Treatment of women with heavy menstrual bleeding: Results of a prospective cohort study alongside a randomised controlled trial
European Journal of Obstetrics & Gynecology and Reproductive Biology Dec 13, 2020
Beelen P, van der Velde MGAM, Herman MC, et al. - In this study, the reintervention rate of women who opted for treatment was compared with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. The difference in reintervention rate between women in this observational cohort and women who were randomized was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a randomized controlled trial (RCT). Researchers performed an observational cohort study alongside a multicentre RCT between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. In the analysis, 276 women were included in the observational cohort: 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. In comparison with women who receive endometrial ablation, women who receive an LNG-IUS are more likely to undergo an additional intervention. In the cohort and RCT population, the reintervention rates of women were comparable. The outcomes of this research endorse the data of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding.
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