INTRODUCTION: Our objectives were to compare the 1-year follow-up clinical performance of the TCu380A intrauterine device (TCu380A-IUD) and levonorgestrel (LNG) 52-mg intrauterine system (IUS) inserted at post-placental period. MATERIAL AND METHODS: We conducted an open-label, parallel-group, randomized clinical trial, 1:1 with pregnant women admitted for childbirth independently of the mode of birth. Our primary outcome was expulsion up to 1 year after device placement by type of IUD and mode of delivery. During the follow up (42, 90 and 365 days (±7 days) after device placement), an ultrasound was performed to evaluate the device position. Kaplan-Meier with log-rank test was used to compare the survival curves of the TCu380A IUD and the LNG IUS. Couple-Years of Protection after insertion of both devices was calculated. RESULTS:One hundred and forty women were randomized to the TCu380A IUD (n = 70) or the LNG IUS (n = 70). By the end of the first year after device placement, 38 women experienced device expulsion (27.1%), most of them (33/38; 86.8%) within the first 42 days after delivery. The expulsions were significantly higher among users of TCu380A IUD (39.4%) than among users of the LNG IUS (22.2%; P = .039), and among those with vaginal delivery (43.8%) than among women with cesarean delivery (15%; P = .003). The 1-year cumulative continuation rate was 64.2%, significantly higher for LNG IUS (73.1%) than for TCu380A IUD (54.4%; P = .03), and among women with cesarean delivery (77.6%) than for vaginal delivery (52%; P = .00). The post-placental IUD insertion provided 356.4 Couple-Years of Protection. CONCLUSIONS: Two-thirds of women who accepted a post-placental IUD placement still used the device 1 year after childbirth. However, expulsion was the most prevalent reason for discontinuation, mainly within 42 days after device placement. The expulsion rate was significantly higher among TCu380A IUD users and among women with vaginal delivery.
RCT Entities:
INTRODUCTION: Our objectives were to compare the 1-year follow-up clinical performance of the TCu380A intrauterine device (TCu380A-IUD) and levonorgestrel (LNG) 52-mg intrauterine system (IUS) inserted at post-placental period. MATERIAL AND METHODS: We conducted an open-label, parallel-group, randomized clinical trial, 1:1 with pregnant women admitted for childbirth independently of the mode of birth. Our primary outcome was expulsion up to 1 year after device placement by type of IUD and mode of delivery. During the follow up (42, 90 and 365 days (±7 days) after device placement), an ultrasound was performed to evaluate the device position. Kaplan-Meier with log-rank test was used to compare the survival curves of the TCu380A IUD and the LNG IUS. Couple-Years of Protection after insertion of both devices was calculated. RESULTS: One hundred and forty women were randomized to the TCu380A IUD (n = 70) or the LNG IUS (n = 70). By the end of the first year after device placement, 38 women experienced device expulsion (27.1%), most of them (33/38; 86.8%) within the first 42 days after delivery. The expulsions were significantly higher among users of TCu380A IUD (39.4%) than among users of the LNG IUS (22.2%; P = .039), and among those with vaginal delivery (43.8%) than among women with cesarean delivery (15%; P = .003). The 1-year cumulative continuation rate was 64.2%, significantly higher for LNG IUS (73.1%) than for TCu380A IUD (54.4%; P = .03), and among women with cesarean delivery (77.6%) than for vaginal delivery (52%; P = .00). The post-placental IUD insertion provided 356.4 Couple-Years of Protection. CONCLUSIONS: Two-thirds of women who accepted a post-placental IUD placement still used the device 1 year after childbirth. However, expulsion was the most prevalent reason for discontinuation, mainly within 42 days after device placement. The expulsion rate was significantly higher among TCu380A IUD users and among women with vaginal delivery.
Authors: Mary Anne Armstrong; Tina Raine-Bennett; Susan D Reed; Jennifer Gatz; Darios Getahun; Juliane Schoendorf; Debbie Postlethwaite; Michael J Fassett; Jeffrey F Peipert; Catherine W Saltus; Maqdooda Merchant; Amy Alabaster; Xiaolei Zhou; Laura Ichikawa; Jiaxiao M Shi; Vicki Y Chiu; Fagen Xie; Shannon Hunter; Jinyi Wang; Mary E Ritchey; Giulia Chillemi; Theresa M Im; Harpreet S Takhar; Federica Pisa; Alex Asiimwe; Mary S Anthony Journal: JAMA Netw Open Date: 2022-02-01