Effectiveness, safety and overall satisfaction of early postpartum placement of hormonal IUD compared with standard procedure : An open-label, randomized, multicenter study

Introduction In this open-label, randomized controlled, non-inferiority, multicenter study we aimed to study the risk of termination of pregnancy within 1 year postpartum, the safety profile and patient acceptability after early postpartum insertion of a hormonal intrauterine device (LNG-IUS, Mirena (R)) compared with standard placement 6-8 weeks postpartum. Material and methods April 2018 to January 2020 women with uncomplicated vaginal delivery at four urban birth centers in Sweden, were randomized to either early placement within 48 h after delivery (early group) or standard placement 6-8 weeks postpartum (standard group) of a hormonal intrauterine device. The main outcome measure was the proportion of terminations of pregnancies in each group during the first year after placement of the intrauterine device. Registration EudraCT database no. 2017-001945-29. Results The study was prematurely stopped according to the protocol due to an expulsion rate >20% in the early group. No pregnancies occurred. Fifty-two women were randomized to early and 49 women to standard insertion. In the early group, 23/52 (44.2%) of the intrauterine devices were expelled. After expulsion, 10 women chose to have another hormonal intrauterine device placed but still significantly fewer women (39/52, 75%, p = 0.22) in the early group used the hormonal intrauterine device method at study completion. No expulsions occurred in the standard group, but 5/49 (10.2%) requested removal and 41/49 (83.7%, p = 0.22) had used the hormonal intrauterine device method continuously for 1 year. Conclusions Early hormonal intrauterine device insertion after vaginal delivery is associated with high expulsion rates. Despite this, a high continuation rate of the hormonal intrauterine device method is seen among women once choosing the method. In the light of high continuation rates, the advantages of early insertion could balance the risk of expulsion for well-informed women.Funding Agencies|County Council of Ostergotland (ALF) [LIO-931995, LIO-794921]