Heavy Menstrual Bleeding
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEhysteroscopy
uterine hysteroscopy right after Novasure endometrial ablation
Sponsors
Maxima Medical Center
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Endometrial ablation between 2012 and 2023 in Máxima Medical Centre * Women had to suffer from heavy menstrual bleeding
Exclusion criteria
\- No saved hysteroscopy images or bad quality hysteroscopy images
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pictorial Blood Assessment Chart (PBAC) score | 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of reintervention | 24 months | Surgical and Medical reintervention |
| Dysmennorrhea | 24 months | Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe. |
| Number of patients having controlled bleeding | 24 months | Pictorial Blood Assessment Chart (PBAC) score less than 75. |
| Satisfaction of the patient with the treatment | 24 months | Satisfaction measured with a 5-point Likert scale. 1=very unsatisfied, 2= unsatisfied, 3= neutraal, 4= satisfied, 5= very satisfied. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of possible prognostic variables predicting the occurrence of incomplete endometrial ablation. | baseline | 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 |
Countries
Netherlands
Outcome results
None listed