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

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01377779
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
17
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxiplex/AP gel
  • Drug: Normal Saline
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Intercoat (Oxiplex/AP Gel) for Preventing Intrauterine Adhesions Following Operative Hysteroscopy for Suspected Retained Products of Conception - a Prospective Randomized Pilot Study
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Nov 1, 2010
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intercoat treatment

women treated by Intercoat gel following hysteroscopy for retained products of conception

Drug: Oxiplex/AP gel
Intrauterine application of Intercoat following hysteroscopy
Other Names:
  • Intercoat

    		•
    Placebo Comparator: Control group

    No additional treatment following hysteroscopy was performed

    Drug: Normal Saline
    No intrauterine application of Intercoat following hysteroscopy
    Other Names:
  • Distention media

    		•

    Outcome Measures

    Primary Outcome Measures

    1. safety of intrauterine application of Intercoat [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

    Secondary Outcome Measures

    1. efficacy of intrauterine application of Intercoat gel in reducing adhesion formation following hysteroscopic treatment for retained products of conception [14 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age between 18 and 50 years

    • Availability of the results of vaginal ultrasound or diagnostic hysteroscopy

    Exclusion Criteria:

    • Signs of infection upon admission

    • Ongoing pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asaf Harofe MC Zerifin Israel 70300

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    • Principal Investigator: Moty Pansky, MD, Asaf Harofe MC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01377779
    Other Study ID Numbers:
    • 2*13/09
    First Posted:
    Jun 21, 2011
    Last Update Posted:
    Jun 21, 2011
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    Oxiplex/AP gel
    Prevention of Asherman's syndrome
    Intra uterine adhesions
    Additional relevant MeSH terms:
    Gynatresia
    Tissue Adhesions

    Study Results

    No Results Posted as of Jun 21, 2011