intrauterine enabler device technique with the conventional method for inserting the copper 380 mm² intrauterine device (Cu-IUD), focusing on the fundal placement achieved by both methods. Methods This randomized controlled trial compared the provider and client experiences as well as the technique for inserting the Cu-IUD using the intrauterine enabler device and the conventional no-touch technique. A total of 100 clients underwent Cu-IUD insertion: 50 participants (Group A) received the conventional no-touch technique, while 50 participants (Group B) were treated with the intrauterine enabler device. Results Pain experienced during sounding with the Esa (plastic sound provided with an inserter device) was significantly lower compared to the metallic sound (p < 0.0001). Providers in Group B reported that loading the arms of the Cu-IUD was easy 94% of the time, compared to only 26% in Group A (p < 0.0001). Setting the measurement of uterine depth on the inserter tube was achieved easily every time in Group B and 90% of the time in Group A (p = 0.054). The placement technique for the device was easy every time in Group B, while it was reported as easy 86% of the time in Group A (p = 0.012). Overhandling of the device was significantly easier with the intrauterine enabler (98%) compared to the conventional method (64%) (p < 0.0001). Additionally, the time taken for insertion was significantly shorter with the intrauterine enabler compared to the conventional method (p < 0.0001). Conclusions The insertion of the Cu-IUD using a novel intrauterine enabler device is as safe and effective as the conventional method. The overall experience of insertion is more comfortable for the provider and less painful for the client.