Impact of Incomplete Endometrial Ablation

NCT ID: NCT06122363

Last Updated: 2025-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Heavy Menstrual Bleeding

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Complete Novasure endometrial ablation

After treatment with novasure, the hysteroscopy showed no remains of endometrium, , so a complete novasure endomentrial ablation

hysteroscopy

Intervention Type DEVICE

uterine hysteroscopy right after Novasure endometrial ablation

Incomplete Novasure endometrial ablation

After treatment with novasure, the hysteroscopy showed remains of endometrium, so an incomplete novasure endomentrial ablation

hysteroscopy

Intervention Type DEVICE

uterine hysteroscopy right after Novasure endometrial ablation

Interventions

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hysteroscopy

uterine hysteroscopy right after Novasure endometrial ablation

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maxima Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Danique Roelen

Medical student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlies M.Y. Bongers, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Maxima Medical Center

Locations

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Máxima MC

Veldhoven, North Brabant, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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Incomplete Novasure ablation

Identifier Type: -

Identifier Source: org_study_id

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