Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation
Sponsor
University of Oulu (Other)
Overall Status
Completed
CT.gov ID
NCT01829451
Collaborator
(none)
32
2
19
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Jan 1, 2011
Actual Primary Completion Date
:
Apr 1, 2012
Actual Study Completion Date
:
Aug 1, 2012
Arms and Interventions
| 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
--------------------------------------------------------------------------------
|
| Placebo Comparator: No hyaluronic acid gel An empty Pipelle device is taken into the uterus after endometrial ablation as an placebo procedure |
Outcome Measures
Primary Outcome Measures
- prevention of intrauterine adhesion formation [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
Criteria
Ages Eligible for Study:
35 Years
to 52 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- menorrhagia
Exclusion Criteria:
-
abnormal uterine cavity,
-
abnormal endometrial biopsy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Oulu
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Oulu
ClinicalTrials.gov Identifier:
NCT01829451
Other Study ID Numbers:
- Uoulu
First Posted:
Apr 11, 2013
Last Update Posted:
Apr 11, 2013
Last Verified:
Apr 1, 2013