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 ]
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 ]
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