Treatment of women with heavy menstrual bleeding: Results of a prospective cohort study alongside a randomised controlled trial

P. Beelen*, M.G.A.M. van der Velde, M.C. Herman, P.M. Geomini, M.J. van den Brink, R.G. Duijnhoven, M.Y. Bongers

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective: The objective of this study was to compare the reintervention rate of women who opted for treatment with the levonorgestrel-releasing intrauterine system (LNG-IUS) to women who opted for endometrial ablation. Furthermore, the difference in reintervention rate between women in this observational cohort and women who were randomised was compared, with the hypothesis that women who actively decide on treatment have lower reintervention rates compared to women in a RCT.Study design: An observational cohort study alongside a multicentre randomised controlled trial (RCT) was conducted between April 2012 and January 2016, with a follow-up time of 24 months, in 26 hospitals and nearby general practices in the Netherlands. Women suffering from heavy menstrual bleeding, aged 34 years and older, without intracavitary pathology and without a future fertility desire, were eligible for this trial. Women who declined randomisation were asked to participate in the observational cohort. The outcome measure was reintervention rate at 24 months of follow-up.Results: 276 women were followed in the observational cohort of which 87 women preferred an initial treatment with LNG-IUS and 189 women preferred an initial treatment with endometrial ablation. At 24 months of follow-up women in the LNG-IUS-group were more likely to receive a reintervention compared to the women in the ablation group, 28/81 (35 %) versus 25/178 (14 %) (aRR 2.42, CI 1.47-3.98, p-value 0.001). No differences in reintervention rates were found between women in the observational cohort and women in the RCT.Conclusions: Women who receive an LNG-IUS are more likely to undergo an additional intervention compared to women who receive endometrial ablation. Reintervention rates of women in the cohort and RCT population were comparable. The results of this study endorse the findings of the RCT and will contribute to shared decision making in women with heavy menstrual bleeding. (C) 2020 Elsevier B.V. All rights reserved.
Original languageEnglish
Pages (from-to)1-5
Number of pages5
JournalEuropean Journal of Obstetrics & Gynecology and Reproductive Biology
Volume257
DOIs
Publication statusPublished - 1 Feb 2021

Keywords

  • bipolar
  • endometrial ablation
  • heavy menstrual bleeding
  • hysterectomy
  • levonorgestrel intrauterine system
  • menorrhagia
  • preferences
  • reintervention
  • thermal balloon ablation
  • MENORRHAGIA
  • Reintervention
  • Heavy menstrual bleeding
  • LEVONORGESTREL INTRAUTERINE SYSTEM
  • HYSTERECTOMY
  • BIPOLAR
  • THERMAL BALLOON ABLATION
  • PREFERENCES
  • Endometrial ablation
  • Levonorgestrel intrauterine system
  • ENDOMETRIAL ABLATION

Cite this