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Active, Not Recruiting

NCT Number: NCT06122363

Impact of Incomplete Endometrial Ablation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heavy Menstrual Bleeding Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Menorrhagia Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Diseases Uterine Hemorrhage

Sex eligibility

Female

Study type

Observational

Primary location

Máxima MC

Veldhoven, North Brabant, 5500MB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysteroscopy

Device

uterine hysteroscopy right after Novasure endometrial ablation

Primary outcomes

  1. Pictorial Blood Assessment Chart (PBAC) score

    Time frame: 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 outcomes

  1. Rate of reintervention

    Time frame: 24 months

    Surgical and Medical reintervention

  2. Dysmennorrhea

    Time frame: 24 months

    Presence of dysmennorrhea. Categorized as absence, mild, moderate and severe.

  3. Number of patients having controlled bleeding

    Time frame: 24 months

    Pictorial Blood Assessment Chart (PBAC) score less than 75.

  4. Satisfaction of the patient with the treatment

    Time frame: 24 months

    Satisfaction measured with a 5-point Likert scale. 1=very unsatisfied, 2= unsatisfied, 3= neutraal, 4= satisfied, 5= very satisfied.

Other outcomes

  1. Number of possible prognostic variables predicting the occurrence of incomplete endometrial ablation.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Maxima Medical Center

Other

Registry information

Official study title

The Impact of Incomplete Endometrial Ablation on the Success Rate of Novasure Endometrial Ablation

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2023
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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