Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
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ClinicalTrials.gov Identifier: NCT01829451 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
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Sponsor:
University of Oulu
Information provided by (Responsible Party):
University of Oulu
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Brief Summary:
The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menorrhagia | Other: Hyaluronic acid gel | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Autocrosslinked Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Bipolar Radiofrequency Endometrial Ablation: a Randomised, Controlled and Double Blind Study |
Study Start Date : | January 2011 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | August 2012 |
Arm | Intervention/treatment |
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Experimental: Hyaluronic acid gel
Hyaluronic acid gel is placed into the uterus after endometrial ablation
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Other: Hyaluronic acid gel
Hyaluronic acid gel is placed into the uterus after endometrial ablation -------------------------------------------------------------------------------- |
Placebo Comparator: No hyaluronic acid gel
An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure
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Primary Outcome Measures :
- prevention of intrauterine adhesion formation [ Time Frame: 3 months ]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.
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Ages Eligible for Study: | 35 Years to 52 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- menorrhagia
Exclusion Criteria:
- abnormal uterine cavity,
- abnormal endometrial biopsy
No Contacts or Locations Provided
Responsible Party: | University of Oulu |
ClinicalTrials.gov Identifier: | NCT01829451 |
Other Study ID Numbers: |
Uoulu |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | April 11, 2013 |
Last Verified: | April 2013 |
Additional relevant MeSH terms:
Menorrhagia Pathologic Processes Uterine Hemorrhage Uterine Diseases Hemorrhage Menstruation Disturbances |
Hyaluronic Acid Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Viscosupplements Protective Agents |