Clinical Trial: Efficiency of Intercoat (Oxiplex/AP Gel)in Decreasing Intrauterine Adhesions

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study

Brief Summary: This is a prospective single blind randomized controlled pilot study was designed to investigate whether the biological barrier Intercoat (Oxiplex/AP gel) reduces formation of intrauterine adhesions following hysteroscopic treatment for retained products of conception.

Detailed Summary: Thirty women randomly divided equally into those who received Intercoat following hysteroscopic treatment for retained products of conception (study group) and those who did not receive the gel (controls). Safety and efficacy of the preparation were evaluated.
Sponsor: Assaf-Harofeh Medical Center

Current Primary Outcome: safety of intrauterine application of Intercoat [ Time Frame: 18 months ]

women treated by Intercoat following their hysteroscopic procedure were followed for immediate and late adverse effects; fever, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern


Original Primary Outcome: Same as current

Current Secondary Outcome: efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception [ Time Frame: 14 months ]

intrauterine adhesions were graded according to the AFS score upon hysteroscopic follow up 6-8 weeks following initial treatment


Original Secondary Outcome: Same as current

Information By: Assaf-Harofeh Medical Center

Dates:
Date Received: June 15, 2011
Date Started: September 2009
Date Completion:
Last Updated: June 20, 2011
Last Verified: July 2009