Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the uterus linked with HMB. The investigators aim to recruit approximately 130 participants across two study sites over three years, including people with and without HMB.
18-45
Having Periods
Currently pregnant or breastfeeding.
Known uterine malignancy, severe anaemia requiring urgent treatment, or other acute gynaecological emergencies.
Inability to undergo MRI (e.g., pacemaker, severe claustrophobia).
Inability to provide informed consent.
Participants will be recruited from in and around Hampshire with the ability to attend Southampton General Hospital for appointments. They will be recruited from both within hospital settings but also the community as many women suffer with HMB without seeking support.
Cohort
Prospective
Not listed
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
Frequency of uterine contractions quantified from cine MRI sequences and compared between participants with heavy menstrual bleeding and controls.
Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
Dominant frequency (Hz) of uterine bioelectrical signals recorded using wearable pelvic surface electrodes and analysed using frequency-domain methods.
Acceptability of wearing device (usability score)
Participant-reported usability and acceptability assessed using a structured usability questionnaire developed for this study, comprising 9 items with ordinal response scales. Responses will be assigned numerical values and summed to generate a composite usability score (range 9-36, with higher scores indicating greater acceptability).
Molecular markers in endometrial biopsy sample
Quantification of molecular biomarkers in endometrial biopsy tissue using histological and molecular analysis techniques (units dependent on biomarker, e.g., pg/mg tissue).
Molecular markers in vaginal swab samples
Measurement of molecular markers from vaginal swabs using laboratory-based assays.
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University Hospital Southampton NHS Foundation Trust
Lead sponsor
University of Auckland, New Zealand
Collaborator
