ABSTRACT
Preliminary data and clinical experience have suggested an increased risk of abnormal uterine bleeding (AUB) in women of reproductive age treated with anticoagulants, but solid data are lacking. The TEAM-VTE study was an international multicenter prospective cohort study in women aged 18 to 50 years diagnosed with acute venous thromboembolism (VTE). Menstrual blood loss was measured by pictorial blood loss assessment charts at baseline for the last menstrual cycle before VTE diagnosis and prospectively for each cycle during 3 to 6 months of follow-up. AUB was defined as an increased score on the pictorial blood loss assessment chart (>100 or >150) or self-reported AUB. AUB-related quality of life (QoL) was assessed at baseline and the end of follow-up using the Menstrual Bleeding Questionnaire. The study was terminated early because of slow recruitment attributable to the COVID-19 pandemic. Of the 98 women, 65 (66%) met at least one of the 3 definitions of AUB during follow-up (95% confidence interval [CI], 57%-75%). AUB occurred in 60% of women (36 of 60) without AUB before VTE diagnosis (new-onset AUB; 95% CI, 47%-71%). Overall, QoL decreased over time, with a mean Menstrual Bleeding Questionnaire score increase of 5.1 points (95% CI, 2.2-7.9), but this decrease in QoL was observed only among women with new-onset AUB. To conclude, 2 of every 3 women who start anticoagulation for acute VTE experience AUB, with a considerable negative impact on QoL. These findings should be a call to action to increase awareness and provide evidence-based strategies to prevent and treat AUB in this setting. This was an academic study registered at www.clinicaltrials.gov as #NCT04748393; no funding was received.
Subject(s)
COVID-19 , Venous Thromboembolism , Humans , Female , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology , Venous Thromboembolism/complications , Quality of Life , Incidence , Prospective Studies , Pandemics , Uterine Hemorrhage/chemically induced , Uterine Hemorrhage/epidemiology , COVID-19/complications , Anticoagulants/adverse effectsABSTRACT
Déclaration de liens d’intérêts: Liens d’intérêts sur les 5 dernières années : • investigateur d’essais thérapeutiques financés ou co-financés par : Bayer, BMS-Pfizer, Daichii-Sankyo, Leo-Pharma;• invité à des congrès par : Aspen, Bayer, BMS-Pfizer, Leo-Pharma;• orateur dans des symposiums financés ou co-financés par : Aspen, Bayer, BMS-Pfizer, Leo-Pharma, Sanofi.
ABSTRACT
Déclaration de liens d’intérêts: Les auteurs déclarent ne pas avoir de liens d’intérêts.