Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Endometrial Ablation

Menorrhagia Clinical Trial

Official title:

Autocrosslinked Hyaluronic Acid Gel in Prevention of Intrauterine Adhesions After Bipolar Radiofrequency Endometrial Ablation: a Randomised, Controlled and Double Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829451
• Other study ID #: Uoulu
• Status: Completed
• Phase: N/A
• First received: March 14, 2013
• Last updated: April 10, 2013
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 52 Years

Eligibility

Inclusion Criteria:

• menorrhagia

Exclusion Criteria:

• abnormal uterine cavity,

• abnormal endometrial biopsy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Menorrhagia

Intervention

Other:
• Hyaluronic acid gel
Hyaluronic acid gel is placed into the uterus after endometrial ablation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months	No