Back to resultsHyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
Primary Purpose
Menorrhagia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Hyaluronic acid gel
Sponsored by
About this trial
This is an interventional prevention trial for Menorrhagia
Eligibility Criteria
Inclusion Criteria:
- menorrhagia
Exclusion Criteria:
- abnormal uterine cavity,
- abnormal endometrial biopsy
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hyaluronic acid gel
No hyaluronic acid gel
Arm Description
Hyaluronic acid gel is placed into the uterus after endometrial ablation
An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure
Outcomes
Primary Outcome Measures
prevention of intrauterine adhesion formation
The effect of hyaluronic acid gel on the formation of intrauterine adhesions after endometrial thermal ablation is assessed in an outpatient hysteroscopy after 3 months. Classification of intrauterine adhesions has been created for this study specifically.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01829451
Brief Title
Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
Official Title
Autocrosslinked Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Bipolar Radiofrequency Endometrial Ablation: a Randomised, Controlled and Double Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid gel
Arm Type
Experimental
Arm Description
Hyaluronic acid gel is placed into the uterus after endometrial ablation
Arm Title
No hyaluronic acid gel
Arm Type
Placebo Comparator
Arm Description
An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid gel
Intervention Description
Hyaluronic acid gel is placed into the uterus after endometrial ablation
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Primary Outcome Measure Information:
Title
prevention of intrauterine adhesion formation
Description
The effect of hyaluronic acid gel on the formation of intrauterine adhesions after endometrial thermal ablation is assessed in an outpatient hysteroscopy after 3 months. Classification of intrauterine adhesions has been created for this study specifically.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
menorrhagia
Exclusion Criteria:
abnormal uterine cavity,
abnormal endometrial biopsy
12. IPD Sharing Statement
Learn more about this trial
Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
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