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Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829451
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
University of Oulu

Study Description
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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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hyaluronic acid gel
Hyaluronic acid gel is placed into the uterus after endometrial ablation
 Other: Hyaluronic acid gel

Hyaluronic acid gel is placed into the uterus after endometrial ablation

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Placebo Comparator: No hyaluronic acid gel
An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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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:
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Menorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Hemorrhage
Menstruation Disturbances
 Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents