Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete Novasure endometrial ablation | After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation |
| |
| Incomplete Novasure endometrial ablation | After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hysteroscopy | Device | uterine hysteroscopy right after Novasure endometrial ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of reintervention | Surgical and Medical reintervention | 24 months |
| Dysmennorrhea | Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
- No saved hysteroscopy images or bad quality hysteroscopy images
men can not suffer from heavy menstrual bleeding
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marlies M.Y. Bongers, PhD, MD | Maxima Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Máxima MC | Veldhoven | North Brabant | 5500MB | Netherlands |
Not provided
| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 months |
| Number of patients having controlled bleeding | Pictorial Blood Assessment Chart (PBAC) score less than 75. | 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. | 24 months |
| baseline |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |