Postplacental placement of intrauterine devices: A randomized clinical trial

Objective: To compare the expulsion rate of the TCu380A intrauterine device (IUD) or levonorgestrel (LNG) 52 mg intrauterine system (IUS) up to 90 days after postplacental placement (10 min after delivery of the placenta). Study design: Randomized trial (1:1) of women aged 18-43 years and >= 37 weeks pregnant enrolled during early or prodromal labor at the University of Campinas, Brazil. Follow-up was scheduled at 42 and 90 days after device placement. We confirmed the IUD or IUS location using ultrasonography. Multivariate logistic regression was used to assess variables associated with expulsion. Results: We enrolled 140 women, and assigned 70 to the TCu380A IUD and 70 to the IUS groups. By the 90-day follow-up visit, 22/60 women (36.7%) in the TCu380A IUD group had expelled the device, as had 12/60 women in the IUS group (20%). Thirty-three of the 34 expulsions had occurred by the 42-day visit. Multivariate analysis demonstrated that the expulsion odds ratio ([OR]; 95% confidence interval [CI]) was higher after vaginal delivery than after Cesarean delivery (OR 5.60; 95% CI 2.08-15.10; P < 0.00) and higher among women with one (OR 4.38; 95% CI 1.33-14.43: P 0.00) or three or more deliveries (including the present one) (OR 6.08; 95% CI 1.78-20.77; P 0.00) than those with two deliveries. Conclusions: Postplacental TCu380A IUD placement had a higher expulsion rate than the IUS, and the expulsion rate was higher among women who had a vaginal delivery than those who had a Cesarean delivery. Most of the expulsions occurred within 42 days. (C) 2019 Elsevier Inc. All rights reserved.