Treatment of women with heavy menstrual bleeding: Results of a prospective cohort study alongside a randomised controlled trial
| Autor: | Marian J van den Brink, Marlies Y. Bongers, Marleen G A M van der Velde, Peggy M.A.J. Geomini, Pleun Beelen, Malou C. Herman, Ruben G. Duijnhoven |
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| Přispěvatelé: | RS: GROW - R4 - Reproductive and Perinatal Medicine, Obstetrie & Gynaecologie, MUMC+: MA Medische Staf Obstetrie Gynaecologie (9), Obstetrics and Gynaecology, APH - Methodology |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Adult
medicine.medical_specialty medicine.medical_treatment BIPOLAR Population MENORRHAGIA Reintervention Levonorgestrel PREFERENCES law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law medicine Contraceptive Agents Female Humans 030212 general & internal medicine Prospective cohort study education Endometrial ablation Endometrial Ablation Techniques Netherlands education.field_of_study 030219 obstetrics & reproductive medicine Hysterectomy Obstetrics business.industry Heavy menstrual bleeding Intrauterine Devices Medicated Obstetrics and Gynecology Reproductive Medicine Cohort THERMAL BALLOON ABLATION HYSTERECTOMY Observational study Female business Cohort study Levonorgestrel intrauterine system |
| Zdroj: | European Journal of Obstetrics, Gynecology, and Reproductive Biology, 257, 1-5. ELSEVIER SCIENCE BV European Journal of Obstetrics & Gynecology and Reproductive Biology, 257, 1-5. Elsevier European Journal of Obstetrics and Gynecology and Reproductive Biology, 257, 1-5. Elsevier Ireland Ltd |
| ISSN: | 0301-2115 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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