Clinical Question

What changes in vaginal bleeding can women expect after the placement of a levonorgestrel-releasing intrauterine system (52 mg; Mirena or Liletta)?

Bottom Line

Bleeding decreased over time for most women after the insertion of a levonorgestrel-releasing intrauterine system. Bleeding or spotting requiring the use of sanitary products occurred for a mean of 36 of the first 90 days after insertion and then decreased markedly for most women (to means of 19, 14, and 12 days in the three succeeding 90-day periods, respectively). Days of frank bleeding were fewer on average, with means of 13, eight, six, and five days in each of the four 90-day periods after insertion. (Level of Evidence = 2a)

Synopsis

This systematic review and meta-analysis was conducted for the stated purpose of providing information to help clinicians counsel patients about what to expect regarding vaginal bleeding after the placement of a levonorgestrel-releasing intrauterine system. The authors identified seven studies, four randomized controlled trials, two cohort studies, and one reanalysis of randomized controlled trial data, that met the inclusion criteria with a total of 5,098 participants from 10 countries. Included studies reported outcomes of interest for women with a history of normal menstrual periods for at least 90 days after the placement of the levonorgestrel-releasing intrauterine system according to bleeding diaries. Bleeding outcomes were the number of bleeding and/or spotting days based on World Health Organization definitions. The authors excluded studies if the study population was women with heavy or prolonged menstrual periods, who were actively breastfeeding, who used long-acting contraception methods within six months before placement, or who had anatomic pathologies (such as fibroids or cancer). The authors extracted mean or median days of bleeding only, spotting only, and bleeding and/or spotting in 90-day intervals for the year after placement. They found that bleeding decreased markedly after the first 90-day interval. For bleeding and/or spotting, the results over succeeding periods were 35.6 days (95% CI, 32.2 to 39.1), 19.1 days (95% CI, 16.1 to 21.5), 14.2 days (95% CI, 11.7 to 16.8), and 11.7 days (95% CI, 9.7 to 13.7). The results for bleeding-only days were 13.3 days (95% CI, 10.8 to 15.7), 7.8 days (95% CI, 6.5 to 9.1), 6.2 days (95% CI, 4.9 to 7.5), and 5.0 days (95% CI, 3.9 to 6.1), respectively, for the four 90-day periods. The authors conducted several sensitivity analyses to account for heterogeneity between studies, which did not materially change the findings.

Study design: Meta-analysis (other)

Funding source: Government

Setting: Outpatient (specialty)

Reference: Maldonado LY, Sergison JE, Gao X, et al. Menstrual bleeding and spotting with the levonorgestrel intrauterine system (52 mg) during the first-year after insertion: a systematic review and meta-analysis. Am J Obstet Gynecol. 2020;222(5):451–468.e9.