Comparative safety and efficacy of a dedicated postpartum IUD inserter versus forceps for immediate postpartum IUD insertion: a randomized trial

Objective: To compare postpartum intrauterine device (PPIUD) insertion using a newly developed dedicated PPIUD inserter (inserter) to insertion with modified Kelly placental forceps (forceps). Study design: We randomized 500 women at five Indian academic centers to PPIUD insertion of a Copper T380A with either the inserter or forceps. The primary outcomes were fundal placement (assessed by postinsertion ultrasound), ease of insertion on a 5-point Likert scale and safety (infection/perforation). Secondary outcomes included IUD status at 6-8 weeks postpartum, assessed by string check, ultrasound or x-ray. Results: Between September 2015 and July 2016, 241 women in the inserter group and 239 women in the forceps group completed the study, with 20 women excluded due to consent withdrawal (n=4), lost to follow-up (n=10) and protocol deviation (n=6). Median distance from the fundus was similar (p=.36): 5.2 mm (0-130) and 5.8 mm (0-120) in the inserter and forceps groups, respectively. Most providers reported insertion to be easy or very easy with inserter (n=195, 81%) and forceps (n=206, 86%; p=.51). There were no perforations or insertion-related infections. Complete expulsion occurred in 19 (7.9%) in the inserter and 13 (5.4%) forceps groups (p=.28). The inserter group had more partial expulsions (n=26, 10.8% versus n=12, 5.0%,) and self-removals (n=4, 1.7% versus n=0); however, most retained their IUD [174 (72.2%) and 200 (83.7%), respectively] (p=.01). Strings were not visible at follow-up in 23 (13.1%) participants in the inserter group and 45 (22.4%) in the forceps group (p=.04). Conclusions: High fundal placement was similar between groups, with strings subsequently seen more frequently in the inserter group. The inserter's increased partial expulsions and self-removals are likely associated with the longer string. (C) 2018 Elsevier Inc. All rights reserved.