An observational study in Heavy Menstrual Bleeding, sponsored by Maxima Medical Center. Active, not recruiting at 1 site in Netherlands. Open to female participants. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Maxima Medical Center · Observational
The aim of the proposed protocol is to study the impact of incomplete endometrial ablation on the PBAC score, reintervention, satisfaction, controlled bleeding and dysmenorrhea at 24 months after Novasure endometrial ablation, in women with heavy menstrual bleeding treated at Máxima Medical Centre Veldhoven, in The Netherlands.
The primary outcome is blood loss at 24 months after treatment, measured with the PBAC-score according to Higham. To calculate this score women were asked, in the MIRA and MIRA2 study, to record their menstrual blood loss for one month counting the number of super tampons or pads used each day. The total score was calculated using a score of 1 for each lightly saturated tampons. For pads the scores were respectively 1, 5 and 20. Secondary outcome measures were controlled bleeding, defined as a PBAC-score not exceeding 75 points, PBAC score of zero, re-intervention rate 24 months after treatment, satisfaction with treatment (measured with a 5-point Likert scale) and dysmenorrhea.
In addition, multiple variables were analyzed in predicting the occurrence of incomplete endometrial ablation, including age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization. Information was collected from EPD and the MIRA and MIRA2 databases.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's planned enrollment of 121 is below the median of 300 across 41 observational studies indexed under Menorrhagia.
Browse Menorrhagia studies →Maxima Medical Center is the lead sponsor of 28 studies on the registry; 15 are open to participants now.
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This retrospective cohort study was carried out using the data of women who participated in the MIRA study and the MIRA2 study including RCT and prospective cohort database. These women have given informed consent for their data to be used for future research into treatments for heavy menstrual bleeding. To be eligible for study inclusion, women had to suffer from heavy menstrual bleeding, and have undergone Novasure endometrial ablation at Máxima MC between January 2012 and July 2023. Women were excluded from the database if the hysteroscopy images were not saved, or these images were of poor quality.
Exclusion Criteria:
After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation
Device: hysteroscopy
After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation
Device: hysteroscopy
uterine hysteroscopy right after Novasure endometrial ablation
Pictorial Blood Assessment Chart (PBAC) score
Blood loss of 1 month, measured by the number of needed tampons/pads and how heavily they are filled with blood. The higher the score, the more severe blood loss. From 150 points the amount is defined as heavy menstrual bleeding.
Time frame: 24 months
Rate of reintervention
Surgical and Medical reintervention
Time frame: 24 months
Dysmennorrhea
Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe.
Time frame: 24 months
Number of patients having controlled bleeding
Pictorial Blood Assessment Chart (PBAC) score less than 75.
Time frame: 24 months
Satisfaction of the patient with the treatment
Satisfaction measured with a 5-point Likert scale. 1=very unsatisfied, 2= unsatisfied, 3= neutraal, 4= satisfied, 5= very satisfied.
Time frame: 24 months
Number of possible prognostic variables predicting the occurrence of incomplete endometrial ablation.
Age, BMI, cavum length, cavum width, ablation time, ablation power, nulliparity, sterilization in history, section caesarea in history, position of the uterus (AVF/RVF), presence of myomas, the presence of adenomyosis and surgery under local anesthesia, generally without sterilization or generally in combination with sterilization
Time frame: baseline
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Maxima Medical Center