Expulsions and Adverse Events Following Immediate and Later Insertion of a Levonorgestrel-releasing Intrauterine System After Medical Termination of Late First- and Second-trimester Pregnancy: a Randomised Controlled Trial
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Objectives: To compare expulsions and adverse events (AEs) between immediate and delayed insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) following medical termination of pregnancy (MTOP).
Design: Randomised controlled trial.
Setting: Helsinki University Hospital, Finland, January 2013-December 2014.
Population: Cohorts of 102 (gestational age 64-84 days, late first trimester) and 57 (gestational age 85-140 days, second trimester) women requesting MTOP and LNG-IUS contraception.
Methods: LNG-IUS insertion occurred immediately (same day) or 2-4 weeks following MTOP. Follow-up visits were at 2-4 weeks, 3 months, and 1 year.
Main Outcome Measures: LNG-IUS expulsion by 3 months and 1 year. AEs and bleeding profiles within 3 months.
Results: Following late first-trimester MTOP the LNG-IUS expulsion rates by 3 months were 14 (27.5%) in the immediate-insertion group and two (4.0%) in the delayed-insertion group (risk ratio, RR 6.86; 95% confidence interval, 95% CI 1.64-28.66). By 1 year the expulsion rates were 17 (33.3%) and six (12.0%) (RR 2.78, 95% CI 1.19-6.47). Following second-trimester MTOP LNG-IUS expulsion rates by 3 months and 1 year were five (18.5%) in the immediate-insertion group and one (3.6%) in the delayed-insertion group (RR 5.19, 95% CI 0.65-41.54). No differences in AEs and bleeding profiles emerged between the groups.
Conclusions: Immediate LNG-IUS insertion after late first- or second-trimester MTOP is feasible, does not increase the complication rate, or alter the uterine bleeding patterns; however, immediate insertion increased the expulsion rate, which may limit the cost-effectiveness.
Tweetable Abstract: Immediate insertion of LNG-IUS following MTOP at 9-20 weeks of gestation is feasible and safe.
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